This document provides guidance on technical documentation and design dossiers for non-active medical devices. It discusses the differences between technical documentation used for class I, IIa, and IIb devices, and design dossiers used for class III devices. Technical documentation is retained by the manufacturer or authorized representative, while design dossiers must be submitted to a notified body for review prior to CE marking. The document outlines the structure and required contents for technical documentation and design dossiers, including essential requirements checklists, risk analysis documentation, drawings and specifications, preclinical test reports, and more. Proper documentation helps ensure compliance and allows for efficient review.
Infeksi Nosokomial atau Healthcare Associated Infections (HAIs) pjj_kemenkes
Dokumen tersebut membahas tentang infeksi nosokomial atau infeksi yang didapatkan selama dirawat di rumah sakit. Angka kejadian infeksi nosokomial cukup tinggi, sekitar 5-10% dari seluruh pasien rawat inap. Faktor-faktor yang mempengaruhi terjadinya antara lain kondisi tubuh pasien, jenis agen infeksi, kontak dengan sumber infeksi, dan penggunaan alat medis seperti kateter. Dampaknya ber
Ringkasan dari dokumen tersebut adalah:
1. Dokumen tersebut merangkum 7 langkah menuju keselamatan pasien di fasilitas kesehatan.
2. Langkah-langkah tersebut meliputi membangun kesadaran akan nilai keselamatan pasien, memimpin dan mendukung staf, mengintegrasikan pengelolaan risiko, mengembangkan sistem pelaporan, melibatkan pasien, belajar dari pengalaman, dan mencegah cedera.
Dokumen tersebut membahas tentang dokumentasi asuhan keperawatan infeksi. Dibahas mengenai definisi infeksi, rantai infeksi yang terdiri dari agens infeksius, reservoar, portal keluar, cara penularan, portal masuk, dan pejamu yang rentan. Juga dibahas mengenai proses infeksi, jenis-jenis infeksi, pertahanan tubuh terhadap infeksi, dan infeksi nosokomial.
Stres dan adaptasi merupakan topik utama dokumen tersebut. Dokumen tersebut menjelaskan bahwa stres dapat berasal dari sumber internal maupun eksternal dan dapat memengaruhi seseorang secara fisiologis maupun psikologis. Adaptasi adalah proses dimana seseorang berusaha menyesuaikan diri dengan stresor tersebut, yang dapat berupa adaptasi morfologi, fisiologi, atau tingkah laku. Dokumen tersebut jug
Infeksi Nosokomial atau Healthcare Associated Infections (HAIs) pjj_kemenkes
Dokumen tersebut membahas tentang infeksi nosokomial atau infeksi yang didapatkan selama dirawat di rumah sakit. Angka kejadian infeksi nosokomial cukup tinggi, sekitar 5-10% dari seluruh pasien rawat inap. Faktor-faktor yang mempengaruhi terjadinya antara lain kondisi tubuh pasien, jenis agen infeksi, kontak dengan sumber infeksi, dan penggunaan alat medis seperti kateter. Dampaknya ber
Ringkasan dari dokumen tersebut adalah:
1. Dokumen tersebut merangkum 7 langkah menuju keselamatan pasien di fasilitas kesehatan.
2. Langkah-langkah tersebut meliputi membangun kesadaran akan nilai keselamatan pasien, memimpin dan mendukung staf, mengintegrasikan pengelolaan risiko, mengembangkan sistem pelaporan, melibatkan pasien, belajar dari pengalaman, dan mencegah cedera.
Dokumen tersebut membahas tentang dokumentasi asuhan keperawatan infeksi. Dibahas mengenai definisi infeksi, rantai infeksi yang terdiri dari agens infeksius, reservoar, portal keluar, cara penularan, portal masuk, dan pejamu yang rentan. Juga dibahas mengenai proses infeksi, jenis-jenis infeksi, pertahanan tubuh terhadap infeksi, dan infeksi nosokomial.
Stres dan adaptasi merupakan topik utama dokumen tersebut. Dokumen tersebut menjelaskan bahwa stres dapat berasal dari sumber internal maupun eksternal dan dapat memengaruhi seseorang secara fisiologis maupun psikologis. Adaptasi adalah proses dimana seseorang berusaha menyesuaikan diri dengan stresor tersebut, yang dapat berupa adaptasi morfologi, fisiologi, atau tingkah laku. Dokumen tersebut jug
Makalah ini membahas tentang hernia nukleus pulposus (HNP) yang merupakan kondisi dimana bantalan lunak antara tulang belakang mengalami tekanan dan pecah sehingga menekan saraf tulang belakang dan menyebabkan nyeri. Makalah ini menjelaskan anatomi, etiologi, patofisiologi, manifestasi klinis, komplikasi, diagnosis, dan penatalaksanaan HNP.
Blueprint merupakan pedoman umum untuk mengembangkan ujian kompetensi perawat. Tujuannya adalah untuk memastikan bahwa perawat baru memiliki kompetensi yang dibutuhkan untuk melindungi masyarakat dan menjalankan praktik dengan aman dan efektif. Dokumen ini membahas tentang domain dan tingkat kompetensi apa saja yang akan diujikan beserta contoh penentuan jumlah soal berdasarkan blueprin
1. Laporan pendahuluan ini membahas tentang HIV/AIDS, meliputi pengertian, etiologi, cara penularan, patofisiologis, tanda dan gejala, manifestasi klinis, komplikasi, pemeriksaan diagnostik, dan penatalaksanaan medisnya.
Dokumen ini membahas tentang penyakit myelitis, yaitu peradangan pada medula spinalis. Beberapa penyebab myelitis adalah antigen viral, penyakit autoimun seperti lupus eritematosus sistemik dan sindrom Sjogren, sarcoidosis, malformasi arteriovena spinal dan aterosklerosis. Gejala-gejala myelitis meliputi nyeri akut, hilangnya sensorik, paralisis ekstermitas, gangguan eliminasi urin, disfungsi kandung kemih dan B
Dokumen tersebut membahas tentang fasilitas dan peralatan yang wajib ada di ICU, meliputi ruangan, sarana prasarana, dan peralatan. Ruangan ICU harus memiliki fasilitas dasar seperti resusitasi jantung paru, pengelolaan jalur nafas, pemantauan EKG berkelanjutan, dan kemampuan melakukan terapi lanjutan. Sarana prasarana minimal mencakup lokasi dekat unit darurat, desain yang baik, area pasien dan kerja
Dokumen tersebut membahas tentang teori-teori sikap, komponennya, jenis-jenis teori sikap, persuasi sebagai upaya mengubah sikap orang lain, dan hubungan antara sikap dengan perilaku.
1. Karsinoma tulang adalah pertumbuhan sel ganas abnormal pada tulang dan jaringan terkaitnya.
2. Penyebabnya belum jelas tetapi kemungkinan termasuk genetik, radiasi, bahan kimia, dan trauma.
3. Gejalanya berupa nyeri tulang, bengkak, dan fraktur patologis yang dapat menyebar ke organ lain.
Teori Interaksi Simbolik berfokus pada pentingnya makna dalam perilaku manusia, pembentukan makna melalui interaksi sosial, dan hubungan antara individu dan masyarakat. Teori ini menekankan bahwa manusia bertindak berdasarkan makna, makna terbentuk melalui interaksi, dan konsep diri mempengaruhi perilaku. Teori ini digunakan untuk memahami bagaimana manusia membangun identitas melalui interaksi sosial.
Dokumen tersebut membahas etika dan isu-isu dalam keperawatan bencana. Isu-isu tersebut meliputi pencatatan dan pelaporan penyakit, informasi kesehatan, karantina, isolasi, vaksinasi, pengobatan penyakit, pemeriksaan dan pengujian, lisensi profesional, alokasi sumber daya, tanggung jawab profesional, dan penyediaan perawatan yang memadai. Dokumen tersebut juga membahas analisis risiko benc
Dokumen tersebut membahas tentang surveilans kesehatan masyarakat, termasuk definisi, tujuan, dan jenis-jenis surveilans. Surveilans dilakukan untuk mengumpulkan, menganalisis, dan menyebarkan informasi kesehatan secara terus-menerus guna mendukung pengambilan keputusan dalam pencegahan penyakit. Terdapat beberapa jenis surveilans seperti surveilans individu, penyakit, sindromik, berbasis
Dokumen tersebut membahas laporan pendahuluan keperawatan jiwa mengenai perubahan proses pikiran berupa waham. Laporan ini menjelaskan pengertian, penyebab, gejala, akibat, dan rencana tindakan keperawatan untuk menangani masalah tersebut seperti meningkatkan hubungan saling percaya, menghadirkan realitas, serta meningkatkan harga diri dan kemampuan klien.
Analisa kebutuhan tenaga keperawatan di rumah sakitRahayoe Ningtyas
Dokumen tersebut membahas beberapa metode untuk menganalisis kebutuhan tenaga keperawatan di rumah sakit, termasuk metode rasio, Gillies, dan standar Depkes. Metode-metode tersebut mempertimbangkan faktor seperti tingkat ketergantungan pasien, jumlah pasien, dan jam perawatan yang dibutuhkan."
BSI British Standards' presentation of EU Medical Devices Directive M5 Amendment 93 42 EEC regulatory updates.
Presented at the HKTDC Hong Kong International Medical Devices and Supplies Fair 2009.
By Jan van Lochem, Gert Bos and Suzanne Halliday.
Seminar “Regulatory update on medical devices in Asia and EU”.
It covers the revision of the EU medical device directive, implementation of the revised directive, the key changes, changes to clinical requirements, introduction of technical file sampling, and the impact revision on technical or design dossiers.
Makalah ini membahas tentang hernia nukleus pulposus (HNP) yang merupakan kondisi dimana bantalan lunak antara tulang belakang mengalami tekanan dan pecah sehingga menekan saraf tulang belakang dan menyebabkan nyeri. Makalah ini menjelaskan anatomi, etiologi, patofisiologi, manifestasi klinis, komplikasi, diagnosis, dan penatalaksanaan HNP.
Blueprint merupakan pedoman umum untuk mengembangkan ujian kompetensi perawat. Tujuannya adalah untuk memastikan bahwa perawat baru memiliki kompetensi yang dibutuhkan untuk melindungi masyarakat dan menjalankan praktik dengan aman dan efektif. Dokumen ini membahas tentang domain dan tingkat kompetensi apa saja yang akan diujikan beserta contoh penentuan jumlah soal berdasarkan blueprin
1. Laporan pendahuluan ini membahas tentang HIV/AIDS, meliputi pengertian, etiologi, cara penularan, patofisiologis, tanda dan gejala, manifestasi klinis, komplikasi, pemeriksaan diagnostik, dan penatalaksanaan medisnya.
Dokumen ini membahas tentang penyakit myelitis, yaitu peradangan pada medula spinalis. Beberapa penyebab myelitis adalah antigen viral, penyakit autoimun seperti lupus eritematosus sistemik dan sindrom Sjogren, sarcoidosis, malformasi arteriovena spinal dan aterosklerosis. Gejala-gejala myelitis meliputi nyeri akut, hilangnya sensorik, paralisis ekstermitas, gangguan eliminasi urin, disfungsi kandung kemih dan B
Dokumen tersebut membahas tentang fasilitas dan peralatan yang wajib ada di ICU, meliputi ruangan, sarana prasarana, dan peralatan. Ruangan ICU harus memiliki fasilitas dasar seperti resusitasi jantung paru, pengelolaan jalur nafas, pemantauan EKG berkelanjutan, dan kemampuan melakukan terapi lanjutan. Sarana prasarana minimal mencakup lokasi dekat unit darurat, desain yang baik, area pasien dan kerja
Dokumen tersebut membahas tentang teori-teori sikap, komponennya, jenis-jenis teori sikap, persuasi sebagai upaya mengubah sikap orang lain, dan hubungan antara sikap dengan perilaku.
1. Karsinoma tulang adalah pertumbuhan sel ganas abnormal pada tulang dan jaringan terkaitnya.
2. Penyebabnya belum jelas tetapi kemungkinan termasuk genetik, radiasi, bahan kimia, dan trauma.
3. Gejalanya berupa nyeri tulang, bengkak, dan fraktur patologis yang dapat menyebar ke organ lain.
Teori Interaksi Simbolik berfokus pada pentingnya makna dalam perilaku manusia, pembentukan makna melalui interaksi sosial, dan hubungan antara individu dan masyarakat. Teori ini menekankan bahwa manusia bertindak berdasarkan makna, makna terbentuk melalui interaksi, dan konsep diri mempengaruhi perilaku. Teori ini digunakan untuk memahami bagaimana manusia membangun identitas melalui interaksi sosial.
Dokumen tersebut membahas etika dan isu-isu dalam keperawatan bencana. Isu-isu tersebut meliputi pencatatan dan pelaporan penyakit, informasi kesehatan, karantina, isolasi, vaksinasi, pengobatan penyakit, pemeriksaan dan pengujian, lisensi profesional, alokasi sumber daya, tanggung jawab profesional, dan penyediaan perawatan yang memadai. Dokumen tersebut juga membahas analisis risiko benc
Dokumen tersebut membahas tentang surveilans kesehatan masyarakat, termasuk definisi, tujuan, dan jenis-jenis surveilans. Surveilans dilakukan untuk mengumpulkan, menganalisis, dan menyebarkan informasi kesehatan secara terus-menerus guna mendukung pengambilan keputusan dalam pencegahan penyakit. Terdapat beberapa jenis surveilans seperti surveilans individu, penyakit, sindromik, berbasis
Dokumen tersebut membahas laporan pendahuluan keperawatan jiwa mengenai perubahan proses pikiran berupa waham. Laporan ini menjelaskan pengertian, penyebab, gejala, akibat, dan rencana tindakan keperawatan untuk menangani masalah tersebut seperti meningkatkan hubungan saling percaya, menghadirkan realitas, serta meningkatkan harga diri dan kemampuan klien.
Analisa kebutuhan tenaga keperawatan di rumah sakitRahayoe Ningtyas
Dokumen tersebut membahas beberapa metode untuk menganalisis kebutuhan tenaga keperawatan di rumah sakit, termasuk metode rasio, Gillies, dan standar Depkes. Metode-metode tersebut mempertimbangkan faktor seperti tingkat ketergantungan pasien, jumlah pasien, dan jam perawatan yang dibutuhkan."
BSI British Standards' presentation of EU Medical Devices Directive M5 Amendment 93 42 EEC regulatory updates.
Presented at the HKTDC Hong Kong International Medical Devices and Supplies Fair 2009.
By Jan van Lochem, Gert Bos and Suzanne Halliday.
Seminar “Regulatory update on medical devices in Asia and EU”.
It covers the revision of the EU medical device directive, implementation of the revised directive, the key changes, changes to clinical requirements, introduction of technical file sampling, and the impact revision on technical or design dossiers.
The document outlines the key quality, technical, and business issues to consider when upgrading part of a manufacturing facility while maintaining production in the remaining area, including obtaining regulatory acceptance of upgrade plans, conducting risk analysis, ensuring containment and preventing cross-contamination, requalifying and validating equipment and software, and managing costs, timelines, and documentation.
Prioritizing Documentation for MDR Transition PlanningGreenlight Guru
This session will discuss the one year delay of the MDR date of application as well as some strategies to employ during the MDR Transition. In addition, some approaches for determining documents to prioritize for the transition will be discussed.
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
This document provides a checklist for auditing sterilization processes using ethylene oxide according to ISO 11135-1. The checklist covers quality management systems, sterilizing agent characterization, process and equipment characterization, product definition, process definition, and validation. It includes questions to evaluate whether requirements for documentation, responsibilities, purchasing, calibration, nonconforming products, sterilizing agent specifications, process parameters, equipment specifications, product safety and microbiological quality are fulfilled. The goal is to examine if ISO 11135-1 requirements are met to ensure satisfactory sterilization with ethylene oxide.
3.I Qualification of premises and air conditioning (HVAC) systems.docxSamehMostafa33
The document discusses the qualification of premises and HVAC systems in pharmaceutical facilities. It addresses the objectives of qualification, which are to systematically and documentedly prove that premises and systems are suitable for their intended use and compliant with GMP requirements. Qualification helps ensure products are manufactured safely and reproducibly. The document outlines regulatory requirements and discusses the different stages of qualification - design, installation, operational, and performance qualification. It emphasizes the importance of thorough design qualification to identify issues early on and control costs.
C5 eCTD Summit: Electronic submissions and the new Variations Regulationseront
GlaxoSmithKline Biologicals submitted the first worksharing variation in Europe to manage changes for 21 products using a single submission. This allowed them to use a single application form, cover letter, and data package rather than submitting variations for each product individually. However, managing worksharing submissions required more coordination between GSK and regulatory authorities. While it saved resources for GSK to prepare a single dossier, it did not necessarily reduce authorities' workload as they still had to assess each product. Communication with local operating companies in other countries was also important to ensure worksharing was implemented correctly.
Supplement 7- Annex9- WHO guideline: Qualification of temperature controlled storage areas
Technical supplement to WHO Technical Report Series, No. 961, 2011 Annex 9: Model guidance for the storage and transport of time and temperature–sensitive pharmaceutical products
USE OF ETAGs AS EADs FOR EUROPEAN TECHNICAL ASSESSMENTs
The concept “fitness for use” disappeared from the CPR
In general, the ETAG technical information is applicable but information linked to the CPD clauses and terms is not
Conditions, a part from those influencing the performance(s) of the product(s), or recommendations can not be included in the ETA (EC)
Threshold values as such can only be used if agreed to with EC
The ETA is the base to be used by the manufacturer for preparing the DoP
Responsibilities, role, tasks or information already stated in the legal bases must not be repeated (EC)
MDR- Significant changes in the design and intended purposeAntonio Bartolozzi
1. The document discusses significant changes in medical device software design and intended purpose according to the Medical Device Regulation (MDR). It notes that software changes that modify algorithms, database structures, operating platforms, architecture, user interfaces, or interoperability channels require a new UDI.
2. Guidance is provided on assessing whether software changes are significant based on factors like performance, safety, intended use, and data interpretation. Examples are given of specifying performance and safety tolerances.
3. Tips are provided like documenting intended use clearly and reviewing risk analysis documents after changes affecting data interpretation or certain software modifications.
If you are developing a medical device, you will need to become familiar with Design Controls. 21 CFR 820.30 states that every class III and class II medical device manufacturer “shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met”. Design controls are an essential part of any medical device’s quality system since they link user needs, design inputs, design outputs, design verification, and design validation to show proof of safety and effectiveness...
This document provides explanatory notes for pharmaceutical manufacturers on preparing a Site Master File. It includes guidelines on the content that should be included in a Site Master File, such as: general information on the manufacturer including contact details and manufacturing authorizations; description of the quality management system; information on product release procedures, management of suppliers and contractors, quality risk management processes, and personnel. The document also provides a revision history and references regulatory requirements related to Site Master Files.
This document provides explanatory notes for pharmaceutical manufacturers on preparing a Site Master File. It discusses the purpose and scope of a Site Master File, and provides guidance on the content that should be included. A Site Master File is intended to provide regulatory authorities with clear information on a manufacturer's GMP-related activities to aid inspections. It should contain details on quality management, personnel, premises, equipment, production, quality control, distribution of products, and complaints and product recalls. Appendices may include manufacturing authorizations, lists of products and suppliers, and organization charts.
The dossier is a collection of documents that contain all the technical data of pharmaceutical products to be approved\ registered\ marketed in a country.
Guidance for Industry on Providing Regulatory Information in eCTD Format Cláudio Carneiro
This document provides guidance for submitting regulatory information to Swissmedic in electronic Common Technical Document (eCTD) format. It outlines the structure and technical requirements for eCTD submissions, including file naming conventions and metadata standards. The guidance also covers life cycle management of eCTD submissions and special considerations for periodic safety update reports and risk management plan updates. It aims to harmonize electronic submissions with International Conference on Harmonization guidelines and allow Swissmedic to accept fully electronic applications.
The document outlines the requirements and expectations for a chemical plant design project. It includes sections on the project scope, required deliverables, evaluation criteria, and technical considerations. Students will work in groups of up to 4 people to develop a complete design package for a chemical process. The project is due on December 1st and must include items such as a technology review, heat and material balances, process flow diagrams, equipment specifications, and a cost analysis. Updates on progress must be submitted every two weeks.
AtharBuchheitHussein-A3-EU PLAN REGULATORY STRATEGYScott Buchheit
This 3-page document provides a regulatory strategy for obtaining CE marking and marketing approval for an implantable bone screw in the European Union. It outlines the key deliverables, timelines, and conformity assessment process. The strategy involves obtaining ISO 13485 certification, submitting a technical file including clinical data to a Notified Body for approval, and CE marking once all requirements are met to allow marketing in EU countries.
This document provides an overview and outline of a Standard Operating Procedure (SOP) for filing a Clinical Trial Application (CTA) to Health Canada. The SOP aims to facilitate successful CTA filing by providing tools, relevant links and standardized procedures. It discusses the contents and modules of a CTA, including an introduction, project charter, scope, stakeholders, types of clinical trials, application outline, quality management, standard operating procedures, and records. The overall goal is to create an SOP that guides CTA preparation and avoids discrepancies with Health Canada requirements.
This document discusses functional safety standards and how to determine safety integrity levels and performance levels for machine safety. It provides an overview of key standards including IEC 61508, IEC 62061, ISO 13849-1, ISO 12100 and the Machinery Directive. The document uses an example of a robot cell to demonstrate applying a risk assessment process and decomposing safety functions to determine the required performance level for the safety control system based on ISO 13849-1.
The document discusses current functional safety standards for machinery, specifically ISO 13849-1 and IEC 62061. It notes that while both standards have similar basic requirements, there are differences in detail. It is intended that the standards will be combined into a single standard, ISO/IEC 17305. The presentation will explain techniques for complying with the current standards in preparation for the new single standard. It discusses key aspects of ISO 13849-1 and IEC 62061 such as performance levels, safety integrity levels, and requirements for realization and verification of safety functions. Checklists are also provided.
This document provides an overview of key concepts from IEC/EN 61508, the international standard for functional safety of electrical, electronic, and programmable electronic safety-related systems. It introduces safety life cycles, risk assessment, safety integrity levels (SIL), probability of failure calculations, and different system architectures. The document contains examples to illustrate these concepts and clarify technical terms defined in the standard.
This document provides an introduction to functional safety for machinery. It defines functional safety and explains that it involves ensuring automatic actions occur to reach a safe state. The document discusses relevant functional safety standards like ISO 13849 and IEC 61508. It also examines functional safety concepts like risk assessments, safety integrity levels, safety elements involving structure, reliability, diagnostics and systematic capability. The document uses an example safety circuit diagram to demonstrate functional safety concepts like input channel fault detection.
This document discusses machine safety and achieving regulatory compliance. It provides an overview of a training session that will discuss identifying and addressing safety concerns based on new global standards. The session agenda includes discussing safety functional requirements, the risk assessment process, the concept of risk, an overview of the evolution of safety standards, and the safety life cycle. The document provides background on how new functional safety standards like ISO 13849-1 and IEC 62061 evaluate safety systems based on their performance rather than categories, and the transition from the old EN954 standard. It also explains the risk assessment process and how it is used to identify hazards, estimate risks, and iteratively reduce risks to an acceptable level to inform the design of safety systems.
This document provides an overview of understanding machinery directives and CE marking requirements in Europe. It discusses:
1) The document aims to provide machine designers, quality managers, and others a roadmap to understanding the Machinery Directive and CE marking process requirements in Europe.
2) It introduces the key elements of the Machinery Directive, standards, risk assessment process, and CE marking steps in an easy-to-understand format.
3) It also provides guidance on safety component selection and application based on risk categories to help ensure machinery meets the essential health and safety requirements outlined in the Machinery Directive.
Type-B standards relate to hazards and aspects of machinery design. They include standards for substances, thermal hazards, fire hazards, electrical hazards, vibration and shock, ergonomics, radiation hazards, noise, dimensions and distances, power sources, safety devices, alarms and warnings, control systems, and assembly of machinery. There are also many Type-C standards that are specific to particular machinery or equipment types.
Rockwell Automation provides tools throughout each phase of the Safety Life Cycle to simplify safety system development and improve compliance. These include Safety Automation Builder for designing safety systems, Safety Functions with complete documented solutions, and SISTEMA for evaluating safety components. Additional tools help with system design, programming, diagnostics, and determining return on investment from safety improvements.
This document provides an overview and comparison of two machinery safety standards: EN 62061 and EN ISO 13849-1. It outlines the basic procedures for complying with machinery directives, including performing a risk assessment. EN 62061 focuses on functional safety for electrical/electronic control systems, using Safety Integrity Levels (SILs). EN ISO 13849-1 applies to all machinery and determines Performance Levels (PLs) based on factors like categories and probability of failure. The document provides details on how each standard specifies safety parameters and calculations for achieving the required safety level.
This document provides an overview of regulations and standards for safety related control systems for machinery in Europe, the US, and Canada. It discusses the key EU Machinery Directive and regulations regarding essential health and safety requirements, standards, risk assessment, protective measures, safety distance calculation, prevention of unexpected startup, functional safety, system design according to standards, and application examples.
The document is a user manual for the DriveGuard Safe Torque Off option for PowerFlex 40P and 70 drives. It provides descriptions of:
- What the Safe Torque Off option is and how it works to inhibit torque generation in motors connected to the drives.
- Certifications for safety performance levels that the option achieves when used with the drives.
- Important safety considerations for using the option in safety applications.
- Requirements to achieve Safety Category 3 / Performance Level d certification.
- Operating principles and examples of connection configurations.
This document provides an overview of machinery safety standards and regulations. It discusses the key concepts in three areas:
1) Legal framework - It outlines the Machinery Directive and Work Equipment Directive which establish health and safety requirements for machinery in Europe. It also discusses the role of harmonized standards in establishing conformity.
2) Standards structure - European machinery safety standards are divided into three types: A) general standards, B) standards on specific safety aspects or safeguards, and C) machine-specific standards.
3) Manufacturer/user responsibilities - Manufacturers placing machinery on the EU market must comply with the Machinery Directive, while users must ensure purchased machines are CE marked and safe to use according to instructions.
The document discusses categories for safety-related parts of control systems as defined in EN 954-1. It describes five categories (B, 1, 2, 3, 4) that represent classifications based on the parts' ability to withstand faults and their behavior if faults occur. Higher categories signify greater fault tolerance and ability to ensure safety functions. Category B has the lowest requirements, while category 4 can withstand single or accumulated unobserved faults to prevent loss of safety functions. The categories are intended to reduce risk from machinery by measures at the control system level.
This document summarizes key aspects of ISO 13849-1, an international machinery safety standard that addresses control systems. It discusses factors like redundancy, component quality, and wiring configuration that impact safety. While intended to introduce reliability calculations, ISO 13849-1 has proven complex to implement in practice. The document advises safety professionals to understand the standard's basics to make informed decisions about control system safety that optimize resources for the greatest safety benefits.
The document discusses the replacement of the EN 954-1 standard for safety-related control systems with the new EN ISO 13849-1:2006 standard. It notes that EN ISO 13849-1:2006 introduces probabilistic considerations in addition to the previous deterministic approach. There is a transition period until November 2009, after which conflicting standards must be withdrawn. The document provides an overview of the key aspects and changes introduced in EN ISO 13849-1:2006, such as new risk assessment methods, designated architectures, and validation requirements.
The European standard EN 954-1 for evaluating safety-related machine components will be replaced by the international standard EN ISO 13849-1:2006. This new standard is better suited for modern machine control technologies. It is important to prepare for this change as acceptance in the competitive market will increase and evaluation testing can take several months. TUV Rheinland offers specialized testing and certification services according to relevant safety standards, including B10d testing to determine component reliability parameters, which provides a qualified test report and safety marks if desired. B10d testing involves concurrently testing sample components under load to determine the number of cycles until 10% fail, from which the mean time to dangerous failure can be estimated.
A review on techniques and modelling methodologies used for checking electrom...nooriasukmaningtyas
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1. Guidance Technical Documentation and
Design Dossiers forNon Active Medical Devices
TÜV SÜD PRODUCT SERVICE GMBH Page 1 of 25
Whereas the term “Technical Documentation or Technical File“ is used for
medical devices of class I, class IIa and class IIb, the term “Design Dossier“ is
used for the class III products.
Technical Documentation are retained in the premises of the manufacturer or the
Authorized Representative for potential review of Competent Authorities and Noti-
fied Body. Part B of the Technical File may be available at the manufacturer only.
Whereas Design Dossiers have to be submitted to the Notified Body for review
prior to CE-Marking of the product (use form MDD Application for CE Conformity Assessment
MED_F_03.15; http://www.tuev-sued.de/industry-and-consumer-products/download-
center/applications). We will assign a project coordinator who will entrust one or more further
experts with the review of particular modules. All experts are at your disposal directly or indi-
rectly through the project coordinator. After successful review, the Notified Body issues a design
examination certificate according to Annex II.4 of the Council Directive certifying compliance
with the relevant provisions of Annex I of the MDD.
Article 5 of the Council Directive describes consideration of the European harmonized stan-
dards by the manufacturer in order to demonstrate compliance with the Essential Requirements.
This aspect is even more important as International Standard Organizations have adopted
European Norms (and vice versa) and demonstrating compliance with these standards could be
very helpful in international mutual recognition of the CE-Marking process.
It is not necessary to include all documents in the Design Dossier which have already been sub-
ject to an ISO / EN / MDD Audit by the Notified Body. Examples of documents not necessary to
be included are Quality Manuals and related lower level documents.
If the manufacturer of a medical device provides detailed information according to the checklist
described below, the requirements of the Directive are appropriately addressed.
This is even more important in case a Competent Authority or another Notified Body wishes to
review the documentation.
Generally, the information should be provided as conclusions, summaries, reports, tables or
flow charts (with reference to the full documentation in the Essential Requirement checklist).
Special care should be taken to ensure that any information is consistent throughout the
Technical File/Design Dossier (e.g. Intended Use in product description, Information for Use,
Risk Management file, Clinical Evaluation Report, etc.).
A complete pagination of the Technical File/Design Dossier or another type of control mecha-
nism is necessary, e.g. revision control of each section. A hard copy of the documentation and
an electronic version are required to achieve an appropriate review time.
In general, design changes described in the MDD (93/42/EEC as amended by 2007/47/EC),
Annex II.4.4 shall be reported to the Notified Body. Please use form MDD Application + Appen-
dix D Change Notification (http://www.tuev-sued.de/industry-and-consumer-products/download-
center/applications) in order to ensure conformity with the requirements defined in the Annex
2. TÜV SÜD PRODUCT SERVICE GMBH Page 2 of 25
II.4.4 and in order to ensure that the Design Dossiers retained at the Notified
Body’s archive are complete and up-to-date.
Furthermore at least one sample of the device should be provided.
For all data SI units of measurement shall be used.
Important hint: Technical Documentation/Design Dossiers that accurately
conform to the below guidance can be reviewed more efficiently!
In this regard it is recommended to compile a Design Dossier or Technical File as follows
(see also NB-MED/2.5.1 and GHTF document SG1 (PD)/N011R20: STED):
PART A: Technical Documentation / Design Dossier
1. Table of Content
2. Introduction
3. Design Dossier/Technical Documentation Summary Information
PART B: Annexes
1. Essential Requirements Checklist
2. Risk Analysis
3. Drawings, Design -, Product - Specifications
4. Chemical, Physical and Biological Tests
4.1 In Vitro Testing - Preclinical Studies
4.2 In Vivo Testing - Preclinical Studies
4.3 Biocompatibility Tests
4.4 Bio-stability Tests
4.5 Microbiological Safety, Animal Origin Tissue
4.6 Drug / medical device combination
4.7 Blood Derivates, Human Tissue / medical device combination
4.8 Coated Medical Devices
5. Clinical Data
6. Labels and Instructions for Use
7. Manufacturing
8. Package Qualification and Shelf life
9. Sterilization
10. Measuring Function
11. Combination with other Medical Devices
12. Compatibility to drugs
13. Other applicable directives and regulations
14. Conclusion
15. Declaration of Conformity (Draft)
3. TÜV SÜD PRODUCT SERVICE GMBH Page 3 of 25
PART A: Technical Documentation / Design Dossier
1. Table of Content
Content of both Parts A and B
2. Introduction
o Revision history of Technical Documentation / Design Dossier: change no-
tifications, revision numbers and approvals of all documents including all amendments.
o Regulatory Information:
o Name, postal address, Notified Body, certifications (valid copies attached!) of:
the manufacturer (incl. contact person)
OEM and critical component suppliers, subcontractors for outsourced critical
processes (e.g. contract sterilizer)
European Representative (if applicable)
o Product and accessory classification, rule according to MDD, Annex IX (including
bullet point chosen) and classification according to EN ISO 10993-1 Annex A.1
o Conformity Assessment Route chosen
o UMDNS- and/or GMDN-code
o Product History: approvals (e.g. FDA 510(k) or PMA clearance), market release,
status of any pending request for market clearance; items sold, countries in which
product is marketed.
o Brief description of the product:
o Intended use, model names, configurations, variants
o Accessories for the product, integral parts of package
o Applied standards (list or table including the full title, identifying numbers, date, and
the organization that created the standard)
Note: Please make sure to use current standards only or provide a gap analysis
and rationale
o Rationale if applicable standards or parts thereof have not been considered
o Brief description of the development process:
o Name, postal address of Design Centre
o Certification status of Design Centre
o Flowchart of the development process or process description (e.g. SOP)
o Design Input / Output, Design Control, Design Verification, Design Validation
3. Design Dossier / Technical Documentation Summary Information (reference to
supporting documents filed in Part B)
o Comprehensive description of the system and each functional component of the device
and the related accessories including utilized material or ingredient (animal/human ori-
gin, drug device combination), packaging, method of sterilization, shelf life, combination
with active medical devices. The description should be supported by diagrams, photo-
graphs or drawings, as appropriate.
o Basic scientific concepts that form the fundamentals for the device including medical,
biological, chemical, and physical background information
o In case of a Change Notification: description of all changes in comparison with the pre-
vious design or manufacturing process (e.g. tabular format considering all chap-
ters/modules of the list of contents on page 2)
o Summary of the essential data and results as detailed in Part B
o Information as provided in the Instructions / Directions for Use/ Manual (detailed in sec-
tion B): Intended Use, Indications, Contraindications, Warnings, Adverse events, Opera-
tion and use of accessories
o Planned changes
o Summary description of manufacturing process (including a clear description of inter-
faces to outsourced processes involved)
o Any other important safety/performance related information.
4. TÜV SÜD PRODUCT SERVICE GMBH Page 4 of 25
This structure enables efficient project planning and management. Part A can
be used for a pre-review in order to instantly notify the manufacturer of open
issues or in case particular aspects are not covered in the Design Dossier.
5. TÜV SÜD PRODUCT SERVICE GMBH Page 5 of 25
PART B: Annexes
1. Essential Requirements Checklist
Example:
E.R. applicability all applied
standards (with
date of issue)
compliance
demonstrated by
(referenced documents)
location -
section
7.1
(text)
yes EN ISO 10993
-1:2009
-5:2009
etc.
laboratory test reports:
- cytotoxicity (report num-
ber and date)
Section 6.1
a) b) c)
See also Attachment I: European Norms and Standards and other Documents support-
ing Technical Documentation and Design Dossiers.
2. Risk Analysis
The document (Risk Management File) which describes the result of the risk manage-
ment (including risk analysis, evaluation, mitigation and overall residual risk evaluation
and production/post production information see EN ISO 14971 fig. B1 for an overview)
process should contain at least the following information:
2.1 General information
o Summary
o Purpose of the document including all project phase(s) / life cycle phase(s) for
which the risk analysis was performed and reviewed Scope (e.g. design/product,
manufacturing process, user/operation); product identification and description; in-
tended use, shelf life.
o Risk Management SOP and Risk Management Plan
o Reference to: Risk Management Policy, standards (EN ISO 14971, EN ISO 22442
part 1 -3 strongly recommended), specification documents, design documents,
procedures, protocols, reports, manufacturing and production process information
o Definition of terms, abbreviations and acronyms
o Participants of the risk analysis team (persons and organisations), their qualifica-
tion, responsibility and authority.
o Note: the Risk Analysis shall include a medical knowledgeable and experienced
expert in the corresponding field of application.
o Note: The Risk Analysis in relation to Biocompatibility shall include a knowledge-
able and experienced expert in the corresponding field of biocompatibility testing.
o Note: The Risk Management Plan according to EN ISO 14971 -especially in rela-
tion to risk acceptance criteria- has to be defined by the top management under
consideration of the estimated production volume to be sold per year and under
consideration of regulatory requirements.
o Identification of medical device characteristics that could impact on safety, e.g. ac-
cording to EN ISO 14971.
o If applicable consideration of data obtained from literature review, usability testing,
market surveillance of similar devices, post market surveillance or post market
clinical follow-up (also related to e.g. change notifications, predicate or otherwise
comparable devices): complaint history, incidents per number of devices sold,
analysis of underlying causes and final outcome, corrective and preventive action
including proof of effectiveness
o Note: in case part of manufacturing is outsourced, still the risk analysis of the out-
sourced production step needs to be provided.
o Revision history
6. TÜV SÜD PRODUCT SERVICE GMBH Page 6 of 25
o Methodology
o Hazards / hazardous situations in normal condition: Hazard
Analysis; patient/user related (top-down approach), e.g. Fault Tree
Analysis, table format
Clinical experience and clinical risks
Method for identification of applicable hazards; sources of infor-
mation used
Method for determination of the potential causes of hazards; sources of infor-
mation used
System used for categorization of severity levels (e.g. examples); description
of consequences to patients, users and other persons
System used for categorization of occurrence of each hazard cause (probabil-
ity estimate, frequency expressed as e.g. ‘events per device and time’)
Method for combination of severity and occurrence to risk level (e.g. diagram,
graph, formula)
Criteria for risk acceptance (e.g. acceptable, unacceptable) under considera-
tion of the risk management plan and accumulated risks
Note: If residual risks remain in ALARP region a rational is required to sub-
stantiate that no further mitigation was possible according to risk control option
analysis.
o Hazards / hazardous situations in fault condition: e.g. FMEA; device related
(bottom-up approach)
Method for identification of applicable failure modes; sources of information
used
Method for determination of the potential causes of failure modes; sources of
information used
System used for categorization of severity levels; description of consequences
to patients, users and other persons
System used for categorization of occurrence of each failure mode (probability
estimate, frequency expressed as e.g. ‘events per device and time’)
System used for categorization of detectability of each failure mode (criteria
for detectability, frequency of in-process testing: 100%, sampling, or no testing
i.e. validated process)
Method for combination of severity, occurrence and detectability to risk level
under consideration of the risk definition (see EN ISO 14971, e.g. diagram,
graph, formula)
Criteria for risk acceptability (e.g. acceptable, unacceptable) under considera-
tion of the risk management plan and under consideration of accumulated
risks
Note: If residual risks remain in ALARP region a rational is required to sub-
stantiate that no further mitigation was possible according to risk control option
analysis.
o Result (signed and dated documents): Risk Management Report
o Hazards / hazardous situations in normal condition: list of applicable hazards;
for each hazard (table format in hierarchical structure, if applicable):
List of potential worst case effects (description of consequences to patients,
users and other persons)
List of potential causes of hazards as appropriate
Estimation of risk before mitigation (severity, occurrence, risk) including deci-
sion on acceptability
Definition of risk reduction measures including reference to methods (e.g. de-
sign, testing, manufacturing) and results of verification (implementation and ef-
fectiveness)
Estimation of risk after mitigation (severity, occurrence, risk) including decision
on acceptability under consideration of the risk management plan and under
consideration of accumulated risks
7. TÜV SÜD PRODUCT SERVICE GMBH Page 7 of 25
Risk / benefit weighting under consideration of the state of the art
o Hazards / hazardous situations in fault condition: list of applicable
failure modes; for each failure mode (table format in hierarchical
structure, if applicable):
List of potential failure modes
List of potential worst case effects (description of consequences
to patients, users and other)
List of potential causes of failures (as appropriate)
Estimation of risk before mitigation (severity, occurrence, detectability, risk) in-
cluding decision on acceptability
Definition of risk reduction measures including reference to methods (e.g. de-
sign, testing, manufacturing) and results of verification (implementation and ef-
fectiveness)
Estimation of risk after mitigation (severity, occurrence, detectability, risk) in-
cluding decision on acceptability
Risk / benefit weighting under consideration of the state of the art
o New hazards: Assessment of risks associated with new hazards in normal and
fault condition generated by risk mitigation measures. Corresponding risk reduc-
tion, if applicable
o Final judgment, statement of:
o Completeness of risk evaluation
o Effectiveness of mitigation measures including a link to the verification documents
o Overall acceptability of residual risk
o Signed and dated by the team leader or responsible person
2.2 Usability engineering file
o Documentation according EN /IEC 62366 in relation to the accompanying docu-
ments (IFU, labelling) and use scenario of the medical device
o Comprehensive documentation of usability related risks of the primary operation
functions of the medical device:
o Risk assessment in “normal condition state” acc. 14971 and for foreseeable
misuse in relation to the intended use of the device
o Link from risk management to the usability validation data as evidence for risk
verification
o If applicable: Market data on use errors including:
o Amount product sold and complaints received in relation to usability (may be
link to post market clinical follow up)
o Statement if the design of the device in relation of the marketed design has
changed
o Usability validation documentation including:
o Statement on usability verification of the final design
o Description of worst case scenario and frequent case scenario of the testing
environment and conditions.
o Sampling rationale on amount of users and patients used at validation taking
into account the risk reduction stated in the risk management file (shall reflect
the occurrence reduction due to the defined risk control measure)
o Acceptance criteria for pass or fail of the usability study
o Evidence on competence of the laboratory conducting the study (including im-
partiality of the testing personnel
o Final conclusion and verifiable feedback into the risk management system.
3. Drawings, Design-, Product-Specifications
o Comprehensive description of the product
o Components and materials: complete chemical, biological and physical characterization
o Photographs, Blueprints
8. TÜV SÜD PRODUCT SERVICE GMBH Page 8 of 25
o Functional characteristics and technical performance specifications such as
mechanical, physical, electrical, biological, chemical, sterility, stability,
packaging, transport, storage, combination with other medical devices, ac-
curacy, sensitivity, specificity of measuring and diagnostic devices, reliabil-
ity
o Other important descriptive characteristics not detailed above
o Final product release criteria including reference to verification test / validation
4. Chemical, Physical and Biological Tests
4.1 In Vitro Testing - Preclinical Studies
o In general testing must be conducted to predict the adequacy of device response to
physiological and pathological stresses, undesirable conditions and forces, long-term
use and all known and possible or foreseeable failure modes
o Testing: e.g. visual, chemical, biological, physical/mechanical testing (i.e. tensile
strength, durability, corrosion, fatigue, long term stability), efficacy / performance testing,
simulated use
o Testing shall be performed on finished product (devices from the normal manufacturing
and after sterilization)
o Otherwise, use of semi-finished devices, components, or raw materials must be charac-
terized and justified
o Finite Element Analysis if applicable:
o Drug Compatibility: Interaction between drug and device (e.g. adsorption)
o Test protocols:
o Purpose and objective of testing
o Standard applicability matrix
List or table including the full title, identifying numbers, date, and the organiza-
tion that created the standard
List of all sections
Justification if particular sections are not applicable
Reference to verification test / validation
o Justification if applicable standards or parts thereof are not considered
If other methods, such as internal standards are used, these methods shall be
described in detail
o Accelerated and real time ageing and simulated distribution (package testing) prior
to testing. Otherwise a justification is required
o Conditions of accelerated ageing (formula used to calculate shelf life: e.g. ASTM F
1980)
o For each test:
Parameters to be measured and test description including reference to test
procedure if applicable
Measuring and testing equipment
Calibration arrangements
Acceptance criteria
Number of test samples including sample size rationale
o Test reports:
o Deviations and amendments to the protocols and justification
o Reference to raw data including date, laboratory, location, engineer, testing
equipment (device number and calibration date)
o Statistical analysis
o Interpretation of data and conclusion(s)
o Approval signature(s)
4.2 In Vivo Testing - Preclinical Studies
Pre-clinical animal studies used to support the probability of effectiveness in humans
9. TÜV SÜD PRODUCT SERVICE GMBH Page 9 of 25
o Good Laboratory Practice (GLP Animal Studies)
o Objectives, methodology, rationale for selecting the particular animal model
including transferability to humans and limitations
o Results, analysis (also statistical) of the functional effectiveness and the
device's interactions with animal fluids and tissues
o Pharmacological / pharmacokinetical / toxicological studies i.e. purity, toxic-
ity, ADME (adsorption, distribution, metabolism, elimination studies, LD50)
o Manufacturer's conclusions
4.3 Biological Evaluation
The structured biological evaluation program within the risk management process shall com-
prise the following:
o Biological evaluation plan
o Purpose of the document and all applied standards
o Scope, Description of the medical device
Categorization of the medical device based on EN ISO 10993-1: Table A1 ac-
cording to:
Nature of body contact
Contact duration
(The category defines which effects need to be considered at least)
List of components/materials having direct or indirect body contact:
Properties and characteristics of the finished product
All materials used in the manufacturing process, including auxiliary materi-
als, additives, process contaminants and residues, leachables, degradation
products, other components that do interact with the final product, etc., or
reference to the applicable section of the Design Dossier
Where appropriate, mention suppliers (Note: Re-evaluation is necessary if
source or specification of the materials used change.
Where appropriate, define total surface area contacting the body or body
fluids
Characterize for the materials used chemical/toxicological/physical/ electri-
cal/morphological/mechanical properties
List all known possible biological hazards.
o Description of tested item(s) (finished device, part of device, raw material):
Testing shall be performed on the final product or representative samples
taken from the final product or from materials processed in the same manner
as the final product (if applicable provide LOT/REF. No., etc.)
Rationale for the selection of the sample tested
Statement on the sterile state of the test sample. If the test sample was not
sterilized, a rationale shall be given why sterilization has no influence on bio-
compatibility of the final device
Assign appropriate tests to the biological effects. (Only such tests shall be per-
formed which lead to evident results)
Assure that no residues coming out of packaging may negatively influence the
product performance and safety
o Overview of biological effects to be considered in the biological evaluation:
The selection and evaluation of any material or device intended for use in hu-
mans requires a structured programme of assessment (refer to EN ISO
10993-1 Fig 1)
o Justification for biological effects not considered or tests not performed:
The quality and the extent of documentation as well as the assessment in re-
gard to the intended use determine whether or not biological tests shall be
performed with the final product and to what extent
Biological evaluation may include both a study of relevant experience and ac-
tual testing. Such an evaluation may result in the conclusion that no testing is
10. TÜV SÜD PRODUCT SERVICE GMBH Page 10 of 25
needed if the material has a documented history of use in a
specified role that is equivalent to that of the device under design
Each device should be examined on its own features. Data may
be available from suppliers or in the literature. In this case full
transferability is to be demonstrated. Test systems, test sensitivi-
ty and concentrations used should be taken into consideration
Waiving of tests shall be recorded
o Biocompatibility testing
o Qualification of the test laboratory, i.e. accreditation
o Testing should be conducted according to appropriate good laboratory practices
followed by evaluation by competent informed persons
o For qualitative data: acceptance criteria
o Biocompatibility test reports (copies)
o For qualitative data/results: interpretation
o Positive results – What to do?
Verification of results
Chemical characterization of leachables
Overall interpretation of the biological evaluation of the device
Relevance of clinical use
o Biocompatibility evaluation and summary report
o Review of available toxicity and prior use data for each material/chemical with
body contact (Include where appropriate data on residual contaminants (e.g. cleaning
aids), additives, catalysts, solvents used in the synthesis, sterilization agents and other
processing chemicals, mould release agents, residual monomers, degradation products,
experience from clinical use, etc.)
o Toxicological risk assessment of leachables (EN ISO 10993-17)
o Critical evaluation of the literature review (Annex C)
o Compilation of tests performed in tabular form - Example:
Test
Report No.
Report date.
Result
Cytotoxicity test -
MTT
XY
yyyy-mm-dd
In this study under the given conditions no
substances with significant cytotoxicity (leading
to a cell growth inhibition of more than 30%)
were released from the test item
Further relevant information on the tests:
Test sample (part tested) e.g. catheter shaft or tip, balloon, whole device
Specification (polymer type, supplier, trade name, additives) e.g. PUR,
Pellethane 2363-90A, 20% BaSO4
Status of test material (final product, sterile)
Type of body contact e.g. circulating blood
Contact duration e.g. limited contact duration (≤ 24 h)
Standard/norm e.g. EN ISO 10993-5: 2009
Extract preparation (medium, surface/mass to volume ratio, temperature, time)
Action taken on positive results (see above)
o Compilation of tests performed in addition
o The validity of tests performed according to standards which are meanwhile super-
seded shall be verified by a gap analysis to show whether the product is still in
compliance with the valid (revised/new) standards.
o Overall residual risk/benefit evaluation (Annex B, 2.3)
o Post-production information (Annex B, 2.5)
o Biological evaluation report acc. to Annex B.4:
- summary of the results of the overall evaluation
- confirm that the risk analysis and risk control have been completed
o Final assessment of the data reviewed:
11. TÜV SÜD PRODUCT SERVICE GMBH Page 11 of 25
The documentation should include an appraisal of the toxicological sig-
nificance of the data. This shall be done by a person with experience in
the assessment of the biological safety of medical devices. Suitability of
the materials for the intended use should be judged on the basis that
there is sufficient information to provide a realistic level of assurance
that the risk/benefit ratio is acceptable or toxicological risks are not
higher than those currently deemed acceptable for existing devices.
o Conclusion:
A final statement of the manufacturer is necessary. (The manufacturer might
conclude that in his opinion, based on the submitted documentation, the product safe-
ty is ensured)
o i.a annual biological risk evaluation
4.4 Biostability Tests
Influence of the biological matrix on the device, i.e.
o Surface Stress Cracking on Polymers
o Corrosion of load-bearing metal screws
o Coating Stability
4.5 Microbiological Safety, Animal Origin tissue
Geographical origin and boarding of animals: Species, Country, Herd, Feeding, Age
Origin of material used/nature of starting tissue:
Specified risk material: organ, tissue, body fluid
For TSE-relevant species: If available certificate of suitability of starting materials
with respect to TSE issued by EDQM
Veterinary controls:
Certificate demonstrating conformance with veterinary inspection criteria indicating
that the raw material was fit for human consumption.
Certificate documenting that the applied techniques for stunning and slaughtering
were suitable to avoid cross contamination with specified risk material. (References:
EN ISO 22442-2/SSC guidelines/EC decisions.)
Risk analysis
Risk analysis performed according to EN ISO 14971 and EN ISO 22442-1/-2/-3, includ-
ing immunological, toxicological, and (chemical / liquid) sterilization risks.
Documentation of significant processing steps
A flowchart including the starting material and all intermediate and relevant process pa-
rameters such as temperature, duration, and pH are required.
A detailed description of the manufacturing process including all in-process controls
Procedure for reduction or inactivation of potentially existing infectious agents
Documents on the systematic approach to gather information on new relevant zoo noses
and infectious agents:
A validation study on virus inactivation / elimination including:
A current literature survey on relevant zoo noses
Information on the production step with potential for inactivation
The study protocol (including information on the test article, test organism, rational for
the choice of relevant or model organism, indicator cell, virus titer, test method, controls,
methods for calculating the results, scaling down, interference and cytotoxicity tests)
The final test report
The raw data
12. TÜV SÜD PRODUCT SERVICE GMBH Page 12 of 25
Such a study is dispensable if the inactivation potential of the processing
step under consideration is well established in the scientific literature.
Slaughtering, transport, and handling
Include a statement and respective certificates that requirements of Regu-
lation 1069/2009 are met, that is: A certificate is required that the animals
have received ante and post mortem inspection by a veterinarian and were deemed fit
for human consumption.
Traceability, e.g. a lot-wise documentation of individual animals
Measures adopted to avoid cross-contamination during slaughter, transport, storage and
manufacturing
Combination with other medical devices
Impact on the materials of animal origin
Quantity of raw material per medical product
Raw material required for one daily dose: amount (mass in grams) used for production of the
single unit equivalent to one daily dose.
Possible number of applications of medical device
Number of daily doses
Route of application
Product coming into contact with the central nervous system region, central circulatory system,
damaged/breached skin, mucosal membrane, undamaged skin, etc.
A justification for the use of animal tissues or derivatives in the medical device, including a ra-
tionale for the acceptability of the overall (TSE) risk estimate, the evaluation of alternative mate-
rials, and the expected clinical benefit
Clinical benefit
o Justification for the use of material of animal origin
o Critical discussion of alternatives (e.g. synthetic, allogenic, autologous, or xenogenic ma-
terial from non-TSE-relevant species)
o Unique characteristics of the product under consideration
Source establishments and/or third party suppliers for the animal material used
Documentation of the contractual agreements and the procedures in place with regard to the
auditing of source establishments and/or third party suppliers for the animal material
4.6 Drug / medical device combination
Considerations for the consultation procedure to the competent bodies of the member
states or the EMA regarding the assessment of usefulness and safety applied to a me-
dicinal substance, which is of ancillary purpose, in a drug-device combination.
o Guidance Documents and regulations:
o 2001/83/EC
o 2004/27/EC
o MEDDEV 2. 1/3
o Clinical Safety Data Management ICH E2
o Dose Response Information to Support Drug Registration ICH E4
o Good Clinical Practice ICH E6
o Investigation of Drug Interactions (CPMP/EWP/560/95)
13. TÜV SÜD PRODUCT SERVICE GMBH Page 13 of 25
o The documentation for the drug to be consulted should be provided in CTD
format. A guideline to the contents is to be found in MEDDEV 2.1/3 part B
(see also 4.7)
o Bench Testing:
o Demonstration that the drug and device neither chemically nor physical-
ly interact adversely with each other
o Assessment how application of the drug and drug-carrier to the device may affect its
fatigue and corrosion properties, coating integrity, durability, and any other relevant
product-specific components.
o Pharmacodynamics (proof of concept)
o Non-clinical pharmacokinetic testing:
o In vivo pharmacokinetic studies to quantify the duration of drug exposure.
o Drug concentrations should be measured at the local (tissue), regional (organ), and
systemic levels in animals
o In the case of very small drug doses, time-release profiles usually suffice to demon-
strate safety for human trials
o Determination of the quantity of drug remaining on the device.
o Preclinical toxicity studies: Dosing studies to establish an efficacy margin between the
sub-therapeutic dose and the therapeutic dose, and a safety margin between the thera-
peutic dose and the toxic dose. When polymer of carrier is present, additional controls to
evaluate the carrier alone, without the drug, must be included.
o Clinical testing of the active substance if not an approved medicinal product: Additional
animal toxicity and human Phase I studies are to be expected if the drug component is
not approved.
o Clinical Data:
o Clinical pharmacokinetic testing: Human toxicity Phase I studies are to be expected
to determine the no observed adverse effect level (NOAEL) if the drug component is
not approved
o Confirmatory clinical trials: When the medicinal substance of the combination is
known to the competent authority and already registered in the setting of a DES and
the applicant claims comparative medicinal substance release characteristics the use
of clinical surrogate measures in the setting of a non-inferiority study against an ap-
proved device may be acceptable, provided that long-term safety concerns can be
clearly ruled out for the claimed target population.
o For further requirements regarding Clinical Data see section 5.
4.7 Blood Derivates, Human Tissue / medical device combination
o Human blood derivatives as specified in Annex I MDD, section 7.4 – only where the sub-
stance is liable to act upon the body with action ancillary to that of the device.
o Guidance Documents and regulations:
o 2000/70/EC
o 2001/83/EC
o 2002/98/EC
o 2004/33/EC
o Note for Guidance on Plasma-Derived Medicinal Products CPMP/BWP/269/95
o Note for Guidance on Assessing the risk for Virus Transmission - New Chapter 6 of
the NfG on Plasma-derived medicinal products (CPMP/BWP/5180/03)
o Guideline on the Scientific Data Requirements for a Plasma Master File (PMF)
(EMEA/CPMP/BWP/3794/03)
o European Medicines Agency recommendation on the procedural aspects and dos-
sier requirements for the consultation to the European Medicines Agency by a noti-
fied body on an ancillary medicinal substance or an ancillary human blood derivative
incorporated in a medical device or active implantable medical device
(EMA/CHMP/578661/2010)
14. TÜV SÜD PRODUCT SERVICE GMBH Page 14 of 25
o Note for Guidance on virus validation studies: the design, contribution
and interpretation of studies validating the inactivation and removal of
viruses (CPMP/BWP/268/95)
o Relevant European Pharmacopoeia monographs
o Guideline on the Investigation of Manufacturing Processes for Plasma-
Derived Medicinal Products with regard to vCJD Risk
(CPMP/BWP/5136/03)
o CHMP Position Statement on CJD
o The documentation should be provided in CTD format. A guideline to the contents is to
be found in MEDDEV 2.1/3 part B:
o General information:
o Description of the device (components, intended use)
o Justification for the use of blood derivatives (intended purpose, suitability of the
substance, critical evaluation of alternatives)
o Critical evaluation of the results of the risk analysis (potential risk in relation to the
expected benefit)
o Qualitative and quantitative particulars of the constituents:
o Description of the substance
o The amount included in the device
o If modifications were introduced, adequate description required
o Description of method of manufacture:
o Overall description of the device manufacturing process
o Process description for the substance
o Controls of starting materials:
o Specification of the blood derivate
o EU Pharm to be referenced (if applicable)
o National references (if applicable)
o Plasma Master File(s)
o Control tests carried out at intermediate stages of the manufacturing process of the
medical device:
o In-process controls (if applicable)
o Control tests on finished products:
o Qualitative test(s)
o Quantitative test(s)
o Stability:
o Desired function to be maintained during shelf life
o Recommended storage conditions
o Toxicity:
o Toxicological profile of the substance
o New substance: results of toxicity tests (EN ISO 10993)
o Reproductive function:
o Toxicological profile of the substance
o New substance: results of toxicity tests (EN ISO 10993)
o Embryo/fetal and perinatal toxicity:
o Toxicological profile of the substance
o New substance: results of toxicity tests (EN ISO 10993)
o Mutagenic potential:
o Toxicological profile of the substance
o New substance: results of toxicity tests (EN ISO 10993)
o Carcinogenic potential:
o Toxicological profile of the substance
o New substance: results of toxicity tests (EN ISO 10993)
o To be considered: genotoxicity, chemistry, duration of exposure
o Pharmacodynamics:
o Intended action of the substance with regard to the medical device
o Pharmacokinetics:
15. TÜV SÜD PRODUCT SERVICE GMBH Page 15 of 25
o Description of the pattern of local and systemic exposure to the
medicinal substance
o Maximum level and duration of exposure should be considered
o Potential level of exposure a safety concern?
o New substance: release characteristics, subsequent distribution,
and elimination
o Local tolerance:
o Relevant results from EN ISO 10993 to be provided
o Where appropriate: relevant literature
4.8 Coated Medical Devices (Bio-mimicry)
requirements on performance and product safety to be considered
o Stability of Coating in Biological Matrix
o Microbiological Evaluation
o Fibrinogen Adsorption
o Platelet Adhesion / Activation
o Contact Activation Tests
o Examples:
o Hydrophilic coating
o Heparin - coating
o Silver / Gold - coating
o Pyrolytic Carbon coating
o MPC - ML - coating (Methacryloyl Phosphoryl Choline Lauryl Methacrylate)
o Parylene Polymer coating
o Collagen / Gelatine coating
o PEG coating (Polyethyleneglycol as lubrication)
o Titanium / HA Spray – coating
5. Clinical Data
5.1 Clinical report
A clinical report for a medical device calling for CE-marking shall fulfil the requirements of
MEDDEV 2.7.1. The following hints which are generally checked during an in-house review
of a clinical report are based on our experience with submitted documentation in the past;
they should give additional advice for the demands outlined in the MEDDEV.
Content-related aspects
The report should contain a technical description, as well as a detailed description of the In-
tended Use of the device. A pure reference to the technical documentation cannot be re-
garded adequate
Any clinical risk associated with the use of the device and the medical procedure where the
device is used shall be identified and assessed in the clinical report. In that context, the se-
verity of any hazard, as well as the probability of occurrence of the harm shall be character-
ized. A pure reference to the formal risk analysis cannot be regarded adequate
The acceptability of any identified risk shall be assessed adequately. Such a process may
include a systematic literature review, bench testing, pre-clinical or clinical studies
In case the literature route is used, transferability of device technology used in publications,
to the device under assessment is often critical
Notes:
In the majority of cases, a pure literature review will not be sufficient. Rather, the equiva-
lence shall be demonstrated
The adequacy of methods used in the discussed publications shall also be taken into ac-
count
In case a clinical study is performed, attention should be paid to:
16. TÜV SÜD PRODUCT SERVICE GMBH Page 16 of 25
The fulfilment of requirements outlined in EN ISO 14155-1 and -2
Adequacy of study follow-up regarding the evaluation of safety and perform-
ance of the device
Adequacy of primary and secondary objectives regarding the evaluation of
safety and performance
Adequacy of inclusion/ exclusion criteria regarding the evaluation of safety
and performance
Adequacy of statistical methods employed, including sample size estimation
Intent-to-treat and per-protocol analysis
Bench tests, pre-clinical and clinical studies, if used for the demonstration of safety and per-
formance of the device, shall be detailed and discussed in the clinical report. A pure refer-
ence to the technical documentation cannot be regarded adequate
Notes:
The adequacy of pre-clinical or clinical testing is dependent on the novelty of the device or
treatment procedure, compared to established devices or methods
It should be taken into account that statistical issues might also be relevant for the as-
sessment of adequacy of such tests
In that equivalence with the current “state-of the- art” shall be demonstrated for any medical
device calling for CE-marking, not only the identified risks of the device itself may be evalu-
ated for the overall risk-to-benefit assessment of the device. Rather, an adequate “state-of-
the-art” review shall be included in the clinical report.
“State-of-the-art” review:
“State-of-the-art” is understood as detailed description and discussion of all currently
available treatment options and medical devices, for the same Intended Use as the device
calling for CE-marking, reflecting current medical practice and the acknowledged tech-
nologies
To document a systematic “state-of-the-art” review, a protocol for the identification, selec-
tion, collation and review of scientific literature including search databases, search terms,
selection criteria and rationale shall be attached to the clinical report
Reasons for believing that all relevant references, both favourable and unfavourable are
included in the review, shall be given
Also, the acceptability of publications quoted (i.e., reviewed journal, publication year,
qualification of the author) should be included in the discussion
In case there are comparable or predecessor devices, this clinical experience should also be
included in the report
The overall risk-to-benefit assessment of the device shall include the comparison of the de-
vice under assessment, and the established treatment options/ medical devices mentioned in
the state-of-the-art section
The author´s conclusions shall be substantiated by the presented data
Formal aspects
The quotation index of the referenced literature shall be attached to the clinical report
Intended Use/ Indications/ Contraindications shall be conclusive in the different parts of the
documentation
Every claimed Intended Use/ Indications/ Contraindications shall be substantiated by the
provided clinical data
Relevance of the background and expertise of the author of the clinical report in relation to
the particular device and/or medical procedure involved shall be demonstrated by a scientific
curriculum vitae
The data provided in the different parts of the documentation should be consistent (e.g., indi-
cations, technical parameters, etc.)
5.2 Other documents to be included in the clinical data documentation
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Copies of the publications quoted in the clinical report
Reports of all bench tests quoted in the clinical report
Study protocols and study reports in the case pre-clinical or clinical studies
were performed. In case a clinical study was performed, the “letter of no objec-
tion” from the Competent Authority, as well as the Ethics Committee opinion
have to be included
Instructions for Use, including indications, contraindications, risks/side effects/adverse events
Risk Analysis, including clinical risks
Post-market experience data of predecessor devices, if applicable
PMCF-plan, if applicable
6. Labels and Instructions for Use - patient information - advertising materials
Demonstration of compliance with MDD Annex I.13, EN 980, EN 1041, EN ISO 15223
Sample of labels (shipping labels, sterile package labels) - Instructions for use - patient in-
formation
Submission of labels / IFU in German or English only is acceptable, but verify compliance
with European Language Requirements!
Label and IFU content shall be consistent
Instructions for Use:
Description of the device
Indication for Use (disease or condition that the device will diagnose, treat, prevent, cure
or mitigate including target patient population)
Contraindications (disease or condition and patient population for which the device should
not be used because the risk of use clearly outweighs any possible benefit)
Warnings (specific hazard alert information)
Precautions (special care necessary for the safe and effective use of the device, e.g. ac-
tions to be taken to avoid effects on patients/users, adverse effects on the device of use
or misuse)
Adverse Events (potential undesirable and serious outcomes under normal conditions)
Operation (Directions for Use)
If applicable: Specifications / Variants / Individualization of Treatment (e.g. procedures,
methods, frequency, duration, quantity, preparation) / Alternative Procedure (for diagno-
sis, treatment or therapy) / Patient Counselling Information / instructions for any procedure
the patient is expected to perform / How Supplied / Storage / Accessories / Sterilization In-
formation / Patient Registration / Magnetic Resonance Environment / Installation and
Maintenance / Requirement of User Training prior to Use
Where appropriate, the instruction for use must contain the following particulars:
Clause 13.6(h): If the device bears an indication that the device is for single use, infor-
mation on known characteristics and technical factors known to the manufacturer that
could pose a risk if the device were to be re-used.
Clause 13.6(q): Date of issue or the latest revision of the IFU.
7. Manufacturing (Description of the manufacturing process)
Multiple facilities, critical suppliers, contract sterilizer, etc.: quality assurance certificates is-
sued by an accredited third party inspection body for each facility
Flow charts including inspection and preventive monitoring steps
Control specifications for incoming critical material/components, in-process controls
Final product release criteria
18. TÜV SÜD PRODUCT SERVICE GMBH Page 18 of 25
Summary of manufacturing methods (molding, extrusion, chemical processes,
assembly, etc.)
Manufacturing conditions (compliance with e.g. FS 209E, EN ISO 14644, EN
ISO 14698)
QM (EN ISO 13485) certificate issued by Notified Body or other registrar for the
manufacturing plant
EC-certificate according to Annex II, 3 (Full Quality Assurance System) for the legal manu-
facturer
Labelling control
Traceability
Product and environmental bioburden, particles
Pyrogene testing
Preventive monitoring of processes (e.g. SPC)
Viral- Prion Deactivation steps
8. Package Qualification and Shelf life
o Physical package qualification
o Performance of the product after real time and/or accelerated aging
o Shelf life: Maintenance of sterility and performance over the shelf-life of a product, e.g.
per:
o EN 868 -2 ff packaging materials for sterilization of wrapped goods,
o EN ISO 11607-1-2 and referenced standards therein
o ISTA 2A for transport validation
o Real time aging,
o ASTM F 1980 Q10 - accelerated aging test
o Following documents are required for the evaluation of sterile devices:
o Summary report according to EN ISO 11607
o Detailed description of the packaging and packaging materials
o Supplier certificates
o Compliance of the packaging material with the proposed sterilization method
o Biocompatibility of packaging, if necessary
o Each test method has to be validated and a rational why it was chosen including a
rationale for statistical compliance of the sample size has to be provided
o Packaging integrity test (including visual inspection, dye penetration test, creep and
burst testing, bubble emission testing)
o Microbial barrier test
o Labelling compatibility
o For aseptical presentation, if applicable: Peelability and Seal strength test
o Real time aging study
o Accelerated aging study, if applicable
o Shipment simulation test (vibration-, drop- and rolltest): transport validation report
o Packaging process validation report including definition of the packaging and sealing
equipment
9. Sterilization
9.1 Terminally sterilized medical devices
Ethylene OxideEN ISO 11138-2; EN ISO 11135; EN ISO 11737; EN ISO 10993-7
Moist Heat:EN ISO 11138-3, EN ISO 17665-1, EN ISO 11737
Irradiation:EN ISO 11137, EN ISO 11737
o EN 556-1
o Brief description of the installation qualification and validation summary (method shall
assure at least a SAL of 10-6
).
19. TÜV SÜD PRODUCT SERVICE GMBH Page 19 of 25
o Process Validation Report with physical performance qualification and
microbiological performance qualification
o Sterilization plant certified by a Notified Body (EN ISO 13485 with EN ISO
1113x series).
General information:
Reason for validation (initial/re-validation, change of product etc.)
Manufacturer (name, address), operator of facility (name, address),
date of validation, approval of validation, date of next approval of validation report valid-
ity, if applicable date of next validation, criteria for revalidation
Product:
o Description of the product (if applicable drawings/samples) evidence for the usability
for the respecting sterilization method.
o Short description of manufacturing conditions (clean room with classification)
o If applicable transportation specification (from the manufacturer to the sterilization fa-
cility)
o If applicable product families specification of the product with the greatest challenge
to the sterilization process ("worst-case product") with rationale, if applicable evidence
by experimental data (link to data)
o If applicable average bioburden and bioburden trending data, bioburden recovery,
bacteristasis and fungistasis, endotoxin, objective evidence for validated microbial
methods according to EN ISO 11737.
o Statement on functional product qualification
Load description:
o Description of the most challenging position, if applicable evidence by experimental
data (link to data)
o Specifications of bioburden with limits and if applicable justification of upper limit in re-
lation to endotoxins
Sterilizer:
o Cycle name (e.g. vacuum cycle Nr. 9); sterilizer description (type, manufacturer, vol-
ume)
o If applicable: preconditioning room (type, manufacturer volume), conditioning (type,
manufacturer volume), aeration room (type, manufacturer volume), Transportation
route trough the sterilizer (e.g. at irradiation sources)
Statement on Commissioning/Installation Qualification:
o Date of last commissioning, specification/statement that at time of validation all
measurement and control equipment was maintained and calibrated (with date of
last maintenance/calibration), specification where data of commissioning can be re-
viewed
o If applicable statement on steam quality
Specifications of physical Performance Qualification:
o Packaging including transportation package and sterilization containers
o Specification of loading including position in preconditioning , in sterilizer, aeration
(including drawings, maps), amount of packed products and if applicable process
challenge devices
o Description of the distribution of sensors (e.g. thermal, humidity, dosimetry etc.) incl.
positioning at/in the product/in product load under consideration of the critical posi-
tions, description of reference measurement point and relations to its position
20. TÜV SÜD PRODUCT SERVICE GMBH Page 20 of 25
Sterilization cycle description (set-point specification):
o Sterilization cycle validation approach according to a harmonized stan-
dard (e.g. Method A, B, C (Ethylene Oxide), Overkill (Steam)…)
o Preconditioning (if applied):
o Minimum temperature of the product load at entering, temperature,
relative humidity, time, description of conditioning as far as applied, maximum
elapsed time between preconditioning an commencement of the process
o I. Ethylene Oxide:
o Sterilization cycle as defined in EN ISO 11135-1 9.5.4:
Temperature, relative humidity, time, concentration of Ethylene Oxide
(incl. course of pressure, Ethylene Oxide volume/weight – reduction at
exposure), description of the Ethylene Oxide exposure time, description
of flushing and aeration
o Aeration:
Temperature, amount of air exchanges/hour, if applicable pressure, time
Ethylene Oxide residuals according to EN ISO 10993 – 7
o II. Moist Heat:
Type of process, temperature, pressure, z-value, F0-value, time, D121°C,
Temperature during holding time, maximum temperature difference, fluc-
tuation of temperature, equilibrium time, F0 measured, chamber leak test
o III. Irradiation sterilization:
Type of process, transportation route trough sterilizer, irradiation dose,
pass mode, verification dose, verification dose range, accomplished veri-
fication dose, amount of samples, assigned dose map including:, min
max dose(and positional data e.g. drawing/scheme), correlation to worst
case position and routine measurement, dosimeters (type and manufac-
turer, tracing to national standard calibration institute)
If applicable: conveyor speed, scan height, electron acceleration
special requirements:
o SIP description (Sample Item Proportion), product/load density, prod-
uct materials, dimension of product and load and its orientation in re-
lation to the irradiation source, sterility testing, allowable maximum
dose
Specifications of microbiological performance qualification (if applicable)
o Specification of the applied procedure (e.g. Method A,B,C for Ethylene Oxide); speci-
fication of the applied bioindicators (BIs) if used (strain, lot code, manufacturer, cfu,
D-value, if applicable z-value and conformity to EN ISO 11138; incoming BI inspec-
tion after purchase and before release
o Amount and distribution of the BIs (incl. positioning in product and use as spore strips
and spore suspensions)
o Description of the extraction of BIs (time of extraction)
o Times/temperatures between extraction and incubation, if applicable storage in-
between, extraction method
o Specification of incubation procedure (media, media volumes, incubation time and
temperature), if applicable results of surviving organisms (method A, sec. 7.2.1.2)
o If applicable evidence of suitability of the process challenge device
o If applicable endotoxin measurements
Summary / Result of validation
21. TÜV SÜD PRODUCT SERVICE GMBH Page 21 of 25
o Summary of the physical performance qualification (PPQ has demon-
strated that all parameters were in the limits of their specifications. Ex-
planations for possible deviations and their impact
o Summary of the microbial performance qualification (MPQ has demon-
strated a SAL of 10-6
was reached). Explanations for possible deviations
and their impact
o Specification of control parameters including limits for routine processing
o Documented evidence of compliance to the specified Ethylene Oxide residuals (in-
cluding also re-sterilization if applicable)
22. TÜV SÜD PRODUCT SERVICE GMBH Page 22 of 25
Description of routine monitoring:
o if applicable parametric release, amount/distribution of BIs, bioburden
o link to essential control parameters / release criteria
9.2 Aseptic filling:
o EN 556-2
o Validation plan, risk management strategy, identification and evaluation concern-
ing contamination risks, monitoring and evidence/prevention of contamination,
definition of aseptic process according to EN ISO 13408-1
o Description on manufacturing environment according to EN ISO 13408-1 (e.g.
Facility lay out, clean room concept, infrastructure, material and personnel influ-
ence, filter systems, clean room qualification, media, manufacturing aids, envi-
ronmental and personnel monitoring systems, equipment (qualification, service),
personnel (training, cloth change, manufacturing)
o Validation report on 3 media fill runs according to EN ISO 13408-1
9.2 Reprocessing of resterilizable medical devices
o Documentation according EN ISO 17664 and EN ISO 15883
o For sterilization and packaging see applicable sterilization and packaging stan-
dards in section 8 and 9.1
o IFU: clear description of the reprocessing process and related parameters and
tolerances: point of use, cleaning, disinfection, packaging and sterilization
Risk Management discussing:
o initial contamination at point of use
o and for each step of reprocessing how the related contamination is re-
moved (e.g. µg or log reductions) with a clear link to validation documen-
tation giving evidence on compliance.
o Usability related topics on the reprocessing process
Validation documentation for each reprocessing step
Evidence on product conformance after the maximum reprocessing cycle stated: in-
cluding mechanical testing and biocompatibility of the medical device
Evidence on validated test methods for life cycle reprocessing simulation and valida-
tion (e.g. certification status of applied laboratories)
If applicable: Evidence on the effectiveness of the applied disinfectant to achieve at
the defined conditions the claimed disinfection.
If applicable: Scientific evidence on the effectiveness of the applied cleaning agent
and process to remove prions
10. Measuring Function
o 80/181/EWG; MEDDEV 2.1/5
o Sufficient accuracy and stability within appropriate limits of accuracy
11. Combination with other Medical Devices
,
o The whole combination must be safe and must not impair the specified perform-
ances of the devices (e.g. electrical safety by combination with active Medical
Devices)
12. Compatibility to drugs
o Devices must be compatible with the medicinal products concerned according to
the provisions and restrictions governing these products.
23. TÜV SÜD PRODUCT SERVICE GMBH Page 23 of 25
13. Other applicable directives and regulations
o Brief description of applicability and summary of compliance with regulation.
o Personal Protective Equipment Directive 89/686/EEC
o Registration, Evaluation, Authorisation and Restriction of Chemicals REACH
(Regulation (EC) No. 1907/2006)
o Dangerous Preparations (1999/45/EC)
14. Conclusion
o Summary of the Design Dossier data
o Risk vs. benefit statement
o Date and signature of company representative
24. TÜV SÜD PRODUCT SERVICE GMBH Page 24 of 25
15. Declaration of Conformity Template
DECLARATION OF CONFORMITY
MANUFACTURER: NAME AND ADDRESS
EUROPEAN REPRESENTATIVE: NAME AND ADDRESS
PRODUCT: NAME, TYPE AND/OR MODEL
CLASSIFICATION: CLASS, RULE ACCORDING TO ANNEX IX OF THE MDD
(NOT MANDATORY BUT RECOMMENDABLE)
CONFORMITY ASSESSMENT
ROUTE: EC DIRECTIVE(S) AND ANNEXES APPLIED
WE HEREWITH DECLARE EXCLUSIVELY UNDER SOLE RESPONSIBILITY THAT THE ABOVE MEN-
TIONED PRODUCTS MEET THE PROVISIONS OF THE COUNCIL DIRECTIVE 93/42/EEC FOR MED-
ICAL DEVICES. ALL SUPPORTING DOCUMENTATION IS RETAINED UNDER THE PREMISES OF THE
MANUFACTURER.
STANDARDS APPLIED: LIST OF (HARMONIZED) STANDARDS FOR WHICH DOCU-
MENTED EVIDENCE OF COMPLIANCE CAN BE PROVIDED
NOTIFIED BODY: NAME, ADDRESS AND IDENTIFICATION NUMBER
(EC) CERTIFICATE(S): EC CERTIFICATE(S) NUMBER(S)
START OF CE-MARKING: DATE, LOT NUMBER OR SERIAL NUMBER OF FIRST CE-
MARKING
PLACE, DATE OF ISSUE: CITY, DATE
SIGNATURE: ____________________
NAME
POSITION (FUNCTION)