Medical Device Standards State-of-the-Art

1. Prepared By Sam Lazzara
medicaldevicequality.blogspot.com
sam@lazzara.net
+1 510 397 9739
MEDICAL DEVICE STANDARDS
‘ STATE-OF-THE-ART ’
Coping with ever-changing standards
in a cost-effective way
Updated 2012-12-13

3. Presentation Topics
• State-of-the-Art
• Standards Basics
• Identifying Standards for Particular Devices
• Proving Equivalence Between Standards
• Tracking New/Revised Standards
• Standards Purchasing Advice
• State-of-the-Art Review Reports
• 2012 State-of-the-Art Impact Assessments
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
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4. Sam’s Webinar Resource Folder
• Lazzara Standards Webinar Excel Workbook
– EN Standard Pricing Comparison Survey Data
– Hyperlinks to 33 CEN/CENELEC national standards bodies
• Lazzara State-of-the-Art Review Report template (Word)
• Lazzara State-of-the-Art Change Assessments (Word & PDF)
– EN ISO 13845:2012
– EN ISO 14971:2012
– EN ISO 15223-1:2012
• Europe Medical Device Harmonised Standards Lists 2012-08-30
• PowerPoint Presentation Slides (with hyperlinks)
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
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5. Disclaimers
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
• Damn! These slides are way too busy -- Planning to streamline…later
• Webinar focused on STANDARDS - not laws, regulations, guidelines
• Sam is opinionated, obstinate and always right
• If Sam screws up, tell him in chat window when you notice
– Send brief messages to correct him or ask him to clarify
– Nobody but Sam will see your messages
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6. Webinar Format
• Presentation: 90 minutes (nominal)
– Video and audio will be recorded
– Participants will be muted
– Do not hang up if Sam does (stay on the phone/web line)
– Send chat messages (questions, comments, error corrections)
– Will address pre-meeting questions during presentation
• Break – 10 minutes only
• Live Question/Answer Discussion Session: 20 minutes (nominal)
– Use chat window
– Raise hand and I will ‘unmute’ you
• Post Webinar Activities
– Feedback on Sam’s performance
– Knowledge Assessment to obtain Certificate of Competence
– Updates for Webinar Resource Folder (PPT slides, etc.)
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
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7. Sam Lazzara MDQC
Medical Device Quality Consulting
• MS Engineering – Case Western Reserve University
BS Engineering – Brown University
Certified Biomedical Auditor
• 30 years medical device industry experience
• 26 years in-company experience for 7 device manufacturers
• Quality Systems
– Tailored, turnkey, state-of-the-art quality systems
– Lazzara systems have passed dozens of external audits performed by:
• 7 different European Notified Bodies
• United States FDA, California Department of Health
• Japan MHLW
• Since 2000, Sam has directly assisted over 10 clients to achieve ISO 13485
registration, and international marketing compliance, clearance and approval
• Contact Information
Telephone: +1 510 397 9739
Email: sam@lazzara.net
Blog: medicaldevicequality.blogspot.com
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
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8. Most Frustrating Aspects of Standards
for Webinar Attendees
• High cost
• Fuzzy wording
• Frequent changes
• Too many acronyms
• Keeping up to date with changes/revisions
• Understanding what specific changes were made
• Changes made to standards that require significant
rework of product or systems that are working fine
• Differing interpretations among Notified Bodies
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
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9. Presentation Topics
• State-of-the-Art
• Standards Basics
• Identifying Standards for Particular Devices
• Proving Equivalence Between Standards
• Tracking New/Revised Standards
• Standards Purchasing Advice
• State-of-the-Art Review Reports
• 2012 State-of-the-Art Impact Assessments
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
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10. ‘State-of-the-Art’ Background
• Solutions for quality system and device design must take the
current 'State-of-the-Art' into account
– Basis for European medical device regulatory system
• Documents of external origin must be controlled
(ISO 13485 clause 4.2.3)
• External documents include:
– Regulations
– Standards: current consensus on ‘State-of-the-Art’
– Guidelines: could be interpreted as ‘State-of-the-Art’ documents
but some are not generated by consensus with all stakeholders
• Standards will be the focus of this presentation
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
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11. ‘State-of-the-Art’ Descriptions
• Risk Management Standard (ISO 14971 / EN ISO 14971)
• European Directives
– MDD Essential Requirement 2; Annex X
– AIMDD Essential Requirement 6
– IVDMDD Essential Requirements 2, 3; Annex IV
• Europe Guidelines for Clinical Evaluations (MEDDEV 2.7.1)
• Management Challenge
Continual changes in quality management system (QMS) and
regulatory requirements, as well as advances in medical device
design and manufacturing technologies
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
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12. ‘State-of-the-Art’ in Risk Management
EN ISO 14971
• Production and Post Production Information
– New or revised standards
– Literature review
– Publicly available databases on similar devices
(FDA TPLC/MAUDE, UK MHRA, etc.)
– Supplier performance
– Manufacturing process capability, yields, reasons for rejection
– Nonconforming products
– Customer feedback
– Product complaints
– Adverse events
– Corrections and removals (including Field Safety Corrective Actions)
• Post Production Information = Post Market Surveillance (PMS)
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
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13. ‘State-of-the-Art’ in European Directives
• Essential Requirements (MDD/IVDMDD ER 2, AIMDD ER 6)
Design and construction solutions must conform to safety
principles, taking into account the generally acknowledged
state of the art
• Standards describe the “generally acknowledged state-of-the-art”
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
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14. ‘State-of-the-Art’ in European Directives
• Software Essential Requirements (MDD ER 12.1, AIMDD ER 9)
Device software validation must be state of the art taking into
account the principles of development lifecycle, risk management,
validation and verification
• Clinical Evaluation (MDD Annex X, AIMDD Annex 7)
– Clinical evaluation and its documentation must be actively
updated with data obtained from post-market surveillance
– Clinical investigations must be performed on the basis of an
appropriate plan of investigation reflecting the latest scientific
and technical knowledge (MDD Annex X)
– Clinical investigations shall be performed according to an
appropriate state of the art plan of investigation
(AIMDD Annex 7)
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
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15. ‘State-of-the-Art’ in MEDDEV 2.7.1
Clinical Evaluation Guidelines
• Device risk/benefit analysis must be assessed in light of the
current state of the art
• Persons performing clinical evaluation must be
knowledgeable about the state of the art, encompassing
both technical and medical aspects
• Clinical literature reviews must reflect current medical
practice and generally acknowledged state of the art
technologies
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
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16. Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
When a standard is updated, when is it appropriate to go backwards and
remediate documentation vs. just making standards updates and using them
for any new projects going forward? AW
SAM ANSWER – Ideally, you should always try to maintain ‘State-of-the-Art’.
1. Do current QS documents already conform with new/updated standard?
If YES, update QS documents to reference new/updated standard.
If NO, make changes to QS documents and reference new/updated std.
2. Do current devices already conform with new/updated standard?
If YES, update device documents to reference new/updated standard.
If NO, used risk-based approach to evaluate complexity of making device
changes to conform with new requirements. Manage as CAPA project.
QUESTION & ANSWER
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17. ‘State-of-the-Art’ in practice
The Sam Way
• The Big 3
– Risk Management Report (RMR)
– Product Specification (PS)
– Essential Requirements Checklist (ERC)
• The Fabulous 5
– Clinical Evaluation Report (CER)
– Technical File / Design Dossier
– Declaration of Conformity (DoC)
– Post Market Surveillance Report
– State-of-the-Art Review Report
• Templates for all of the above available from Sam Lazzara
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
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18. ‘State-of-the-Art’ in practice
The Sam Way
• The Big 3
– Risk Management Report (RMR)
• references PS, ERC, Design History File, Design Output, IFU
– Product Specification (PS)
• contains master list of applied standards
– Essential Requirements Checklist (ERC)
• references standards by document number only;
references PS for standard titles and revision
• references PS, RMR, V&V Reports, CER, Design Output
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
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19. ‘State-of-the-Art’ in practice
The Sam Way
• The Fabulous 5
– Clinical Evaluation Report (CER)
– Technical File / Design Dossier
• high level pointer / index document
• references the Big 3 and rest of Fabulous 5
– Declaration of Conformity
• very brief, does not reference standards – it does not have too!
– Post Market Surveillance Report
• annual update; supplements original CER
– State-of-the-Art Report
• annual update; justifies new vs. old standards
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
19

20. Presentation Topics
• State-of-the-Art
• Standards Basics
• Identifying Standards for Particular Devices
• Proving Equivalence Between Standards
• Tracking New/Revised Standards
• Standards Purchasing Advice
• State-of-the-Art Review Reports
• 2012 State-of-the-Art Impact Assessments
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
20

21. What is a standard? (per ISO)
• Standards provide requirements, specifications, guidelines
or characteristics used to ensure that materials, products,
processes and services are fit for their purpose
• Standards belong to the knowledge economy that
underpins industry and society
• Standards aim to:
– increase market potential
– encourage technological development
– guarantee safety/health of consumers and workers
• Standards compliance facilitates trade
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
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22. Key Concepts for Standards
• Standards are generally voluntary
– Exception: Canada regulatory system requires ISO 13485
• Standards-making process
– involves all interested parties
(manufacturers, consumers, regulators)
– transparent (open to public scrutiny)
– consensus-based
– established appeals process
• Standards are protected by copyright
– Laws, regulations, guidelines not protected by copyright
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
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23. Quality System Document Hierarchy
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
Laws
Regulations
Standards
Guidelines
Quality Manual
Quality System Procedures
Product/Process-Specific Documents
Quality Records
External
Internal
Mandatory/
Compulsory
Voluntary unless required
by law/regulation
Voluntary
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24. Quality System Regulations/Standards
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
External Document Description Applicability
ISO 13485:2003
EN ISO 13485:2012
Quality systems - Medical devices Outside USA
ISO 14971:2007
EN ISO 14971:2012
Risk management for medical devices Worldwide
ISO 14155:2011
EN ISO 14155:2011
Clinical investigation of medical devices for
human subjects
Worldwide
21 CFR 820* FDA Quality System Regulation USA
21 CFR XXX* FDA - various other regulations USA
90/385/EC* (AIMDD)
93/42/EEC* (MDD)
98/79/EC* (IVDMDD)
Medical Device Directives Europe
(31+ countries)
SOR/98-282* Canada Medical Devices Regulations Canada
* As amended
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25. Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
Since compliance to a standard is not obligatory to meet essential
requirements, can you claim compliance to a “down year” standard if
you have a justification as to how you already meet all the essential
requirements without complying to the latest version? JF
SAM ANSWER
Yes, but the applicable regulatory authority (e.g., Notified Body, FDA) has to
accept it based on expert technical and clinical considerations
QUESTION & ANSWER
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26. Role of Standards in European Regulatory System
MDD/AIMDD Article 5 – Reference to standards
• The Essential Requirements are mandatory.
• Presumption of Conformity
Manufacturer’s conformance with European harmonised
standards requires Member States to presume compliance with
the essential requirements
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
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27. Standards Hierarchy
• International – IEC, ISO
• Regional – EN (Europe)
• National – ANSI, BS, DIN, etc.
• Trade Organizations – AAMI, ASME, ASTM, GS1, ISTA, TAPPI, etc.
• Manufacturer’s Internal “Standards” (European framework)
– Manufacturers free to choose any technical solution that provides
compliance with the Directive’s Essential Requirements
– Provides room for technical development
– Important for manufacturers of new/innovative products for which
standards do not yet exist
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
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28. International Classification for Standards (ICS)
11: HEALTH CARE TECHNOLOGY
11.020 (Medical sciences and health care facilities in general)
11.040 (Medical equipment)      
11.060 (Dentistry)
11.080 (Sterilization and disinfection)
11.100 (Laboratory medicine)
11.120 (Pharmaceutics)
11.140 (Hospital equipment)
11.160 (First aid)
11.180 (Aids for disabled or handicapped persons)
11.200 (Birth control. Mechanical contraceptives)
11.220 (Veterinary medicine)
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
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11.040 (Medical equipment)
11.040.01 (Medical equipment in general)
11.040.10 (Anaesthetic, respiratory and reanimation equipment)
11.040.20 (Transfusion, infusion and injection equipment)
11.040.25 (Syringes, needles and catheters)
11.040.30 (Surgical instruments and materials)
11.040.40 (Implants for surgery, prosthetics and orthotics)
11.040.50 (Radiographic equipment)
11.040.55 (Diagnostic equipment)
11.040.60 (Therapy equipment)
11.040.70 (Ophthalmic equipment)
11.040.99 (Other medical equipment)

29. Standards Developing Organizations (SDO)
International
ISO
International Organisation for Standardization
164 member countries
IEC
International Electrotechnical Commission
82 member countries
European Standardization Organisations (ESO)
CEN
European Committee for Standardization
33 member countries
CENELEC
European Committee for Electrotechnical Standardization
33 member countries
ETSI
European Telecommunications Standards Institute
62 member countries
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
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30. CEN/CENELEC
33 National Member Countries
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
Country Website
Austria http://www.ove.at
Belgium http://www.ceb-bec.be
Bulgaria http://www.bds-bg.org
Croatia http://www.hzn.hr
Cyprus http://www.cys.org.cy
Czech Republic http://www.unmz.cz
Denmark http://www.ds.dk
Estonia http://www.evs.ee
Finland http://www.sesko.fi
France http://www.ute-fr.com
Germany http://www.dke.de
Greece http://www.elot.gr
Hungary http://www.mszt.hu
Iceland http://www.stadlar.is
Ireland http://www.nsai.ie
Italy http://www.ceiweb.it
Latvia http://www.lvs.lv
Lithuania http://www.lsd.lt
Luxembourg http://www.ilnas.public.lu
Macedonia http://www.isrm.gov.mk
Malta http://www.mccaa.org.mt
Netherlands http://www.nen.nl
Norway http://www.nek.no
Poland http://www.pkn.pl
Portugal http://www.ipq.pt
Romania http://www.asro.ro
Slovakia http://www.sutn.gov.sk
Slovenia http://www.sist.si
Spain http://www.aenor.es
Sweden http://www.elstandard.se
Switzerland http://www.electrosuisse.ch
Turkey http://www.tse.org.tr
United Kingdom http://www.bsigroup.com
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31. Some European National Standards Organizations
Austria - Onorm
Österreichisches Normungsinstitut (ON)
Belgium - NBN
Bureau De Normalisation (NBN)
Bulgaria - BIS
Bulgarian Institute for Standardization (BDS)
Cyprus - CYS
Cyprus Organization for Standardization (CYS)
Czech Republic - CSN
Czech Standards Institute (CNI)
Denmark - DS
Dansk Standard (DS)
Estonia - EVS
Eesti Standardikeskus (EVS)
Finland - SFS
Finnish Standards Association SFS (SFS)
France - NF
Association française de normalisation (AFNOR)
Greece - ELOT
Hellenic Organization for Standardization (ELOT)
Hungary - MSZ
Magyar Szabványügyi Testület (MSZT)
Iceland - IST
Icelandic Standards (IST)
Latvia - LVS
Latvian Standard (LVS)
Lithuania - LST
Lithuanian Standards Board (LST)
Luxembourg - DIN
Service de l'Energie de l'Etat (SEE)
Malta - MSA
Malta Standards Authority (MSA)
Norway - NS
Standards Norway (SN)
Poland - PN
Polish Committee for Standardization (PKN)
Portugal - IPQ
Instituto Português da Qualidade (IPQ)
Romania - SR
Asociatia de Standardizare din România (ASRO)
Slovakia - STN
Slovak Standards Institute (SUTN)
Slovenia - SIST
Slovenian Institute for Standardization (SIST)
Spain - UNE
Asociación Española de Normalización y
Certificación (AENOR)
United Kingdom - BS
British Standards Institution (BSI)
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara (for exclusive use of my clients by invitation)
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32. Standards Developing Organizations (SDO)
• National (examples)
– ANSI USA
– BSI UK
– DS Denmark
– EVS Estonia
– DIN Germany
– NSAI Ireland
• Non-Government (examples)
– AAMI USA
– ASTM USA
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
32

33. ISO/IEC vs. CEN/CENELEC vs. AAMI
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
• CEN/CENELEC, ISO/IEC parallel voting system
• ISO/IEC standards typically become EN standards with same number/content
• AAMI, ISO/IEC parallel voting system
• Harmonised EN standards
– typically have identical normative content as ISO/IEC standard
– have added informative Z annexes that correlate standard clauses to the
Essential Requirements of the applicable Directives
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34. ISO vs. CEN vs. AAMI Standards
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
• Corrigendum – error corrections
– ISO “TC” = Technical Corrigendum
– EN “AC” = Amending Corrigendum
• Base standard and corrigendum exist separately
• TCs and ACs are typically free on ISO/CEN country sites
ISO 13485:2003/TC1:2009
EN ISO 13485:2012/AC:2012
ANSI/AAMI/ISO 13485:2003/(R)2009
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35. Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara (for exclusive use of my clients by invitation)
CEN Catalogue
EN ISO 13485:2012
Prefixes of National
Standards Organization
shown
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36. CEN Information for EN ISO 13485:2012
EN ISO 13485:2012
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara (for exclusive use of my clients by invitation) 36

37. Who sells standards?
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
• Standards Developing Organizations
– Exception: CEN, CENELEC do not sell or distribute EN
standards. They are sold by national members.
• Standards Resellers
Document Center
IHS
SAI Global
Techstreet
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38. Recognized Consensus Standards
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
• FDA CDRH is supposed to develop “performance standards” for
Class II devices, but has not done much of that
• Instead, since the FDA Modernization Act (FDAMA) of 1997,
CDRH has moved to recognize standards developed by SDOs
• Consensus Standard
Voluntary standard developed by a private sector standards body
using consensus process
• Recognized Consensus Standard
Consensus Standard recognized by FDA to satisfy a regulatory
requirement (published in Federal Register)
• Form FDA 3645 – Standards Data Report for 510(k)s
– Used when submitting 510(k) that references a national or
international standard
– Describes extent of application of each standard
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39. Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
• FDA Recognized Consensus Standards Database
39
Recognized Consensus Standards

40. Presentation Topics
• State-of-the-Art
• Standards Basics
• Identifying Standards for Particular Devices
• Proving Equivalence Between Standards
• Tracking New/Revised Standards
• Standards Purchasing Advice
• State-of-the-Art Review Reports
• 2012 State-of-the-Art Impact Assessments
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
40

41. Identifying Standards for Particular Devices
Key Questions
• Is it a medical device?
• Active or non-active?
• Active Type B, BF, CF?
• Type of patient contact? (invasiveness)
• Duration of patient contact? (transient, short term, permanent)
• Provided sterile? EO? Radiation? Steam? Dry heat?
• Reusable? Resterilizable?
• Materials – metal, polymer, ceramic?
• Device/drug combination?
• Is it software, or does it include software?
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
41

42. Identifying Standards for Particular Devices
Resources
• FDA Recognized Consensus Standards
• Europe Harmonised Standards Reference Lists
– MDD, AIMDD, IVDMDD
• SDO websites (ISO, IEC, CEN, CENELEC, BSI, EVS, ASTM, etc.)
• Search by ICS Code, TC Number, Keywords, Standard Number
• BSI website good for EN, ISO and IEC standards
• EVS website has good preview features
• Links
– AAMI
– ISO
– IEC
– EVS
– BSI
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
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43. Identifying Standards for Particular Devices
• Standards that apply to most medical devices
– Quality Management 13485
– Risk Management 14971
– Usability Engineering 62366
– Clinical Investigation 14155
– Labeling EN 1041, 21 CFR 801, MDD
– Label Symbols 15223-1
– Biocompatibility 10993-x
– Distribution Simulation ASTM D4169
– Accelerated Aging ASTM F1980
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
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44. Identifying Standards for Particular Devices
• Standards that apply to sterile medical devices
– Sterile Packaging 11607-x
– Sterile Package Testing ASTM F88, F1140, F2096, etc,
– Sterilization, General EN 556-1
– Sterilization, Microbiology 11737-x
– Sterilization, EO 11135-x
– Sterilization, Radiation 11137-x
– Sterilization, Moist Heat 17665-x
– Resterilizable Device Info 17664
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
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45. Identifying Standards for Particular Devices
• Standards that apply to all/many surgical implants
– General Requirements 14630
– Instrumentation 16061
– MRI Compatibility (metals) ASTM F2xxx (various)
– Corrosion (metals) ASTM xxxx (various)
• Standards that apply to medical electrical equipment safety and
performance
– Base standard 60601-1
– Collateral standards 60601-1-x
– Particular standards 60601-2-x
– Performance standards 60601-3-x
– Device software 62304
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
45

46. Identifying Standards for Particular Devices
Particular requirements example
Example: Orthopedic Hip Joint Replacement
Standards below all cited on MDD harmonised standards listing.
• EN ISO 14630:2009 (Level 1 Standard)
Non-active surgical implants – General requirements (ISO 14630:2008)
• EN ISO 21534:2009 (Level 2 Standard)
Non-active surgical implants – Joint replacement implants
– Particular requirements (ISO 21534:2007)
• EN ISO 21535:2009 (Level 3 Standard)
Non-active surgical implants – Joint replacement implants
– Specific requirements for hip-joint replacement implants (ISO 21535:2007)
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
46

47. Identifying Standards for Particular Devices
• Recommendations
– Do not reference standards you are not following in some way
– Put primary list of applicable standards in “Product
Specification” (design input document)
– State standard number, revision, title
– Cite same standards in “Essential Requirements Checklist” but
refer to “Product Specification” for revisions and titles
– Maintain External Document Log
• Identify current versions applied
• Cross-reference to internal documents where referenced
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
47

48. Presentation Topics
• State-of-the-Art
• Standards Basics
• Identifying Standards for Particular Devices
• Proving Equivalence Between Standards
• Tracking New/Revised Standards
• Standards Purchasing Advice
• State-of-the-Art Review Reports
• 2012 State-of-the-Art Impact Assessments
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
48

49. Proving Equivalence Between Standards
• ISO vs. ANSI/AAMI/ISO vs. EN ISO
How do the requirements differ?
How does the content differ?
• Normative content vs. Informative content
• Harmonised EN standards have unique informative “Z” annexes that
map clauses of standard to the Directive Essential Requirements
(appears to be overdone in Sam’s opinion)
• Resources to determine whether normative content is identical:
– BSI website (free)
– European Directive Reference Harmonised Standards Lists (free)
– AAMI standards (requires purchasing)
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
49

50. Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara (for exclusive use of my clients by invitation)
Do we need the EN ISO standard if we already have the original
ISO standard?
SAM ANSWER
Are you claiming conformance to the EN ISO version?
If NO, then you don’t need EN ISO version.
If YES, there is a way to avoid it but you need to prove that
normative content is identical, and take your chances with not
knowing the unique informative content
Recommendation to make life simpler and save money
Stop buying “pure” ISO standards.
Only buy corresponding EN ISO standard, and probably not the
BS version.
QUESTION & ANSWER
50

51. Proving
Equivalence
Between
Standards
BSI Website
BS EN ISO
versus
EN ISO
versus
ISO
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
51

52. Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
Proving Equivalence Between Standards
Europe Harmonised Standards References
EN ISO vs. ISO
52

53. Proving Equivalence Between Standards
AAMI “Glossary of equivalent standards”
ISO vs. ANSI/AAMI/ISO
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
53

54. Proving Equivalence Between Standards
AAMI “Glossary of equivalent standards”
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
54

55. Presentation Topics
• State-of-the-Art
• Standards Basics
• Identifying Standards for Particular Devices
• Proving Equivalence Between Standards
• Tracking New/Revised Standards
• Standards Purchasing Advice
• State-of-the-Art Review Reports
• 2012 State-of-the-Art Impact Assessments
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
55

56. Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara (for exclusive use of my clients by invitation)
Are redlines or a description of changes available from the issuing
body when a standard revises?
If so how can we get a hold of them? JF
SAM ANSWER
ASTM offers “redlines” for about $10 additional typically.
Definitely worth it.
AAMI and IEC offer “redlines” for some documents.
I have not investigated this much.
Not sure otherwise – please let me know what you find.
QUESTION & ANSWER
56

57. Tracking New/Revised Standards
• Reactive – wait until your Notified Body tells you
• Proactive – monitor standards development activity
– Subscribe to “AAMI Standards Monitor” emails (free)
– RSS feed for European Directive “References of Harmonised Standards”
• Subscribe to free unfiltered email updates
– IEC “Just Published” emails http://webstore.iec.ch/justpublished
– ASTM Standards Tracker Alert
• Subscribe to standards alert services offered by standards bodies
and distributors (costs money typically)
– Document Center charges $2 per document per year
– SAI Global charges $100 per year for 50 stds, $185 for 200 stds
• Purchase “redline” versions of standards if available
– AAMI, ASTM, IEC, Others?
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
57

58. Tracking New/Revised Standards
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
58

59. Tracking New/Revised Standards
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
59

60. Tracking New/Revised Standards
AAMI Standards on CD Collection
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
• Cost
– $220 annual membership
– $990 for Year 1 of subscription
– $490 per year thereafter
• 200+ AAMI standards and guidance documents
• Compilation CDs published twice per year
• Around-the-clock access for documents released between updates
• Emails when new documents are available
• No, I do not work for AAMI (just a happy member)
• Website: www.aami.org
60

61. Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara (for exclusive use of my clients by invitation)
How often should we review the validity of standards? Today we check for
updates on a bi-annual basis. Is that considered adequate? KT
SAM ANSWER
In my opinion bi-annual is not often enough for ongoing reviews;
annual is sufficient for formal reporting though
SAM RECOMMENDATIONS
1. Collect new/updated standards info regularly
2. Flag the updates in your External Document Log.
3. Get European Harmonised Standards Listings updates quickly (e.g., RSS feed)
Note - If you wait too long you can run across standards like EN ISO 13485:2012
and EN ISO 14971:2012 which were both harmonised on Aug 30, 2012 with
ZERO transition period.
3. Publish formal State-of-the-Art Review Report annually.
QUESTION & ANSWER
61

62. Presentation Topics
• State-of-the-Art
• Standards Basics
• Identifying Standards for Particular Devices
• Proving Equivalence Between Standards
• Tracking New/Revised Standards
• Standards Purchasing Advice
• State-of-the-Art Review Reports
• 2012 State-of-the-Art Impact Assessments
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
62

63. Tips for Saving Money on Standards
• Regulations and guidance documents are free; standards cost money
• Preview standards so you only buy what you really need
– Use “AAMI Standards on CD” collection to screen standards
– Partial preview (first few pages) is free at EVS website and others
– Full preview for 24 hours costs 2 Euro at EVS website
• Buy EN versions instead of “pure” ISO or IEC versions
• EN versions contain them plus “important” informative annexes
• Prices for the “same” document can vary widely
• BSI non-member pricing is relatively high
• Package/member pricing can save you money
– AAMI Standards on CD collection (but no EN standards)
– ASTM Volume pricing is very good per standard
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
63

64. Tips for Saving Money on Standards
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
64

65. Standards Purchasing Advice
Pricing Example - EN ISO 14971:2012
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
Source Cost Document
ANSI $356 BS EN ISO 14971:2012
UK (BSI) $346 BS EN ISO 14971:2012
IHS Global (distributor) $346 BS EN ISO 14971:2012
Techstreet (distributor) $327 BS EN ISO 14971:2012
ANSI $194 SS EN ISO 14971:2012
SAI Global (distributor) $142 IS EN ISO 14971:2012
IHS Global (distributor) $132 DS EN ISO 14971:2012
Slovenia (SIST) $128 SIST EN ISO 14971:2012
Lithuania (LST) $40 LST EN ISO 14971:2012
Estonia (EVS) $29 EVS EN ISO 14971:2012
65

66. Standards Purchasing Advice
EN Standard Pricing Comparison Survey
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
• Prices obtained from websites in December 2012
• 7 Standards Sellers, 25 EN Standards in “English”
– ANSI (SDO) BS and non-BS versions
– BSI (SDO) BS versions only
– Document Center BS versions (Paper only)
– EVS (SDO) EVS versions only
– IHS Global BS and non-BS versions
– SAI Global BS and non-BS versions
– Techstreet BS and non-BS versions
• “Secure PDF” format becoming very common; discuss limitations
66

67. Standards Purchasing Advice
EN Standard Pricing Comparison Survey
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
Organization_Number:Revision Document Title
EN 1041:2008 Information supplied by the manufacturer of medical devices
EN 15223-1:2012 Medical devices – Symbols to be used with medical device labels, labeling, and information to be supplied –
Part 1: General requirements
EN 16061:2009 Instrumentation for use with non-active surgical implants (ISO 16061 2008 corr 2009-03-15)
EN 556-1:2001/AC1:2006 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Req.
for terminally sterilized medical devices
EN 62366:2008 Medical devices – Application of usability engineering to medical devices (IEC 62366:2007)
EN ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
EN ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
EN ISO 10993-11:2009 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
EN ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
EN ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine
control of a sterilization process for medical devices
EN ISO 11137-2:2012 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
EN ISO 11737-1:2006/AC:2009 Sterilization of health care products - Microbiological methods - Part 1: Determination of the population of
microorganisms on product
EN ISO 11737-2:2009 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the
definition, validation and maintenance of a sterilization process
EN ISO 13485:2012 Medical devices - Quality management systems - Requirements for regulatory purposes
EN ISO 14155:2011 Clinical investigation of medical devices for human subjects – Good clinical practice
EN ISO 14630:2009 Non-active surgical implants - General requirements
EN ISO 14971:2012 Medical devices – Application of risk management to medical devices (ISO 14971:2007, Corrected version
2007-10-01)
EN ISO 17664:2004 Information to be provided by manufacturer for processing of resterilizable med devices
EN ISO 17665-1:2006 Sterilization of health care products–Moist heat-Part 1-Req for development, validation and routine control of a
sterilization process for med devices
EN ISO 21534:2009 Non-active surgical implants - Joint replacement implants (ISO 21534 2007)
EN ISO 21535:2009 Non-active surgical implants - Hip joint replacement (ISO 21535 2007)
EN ISO 11607-1:2009 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems
and packaging systems
EN ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and
assembly processes
EN ISO 9000:2005 Quality management systems - Fundamentals and vocabulary
67

68. Standards Purchasing Advice
EN Standard Pricing Comparison Survey
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
68
$494
$2,400
$2,816
$3,390
$4,559
$6,066
$6,106
$6,262
$6,271
$6,275
$6,326
$0 $1,000 $2,000 $3,000 $4,000 $5,000 $6,000 $7,000
EVS (Estonia)
SAI Global IS
IHS Global DIN/DS/SN
ANSI DIN/SS
Techstreet DIN
SAI Global BS
Techstreet BS
BSI BS
ANSI BS
Document Center BS
IHS Global BS
7 Standards Sellers, same 25 EN Standards in “English”

69. Standards Purchasing Advice
Exclusive Offer from Document Center Inc.
• Claudia Bach, President of the Document Center
“We'd love it if you'd announce that Document Center Inc. will meet any
ANSI, IHS Global or Techstreet price, period. Just have them mention your
seminar.”
• Main advantage of this offer is for non-BS standards such as DIN and
DS standards that typically cost less 50% than BSI member prices
• Tell them Sam Lazzara sent you!
• Document Center Inc.
121 Industrial Road Suite 8
Belmont CA 94002 USA
Phone: +650-591-7600
Fax: +650-591-7617
Email: info@document-center.com
Web: www.document-center.com
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
69

70. Standards Purchasing Advice
Recommendations
• Join AAMI and subscribe annually to “Standards on CD”
• Determine what standards apply to your system/devices
– European Directive “References of Harmonised Standards”
– FDA Recognized Consensus Standards Database
– Search SDO websites: CEN/CENELEC, ISO/IEC, BSI, etc.
• Determine equivalence
– ANSI AAMI standards have “pure” ISO/IEC equivalence info
– BSI website has equivalence info
– Europe Harmonised Standards Lists shows ISO/IEC standards
parenthetically
• Determine if EN version exists for the current ISO/IEC standard
• Do not purchase ISO/IEC version if “identical” EN version exists
• Purchase EN version from lowest cost source you can find
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
70

71. Presentation Topics
• State-of-the-Art
• Standards Basics
• Identifying Standards for Particular Devices
• Proving Equivalence Between Standards
• Tracking New/Revised Standards
• Standards Purchasing Advice
• State-of-the-Art Review Reports
• 2012 State-of-the-Art Impact Assessments
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
71

72. State-of-the-Art Review Reports
• Suggestion
– Monitor external document revision activity regularly
– Publish “State-of-the-Art Review Report” annually
• Report Contents
– Review all external documents referenced in internal documents
– Assess impact of new/revised external documents
– Forecast future external documents for future assessment
• Report Template Review
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
72

73. State-of-the-Art Review Reports
• External Document References Added to Internal Documents
• Revised External Document Review Results
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
73

74. State-of-the-Art Review Reports
• Internal Document Review Results
• New/Revised External Documents Identified and Staged for Future Assessment
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
74

75. Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara (for exclusive use of my clients by invitation)
What do regulators expect to see for records for the process of
evaluating and updating the standards? RK
SAM ANSWER
State-of-the-Art Review Report
QUESTION & ANSWER
75

76. Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara (for exclusive use of my clients by invitation)
What sort of transition period can be expected from Notified Bodies regarding
implementation of the revised standards? Specifically the interpretive changes
to 14971 imply revision to SOPs, updating of all RMF document, and possibly
design changes. JF
SAM ANSWER – Ask your Notified Body. Continual open dialog is best.
Most of them seem to be pretty reasonable about this, saying they will audit
any “changes” at next surveillance audit.
I asked 2 NBs about 13485 and 14971 and they only addressed 13485.
NB #1 - The requirements of EN ISO 13485 remain the same; the only change
was to review and amend Annex Z to clarify the correspondence between the
standard and the requirements in the European Directives. So, the audit
reference hasn’t changed. You probably won’t see a difference in audit
procedure – we’re still going to want to see that you apply the standards’
requirements and show conformity.
NB #2 - There is no impact on your certificate at the moment. With the next
audit, the certificate will be changed to the new version.
QUESTION & ANSWER
76

77. Presentation Topics
• State-of-the-Art
• Standards Basics
• Identifying Standards for Particular Devices
• Proving Equivalence Between Standards
• Tracking New/Revised Standards
• Standards Purchasing Advice
• State-of-the-Art Review Reports
• 2012 State-of-the-Art Impact Assessments
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
77

78. State-of-the-Art Impact Assessments
• EN ISO 14971:2012 (Risk Management)
• EN ISO 13485:2012 (Quality Systems)
• EN ISO 15223-1:2012 (Labeling Symbols)
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
78

79. Summary
• State-of-the-Art
• Standards Basics
• Identifying Standards for Particular Devices
• Proving Equivalence Between Standards
• Tracking New/Revised Standards
• Standards Purchasing Advice
• State-of-the-Art Review Reports
• 2012 State-of-the-Art Impact Assessments
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara
(for exclusive use of my clients by invitation)
79

80. END OF
PRESENTATION
Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara (for exclusive use of my clients by invitation)
QUESTIONS?
Sam Lazzara
medicaldevicequality.blogspot.com
sam@lazzara.net
+1 510 3979739
80

81. Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara (for exclusive use of my clients by invitation)
What is the latest acceptable process for Design FMEA and
Process PFMEA per standards (e.g., convention of ranking
Severity, Probability and Detectability, Risk Ranking R > xx
which require risk mitigation?
CC
SAM ANSWER
14971 has informative appendices provide methodology ideas
Detectability not recommended for Design FMEA (by me and others)
but it can be useful for Process FMEA
Individual residual risk level acceptance criteria are up to the
Manufacturer
QUESTION & ANSWER
81

82. Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara (for exclusive use of my clients by invitation)
Does a ‘Controlled Environment’ for manufacturing class II and III
devices need to be a certified clean room? CC
SAM ANSWER
There is no regulation or standard I am aware of that requires
certification to any particular cleanliness class. However, to
maintain sterility assurance it is required to control and monitor the
manufacturing environment and product bioburden.
In my experience, typical industry practice is to manufacture or at
least package terminally sterilized in an ISO Class 8 or ISO Class
7 environment. That is the “old” Class 100,000 or Class 10,000.
If not, are there guidelines and standards on these controlled
environments?
SAM ANSWER
The ISO 14644-x series applies to Cleanrooms and associated
controlled environments
QUESTION & ANSWER
82

83. Medical Device Standards 'State-of-the-Art' 2012-12 By Sam Lazzara (for exclusive use of my clients by invitation)
Sam Lazzara
medicaldevicequality.blogspot.com
sam@lazzara.net
+1 510 3979739
MORE
QUESTIONS?
83