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    I am Modester by name good day. i just went to your profile this time true this site (www.slideshare.net) and i got your detail and your explanation in fact the way you explain your self shows me that you are innocent and maturity and also understand person i decided to have a contact with you so that we can explain to our self each other because God great everyone to make a friend with each other and from that we know that we are from thism planet God great for us ok my dear please try and reach me through my email address (modester4life4@yahoo.com) so that i can send you my picture true your reply we can know each other ok have a nice day and God bless you yours Modester
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    1. 2. MEDICAL DEVICE STANDARDS
    2. 3. What is a medical device? <ul><li>According to IS 15579:2005/ISO 13485:2003, the definition of a medical device is </li></ul><ul><li>Any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purposes of </li></ul><ul><li>Diagnosis, prevention, monitoring, treatment or alleviation of disease, </li></ul><ul><li>Diagnosis, monitoring, treatment, alleviation of or compensation for an injury </li></ul><ul><li>Investigation, replacement, modification, or support of the anatomy or of a physiological process </li></ul><ul><li>Supporting or sustaining life, </li></ul><ul><li>Control of conception, </li></ul><ul><li>Disinfection of medical devices, </li></ul><ul><li>Providing information for medical purposes by means of in vitro examination of specimens derived from human body, </li></ul><ul><li>And which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means. </li></ul>
    3. 4. STANDARDIZATION <ul><li>FORMULTION OF STANDARDS </li></ul><ul><li>ISSUING STANDARDS </li></ul><ul><li>IMPLEMENTING STANDARDS </li></ul>
    4. 5. FIRST DRAFT CIRCULATION TO COMMITTEE MEMBERS P-DRAFT COMMENTS CIRCULATION TO COMMITTEE MEMBERS COMMENTS  WIDE CIRCULATION COMMENTS  NATIONAL  STANDARD NEW WORK ITEM STANDARDS DEVELOPMENT PROCESS MEETING WC DRAFT ADOPTION BY DIVISION COUNCIL F-DRAFT STANDARD MEETING
    5. 6. SCOPE OF MHDC <ul><li>“ Standardization In the Field Of Medical Equipment, Surgical Dressings, Artificial Limbs, Rehabilitation Equipment, Diagnostic Kits, Veterinary Surgery Instruments, Dental Equipment, Laboratory Instruments & Equipment and Hospital Planning” </li></ul>
    6. 7. Structure of a Sectional Committee <ul><li>Members from: </li></ul><ul><li>Manufacturers </li></ul><ul><li>Consumers, Government Departments </li></ul><ul><li>Technologists, Regulating Authorities, Testing Laboratories, Consultants, Universities, Other Experts </li></ul>
    7. 8. SECTIONAL COMMITTEES MHD 01 SURGICAL INSTRUMENTS SECTIONAL COMMITTEE MHD 02 ORTHOPAEDIC INSTRUMENTS, IMPLANTS AND ACCESSORIES SECTIONAL COMMITTEE MHD 03 OBSTRETICS AND GYNAECOLOGICAL INSTRUMENTS AND APPLIANCES SECTIONAL COMMITTEE MHD 04 EAR, NOSE AND THROAT SURGERY INSTRUMENTS SECTIONAL COMMITTEE MHD 05 OPHTHALMIC INSTRUMENTS AND APPLIANCES SECTIONAL COMMITTEE
    8. 9. SECTIONAL COMMITTEES MHD 06 THORACIC AND CARDIOVASCULAR SURGERY INSTRUMENTS SECTIONAL COMMITTEE MHD 07 NEUROSURGERY INSTRUMENTS IMPLANTS AND ACCESSORIES SECTIONAL COMMITTEE MHD 08 DENTISTRY SECTIONAL COMMITTEE MHD 09 ARTIFICIAL LIMBS, REHABILITATION APPLIANCES AND EQUIPMENT FOR THE DISABLED SECTIONAL COMMITTEE MHD 10 MEDICAL LABORATORY INSTRUMENTS SECTIONAL COMMITTEE
    9. 10. SECTIONAL COMMITTEES MHD 11 ANAESTHETIC,RESUSCITATION AND ALLIED EQUIPMENT SECTIONAL COMMITTEE MHD 12 HOSPITAL EQUIPEMNT SECTIONAL COMMITTEE MHD 13 VETERINARY HOSPITAL PLANNING AND SURGICAL INTRUMENTS SECTIONAL COMMITTEE MHD 14 HOSPITAL PLANNING SECTIONAL COMMITTEE MHD 15 ELECTROMEDICAL EQUIPMENT SECTIONAL COMMITTEE
    10. 11. SECTIONAL COMMITTEES <ul><li>MHD 16 SURGICAL DRESSING AND DISPOSABLE </li></ul><ul><li>PRODUCTS SECTIONAL COMMITTEE </li></ul><ul><li>MHD 17 HEALTH INFORMATICS SECTIONAL COMMITTEE </li></ul><ul><li>MHD 18 IMAGING AND RADIOTHERAPY EQUIPMENT </li></ul><ul><li>SECTIONAL COMMITTEE </li></ul><ul><li>MHD 19 IMMUNO-BIOLOGICAL DIAGNOSTIC KITS </li></ul><ul><li>SECTIONAL COMMITTEE </li></ul><ul><li>MHD20 MEDICAL BIOTECHNOLOGY AND NANOTECHNOLOGY </li></ul><ul><li>MHD21 HOSPITAL BIO MEDICAL WASTE MANAGEMENT AND INFECTION CINTROL </li></ul>
    11. 12. Laision with ISO/IEC Committees/Sub-Committees <ul><li>MHD 01 TC 170    Surgical instruments [P-member] </li></ul><ul><li>MH2 02/05/06/07 TC 150    Implants for surgery [P-member] </li></ul><ul><li>TC 150/SC 1 Materials [P-member] </li></ul><ul><li>TC 150/SC 2    Cardiovascular implants and extracorporeal systems [O-member] </li></ul><ul><li>TC 150/SC 3 Neurosurgical implants [O-member] </li></ul><ul><li>TC 150/SC 4    Bone and joint replacements [O-member] </li></ul><ul><li>TC 150/SC 5    Osteosynthesis and spinal devices   [P-member] </li></ul><ul><li>TC 150/SC 6    Active implants   [O-member] </li></ul><ul><li>MHD03 TC 157    Mechanical contraceptives [P-member] </li></ul><ul><li>MHD 04 TC 172    Optics and photonics   [O-member] </li></ul><ul><li>TC 172/SC 1    Fundamental standards [O-member] </li></ul><ul><li>TC 172/SC 3    Optical materials and components [O-member] </li></ul><ul><li>TC 172/SC 6    Geodetic and surveying instruments   [O-member] </li></ul><ul><li>TC 172/SC 7    Ophthalmic optics and instruments   [O-member] </li></ul><ul><li>TC 172/SC 9    Electro-optical systems   [O-member] </li></ul><ul><li>MHD 08 TC 106    Dentistry   [P-member] </li></ul><ul><li>TC 106/SC 1    Filling and restorative materials   [O-member] </li></ul><ul><li>TC 106/SC 2    Prosthodontic materials   [O-member] </li></ul><ul><li>TC 106/SC 3    Terminology   [O-member] </li></ul><ul><li>TC 106/SC 6    Dental equipment   [O-member] </li></ul><ul><li>TC 106/SC 7    Oral care products   [O-member] </li></ul><ul><li>TC 106/SC 8    Dental implants [O-member] </li></ul><ul><li>TC 194    Biological evaluation of medical devices [O-member] </li></ul><ul><li>MHD0 9 TC 173    Assistive products for persons with disability [O-member] </li></ul><ul><li>TC 168    Prosthetics and orthotics   [P-member] </li></ul>
    12. 13. Related ISO/IEC Committees/Sub-Committees(CONT.) <ul><li>MHD 10 TC 84   Devices for administration of medicinal products [P-member] </li></ul><ul><li> and intravascular catheters TC 76    Transfusion, infusion and injection equipment for [O-member] </li></ul><ul><li>medical and pharmaceutical use  </li></ul><ul><li>MHD 11 TC 121 Anaesthetic and respiratory equipment [P-member] </li></ul><ul><li>     TC121/SC6   Medical gas systems   [P-member] </li></ul><ul><li>     TC121/SC8   Suction devices for hospital and [O-member] </li></ul><ul><li> emergency care use </li></ul><ul><li>MHD 12 TC198    Sterilization of health care products [O-member] </li></ul><ul><li>MHD 14 TC210    Quality management and corresponding [P-member] </li></ul><ul><li>general aspects for medical devices  </li></ul><ul><li>MHD 15 IEC TC62 A: Common aspects of Electrical Equipments used in Practice [O-member] </li></ul><ul><li>First revision) </li></ul><ul><li>MHD 16 TC 76 Transfusion, infusion and injection equipment for medical and [O-member] </li></ul><ul><li>pharmaceutical use </li></ul><ul><li>TC 84 Devices fpr administration of medical product and </li></ul><ul><li>intravascular catheters [P member] </li></ul><ul><li>MHD 17 TC 215 Health informatics & its subcommittee </li></ul><ul><li>MHD 18 IEC SC 62B Diagnostic Imaging Equipment [O-member] </li></ul><ul><ul><ul><li>IEC 62 C Equipment for Radiotherapy [O-member] </li></ul></ul></ul><ul><li>MHD 19 TC 194 Biological; evaluation of medical devices [O-member] </li></ul><ul><li>MHD 20 TC 229 Health safety & environmental aspects of [O-member] </li></ul><ul><li>nanotechnology </li></ul><ul><li>TOTAL 36 </li></ul><ul><li>P-MEMBER 11 </li></ul><ul><li>O-MEMBER 25 </li></ul>
    13. 14. Some Important Standards published on Medical Devices <ul><li>IS 8048:1985 Electrocardiograph( first revision ) </li></ul><ul><li>This standard covers the safety and performance requirements and test methods for direct-writing single-channel and multi-channel electrocardiographs </li></ul><ul><li>This standard includes the construction and general requirements, general safety requirements, marking requirements, performance requirements and additional requirements for electrocardiographs to be used with pacemakers and defibrillators. </li></ul><ul><li>In addition, this standard describes various tests methods, for example: </li></ul><ul><li>(i) Type Tests(Dry heat, damp heat, high voltage, stability, leakage current) </li></ul><ul><li>(ii) Acceptance tests(High voltage, overload, accuracy of speed) </li></ul><ul><li>(iii) Routine tests (Stability, time constant, linearity) </li></ul>
    14. 15. … contd IS 8885:1994 Medical Electrical Equipment Electromyograph-Specification( first revision ) <ul><li>Electromyography is a technique for evaluating and recording the activation signal of muscles and it is performed using an instrument called an electromyograph. The record produced i.e electromyogram will be a visual display on the CRT augmented by a sufficiently loud sound pattern as an auditory signal output. </li></ul><ul><li>IS 8885:1994 covers the safety and performance requirements and test methods for single and multi-channel electromyographs. This standard also covers construction and general requirements and controls and connection of the electromyograph. </li></ul>
    15. 16. IS 9286(Part 1):1988 Cardiac defibrillators-safety requirements IS 9286(Part 2):1988 Cardiac defibrillators-Construction and performance requirements <ul><li>Part 1 specifies requirements for the safety of cardiac defibrillators and cardiac defibrillator monitors incorporating a capacitive energy storage device. </li></ul><ul><li>Part 2 specifies construction and performance requirements of cardiac defibrillators and cardiac defibrillators monitors </li></ul><ul><li>From the viewpoint of safety cardiac defibrillators and defibrillator monitors pose special problems not only because of the possible shock hazard to the operator, but also because the defibrillator must deliver the selected output even after a long period of disuse, otherwise the patient safety may be at risk. Therefore, cardiac defibrillator must have a higher degree order of reliability. </li></ul>
    16. 17. IS 11302(Part 1):1985 Electro-encephalograph(EEG) Part 1 General and Safety Requirements & Part 2 Performance Requirements <ul><li>The brain normally produces tiny electrical signals that come from the brain cells and nerves which send messages to each other. Electroencephalography (EEG) is the recording of electrical activity along the scalp produced by the firing of neurons within the brain. The instrument used for electroencephalography is called electroencephalograph. </li></ul><ul><li>Part 1 specifies general and safety requirements for electro-encephalographs and their associated accessories, intended for the production of detachable graphic recording of electrical activity of the brain for diagnostic purposes. </li></ul><ul><li>Part 2 specifies the particular performance requirements. </li></ul><ul><li>Special requirements concerning other requirements in electroencephalography (phono-photic stimulators), EEG telemetry, EEG data storage and retrieval, EEG monitoring of the critically ill, etc, are not covered by these standard. </li></ul>
    17. 18. IS 11754:1986 Specification for Implantable Ventricular Pacemaker <ul><li>A pacemaker is a medical device which uses electrical impulses, delivered by electrodes contacting the heart muscles, to regulate the beating of the heart. The primary purpose of a pacemaker is to maintain an adequate heart rate, either because the heart's native pacemaker is not fast enough, or there is a block in the heart's electrical conduction system </li></ul><ul><li>IS 11754:1986 applies exclusively to wholly implantable cardiac pacemakers, either of preset or the programmable type, and is conforming to those aspects of pacemakers which are concerned only with stimulation of the ventricle(asynchronous pacing) and with sensing and stimulation of the ventricle(ventricular inhibited or ventricular trigerred pacing). </li></ul>
    18. 19. IS 13450(Part 2/Sec 7):2006 Medical Electrical Equipment-Part 2 Particular requirements for the safety Section 7 High voltage generators of diagnostic X-ray generators <ul><li>This standard applies to high voltage generators of medical diagnostic X-ray generators and to their sub-assemblies including the following: </li></ul><ul><li>High voltage generators that are integrated with an X-ray tube assembly </li></ul><ul><li>High voltage generators of radiotherapy treatment simulators </li></ul><ul><li>The object of this standard is to establish particular requirements to ensure safety and to specify methods for demonstrating compliance with those requirements. </li></ul>
    19. 20. IS 13450(Part 2/Sec 45):2007 Medical Electrical Equipment Part 2 Particular requirement for safety Section 45 Mammographic X-ray equipment and mammographic Stereotactic devices <ul><li>This particular standard contains requirements for the safety of X-ray equipment designed for mammography and mammographic stereotactic devices. </li></ul><ul><li>The object of this standard is: </li></ul><ul><li>To formulate appropriate design and manufacturing requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices, reflecting the particular characteristics and circumstances of use of such equipment; </li></ul><ul><li>To establish particular requirements to ensure safety and to specify methods for demonstrating compliance with those requirements </li></ul>
    20. 21. IS 13450(Part 2/Sec 44):2007 Medical Electrical Equipment Part 2 Particular requirement for safety Section 44 X-ray equipment for computed tomography <ul><li>This particular standard applies to X-ray equipment for computed tomography (CT Scanners). It includes safety requirements for the X-ray generator, and those where high voltage generators are integrated with an X-ray tube assembly. </li></ul><ul><li>The object of this standard is to establish particular requirements to ensure safety and to specify methods for demonstrating compliance with those requirements, for CT scanners </li></ul>
    21. 22. STANDARDS ON DENTISTRY <ul><li>IS 5941:1970 Specification for Dental Engine, Electric </li></ul><ul><li>IS 6829:1991 Dental Instruments-Orthodontic pliers, angle wire </li></ul><ul><li>bending-Shape, dimensions and tests </li></ul><ul><li>IS 10663:2003 Dental rotary instruments-Steel and carbid burs </li></ul><ul><li>IS 10664:2003 Dental rotary instruments-Steel and carbide </li></ul><ul><li>finishing burs </li></ul>
    22. 23. STANDARDS ON OPTHALMIC INSTRUMENTS <ul><li>IS 12947:1990 Eye surgery instruments- Tonometers </li></ul><ul><li>- Specification </li></ul><ul><li>IS 8257:1976 Opthalmoscope </li></ul><ul><li>IS 6420:1989 Eye surgery instruments-Retractor, eye, </li></ul><ul><li>lachrymal sac Muller’s pattern (modified) </li></ul><ul><li>- Specification </li></ul><ul><li>IS 9688:1992 Eye surgery instruments-Hook, strabismus-Culler’s </li></ul><ul><li>Pattern </li></ul>
    23. 24. … .contd <ul><li>IS 5226:1989 Eye surgery instruments-Forceps, eye, corneo- </li></ul><ul><li>scleral disc, Elliot’s pattern(modified)-Specification </li></ul><ul><li>(second revision) </li></ul><ul><li>IS 5231:1990 Eye surgery instruments-Forceps, eye tarsal cyst, </li></ul><ul><li>Green’s pattern(modified)-Specification(second </li></ul><ul><li>revision) </li></ul><ul><li>IS 5232:1990 Eye surgery instruments-Forceps, eye cilia, Beer’s </li></ul><ul><li>pattern(modified)- Specification(second revision) </li></ul><ul><li>IS 5233:1990 Eye surgery instruments-Forceps, eye intra- </li></ul><ul><li>capsular, arruga’s and Elschnig’s pattern(modofied)- </li></ul><ul><li>Specification (Second revision) </li></ul>
    24. 25. Other Standards on Medical Devices <ul><li>Hypodermic needles (IS 3317) </li></ul><ul><li>Cystoscope (IS 5738) </li></ul><ul><li>Medical endoscopes(IS 15732/ISO 8600) </li></ul><ul><li>Orthopaedic Implants of different materials (in 18 parts) </li></ul><ul><li>(IS 5347/ISO 5832) </li></ul><ul><li>IUD (IS 12418) </li></ul><ul><li>Rubber condoms (IS/ISO 4074) </li></ul><ul><li>Intra ocular lenses (IS 14323) </li></ul><ul><li>Ultrasonic Therapy Equipment (IS 13020/IEC 60601-2-5) </li></ul><ul><li>Syringes (IS 3235/ISO 59512) </li></ul>
    25. 26. … contd <ul><li>Dental Explorers (IS/ISO 7492) </li></ul><ul><li>Hot air sterilizers (IS 3119) </li></ul><ul><li>Incubators (IS 3118) </li></ul><ul><li>Safety of Lung Ventillator (IS 11661/IEC 60601-2-12) </li></ul>
    26. 27. THANK YOU

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