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Development of ISO standards for AD syringes

Development of ISO standards for AD syringes. G. Injection technologies. Gerald Verollet. SIGN Meeting Cambodia, October 2002. Life span of injection device. Conception & Development. Manufacture. Packaging & Labelling. Advertising. Sale. Use. Disposal. Pre-market.

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Development of ISO standards for AD syringes

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  1. Development of ISO standards for AD syringes G Injection technologies Gerald Verollet SIGN Meeting Cambodia, October 2002

  2. Life span of injection device Conception & Development Manufacture Packaging & Labelling Advertising Sale Use Disposal Pre-market Placing on market Post-market SIGN Meeting Cambodia, October 2002

  3. Medical device safety >>>> First do not harm • Pre-market control • Post market surveillance • Limits SIGN Meeting Cambodia, October 2002

  4. Concept of risk management >>>> Maximal benefits and minimal risks • Risk identification • Risk classification • Risk prevention SIGN Meeting Cambodia, October 2002

  5. The role of each participant >>>> sharing the responsibilities • The manufacturer • The vendor • The users • The public • The government SIGN Meeting Cambodia, October 2002

  6. Standards >>>> definition • Standards are documented agreements containing technical specifications or other precise criteria to be used consistently as rules, guidelines, or definitions of characteristics, to ensure that materials, products, processes and services are fit for their purpose. SIGN Meeting Cambodia, October 2002

  7. Specifications >>>> for products, processes and services • Prescriptive specifications • Design specifications • Performance specifications • Management specifications SIGN Meeting Cambodia, October 2002

  8. Why do we need Standards >>>> just to define what it should be • Definition of quality system • Definition of product • Consensus SIGN Meeting Cambodia, October 2002

  9. New ISO standards for AD syringes >>>> from proposal to approval • New work item Proposal to ISO TC 84 • Work of Ad hoc group • “Committee draft” for comment and vote SIGN Meeting Cambodia, October 2002

  10. Stages of development of ISO Standards • Stage 1: Proposal stage • Stage 2: Preparatory stage • Stage 3: Committee stage • Stage 4: Enquiry stage • Stage 5: Approval stage • Stage 6: Publication stage SIGN Meeting Cambodia, October 2002

  11. Use of Standards >>>> from goodwill to good practices • Voluntary Standards • Conformity assessment /Accreditation • Quality assurance SIGN Meeting Cambodia, October 2002

  12. Work with NRA >>>> Protecting patients - Improving safety • Medical device regulations • Compliance with standards/QA procedure • Monitoring of adverse events SIGN Meeting Cambodia, October 2002

  13. …….Thank YOU • Any questions ? • …….. • …….. SIGN Meeting Cambodia, October 2002

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