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

2. Life span of injection device Conception & Development Manufacture Packaging & Labelling AdvertisingSaleUseDisposal Pre-marketPost-marketPlacing on market SIGN Meeting Cambodia, October 2002

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

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

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

6. 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 >>>> definition >>>> definition Standards

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

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

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

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

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

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