Towards ISO Models for Advertisement syringes: Upgrade from WHO.

Uploaded on:
The Good AD Syringe definition: The World\'s Perspective . Made by benchmarks Used just onceSafe and simple to arrange. Promotion syringe showcase: The circumstance today . CurativeMajor marketMultiple client profilesAbsence of standards and standardsAbsence of proof with respect to counteractive action adequacy.
Slide 1

Towards ISO Standards for AD syringes: Update from WHO Gerald Verollet World Health Organization third SIGN Meeting - New Delhi

Slide 2

The Good AD Syringe definition: The World\'s Perspective Manufactured by gauges Used just once Safe and simple to arrange

Slide 3

Curative Major market Multiple client profiles Absence of standards and models Absence of proof in regards to aversion viability Immunization Limited market all around characterized clients existing details WHO/UNICEF strategy for utilization of AD syringes in Immunization AD syringe advertise: The circumstance today

Slide 4

From the last SIGN meeting Specific International Standard for AD syringes was prescribed

Slide 5

Standard: Definition Documented assentions For predictable use as: Rules Guidelines Definitions of attributes To guarantee that materials, items, procedures, and administrations are fit for their motivation.

Slide 6

Principle Consensus extensive Voluntary Actors Manufacturers users National standard bodies Specialists WHO ? Advancement of International Standards

Slide 7

ISO Standards ISO 9001 and 9002 General application for items and administrations ISO 13485 and 13488 Medical gadget industry with or without configuration control necessity ISO 7886-1 Sterile hypodermic syringes for single utilize section 1: Syringes for manual utilize ISO ???? Advertisement Syringes

Slide 8

WHO relations with ISO Category A contact status with TC 84 Official connection with ISO

Slide 9

Stages of the advancement of International Standards Proposal: Presentation of the proposition to the ISO/TC 84 "NEW WORK ITEM PROPOSAL" Preparatory Committee Enquiry Approval Publication

Slide 10

World Health Organization Contact with ISO for the proposition Contribution to handle assessment of AD syringes Independent audit of field assessment comes about advancement of rule for control on MD Aide-memoire on therapeutic gadget Co-appointment of post-market observation Arbitration on fare accreditation Ethical affirmation Contacts with Ministries of Health

Slide 11

AD Syringes Manufacturers Assurance that syringes meet/surpass norms Concept and configuration Manufacturing Packaging and naming Technical coordinated effort to enhance benchmarks and security International Association of Safe Injection Technologies (IASIT) PULL or PUSH > Proactive Approach ?

Slide 12

Recognition and utilization of worldwide benchmarks Production of good gauges is insufficient Recognition of models is required

Slide 13

National Regulatory Authorities Responsibility to guarantee syringes wellbeing and adequacy Periodic survey of arrangements and directions choice of control powers

Slide 14

Control Authorities Manufacturer\'s announcements Private testing research facilities E.g., "Informed body" for CE stamp items E.g., TUV in Germany Each nation could have its own Auditing

Slide 15


Slide 16

Our Objective is currently to... S peed up the I ntroduction of G ood N orms & Standards … ... for AD Syringes

View more...