DS/EN ISO 7886-4:2009 ( Withdrawn )

Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature


Status:
Withdrawn
Type:
Standard
Language:
English
Subject:
Replaced by:
Price from:
€ 68.17
Legislation:

Legislation

Harmonized under:
  • Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

Harmonized standards:
Links

Scope

This part of ISO 7886 specifies requirements for sterile single-use hypodermic syringes made of plastics materials with or without needle, and intended for the aspiration of fluids or for the injection of fluids immediately after filling and of design such that the syringe can be rendered unusable after use.
This part of ISO 7886 is not applicable to syringes made of glass (specified in ISO 595), auto-disable syringes for fixed dose immunization (ISO 7886-3) and syringes designed to be pre-filled. It does not address compatibility with injection fluids. Other standards can be applicable when syringes are used for any other intended purpose than those specified in this part of ISO 7886.
NOTE – Syringes designed to reduce the risk of needlestick injuries can also comply with this part of ISO 7886 with regard to their re-use prevention properties, but it is stressed that anti-needlestick properties of syringes are not in themselves addressed in this part of ISO 7886.


Number of pages: 32

Published: 2010-01-11

Date of approval: 2009-10-22

Date of withdrawal: 2019-09-30

International relationships : EN ISO 7886-4:2009 IDT ISO 7886-4:2006 IDT

ICS: 11.040.01 - Medical equipment in general 11.040.20 - Transfusion, infusion and injection equipment 11.040.25 -

Syringes, needles and catheters

Item number: M238087


Committees

Committee

  • CEN/SS S03
  • ISO/TC 84

Danish committee

DS/S-093