DS/EN ISO 7886-3:2009 ( Withdrawn )

Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization

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Withdrawn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

CE Harmonized

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 the properties and performance of sterile single-use hypodermic syringes with or without needle, made of plastic materials and stainless steel and intended for the aspiration of vaccines or for the injection of vaccines immediately after filling. Upon delivering a fixed dose of vaccine, the syringe is automatically rendered unusable.
This part of ISO 7886 does not specify the design of the auto-disable feature, which is left to the discretion of the manufacturer.
This part of ISO 7886 is not applicable to syringes for use with insulin (specified in ISO 8537), syringes made of glass (specified in ISO 595), syringes for use with power-driven syringe pumps (specified in ISO 7886-2), auto-disable syringes for variable dose delivery and syringes designed to be prefilled. It does not address compatibility with injection fluids/vaccines.
NOTE – A fourth part of ISO 7886 is being prepared to cover syringes with reuse prevention feature.

Replaces:

Number of pages: 32

Published: 2010-01-29

Date of approval: 2009-10-22

Date of withdrawal: 2020-11-30

International relationships : EN ISO 7886-3:2009 IDT ISO 7886-3:2005 IDT

ICS: 11.040.20 - Transfusion, infusion and injection equipment 11.040.25 -

Syringes, needles and catheters

Item number: M238086

Committees

Committee

  • CEN/SS S03
  • ISO/TC 84

Danish committee

DS/S-093