DS/EN ISO 7886-3:2020

Sterile hypodermic syringes for single use – Part 3: Auto-disabled syringes for fixed-dose immunization (ISO 7886-3:2020)


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
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Legislation:

Please note that this standard has not yet been harmonised and thus cannot be used for CE marking. Until harmonisation of this standard has been achieved, please use one of the following standards: 


Legislation

Please note that this standard has not yet been harmonised and thus cannot be used for CE marking. Until harmonisation of this standard has been achieved, please use one of the following standards: 

Links

Scope

This document specifies the properties and performance of sterile single-use hypodermic
syringes with or without needle, made of plastic, rubber or other materials and intended for the
filling and the injection of vaccines immediately after filling. Upon delivering a fixed dose of
vaccine, the syringe is automatically rendered unusable.

This document does not specify the design of the auto-disable feature, which is left to the
discretion of the manufacturer.

This document is not applicable to syringes for use with insulin (specified in ISO 8537), syringes
for use with power-driven syringe pumps (specified in ISO 7886-2), reuse prevention syringes
(specified in ISO 7886-4) and syringes designed to be prefilled. It does not address compatibility
with injection fluids/vaccines.

NOTE – Prefilled syringes are covered in the ISO 11040- series.



Number of pages: 28

Published: 2020-05-26

Date of approval: 2020-05-25

International relationships : EN ISO 7886-3:2020 IDT ISO 7886-3:2020 IDT

ICS: 11.040.25 -

Syringes, needles and catheters

Item number: M332480


Committees

Committee

  • CEN/TC 205
  • ISO/TC 84

Danish committee

DS/S-093