DS/EN ISO 11140-3:2009

Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 74.64
Legislation:

Legislation

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

Harmonized standards:
Links

Scope

This part of ISO 11140 specifies the requirements for chemical indicators to be used in the steam penetration test for steam sterilizers for wrapped goods, e.g. instruments and porous materials. The indicator for this purpose is a Class 2 indicator as described in ISO 11140-1.
Indicators complying with this part of ISO 11140 are intended for use in combination with the standard test pack as described in EN 285. This part of ISO 11140 does not consider the performance of the standard test pack, but does specify the performance of the indicator systems.


Number of pages: 36

Published: 2009-07-02

Date of approval: 2009-06-11

International relationships : EN ISO 11140-3:2009 IDT ISO 11140-3:2007 IDT

ICS: 11.080.01 - Sterilization and disinfection in general 11.080.20 - Disinfectants and antiseptics

Item number: M235359


Committees

Committee

  • CEN/TC 102/WG 7
  • ISO/TC 198/WG 6

Danish committee

DS/S-259