DS/EN ISO 11138-1:2006 ( Withdrawn )

Sterilization of health care products - Biological indicators - Part 1: General requirements


Status:
Withdrawn
Type:
Standard
Language:
English
Subject:
Replaced by:
Price from:
€ 96.69

Scope

1.1 General
1.1.1 This part of ISO 11138 provides general requirements for production, labeling, test methods and
performance characteristics of biological indicator systems, including inoculated carriers and suspensions, and their components to be used in the validation and routine monitoring of sterilization processes.
1.1.2 This part of the standard specifies basic and common requirements that are applicable to all
subsequent parts of the standard. Requirements for biological indicators for particular specified processes are provided in the subsequent parts of this standard. If no specific subsequent part is provided, this part applies.
NOTE – National or regional regulations should be considered.


Number of pages: 52

Published: 2006-09-27

Date of approval: 2006-07-14

Date of withdrawal: 2017-04-05

International relationships : EN ISO 11138-1:2006 IDT ISO 11138-1:2006 IDT

ICS: 11.080.01 - Sterilization and disinfection in general

Item number: 55891


Committees

Committee

  • CEN/TC 102
  • ISO/TC 198/WG 4

Danish committee

DS/S-259