Sterilization of health care products. Biological indicators Biological indicators for moist heat sterilization processes

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

04-30-2017

Publisher

British Standards Institution

This document specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing moist heat as the sterilizing agent.

NOTE1 Requirements for validation and control of moist heat sterilization processes are provided by the ISO17665 series.

NOTE2 National or regional regulations can provide requirements for work place safety.

Committee	CH/198
DevelopmentNote	Supersedes BS EN 866-3, BS EN 866-7 and 04/30078103 DC (08/2006) Supersedes 15/30321508 DC. (04/2017)
DocumentType	Standard
Pages	20
PublisherName	British Standards Institution
Status	Current
Supersedes	BS EN ISO 11138-3:2009 04/30078103 DC : DRAFT JUL 2004 BS EN 866-3:1997 15/30321508 DC : 0 BS EN ISO 11138-3:2006 BS EN 866-7:2000

Standards	Relationship
ISO 11138-3:2017	Identical
NF EN ISO 11138-3 : 2017	Identical
DIN EN ISO 11138-3:2015-10 (Draft)	Identical
NBN EN ISO 11138-3 : 2009	Identical
SN EN ISO 11138-3 : 2017	Identical
UNI EN ISO 11138-3 : 2009	Identical
NS EN ISO 11138-3 : 2017	Identical
UNE-EN ISO 11138-3:2017	Identical
EN ISO 11138-3:2017	Identical
I.S. EN ISO 11138-3:2017	Identical

ISO 18472:2006	Sterilization of health care products Biological and chemical indicators Test equipment
ISO 11138-1:2017	Sterilization of health care products — Biological indicators — Part 1: General requirements
ISO 14161:2009	Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
ISO 17665-1:2006	Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices