Sterilization of health care products. Biological indicators Biological indicators for low-temperature steam and formaldehyde sterilization processes

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

30-04-2017

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 low-temperature steam and formaldehyde as the sterilizing agent.

NOTE1 Requirements for validation and control of low-temperature steam and formaldehyde sterilization processes are provided by ISO14937 .

NOTE2 Requirements for work place safety can be provided by national or regional regulations.

Committee	CH/198
DevelopmentNote	Supersedes BS EN 866-5 and 04/30078111 DC (08/2006) Supersedes 15/30321514 DC. (04/2017)
DocumentType	Standard
Pages	18
PublisherName	British Standards Institution
Status	Current
Supersedes	BS EN 866-5:2000 04/30078111 DC : DRAFT JUL 2004 15/30321514 DC : 0 BS EN ISO 11138-5:2006

Standards	Relationship
EN ISO 11138-5:2017	Identical
I.S. EN ISO 11138-5:2017	Identical
NEN EN ISO 11138-5 : 2017	Identical
UNI EN ISO 11138-5 : 2006	Identical
NS EN ISO 11138-5 : 2017	Identical
SN EN ISO 11138-5 : 2017	Identical
DIN EN ISO 11138-5:2015-10 (Draft)	Identical
NBN EN ISO 11138-5 : 2006	Identical
ISO 11138-5:2017	Identical
UNE-EN ISO 11138-5:2017	Identical
NF EN ISO 11138-5 : 2017	Identical

ISO 14937:2009	Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO 25424:2009	Sterilization of medical devices Low temperature steam and formaldehyde Requirements for development, validation and routine control of a sterilization process for medical devices
EN 14180:2014	Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
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