Sterilization of health care products. Biological indicators Biological indicators for dry 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 dry heat as the sterilizing agent at sterilizing temperatures within the range of 120°C to 180°C.

NOTE1 Requirements for validation and control of dry heat sterilization processes are provided by ISO20857 .

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

Committee	CH/198
DevelopmentNote	Supersedes BS EN 866-6 and 04/30078107 DC (08/2006) Supersedes 15/30321511 DC. (04/2017)
DocumentType	Standard
Pages	20
PublisherName	British Standards Institution
Status	Current
Supersedes	BS EN ISO 11138-4:2006 15/30321511 DC : 0 BS EN 866-6:2000 04/30078107 DC : DRAFT JUL 2004

Standards	Relationship
SN EN ISO 11138-4 : 2017	Identical
NBN EN ISO 11138-4 : 2006	Identical
NS EN ISO 11138-4 : 2017	Identical
UNI EN ISO 11138-4 : 2006	Identical
UNE-EN ISO 11138-4:2017	Identical
NEN EN ISO 11138-4 : 2017	Identical
I.S. EN ISO 11138-4:2017	Identical
DIN EN ISO 11138-4:2015-10 (Draft)	Identical
EN ISO 11138-4:2017	Identical
ISO 11138-4:2017	Identical
NF EN ISO 11138-4 : 2017	Identical

ISO 18472:2006	Sterilization of health care products Biological and chemical indicators Test equipment
ISO 20857:2010	Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices
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