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

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-31-2010

Publisher

British Standards Institution

This part of ISO11140 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 ISO11140-1.

Indicators complying with this part of ISO11140 are intended for use in combination with the standard test pack as described in EN285. This part of ISO11140 does not consider the performance of the standard test pack, but does specify the performance of the indicator systems.

Committee	CH/198
DevelopmentNote	Supersedes BS EN 867-3. (03/2007)
DocumentType	Standard
Pages	32
PublisherName	British Standards Institution
Status	Current
Supersedes	BS EN ISO 11140-3:2007

Standards	Relationship
SN EN ISO 11140-3:2009	Identical
NF EN ISO 11140-3 : 2009	Identical
I.S. EN ISO 11140-3:2009	Identical
DIN EN ISO 11140-3:2009-09	Identical
UNI EN ISO 11140-3 : 2009	Identical
ISO 11140-3:2007	Identical
NBN EN ISO 11140-3 : 2009	Identical
EN ISO 11140-3:2009	Identical
UNE-EN ISO 11140-3:2009	Identical
NS EN ISO 11140-3 : 2009	Identical
NEN EN ISO 11140-3 : 2009	Identical

ISO 5636-3:2013	Paper and board — Determination of air permeance (medium range) — Part 3: Bendtsen method
ISO 15882:2008	Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results
EN 285:2015	Sterilization - Steam sterilizers - Large sterilizers
ISO 187:1990	Paper, board and pulps — Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples
ISO 11140-1:2014	Sterilization of health care products Chemical indicators Part 1: General requirements
ISO 5-4:2009	Photography and graphic technology Density measurements Part 4: Geometric conditions for reflection density
ISO 5457:1999	Technical product documentation Sizes and layout of drawing sheets
ISO 5-3:2009	Photography and graphic technology Density measurements Part 3: Spectral conditions
ISO 5-1:2009	Photography and graphic technology Density measurements Part 1: Geometry and functional notation
ISO 9001:2015	Quality management systems — Requirements
ISO/CIE 10526:1999	CIE standard illuminants for colorimetry
ISO 2248:1985	Packaging Complete, filled transport packages Vertical impact test by dropping
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