• There are no items in your cart

BS EN ISO 11140-4:2007

Current
Current

The latest, up-to-date edition.

Sterilization of health care products. Chemical indicators Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

03-30-2007

This part of ISO11140 specifies the performance for a Class 2 indicator to be used as an alternative to the Bowie and Dick-type test for steam sterilizers for wrapped health care goods (instruments, etc., and porous loads).

NOTE The Bowie and Dick-type test is used for routine testing of steam sterilizers and validation of steam sterilization processes.

An indicator complying with this part of ISO11140 incorporates a specified material which is used as a test load. This test load may, or may not, be re-usable. This part of ISO11140 does not specify requirements for the test load, but specifies the performance of the indicator in combination with the test load with which it is intended to be used. The indicator specified in this part of ISO11140 is intended to identify poor steam penetration but does not necessarily indicate the cause of this poor steam penetration.

This part of ISO11140 does not include test methods to establish the suitability of these indicator systems for use in sterilizers in which the air removal stage does not include evacuation below atmospheric pressure.

Committee
CH/198
DevelopmentNote
Supersedes BS EN 867-4. (03/2007) Supersedes 05/30116432 DC. (04/2007)
DocumentType
Standard
Pages
46
PublisherName
British Standards Institution
Status
Current
Supersedes

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 11140-3:2007 Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
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 5-3:2009 Photography and graphic technology Density measurements Part 3: Spectral conditions
IEC 60751:2008 Industrial platinum resistance thermometers and platinum temperature sensors
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 10012-1:1992 Quality assurance requirements for measuring equipment Part 1: Metrological confirmation system for measuring equipment
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

View more information
US$294.67
Excluding Tax where applicable

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.