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BS ISO 11140-5:2007

Current
Current

The latest, up-to-date edition.

Sterilization of health care products. Chemical indicators Class 2 indicators for Bowie and Dick-type air removal tests
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

05-31-2007

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Indicator system
  5.1 Format
  5.2 Performance
6 Indicator
  6.1 Format
  6.2 Performance
7 Packaging and labelling
8 Quality assurance
9 Sampling conditioning
Annex A (normative) Determination of the degree of
        contrast between the colour of the substrate
        and the indicator agent
Annex B (normative) Method of determining uniform
        colour change on exposure to saturated
        steam
Annex C (normative) Method for determining indicator
        colour change on exposure to dry heat
Annex D (normative) Method for determining transfer of
        indicator agent to standard test pack
Annex E (normative) Standard test pack
Annex F (normative) Method of determining non-uniform
        colour change on exposure to a standard
        fault condition
Annex G (normative) Steam exposure apparatus
Bibliography

Describes the requirements for Class 2 indicators for Bowie and Dick-type air removal tests used to evaluate the effectiveness of air removal during the pre-vacuum phase of pre-vacuum steam sterilization cycles.

This part of ISO11140 specifies the requirements for Class 2 indicators for Bowie and Dick-type air removal tests used to evaluate the effectiveness of air removal during the pre-vacuum phase of pre-vacuum steam sterilization cycles.

Additionally, this part of ISO11140 includes test methods and equipment used to meet these performance requirements.

Committee
CH/198
DocumentType
Standard
Pages
22
PublisherName
British Standards Institution
Status
Current

Standards Relationship
ISO 11140-5:2007 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
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
IEC 60751:2008 Industrial platinum resistance thermometers and platinum temperature sensors
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

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Hardcopy - English
PDF - English
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