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CAN/CSA-ISO 11140-3:18

CAN/CSA-ISO 11140-3:18

Current

Current

The latest, up-to-date edition.

Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (Adopted ISO 11140-3:2007, second edition, 2007-03-15, including technical corrigendum 1:2007)

Available format(s)

Hardcopy , PDF

Language(s)

French, English

Published date

01-01-2018

Publisher

Canadian Standards Association

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Indicator system format
6 Performance requirements
7 Packaging and labeling
8 Quality assurance
Annex A (normative) - Determination of
                      strength after steam sterilization
Annex B (normative) - Estimation of visual
                      difference between colour of
                      the substrate and the changed
                      (or unchanged) indicator system
                      by determination of relative
                      reflectance density
Annex C (normative) - Determination of
                      indicator colour change on
                      exposure to dry saturated
                      steam
Annex D (normative) - Determination of
                      indicator colour change on
                      exposure to dry heat
Annex E (normative) - Accelerated ageing
                      of test samples
Annex F (normative) - Determination of
                      transfer of indicator to
                      standard test pack on
                      processing
Annex G (normative) - Determination of
                      shelf life of the product
Annex H (normative) - Steam exposure apparatus
Annex I (normative) - Determination of sensitivity
                      of the indicator to the
                      presence of air
Annex J (normative) - Air injection system
Annex K (normative) - Standard test pack
Bibliography

CSA Preface This is the first edition of CAN/CSA-ISO 11140-3, Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11140-3 (second edition, 2007-03-15), including Technical Corrigendum 1:2007. Scope This part of ISO 11140 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 ISO 11140-1. Indicators complying with this part of ISO 11140 are intended for use in combination with the standard test pack as described in EN 285. This part of ISO 11140 does not consider the performance of the standard test pack, but does specify the performance of the indicator systems.

CSA Preface This is the first edition of CAN/CSA-ISO 11140-3, Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11140-3 (second edition, 2007-03-15), including Technical Corrigendum 1:2007. Scope This part of ISO 11140 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 ISO 11140-1. Indicators complying with this part of ISO 11140 are intended for use in combination with the standard test pack as described in EN 285. This part of ISO 11140 does not consider the performance of the standard test pack, but does specify the performance of the indicator systems.

DocumentType
Standard
ISBN
978-1-4883-1666-1
Pages
42
PublisherName
Canadian Standards Association
Status
Current

Standards Relationship
ISO 11140-3:2007 Identical

ISO 5636-3:2013 Paper and board — Determination of air permeance (medium range) — Part 3: Bendtsen method
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/CIE 10526:1999 CIE standard illuminants for colorimetry
ISO 2248:1985 Packaging Complete, filled transport packages Vertical impact test by dropping

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Hardcopy - French
PDF - French
Hardcopy - English
PDF - English
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