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CSA Z11138-1 : 2007 : R2012

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
Available format(s)

Hardcopy , PDF

Superseded date

08-01-2017

Language(s)

English

Published date

01-01-2016

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General manufacturing requirements
5 Specific manufacturing requirements
6 Determination of resistance
7 Culture conditions
Annex A (normative) - Determination of viable count
Annex B (normative) - Determination of growth inhibition
        by carriers and primary packaging materials
        exposed to sterilization processes
Annex C (normative) - D value determination by survivor
        curve method
Annex D (normative) - D value determination by fraction
        negative method
Annex E (normative) - Survival-kill response characteristics
Annex F (informative) - Relationship between components
        of biological indicators
Bibliography

Provides general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes.

DocumentType
Standard
Pages
56
ProductNote
Reconfirmed EN
PublisherName
Canadian Standards Association
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
ISO 11138-1:2017 Identical

ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 10241:1992 International terminology standards Preparation and layout
ISO 690:2010 Information and documentation Guidelines for bibliographic references and citations to information resources
ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO 18472:2006 Sterilization of health care products Biological and chemical indicators Test equipment
ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
ISO/TS 11139:2006 Sterilization of health care products Vocabulary
ISO 11137-3:2017 Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 14161:2009 Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
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
ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied

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