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Superseded

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BS EN ISO 11138-1 - STERILIZATION OF HEALTH PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS

Available format(s)

Hardcopy , PDF

Superseded date

30-04-2017

Language(s)

English

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
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

BS EN ISO 11138-1.

Committee	CH/198
DocumentType	Draft
Pages	50
PublisherName	British Standards Institution
Status	Superseded
SupersededBy	BS EN ISO 11138-1:2017

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 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 14161:2009	Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
ISO 15223-1:2016	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
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