Sterilization of health care products. Biological indicators General requirements

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

30-04-2017

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General manufacturing requirements
5 Specific manufacturing requirements
6 Determination of population and 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

Describes 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.

This document specifies 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.

This document specifies basic and common requirements that are applicable to all parts of ISO11138 . Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISO11138 . If no specific subsequent part is provided, this document applies.

NOTE National or regional regulations can apply.

This document does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e.g. filtration processes or processes that combine physical and/or mechanical removal with microbiological inactivation, such as use of washer disinfectors or flushing and steaming of pipelines. This document, however, can contain elements relevant to such microbiological test systems.

Committee	CH/198
DevelopmentNote	Supersedes BS EN 866-1 and 04/30078095 DC (08/2006) Supersedes 15/30321502 DC. (04/2017)
DocumentType	Standard
Pages	52
PublisherName	British Standards Institution
Status	Current
Supersedes	BS EN 866-1:1997 04/30078095 DC : DRAFT JUL 2004 15/30321502 DC : 0 BS EN ISO 11138-1:2006

Standards	Relationship
DIN EN ISO 11138-1:2015-10 (Draft)	Identical
NBN EN ISO 11138-1 : 2006	Identical
UNE-EN ISO 11138-1:2007	Identical
SN EN ISO 11138-1:2017	Identical
UNI EN ISO 11138-1 : 2006	Identical
EN ISO 11138-1:2017	Identical
NS EN ISO 11138-1 : 2017	Identical
ISO 11138-1:2017	Identical
NF EN ISO 11138-1 : 2017	Identical
I.S. EN ISO 11138-1:2017	Identical
NEN EN ISO 11138-1 : 2017	Identical
UNE-EN ISO 11138-1:2017	Identical

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 11140-1:2014	Sterilization of health care products Chemical indicators Part 1: General requirements
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 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

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BS EN ISO 11138-1:2017

Current

Table of Contents

Abstract

Scope

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory

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