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BS EN ISO 11138-1:2017

BS EN ISO 11138-1:2017

$198.66

Sterilization of health care products. Biological indicators – General requirements

Published By Publication Date Number of Pages
BSI 2017 52
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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 ISO 11138 . Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISO 11138 . 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.

PDF Catalog

PDF Pages PDF Title
4 European foreword
5 Endorsement notice
7 Foreword
8 Introduction
10 1 Scope
2 Normative references
3 Terms and definitions
13 4 General manufacturing requirements
4.1 Manufacturing controls
4.1.1 Quality management systems
4.1.2 Traceability
4.1.3 Finished product requirements
4.1.4 Personnel
4.2 Test organism
4.2.1 Strain
14 4.2.2 Originating inoculum for suspension
4.2.3 Test organism count
4.3 Information to be provided by the manufacturer (labelling)
15 4.4 Storage and transport
16 5 Specific manufacturing requirements
5.1 Suspensions
5.2 Carrier, primary and secondary packaging
5.3 Inoculated carrier
17 5.4 Biological indicators
5.5 Self-contained biological indicators
6 Determination of population and resistance
6.1 General resistance requirements
6.2 Test organism
6.3 Population of test organisms
18 6.4 Resistance characteristics
6.5 Test conditions
19 7 Culture conditions
7.1 Incubator
7.2 Growth medium
7.3 Incubation
20 7.4 Software validation
7.5 Incubation time using detection system
21 Annex A (normative) Determination of viable count
23 Annex B (normative) Determination of growth inhibition by carriers and primary packaging materials exposed to sterilization processes
26 Annex C (normative) D value determination by survivor curve method
30 Annex D (normative) D value determination by fraction negative method
46 Annex E (normative) Survival-kill response characteristics
48 Annex F (informative) Relationship between components of biological indicators
49 Bibliography

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BS EN ISO 11138-1:2017
$198.66