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BS EN ISO 11138-1:2017 – TC:2020 Edition

BS EN ISO 11138-1:2017 – TC:2020 Edition

$258.95

Tracked Changes. Sterilization of health care products. Biological indicators – General requirements

Published By Publication Date Number of Pages
BSI 2020 115
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PDF Catalog

PDF Pages PDF Title
67 European foreword
68 Endorsement notice
70 Foreword
71 Introduction
73 1 Scope
2 Normative references
3 Terms and definitions
76 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
77 4.2.2 Originating inoculum for suspension
4.2.3 Test organism count
4.3 Information to be provided by the manufacturer (labelling)
78 4.4 Storage and transport
79 5 Specific manufacturing requirements
5.1 Suspensions
5.2 Carrier, primary and secondary packaging
5.3 Inoculated carrier
80 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
81 6.4 Resistance characteristics
6.5 Test conditions
82 7 Culture conditions
7.1 Incubator
7.2 Growth medium
7.3 Incubation
83 7.4 Software validation
7.5 Incubation time using detection system
84 Annex A (normative) Determination of viable count
86 Annex B (normative) Determination of growth inhibition by carriers and primary packaging materials exposed to sterilization processes
89 Annex C (normative) D value determination by survivor curve method
93 Annex D (normative) D value determination by fraction negative method
109 Annex E (normative) Survival-kill response characteristics
111 Annex F (informative) Relationship between components of biological indicators
112 Bibliography

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BS EN ISO 11138-1:2017 - TC
$258.95