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BS EN ISO 11138-3:2017

BS EN ISO 11138-3:2017

$102.76

Sterilization of health care products. Biological indicators – Biological indicators for moist heat sterilization processes

Published By Publication Date Number of Pages
BSI 2017 20
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This document specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing moist heat as the sterilizing agent.

NOTE 1 Requirements for validation and control of moist heat sterilization processes are provided by the ISO 17665 series.

NOTE 2 National or regional regulations can provide requirements for work place safety.

PDF Catalog

PDF Pages PDF Title
4 European foreword
Endorsement notice
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Test organism
10 6 Suspension
7 Carrier and primary packaging
8 Inoculated carriers and biological indicators
9 Population and resistance
12 Annex A (normative) Method for determination of resistance to moist heat sterilization
13 Annex B (normative) Calculation of z value and coefficient of determination, r2
16 Bibliography

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BS EN ISO 11138-3:2017
$102.76