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BS EN ISO 11138-5:2017

BS EN ISO 11138-5:2017

$102.76

Sterilization of health care products. Biological indicators – Biological indicators for low-temperature steam and formaldehyde sterilization processes

Published By Publication Date Number of Pages
BSI 2017 18
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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 low-temperature steam and formaldehyde as the sterilizing agent.

NOTE 1 Requirements for validation and control of low-temperature steam and formaldehyde sterilization processes are provided by ISO 14937 .

NOTE 2 Requirements for work place safety can be provided by national or regional regulations.

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
10 5 Test organism
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 low-temperature steam and formaldehyde
14 Annex B (informative) Rationale for the liquid-phase test method for low-temperature steam and formaldehyde biological indicators
15 Bibliography

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BS EN ISO 11138-5:2017
$102.76