ISO 11138-5:2017
Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
ISO 11138-5:2017 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.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Test organism
6 Suspension
7 Carrier and primary packaging
8 Inoculated carriers and biological indicators
9 Population and resistance
Annex A (normative) Method for determination of resistance to low-temperature steam and formaldehyde
Annex B (informative) Rationale for the liquid-phase test method for low-temperature steam and formaldehyde biological indicators
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Test organism
6 Suspension
7 Carrier and primary packaging
8 Inoculated carriers and biological indicators
9 Population and resistance
Annex A (normative) Method for determination of resistance to low-temperature steam and formaldehyde
Annex B (informative) Rationale for the liquid-phase test method for low-temperature steam and formaldehyde biological indicators
Bibliography