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ISO 11138-5:2017

Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes

Mar 3, 2017

General information

90.93     Dec 9, 2022

ISO

ISO/TC 198

International Standard

11.080.01  

English   French  

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Published

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 11138-5:2006

NOW

PUBLISHED
ISO 11138-5:2017
90.93 Standard confirmed
Dec 9, 2022

CORRIGENDA / AMENDMENTS

ABANDON
ISO 11138-5:2017/NP Amd 1

National adoptions

SSH EN ISO 11138-5:2017  
DPS

Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2017)

60.60 Standard published

DPS/KT 206 more