ISO 11138-5:2017

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

Publication date: Mar 3, 2017

General information

Current stage: 90.93 Effective date: Dec 9, 2022

Originator: ISO

Owner: ISO/TC 198

Type: International Standard

ICS: 11.080.01

Languages: English French

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Status: Published

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Paper - EC$183.61

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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

Revises
ISO 11138-5:2006

NOW

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

CORRIGENDA / AMENDMENTS

Amended by
ISO 11138-5:2017/NP Amd 1

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