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ISO 11138-4:2017

Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat 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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Scope

ISO 11138-4:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing dry heat as the sterilizing agent at sterilizing temperatures within the range of 120 °C to 180 °C.
NOTE 1 Requirements for validation and control of dry heat sterilization processes are provided by ISO 20857.
NOTE 2 Requirements for work place safety can be provided by national or regional regulations.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 11138-4:2006

NOW

PUBLISHED
ISO 11138-4:2017
90.93 Standard confirmed
Dec 9, 2022

National adoptions

SSH EN ISO 11138-4:2017  
DPS

Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2017)

60.60 Standard published

DPS/KT 206 more