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CSA CAN/CSA-ISO 11138-4:17 (R2022)

Current Reaffirmation

Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization (Adopted ISO 11138-4:2017, second edition, 2017-03)

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Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization (Adopted ISO 11138-4:2017, second edition, 2017-03)
CSA Preface This is the first edition of CAN/CSA-ISO 11138-4, Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11138-4 (second edition, 2017-03). For brevity, this Standard will be referred to as “CAN/CSA-ISO 11138-4” throughout.  This Standard was reviewed for Canadian adoption by the SCC Mirror Committee to ISO/TC 198, under the jurisdiction of the CSA Technical Committee on Medical Device Reprocessing and the CSA Strategic Steering Committee on Health Care Technology & Systems, and has been formally approved by the Technical Committee.  This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group. Scope 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 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.

SDO CSA: Canadian Standards Association
Document Number
Publication Date Dec. 30, 2022
Language en - English
Page Count
Revision Level
Supercedes
Committee
Publish Date Document Id Type View
Dec. 30, 2022 Reaffirmation
Dec. 30, 2022 Reaffirmation