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CSA ISO 11737-1:19 (R2024)

Amendment 1:2023 to CSA ISO 11737-1:19, Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products (Adopted amendment 1:2021 to ISO 11737-1:2018)
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CSA ISO 11737-1:19 (R2024)

Amendment 1:2023 to CSA ISO 11737-1:19, Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products (Adopted amendment 1:2021 to ISO 11737-1:2018)

PUBLISH DATE 2019
PAGES 70
CSA ISO 11737-1:19 (R2024)
Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products (Adopted ISO 11737-1:2018, third edition, 2018-01)
Scope

This document specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package. NOTE 1 The nature and extent of microbial characterization is dependent on the intended use of bioburden data. NOTE 2 See Annex A for guidance on Clauses 1 to 9. This document does not apply to the enumeration or identification of viral, prion or protozoan contaminants. This includes the removal and detection of the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. NOTE 3 Guidance on inactivating viruses and prions can be found in ISO 22442-3, ICH Q5A(R1) and ISO 13022. This document does not apply to the microbiological monitoring of the environment in which health care products are manufactured.

SDO CSA: Canadian Standards Association
Document Number
Publication Date Jan. 1, 2019
Language en - English
Page Count 70
Revision Level
Supercedes
Committee
Publish Date Document Id Type View
Jan. 1, 2019 CSA ISO 11737-1:19 (R2024) Revision
Jan. 1, 2019 CSA ISO 11737-1:19 (R2024) Revision
Jan. 1, 2019 CSA ISO 11737-1:F19 (C2024) Revision
Jan. 1, 2019 CSA ISO 11737-1:F19 (C2024) Revision