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ISO 11737-1:2018

Current
Current

The latest, up-to-date edition.

Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products
Amended by

ISO 11737-1:2018/Amd 1:2021

Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English, French

Published date

12-01-2018

Publisher

International Organization for Standardization

ISO 11737-1:2018 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.

ISO 11737-1:2018 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.

ISO 11737-1:2018 does not apply to the microbiological monitoring of the environment in which health care products are manufactured.

Committee
ISO/TC 198
DevelopmentNote
Supersedes ISO 11737-3 (05/2006) Supersedes ISO/DIS 11737-1. (01/2018) NEW CHILD AMD 1 2021 IS NOW ADDED.
DocumentType
Standard
Pages
48
ProductNote
NEW CHILD AMD 1 2021 IS NOW ADDED.
PublisherName
International Organization for Standardization
Status
Current
Supersedes

AAMI TIR52:2014(R2022) Environmental monitoring for terminally sterilized healthcare products
NASA-STD-8719.27:2022 IMPLEMENTING PLANETARY PROTECTION REQUIREMENTS FOR SPACE FLIGHT

AAMI TIR37 : 2013 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - GUIDANCE ON STERILIZATION OF BIOLOGICS AND TISSUE-BASED PRODUCTS
ISO 14160:2011 Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 11737-2:2009 Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO 11138-2:2017 Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
ISO 13022:2012 Medical products containing viable human cells — Application of risk management and requirements for processing practices
ISO 20857:2010 Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 9001:2015 Quality management systems — Requirements
ISO 7870-4:2011 Control charts Part 4: Cumulative sum charts
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
ISO/IEC 90003:2014 Software engineering Guidelines for the application of ISO 9001:2008 to computer software

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Hardcopy - English
PDF 1 User - English
PDF 3 Users - English
PDF 5 Users - English
PDF 9 Users - English
Hardcopy - French
PDF 1 User - French
PDF 3 Users - French
PDF 5 Users - French
PDF 9 Users - French
Hardcopy - English
PDF 1 User - English
PDF 3 Users - English
PDF 5 Users - English
PDF 9 Users - English
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