ISO 11737-1:2018
Current
The latest, up-to-date edition.
Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
English, French
12-01-2018
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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 |
| Standards | Relationship |
| DIN EN ISO 11737-1:2018-11 | Identical |
| NEN EN ISO 11737-1 : 2018 | Identical |
| UNI EN ISO 11737-1:2018 | Identical |
| PN-EN ISO 11737-1 : 2018-03 | Identical |
| ABNT NBR ISO 11737-1:2023 | Identical |
| GOST ISO 13485:2017 | Identical |
| ONORM EN ISO 11737-1:2019 | Identical |
| UNE-EN ISO 11737-1:2018 | Identical |
| SS-EN ISO 11737-1 : 2018 | Identical |
| EN ISO 11737-1:2018 | Identical |
| ANSI/AAMI/ISO 11737-1:2018 | Identical |
| CSA ISO 11737-1:19 | Identical |
| SN EN ISO 11737-1:2018 | Identical |
| I.S. EN ISO 11737-1:2018&LC:2018 | Identical |
| NF EN ISO 11737-1/A1:2021 | Identical |
| UNI EN ISO 11737-1:2021 | Identical |
| NF EN ISO 11737-1 : 2018 | Identical |
| BS EN ISO 11737-1:2018 | Identical |
| 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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