review of ISO 11737, AAMI/ST-2 and the AAMI ST/WG 8 decided to adopt it verbatim, as a edition of third ANSI/AAMI/ISO 11737-2:2019. AAMI and ANSI procedures require that standards be reviewed and, if necessary, revised every five years to reflect technological advances that may have occurred since publication.

ISO 11737-2, Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition,

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ISO 11737-2:2009 specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process. ISO 11737 consists of the following parts, under the general title Sterilization of medical devices — Microbiological methods: — Part 1: Determination of a population of microorganisms on products — Part 2: Tests of sterility performed in the validation of a sterilization process Europastandarden EN ISO 11737-2:2020 gäller som svensk standard. Detta dokument innehåller den officiella engelska versionen av EN ISO 11737-2:2020.

ANSI/AAMI/ISO 11737-1:2018 - Sterilization of health care products Microbiological methods Part 1: Determination of a population of microrganisms on products for the enumeration and characterization of bacteria on components, raw materials and packages and estimates bioburden in the revision changes.

ISO 11737 consists of the following parts, under the general title Sterilization of medical devices — Microbiological methods: — Part 1: Determination of a population of microorganisms on products — Part 2: Tests of sterility performed in the validation of a sterilization process Europastandarden EN ISO 11737-2:2020 gäller som svensk standard. Detta dokument innehåller den officiella engelska versionen av EN ISO 11737-2:2020. Denna standard ersätter SS-EN ISO 11737-2:2009, utgåva 2 The European Standard EN ISO 11737-2:2020 has the status of a Swedish Standard. This document Europastandarden EN ISO 11737-1:2018 gäller som svensk standard.

EN 556-1:2001/AC:2006, EN ISO 11737-1:2006 + AC:2009, EN ISO 11737-2:2009, EN 980:2008, EN 1041:2008, EN ISO 780:1999, EN ISO 11607-1:2009, 

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iso 11737-2:2019 Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process Buy this standard Abstract ISO 11737-1:2006 specifies requirements and provides guidance for the enumeration and microbial characterization of the population of viable micro-organisms on or in a medical device, component, raw material or package. ISO 11737-1 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products. This second edition cancels and replaces the first edition ( ISO 11737-1:1995 ) which has been technically revised and ISO 11737-3:2004 whose contents it now incorporates.
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New work has started to prepare EN ISO 11737-3 on bacterial endotoxin testing. This will specify general criteria for determination of bacterial endotoxins on or in raw materials, components or health care products.

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UNE EN ISO 11737-1:2018 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on.

EN ISO 11737-2 November 2009 ICS 07.100.10; 11.080.01 Supersedes EN ISO 11737-2:2000 English Version Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009) Stérilisation des dispositifs médicaux - Méthodes A new version of EN ISO 11737-2 on tests of sterility was published as BS EN ISO 11737-2:2020 in May. Some changes parallel those incorporated in EN ISO 11737-1. Others include adding requirements that: the interval between manufacturing the device and sterilizing it reflects routine ISO 11737-1:2018, Sterilization of health care products ? Microbiological methods ? Part 1: Determination of a population of microorganisms on products [37] ISO/IEC 17025:2017, General requirements for the competence of testing and calibration laboratories ISO 11737-2, Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, Mikrobiell karaktärisering (ISO 11737-1) Det biologiska belastningstestet enligt ISO 11737 kan inkludera aeroba bakterier, sporer, aeroba svampar, anaerober eller någon kombination av ovanstående. Vanligtvis inkluderar mikrobiologisk analys en membranfiltrering efter produktekstraktion, mikrobiell tillväxt på mediet och räkning av synliga kolonier. BS EN ISO 11737-1:2018: Title: Sterilization of health care products.

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.

Sterilisering av medicintekniska produkter - Mikrobiologiska metoder - Del 1: Skattning av  EN-ISO 11737-1 enumeration A.8.6. Krav : < 300 cfu/100 cm2.

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