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1.1.1 This document provides guidance for bioburden testing and tests of sterility for biologics and tissue-based products, where this testing is in relation to product sterilization. NOTE This document is intended to be used in conjunction with ISO 11737-1 and ISO 11737-2. 1.1.2 Guidance in this document can be applicable to biologics and tissue-based products that are not sterile but are microbiologically controlled.

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EN-ISO 11737-2 specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent which has been 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. This document is not applicable to: a) sterility testing for routine release of product that has been subjected to a sterilization process, b) performing a test for sterility. c) test of sterility or test for sterility for demonstration of product shelf life, stability and/or package integrity, and d) culturing of biological indicators or inoculated products.

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1.1 This document specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent which has been 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. 1.2 This document is not applicable to: a) sterility testing for routine release of product that has been subjected to a sterilization process, b) performing a test for sterility (see 3.12), NOTE 1 The performance of a) or b) is not a requirement of ISO 11135, ISO 11137-1, ISO 11137-2, ISO 14160, ISO 14937, ISO 17665-1 or ISO 20857. c) test of sterility or test for sterility for demonstration of product shelf life, stability and/or package integrity, and d) culturing of biological indicators or inoculated products. NOTE 2 Guidance on culturing biological indicators is included in ISO 11138-7.

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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.

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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.

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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.

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Amandma A1:2010 je dodatek k standardu SIST EN ISO 14729:2002
This International Standard specifies two test methods for evaluating the antimicrobial activity of products to be marketed for contact lens disinfection by chemical means and for products that are part of a contact lens care regimen. This International Standard is not applicable to the hygienic management of trial lenses.

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1.1 This document specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent which has been 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.
1.2 This document is not applicable to:
a) sterility testing for routine release of product that has been subjected to a sterilization process,
b) performing a test for sterility (see 3.12),
NOTE 1 The performance of a) or b) is not a requirement of ISO 11135, ISO 11137-1, ISO 11137-2, ISO 14160, ISO 14937, ISO 17665-1 or ISO 20857.
c) test of sterility or test for sterility for demonstration of product shelf life, stability and/or package integrity, and
d) culturing of biological indicators or inoculated products.
NOTE 2 Guidance on culturing biological indicators is included in ISO 11138-7.

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Migrated from Progress Sheet (TC Comment) (2000-07-10): UAP of 4 months (TC Res 5/1999) (CC/990525)

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Migrated from Progress Sheet (TC Comment) (2000-07-10): UAP of 4 months (TC Res 5/1999) (CC/990525)
2020-01-20: Originator of XML version: NEN (on behalf of NEN, ASI, DS, SFS, SIS, SN)

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This European Standard specifies requirements for the performance of culture media. It is concerned with the traceability, comparability, reproducibility and suitability of culture media used in microbiological laboratories. These characteristics are achieved by applying the quality criteria outlined in this standard.  This European Standard is applicable to :  a) commercial organizations distributing media to microbiology laboratories in ready-to-use form, as dehydrated media or as semi-finished media (see 2.5 in EN 1659 : 1996) ;  b) non commercial organizations that distribute media to satellite locations ;  c) laboratories that prepare culture media for their own use.  Cell culture media are not covered by this standard.

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This European Standard provides terms for different classifications of culture media used in microbiology (bacteriology and mycology).

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This European Standard specifies requirements for the performance of culture media. It is concerned with the traceability, comparability, reproducibility and suitability of culture media used in microbiological laboratories. These characteristics are achieved by applying the quality criteria outlined in this standard.  This European Standard is applicable to :  a) commercial organizations distributing media to microbiology laboratories in ready-to-use form, as dehydrated media or as semi-finished media (see 2.5 in EN 1659 : 1996) ;  b) non commercial organizations that distribute media to satellite locations ;  c) laboratories that prepare culture media for their own use.  Cell culture media are not covered by this standard.

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This European Standard provides terms for different classifications of culture media used in microbiology (bacteriology and mycology).

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This part of ISO 11737 specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent that is a fraction of the specified sterilization process. These tests are intended to be performed when defining, validating or maintaining a sterilization process.

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2006-03-23  Final text (foreword) to be validated by TC Secretary before Publication.

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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.

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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.

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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.

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1.1 This Part of prEN 1174 specifies general criteria to be applied in the estimation of the population of viable micro-organisms on a medical device or on a component, raw material or package. This estimation consists of both enumeration and characterization of the population.  Note 1: Prior to routine use, a technique for estimating the population of micro-organisms on product is validated. The level to which, during characterization, identification is necessary is dependent on the use to be made of the data generated.   Note 2: Parts 2 and 3 of this European Standard will provide guidance on selection of a technique and outline method(s) which may be used to validate the technique selected.   Note 3: A bibliography of useful standards is given in Annex A.   1.2 This Part of EN 1174 is not applicable to the enumeration or identification of viral contamination.  1.3 This Part of EN 1174 is not applicable to the microbiological monitoring of the environment in which medical devices are manufactured (see Note1).   Note 1: Standards on environmental monitoring are being prepared by CEN/TC 243.   Note 2:  Attention is drawn to the standards for quality systems (see EN 46001 or EN 46002) which control all stages of manufacture including the sterilization process. It is not a requirement of this standard to have a complete quality system during manufacture but certain elements of such a system are required and these are normatively referenced at appropriate places in the text.

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This Part of EN 1174 gives guidance by describing approaches which may be taken when validating techniques for bioburden estimation.  This guidance is not intended to be exhaustive but is intended to highlight important aspects of methodology to which attention should be given.  This document is informative and does not contain requirements.

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This Part of this European Standard provides guidance on the implementation of the requirements specified in EN 1174-1. It is aimed at providing a better understanding of EN 1174-1 as well as assisting in implementing its requirements. The guidance given is not intended to be exhaustive, but to highlight important aspects to which attention should be given.  NOTE: This Part of EN 1174-1 is informative and does not contain requirements.  This Part of this European Standard is not intended as a checklist for assessing compliance with EN 1174-1.

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This Part of this European Standard provides guidance on the implementation of the requirements specified in EN 1174-1. It is aimed at providing a better understanding of EN 1174-1 as well as assisting in implementing its requirements. The guidance given is not intended to be exhaustive, but to highlight important aspects to which attention should be given.  NOTE: This Part of EN 1174-1 is informative and does not contain requirements.  This Part of this European Standard is not intended as a checklist for assessing compliance with EN 1174-1.

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This Part of EN 1174 gives guidance by describing approaches which may be taken when validating techniques for bioburden estimation.  This guidance is not intended to be exhaustive but is intended to highlight important aspects of methodology to which attention should be given.  This document is informative and does not contain requirements.

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1.1 This Part of prEN 1174 specifies general criteria to be applied in the estimation of the population of viable micro-organisms on a medical device or on a component, raw material or package. This estimation consists of both enumeration and characterization of the population.  Note 1: Prior to routine use, a technique for estimating the population of micro-organisms on product is validated. The level to which, during characterization, identification is necessary is dependent on the use to be made of the data generated.   Note 2: Parts 2 and 3 of this European Standard will provide guidance on selection of a technique and outline method(s) which may be used to validate the technique selected.   Note 3: A bibliography of useful standards is given in Annex A.   1.2 This Part of EN 1174 is not applicable to the enumeration or identification of viral contamination.  1.3 This Part of EN 1174 is not applicable to the microbiological monitoring of the environment in which medical devices are manufactured (see Note1).   Note 1: Standards on environmental monitoring are being prepared by CEN/TC 243.   Note 2:  Attention is drawn to the standards for quality systems (see EN 46001 or EN 46002) which control all stages of manufacture including the sterilization process. It is not a requirement of this standard to have a complete quality system during manufacture but certain elements of such a system are required and these are normatively referenced at appropriate places in the text.

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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.

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ISO 11737-3:2004 provides guidance on evaluating and interpreting the data generated during routine monitoring of the microbiological quality of medical devices. ISO 11737-3:2004 is not applicable to the use of bioburden data generated for establishing the extent of treatment to be applied in a sterilization process. ISO 11737-3:2004 is not applicable to microbiological data generated from sampling the environment in manufacturing areas.

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Specifies general criteria for the estimation of the population of viable microorganisms on medical devices or packages. Not applicable for the enumeration or identification of viral contamination and to the microbiological monitoring of the environment in which medical devices are manufactured.

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