NF EN ISO 11737-2 : 2010
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
10-28-2021
01-12-2013
Avant-propos
Introduction
1 Domaine d'application
2 Références normatives
3 Termes et définitions
4 Éléments du système de management de la qualité
5 Sélection du produit
6 Méthodes utilisées pour les controles de stérilité
7 Évaluation de la méthode des controles de stérilité
8 Maintenance de la méthode des controles de stérilité
Annexe A (informative) - Directives concernant les controles
de stérilité pratiqués au moment de la validation et
de la maintenance d'un procédé de stérilisation
Bibliographie
Establishes the general requirements for tests 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 carried out when validating a sterilization process. Does not apply to sterility testing for routine release of product that has been subjected to a sterilization process, nor to performance of a pharmacopoeial sterility test.
| DevelopmentNote |
Indice de classement: S98-118-2. Supersedes NFS 98 118. (03/2004) PR NF EN ISO 11737-2 February 2008. (02/2008)
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| DocumentType |
Standard
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| PublisherName |
Association Francaise de Normalisation
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| Status |
Withdrawn
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| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| DIN EN ISO 11737-2:2010-04 | Identical |
| NBN EN ISO 11737-2 : 2010 | Identical |
| NS EN ISO 11737-2 : 2009 | Identical |
| ONORM EN ISO 11737-2 : 2010 | Identical |
| UNI EN ISO 11737-2 : 2010 | Identical |
| SN EN ISO 11737-2 : 2010 | Identical |
| BS EN ISO 11737-2:2009 | Identical |
| UNE-EN ISO 11737-2:2010 | Identical |
| ISO 11737-2:2009 | Identical |
| EN ISO 11737-2:2009 | Identical |
| NEN EN ISO 11737-2 : 2009 | Identical |
| I.S. EN ISO 11737-2:2009 | Identical |
| NF EN ISO 11135-1 : 2007 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| ISO 11737-1:2006 | Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO 10012:2003 | Measurement management systems — Requirements for measurement processes and measuring equipment |
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