NF EN ISO 14160 : 2011
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
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
12-01-2013
15-03-2023
1 Domaine d'application
2 Références normatives
3 Définitions
4 Généralités
5 Validation
6 Maîtrise et surveillance du procédé
7 Libération du produit après stérilisation
Annexe A (informative) Guide d'application
Annexe B (informative) Références aux Normes européennes
avec leurs équivalents respectifs
Annexe C (informative) Bibliographie
Defines requirements for developing, validating, process control and monitoring of the sterilization, using liquid chemical sterilants, of single-use medical devices consisting either entirely or partly of materials of animal origin. Not applicable to material of human origin.
| DevelopmentNote |
Indice de classement: S98-112. PR NF EN ISO 14160 July 2009. (07/2009)
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| DocumentType |
Standard
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| PublisherName |
Association Francaise de Normalisation
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| Status |
Superseded
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| SupersededBy |
| Standards | Relationship |
| NBN EN ISO 14160 : 2011 | Identical |
| NEN EN ISO 14160 : 2011 | Identical |
| BS EN ISO 14160:2011 | Identical |
| EN ISO 14160:2011 | Identical |
| I.S. EN ISO 14160:2011 | Identical |
| DIN EN ISO 14160:2011-10 | Identical |
| NS EN ISO 14160 : 2011 | Identical |
| ISO 14160:2011 | Identical |
| UNE-EN ISO 14160:2012 | Identical |
| 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 10993-17:2002 | Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances |
| ISO 10993-1:2009 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
| ISO 10012:2003 | Measurement management systems — Requirements for measurement processes and measuring equipment |
| ISO 22442-2:2015 | Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling |