NF EN ISO 14160 : 2011

Superseded

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

Superseded date

03-15-2023

Published date

01-12-2013

Publisher

Association Francaise de Normalisation

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)
DocumentType	Standard
PublisherName	Association Francaise de Normalisation
Status	Superseded
SupersededBy	NF EN ISO 14160:2021

Standards	Relationship
ONORM EN ISO 14160 : 2011	Identical
UNE-EN ISO 14160:2012	Identical
SN EN ISO 14160 : 2011	Identical
NBN EN ISO 14160 : 2011	Identical
UNI 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

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