NF EN ISO 11737-2

NF EN ISO 11737-2

May 2020
Standard Current

Sterilization of health care products - Microbiological methods - Part 2 : tests of sterility performed in the definition, validation and maintenance of a sterilization process

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, andd) culturing of biological indicators or inoculated products.NOTE 2 Guidance on culturing biological indicators is included in ISO 11138-7.

See more
View the extract
Main informations

Collections

National standards and national normative documents

Publication date

May 2020

Number of pages

40 p.

Reference

NF EN ISO 11737-2

ICS Codes

07.100.10   Medical microbiology
11.080.01   Sterilization and disinfection in general

Classification index

S98-118-2

Print number

1

International kinship

ISO 11737-2:2019

European kinship

EN ISO 11737-2:2020
Sumary
Sterilization of health care products - Microbiological methods - Part 2 : tests of sterility performed in the definition, validation and maintenance of a sterilization process

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.

Replaced standards (1)
NF EN ISO 11737-2
January 2010
Standard Cancelled
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 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.

Table of contents
  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Généralités
  • 5 Sélection du produit
  • 6 Méthodes utilisées pour les contrôles de stérilité
  • 7 Évaluation de la méthode des contrôles de stérilité
  • 8 Maintenance de la méthode des contrôles de stérilité
  • Annexe A (informative) Recommandations relatives aux contrôles de stérilité pratiqués au moment de la validation et de la maintenance d'un procédé de stérilisation
  • Annexe B (informative) Répartition type des responsabilités
  • Annexe ZA (informative) Relation entre la présente Norme européenne et les exigences essentielles concernées de la Directive européenne 90/385/CEE relative aux dispositifs médicaux implantables actifs [JO L 189]
  • Annexe ZB (informative) Relation entre la présente Norme européenne et les exigences essentielles concernées de la Directive européenne 93/42/CEE sur les dispositifs médicaux [JO L 169]
  • Annexe ZC (informative) Relation entre la présente Norme européenne et les exigences essentielles de la Directive européenne 98/79/CE relative aux dispositifs médicaux de diagnostic in vitro [JO L 331]
  • Annexe ZD (informative) Relation entre la présente Norme européenne et les exigences générales en matière de sécurité et de performances concernées du Règlement (UE) 2017/745
  • Annexe ZE (informative) Relation entre la présente Norme européenne et les exigences générales en matière de sécurité et de performances concernées du Règlement (UE) 2017/746
  • Bibliographie
ZOOM ON ... the Requirements department
To comply with a standard, you need to quickly understand its issues in order to determine its impact on your activity.

The Requirements department helps you quickly locate within the normative text:
- mandatory clauses to satisfy,
- non-essential but useful clauses to know, such as permissions and recommendations.

The identification of these types of clauses is based on the document “ISO / IEC Directives, Part 2 - Principles and rules of structure and drafting of ISO documents ”as well as on a constantly enriched list of verbal forms.

With Requirements, quickly access the main part of the normative text!

With Requirements, quickly access the main part of the normative text!
What is the Redline format?
The Redline + service - standards comparator allows you to easily and simply identify major changes between the current standard and its last canceled version.

At a glance, you will be able to identify the additions, deletions or modifications to a text, table, figure and formula.
At a glance, you will be able to identify the additions, deletions or modifications to a text, table, figure and formula

The Redlines + service is offered to you on the collection of French standards in force, in French language and in HTML and PDF format.

For an overview of the service, click on View a standard in redline format
Need to identify, monitor and decipher standards?

COBAZ is the simple and effective solution to meet the normative needs related to your activity, in France and abroad.

Available by subscription, CObaz is THE modular solution to compose according to your needs today and tomorrow. Quickly discover CObaz!

Request your free, no-obligation live demo

I discover COBAZ