Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)

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.

Sterilisation von Produkten für die Gesundheitsfürsorge - Mikrobiologische Verfahren - Teil 2: Prüfungen der Sterilität bei der Definition, Validierung und Aufrechterhaltung eines Sterilisationsverfahrens (ISO 11737-2:2019)

1.1   Dieses Dokument legt die allgemeinen Kriterien für Prüfungen der Sterilität von Medizinprodukten fest, die einer Behandlung mit dem sterilisierenden Agens unterzogen wurden, die im Vergleich zu derjenigen, die voraussichtlich bei routinemäßigen Sterilisationsverfahren angewendet wird, reduziert wurde. Diese Prüfungen sind vorgesehen, wenn ein Sterilisationsverfahren definiert, validiert oder aufrechterhalten wird.
1.2   Dieses Dokument gilt nicht für:
a)   die Sterilitätsprüfung für die Routinefreigabe eines Produkts, das einem Sterilisationsverfahren unterzogen wurde;
b)   das Durchführen einer Prüfung auf Sterilität (siehe 3.14);
ANMERKUNG 1   Die Durchführung von a) oder b) ist keine Anforderung von ISO 11135, ISO 11137 1, ISO 11137 2, ISO 14160, ISO 14937, ISO 17665 1 oder ISO 20857.
c)   Prüfung der Sterilität oder Prüfung auf Sterilität zum Nachweis der Haltbarkeitsdauer und Stabilität des Produkts und/oder der Unversehrtheit der Verpackung; und
d)   die Kultivierung biologischer Indikatoren oder beimpfter Produkte.
ANMERKUNG 2   Ein Leitfaden über die Kultivierung biologischer Indikatoren ist in ISO 11138 7 enthalten

Stérilisation des produits de santé - Méthodes microbiologiques - Partie 2: Contrôles de stérilité pratiqués au moment de la définition, de la validation et de la maintenance d'un procédé de stérilisation (ISO 11737-2:2019)

1.1    Le présent document spécifie les critères généraux pour les contrôles de stérilité des dispositifs médicaux qui ont été exposés à un traitement par un agent stérilisant, d'une plus faible ampleur que celui qu'il est prévu d'utiliser dans le procédé de stérilisation de routine. Les essais décrits sont destinés à être réalisés au moment de la définition, de la validation ou de la maintenance d'un procédé de stérilisation.

Sterilizacija izdelkov za zdravstveno nego - Mikrobiološke metode - 2. del: Preskusi sterilnosti pri definiciji, validaciji in vzdrževanju sterilizacijskih postopkov (ISO 11737-2:2019)

General Information

Status
Published
Publication Date
12-May-2020
Withdrawal Date
29-Nov-2020
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
13-May-2020
Completion Date
13-May-2020

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SLOVENSKI STANDARD
SIST EN ISO 11737-2:2020
01-julij-2020
Nadomešča:
SIST EN ISO 11737-2:2010
Sterilizacija izdelkov za zdravstveno nego - Mikrobiološke metode - 2. del:
Preskusi sterilnosti pri definiciji, validaciji in vzdrževanju sterilizacijskih
postopkov (ISO 11737-2:2019)
Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility
performed in the definition, validation and maintenance of a sterilization process (ISO
11737-2:2019)
Sterilisation von Produkten für die Gesundheitsfürsorge - Mikrobiologische Verfahren -
Teil 2: Prüfungen der Sterilität bei der Definition, Validierung und Aufrechterhaltung eines
Sterilisationsverfahrens (ISO 11737-2:2019)
Stérilisation des produits de santé - Méthodes microbiologiques - Partie 2: Contrôles de
stérilité pratiqués au moment de la définition, de la validation et de la maintenance d'un
procédé de stérilisation (ISO 11737-2:2019)
Ta slovenski standard je istoveten z: EN ISO 11737-2:2020
ICS:
07.100.10 Medicinska mikrobiologija Medical microbiology
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 11737-2:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11737-2:2020

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SIST EN ISO 11737-2:2020


EN ISO 11737-2
EUROPEAN STANDARD

NORME EUROPÉENNE

May 2020
EUROPÄISCHE NORM
ICS 07.100.10; 11.080.01 Supersedes EN ISO 11737-2:2009
English Version

Sterilization of health care products - Microbiological
methods - Part 2: Tests of sterility performed in the
definition, validation and maintenance of a sterilization
process (ISO 11737-2:2019)
Stérilisation des produits de santé - Méthodes Sterilisation von Produkten für die
microbiologiques - Partie 2: Contrôles de stérilité Gesundheitsfürsorge - Mikrobiologische Verfahren -
pratiqués au moment de la définition, de la validation Teil 2: Prüfungen der Sterilität bei der Definition,
et de la maintenance d'un procédé de stérilisation (ISO Validierung und Aufrechterhaltung eines
11737-2:2019) Sterilisationsverfahrens (ISO 11737-2:2019)
This European Standard was approved by CEN on 29 April 2020.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11737-2:2020 E
worldwide for CEN national Members.

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SIST EN ISO 11737-2:2020
EN ISO 11737-2:2020 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on active implantable medical devices
[OJ L 189] aimed to be covered . 4
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices [OJ L 169] aimed to be
covered. 6
Annex ZC (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices [OJ L
331] aimed to be covered .
...

SLOVENSKI STANDARD
oSIST prEN ISO 11737-2:2018
01-september-2018
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VWHULOQRVWLSULGHILQLFLMLYDOLGDFLMLLQY]GUåHYDQMXVWHULOL]DFLMVNLKSRVWRSNRY ,62',6

Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility
performed in the definition, validation and maintenance of a sterilization process
(ISO/DIS 11737-2:2018)
Sterilisation von Medizinprodukten - Mikrobiologische Verfahren - Teil 2: Prüfungen der
Sterilität bei der Definition, Validierung und Aufrechterhaltung eines
Sterilisationsverfahrens (ISO/DIS 11737-2:2018)
Stérilisation des dispositifs médicaux - Méthodes microbiologiques - Partie 2: Contrôles
de stérilité pratiqués au moment de la définition, de la validation et de la maintenance
d'un procédé de stérilisation (ISO/DIS 11737-2:2018)
Ta slovenski standard je istoveten z: prEN ISO 11737-2
ICS:
07.100.10 Medicinska mikrobiologija Medical microbiology
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
oSIST prEN ISO 11737-2:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 11737-2:2018

---------------------- Page: 2 ----------------------
oSIST prEN ISO 11737-2:2018
DRAFT INTERNATIONAL STANDARD
ISO/DIS 11737-2
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
2018-06-06 2018-08-29
Sterilization of medical devices — Microbiological
methods —
Part 2:
Tests of sterility performed in the definition, validation
and maintenance of a sterilization process
Stérilisation des dispositifs médicaux — Méthodes microbiologiques —
Partie 2: Contrôles de stérilité pratiqués au moment de la définition, de la validation et de la maintenance
d'un procédé de stérilisation
ICS: 11.080.01; 07.100.10
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 11737-2:2018(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2018

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oSIST prEN ISO 11737-2:2018
ISO/DIS 11737-2:2018(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

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oSIST prEN ISO 11737-2:2018
ISO/DIS 11737-2:2018(E)

Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Quality management system elements .
...

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