CEN ISO/TS 11135-2:2008
(Main)Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1 (ISO/TS 11135-2:2008)
Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1 (ISO/TS 11135-2:2008)
ISO/TS 11135-2:2008 provides guidance for the requirements in ISO 11135-1:2007. It does not repeat the requirements and is not intended to be used in isolation. The exclusions in ISO 11135-1 apply also to this Technical Specification.
This guidance document is intended for people who have a basic knowledge of the principles of EO sterilization but may need help in determining how to best meet the requirements contained in ISO 11135-1. This document is not intended for people lacking a basic knowledge of the principles of EO sterilization.
Sterilisation von Produkten für die Gesundheitsfürsorge - Ethylenoxid - Teil 2: Leitfaden zur Anwendung von ISO 11135-1 (ISO/TS 11135-2:2008)
Diese Technische Spezifikation bietet einen Leitfaden für die Anforderungen in ISO 11135-1:2007. Die Anforderungen werden nicht wiederholt und es ist nicht vorgesehen, dass das Dokument alleinstehend verwendet wird.
Die Ausschließungen in ISO 11135-1 gelten auch in dieser Technischen Spezifikation.
Zum leichten Bezug entspricht die Abschnittsnummerierung in dieser Technischen Spezifikation der in ISO 11135-1:2007 verwendeten. Ein weitergehender Leitfaden für die in ISO 11135-1 enthaltenen Anforderungen ist auch in ISO 11135-1:2007, Anhang C enthalten und sollte gemeinsam mit dieser Technischen Spezifikation verwendet werden.
Das vorliegende anleitende Dokument ist für Personen gedacht, die über ein Grundwissen über die Prinzipien der EO-Sterilisation verfügen, jedoch Hilfe bei der Festlegung benötigen, wie die in ISO 11135-1 enthaltenen Anforderungen am besten erfüllt werden können. Dieses Dokument ist nicht für Personen gedacht, die über keine Grundkenntnisse der Prinzipien der EO-Sterilisation verfügen.
Stérilisation des produits de santé - Oxyde d'éthylène - Partie 2: Directives relatives à l'application de l'ISO 11135-1 (ISO/TS 11135-2:2008)
L'ISO/TS 11135-2:2008 fournit des directives pour satisfaire aux exigences de l'ISO 11135‑1. Elle ne reproduit pas ces exigences et n'est pas censée être utilisée individuellement.
Les directives données dans l'ISO/TS 11135-2:2008 peuvent être utilisées par des personnes ayant une maîtrise de base des principes de la stérilisation à l'oxyde d'éthylène mais susceptibles d'avoir besoin d'aide pour déterminer le meilleur moyen de répondre aux exigences de l'ISO 11135-1. La présente Spécification technique n'est pas destinée aux personnes n'ayant aucune connaissance des principes de la stérilisation à l'oxyde d'éthylène.
Sterilizacija izdelkov za zdravstveno nego - Etilenoksid - 2. del: Navodilo za uporabo ISO 11135-1 (ISO/TS 11135-2:2008)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2008
Sterilizacija izdelkov za zdravstveno nego - Etilenoksid - 2. del: Navodilo za
uporabo ISO 11135-1 (ISO/TS 11135-2:2008)
Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the
application of ISO 11135-1 (ISO/TS 11135-2:2008)
Sterilisation von Produkten für die Gesundheitsfürsorge - Ethylenoxid - Teil 2: Leitfaden
zur Anwendung von ISO 11135-1 (ISO/TS 11135-2:2008)
Stérilisation des produits de santé - Oxyde d'éthylène - Partie 2: Directives relatives à
l'application de l'ISO 11135-1 (ISO/TS 11135-2:2008)
Ta slovenski standard je istoveten z: CEN ISO/TS 11135-2:2008
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
TECHNICAL SPECIFICATION
CEN ISO/TS 11135-2
SPÉCIFICATION TECHNIQUE
TECHNISCHE SPEZIFIKATION
August 2008
ICS 11.080.01
English Version
Sterilization of health care products - Ethylene oxide - Part 2:
Guidance on the application of ISO 11135-1 (ISO/TS 11135-
2:2008)
Stérilisation des produits de santé - Oxyde d'éthylène - Sterilisation von Produkten für die Gesundheitsfürsorge -
Partie 2: Directives relatives à l'application de l'ISO 11135- Ethylenoxid - Teil 2: Leitfaden zur Anwendung von ISO
1 (ISO/TS 11135-2:2008) 11135-1 (ISO/TS 11135-2:2008)
This Technical Specification (CEN/TS) was approved by CEN on 8 June 2008 for provisional application.
The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to submit their
comments, particularly on the question whether the CEN/TS can be converted into a European Standard.
CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS available
promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in parallel to the CEN/TS)
until the final decision about the possible conversion of the CEN/TS into an EN is reached.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 11135-2:2008: E
worldwide for CEN national Members.
Contents Page
Foreword.3
Foreword
This document (CEN ISO/TS 11135-2:2008) has been prepared by Technical Committee CEN/TC 204
“Sterilization of medical devices", the secretariat of which is held by BSI, in collaboration with Technical
Committee ISO/TC 198 "Sterilization of health care products".
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to announce this Technical Specification: Austria, Belgium, Bulgaria, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO/TS 11135-2:2008 has been approved by CEN as a CEN ISO/TS 11135-2:2008 without any
modification.
TECHNICAL ISO/TS
SPECIFICATION 11135-2
First edition
2008-08-01
Sterilization of health care products —
Ethylene oxide —
Part 2:
Guidance on the application of
ISO 11135-1
Stérilisation des produits de santé — Oxyde d'éthylène —
Partie 2: Directives relatives à l'application de l'ISO 11135-1
Reference number
ISO/TS 11135-2:2008(E)
©
ISO 2008
ISO/TS 11135-2:2008(E)
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ISO/TS 11135-2:2008(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 2
4 Quality management systems . 2
4.1 Documentation. 2
4.2 Management responsibility . 2
4.3 Product realization. 3
4.4 Measurement, analysis and improvement — Control of non-conforming product . 3
5 Sterilizing agent characterization . 3
5.1 Sterilizing agent . 3
5.2 Microbicidal effectiveness . 3
5.3 Materials effects. 3
5.4 Environmental considerations . 3
6 Process and equipment characterization .4
6.1 Process characterization . 4
6.2 Equipment characterization. 4
7 Product definition . 5
7.1 General. 5
7.2 Product safety and performance. 8
7.3 Microbiological quality. 9
7.4 Documentation. 9
8 Process definition. 9
9 Validation. 12
9.1 Installation qualification. 13
9.2 Operational qualification. 14
9.3 Performance qualification. 15
9.4 Varying load configurations . 19
9.5 Review and approval of validation. 19
10 Routine monitoring and control . 20
10.1 General. 20
10.2 Parametric release. 21
11 Product release from sterilization. 22
12 Maintaining process effectiveness . 23
12.1 General. 23
12.2 Maintenance of equipment . 23
12.3 Requalification . 24
12.4 Assessment of change. 25
Annex A (informative) Guidance on ISO 11135-1:2007 Annex A Determination of process
lethality — Biological indicator/bioburden approach . 26
Annex B (informative) Guidance on ISO 11135-1:2007 Annex B Conservative determination of
lethal rate of the sterilization process — Overkill approach. 36
Bibliography . 38
ISO/TS 11135-2:2008(E)
Foreword
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an ISO working group and is accepted for publication if it is approved by more than 50 % of the members
of the parent committee casting a vote;
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...
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