EN ISO 11137-2:2007

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01)

ISO 11137-2:2006 specifies methods of determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level (SAL) of 10-6. It also specifies methods of dose auditing in order to demonstrate the continued effectiveness of the sterilization dose.
ISO 11137-2:2006 defines product families for dose establishment and dose auditing.

Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 2: Festlegung der Sterilisationsdosis (ISO 11137-2:2006, korrigierte fassung 2006-08-01)

Dieser Teil von ISO 11137 legt Verfahren zur Ermittlung der Mindestdosis, die zur Erreichung einer festgelegten Anforderung an die Sterilität erforderlich ist, und Verfahren zur Bestätigung der Anwendung von 25 kGy oder 15 kGy als Sterilisationsdosis zur Erreichung eines Sterilitätssicherheitsniveaus, SAL von 10 6 fest. Dieser Teil von ISO 11137 legt auch Verfahren der Dosisüberprüfung zum Nachweis der fortgesetzten Wirksamkeit der Sterilisationsdosis fest.
Dieser Teil von ISO 11137 definiert Produktfamilien für die Dosisfestlegung und Dosisüberprüfung.

Stérilisation des produits de santé - Irradiation - Partie 2: Établissement de la dose stérilisante (ISO 11137-2:2006, version corrigée 2006-08-01)

L'ISO 11137-2:2006 spécifie des méthodes de détermination de la dose minimale nécessaire pour atteindre une exigence spécifiée de stérilité et des méthodes pour justifier l'utilisation de la dose stérilisante de 25 kGy ou de la dose stérilisante de 15 kGy, pour obtenir un niveau d'assurance de la stérilité, s, de 10-6. Elle spécifie aussi des méthodes d'audit de la dose pour démontrer l'efficacité continue de la dose stérilisante.
L'ISO 11137-2:2006 définit des familles de produits pour l'établissement de la dose et l'audit de la dose.

Sterilizacija izdelkov za zdravstveno nego - Sevanje - 2. del: Določanje odmerka sterilizacije (ISO 11137-2:2006, popravljena verzija 2006-08-01)

General Information

• Status: Withdrawn
• Publication Date: 29-May-2007
• Withdrawal Date: 14-Mar-2012
• ICS: 11.080.01 - Sterilization and disinfection in general
• ICS: 11.080.99 - Other standards related to sterilization and disinfection
• Technical Committee: CEN/TC 204 - Sterilization of medical devices
• Drafting Committee: CEN/TC 204 - Sterilization of medical devices
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 15-Mar-2012
• Completion Date: 15-Mar-2012
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
• Ref Project: SIST EN ISO 11137-2:2007 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01)

Relations

• Replaces: EN ISO 11137-2:2006 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006)
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 11137-2:2012 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2012)
• Effective Date: 11-Apr-2012
• Corrected By: EN ISO 11137-2:2007/AC:2009 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006/Cor 1:2009)
• Effective Date: 21-Jan-2009

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2007
1DGRPHãþD
SIST EN 552:2000
SIST EN 552:2000/A1:2000
SIST EN 552:2000/A2:2001
SIST EN ISO 11137-2:2006
6WHULOL]DFLMDL]GHONRY]D]GUDYVWYHQRQHJR6HYDQMHGHO'RORþDQMHRGPHUND
VWHULOL]DFLMH,62SRSUDYOMHQDYHU]LMD
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization
dose (ISO 11137-2:2006, corrected version 2006-08-01)
Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 2: Festlegung
der Sterilisationsdosis (ISO 11137-2:2006, korrigierte fassung 2006-08-01)
Stérilisation des produits de santé - Irradiation - Partie 2: Établissement de la dose
stérilisante (ISO 11137-2:2006, version corrigée 2006-08-01)
Ta slovenski standard je istoveten z: EN ISO 11137-2:2007
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.

EUROPEAN STANDARD
EN ISO 11137-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2007
ICS 11.080.01 Supersedes EN ISO 11137-2:2006
English Version
Sterilization of health care products - Radiation - Part 2:
Establishing the sterilization dose (ISO 11137-2:2006, corrected
version 2006-08-01)
Stérilisation des produits de santé - Irradiation - Partie 2: Sterilisation von Produkten für die Gesundheitsfürsorge -
Établissement de la dose stérilisante (ISO 11137-2:2006, Strahlen - Teil 2: Festlegung der Sterilisationsdosis (ISO
version corrigée 2006-08-01) 11137-2:2006, korrigierte fassung 2006-08-01)
This European Standard was approved by CEN on 12 May 2007.
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 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 Management Centre has the same status as the
official versions.
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
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11137-2:2007: E
worldwide for CEN national Members.

Foreword
The text of ISO 11137-2:2006, corrected version 2006-08-01 has been prepared by Technical
Committee ISO/TC 198 "Sterilization of health care products” of the International Organization
for Standardization (ISO) and has been taken over as EN ISO 11137-2:2007 by Technical
Committee CEN/TC 204 "Sterilization of medical devices", the secretariat of which is held by
BSI.
This European Standard shall be given the status of a national standard, either by publication of
an identical text or by endorsement, at the latest by November 2007, and conflicting national
standards shall be withdrawn at the latest by May 2010.

This document supersedes EN ISO 11137-2:2006.

This document has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association, and supports essential requirements of EU
Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: 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.
Endorsement notice
The text of ISO 11137-2:2006, corrected version 2006-08-01 has been approved by CEN as EN
ISO 11137-2:2007 without any modifications.

ANNEX ZA
(informative)
Relationship between this International Standard and the Essential
Requirements of EU Directives 90/385/EEC of 20 June 1990 concerning
active implantable medical devices, 93/42/EEC of 14 June 1993 concerning
medical devices and 98/79/EC of 7 December 1988 concerning in vitro
diagnostic medical devices
This International Standard has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association to provide one means of conforming to
Essential Requirements of the New Approach Directive, EU Directives 90/385/EEC of 20 June
1990 concerning active implantable medical devices, 93/42/EEC of 14 June 1993 concerning
medical devices and 98/79/EC of 7 December 1998 concerning in vitro diagnostic medical
devices.
Once this standard is cited in the Official Journal of the European Communities under that
Directive and has been implemented as a national standard in at least one Member State,
compliance with the normative clauses of this standard given in Table ZA.1 confers, within the
limits of the scope of this standard, a presumption of conformity with the corresponding Essential
Requirements of that Directive and associated EFTA regulations.

Table ZA.1 — Correspondence between this International Standard and Directive (EU
Directives 90/385/EEC of 20 June 1990 concerning active implantable medical devices,
93/42/EEC of 14 June 1993 concerning medical devices and 98/79/EC of 7 December 1988
concerning in vitro diagnostic medical devices)

Clause(s)/Sub-clause(s) Essential Essential Essential Qualifying
of this EN Requirements Requirements (ERs) Requirements (ERs) remarks/Notes
(ERs) of Directive of Directive of Directive
90/385/EEC 93/42/EEC 98/79/EC
4,5,6,7,8,9,10,11,12 B.2.3
7 8.3 In part
4,5,6,7,8,9,10,11,12
B.2.4
8.4
WARNING: Other requirements and other EU Directives may be applicable to the product(s)
falling within the scope of this standard.

INTERNATIONAL ISO
STANDARD 11137-2
First edition
2006-04-15
Corrected version
2006-08-01
Sterilization of health care products —
Radiation —
Part 2:
Establishing the sterilization dose
Stérilisation des produits de santé — Irradiation —
Partie 2: Établissement de la dose stérilisante

Reference number
ISO 11137-2:2006(E)
©
ISO 2006
ISO 11137-2:2006(E)
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ISO 11137-2:2006(E)
Contents Page
Foreword. v
Introduction . vi
1 Scope .1
2 Normative references .1
3 Abbreviations, terms and definitions .1
3.1 Abbreviations.1
3.2 Terms .3
4 Definition and maintenance of product families for dose setting, dose substantiation and
sterilization dose auditing .4
4.1 General.4
4.2 Defining product families.4
4.3 Designation of product to represent a product family for performance of a verification
dose experiment or sterilization dose audit .5
4.4 Maintaining product families .6
4.5 Effect of failure of establishment of sterilization dose or of a sterilization dose audit on a
product family .7
5 Selection and testing of product for establishing and verifying the sterilization dose .7
5.1 Nature of product.7
5.2 Sample item portion (SIP) .8
5.3 Manner of sampling.8
5.4 Microbiological testing.9
5.5 Irradiation .9
6 Methods of dose establishment.9
7 Method 1: dose setting using bioburden information .10
7.1 Rationale.10
7.2 Procedure for Method 1 for product with an average bioburden W 1,0 for multiple
production batches.11
7.3 Procedure for Method 1 for product with an average bioburden W 1,0 for a single
production batch.16
7.4 Procedure for Method 1 for product with an average bioburden in the range 0,1 to 0,9 for
multiple or single production batches.18
8 Method 2: Dose setting using fraction positive information from incremental dosing to
determine an extrapolation factor.18
8.1 Rationale.18
8.2 Procedure for Method 2A.19
8.3 Procedure for Method 2B.22
9 Method VD — Substantiation of 25 kGy or 15 kGy as the sterilization dose.25
max
9.1 Rationale.25
9.2 Procedure for Method VD for multiple production batches .26
max
9.3 Procedure for Method VD for a single production batch .29
max
9.4 Procedure for Method VD for multiple production batches .30
max
9.5 Procedure for Method VD for a single production batch .33
max
10 Auditing sterilization dose.34
10.1 Purpose and frequency.34
...