EN ISO 11137-2:2006

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006)

20060421 - DOW = DAV+36 months
2006-03-23  Final text (foreword) to be validated by TC Secretary before Publication.
2003-03-31  WIs 00207031 & 032 merged further to merging at ISO level (NT).

Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 2: Festlegung der Sterilisationsdosis (ISO 11137-2:2006)

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 de stérilisation (ISO 11137-2:2006)

Sterilizacija izdelkov za zdravstveno nego - Sevanje - 2. del: Določanje odmerka sterilizacije (ISO 11137-2:2006)

General Information

• Status: Withdrawn
• Publication Date: 14-Apr-2006
• Withdrawal Date: 29-May-2007
• ICS: 11.080.01 - Sterilization and disinfection in general
• 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: 30-May-2007
• Completion Date: 30-May-2007
• 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 11137-2:2006 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006)

Relations

• Replaces: EN 552:1994 - Sterilization of medical devices - Validation and routine control of sterilization by irradiation
• Effective Date: 22-Dec-2008
• Replaces: EN 552:1994/A2:2000 - Sterilization of medical devices - Validation and routine control of sterilization by irradiation
• Effective Date: 22-Dec-2008
• Replaces: EN 552:1994/A1:1999 - Sterilization of medical devices - Validation and routine control of sterilization by irradiation
• Effective Date: 22-Dec-2008
• Merged From: prEN ISO 11137-3 - Sterilization of medical devices - Microbiological methods - Part 3: Guidance on the evaluation and interpretation of bioburden data
• Effective Date: 08-Mar-2023
• Replaced By: 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)
• Effective Date: 22-Dec-2008
• Parent: prEN ISO 11137-3 - Sterilization of medical devices - Microbiological methods - Part 3: Guidance on the evaluation and interpretation of bioburden data
• Effective Date: 22-Dec-2008
• Parent: EN ISO 11137-2:2012 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2012)
• Effective Date: 22-Dec-2008

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2006
1DGRPHãþD
OSIST prEN ISO 11137-2:2004
SIST EN 552:2000
SIST EN 552:2000/A1:2000
SIST EN 552:2000/A2:2001
6WHULOL]DFLMDL]GHONRY]D]GUDYVWYHQRQHJR6HYDQMHGHO'RORþDQMHRGPHUND
VWHULOL]DFLMH,62
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization
dose (ISO 11137-2:2006)
Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 2: Festlegung
der Sterilisationsdosis (ISO 11137-2:2006)
Stérilisation des produits de santé - Irradiation - Partie 2: Établissement de la dose de
stérilisation (ISO 11137-2:2006)
Ta slovenski standard je istoveten z: EN ISO 11137-2:2006
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
April 2006
ICS 11.080.01 Supersedes EN 552:1994
English Version
Sterilization of health care products - Radiation - Part 2:
Establishing the sterilization dose (ISO 11137-2:2006)
Stérilisation des produits de santé - Irradiation - Partie 2: Sterilisation von Produkten für die Gesundheitsfürsorge -
Établissement de la dose de stérilisation (ISO 11137- Strahlen - Teil 2: Festlegung der Sterilisationsdosis (ISO
2:2006) 11137-2:2006)
This European Standard was approved by CEN on 13 April 2006.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, 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
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11137-2:2006: E
worldwide for CEN national Members.

Foreword
This document (EN ISO 11137-2:2006) has been prepared by Technical Committee ISO/TC 198
"Sterilization of health care products" in collaboration with 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 October 2006, and conflicting national standards
shall be withdrawn at the latest by April 2009.

This document supersedes EN 552:1994.

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, 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 has been approved by CEN as EN ISO 11137-2:2006 without any
modifications.
ANNEX ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directives 90/385/EEC concerning active
implantable medical devices, 93/42/EEC concerning medical devices
and 98/79/EEC concerning in vitro diagnostic medical devices

This European 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 concerning
active implantable medical devices, 93/42/EEC concerning medical devices and 98/79/EEC
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 European Standard and EU Directives
90/385/EEC concerning active implantable medical devices, 93/42/EEC concerning medical
devices and 98/79/EEC concerning in vitro diagnostic medical devices

Clause(s)/Sub-clause(s) Essential Essential Essential Qualifying
of this European Requirements Requirements Requirements remarks/Notes
Standard (ERs) of Directive (ERs) of (ERs) of Directive
90/385/EEC Directive 98/79/EEC
93/42/EEC
In part
4, 5, 6, 7, 8, 9, 10, 11, 12 7 8.3 B.2.3
In part
4, 5, 6, 7, 8, 9, 10, 11, 12 8.4 B.2.4

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
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
ISO 11137-2:2006(E)
10.2 Procedure for auditing a sterilization dose established using Method 1 or Method 2. 35
10.3 Procedure for auditing a sterilization dose substantiated using VD . 37
max
11 Worked examples. 41
11.1 Worked examples for Method 1.
...