EN ISO 11137-3:2006

Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects (ISO 11137-3:2006)

ISO 11137-3:2006 gives guidance on the requirements in ISO 11137 parts 1 and 2 relating to dosimetry. Dosimetry procedures related to the development, validation and routine control of a radiation sterilization process are described.

Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 3: Anleitung zu dosimetrischen Aspekten (ISO/FDIS 11137-3:2006)

Dieser Teil von ISO 11137 gibt eine Anleitung zu den Anforderungen von ISO 11137 Teil 1 und 2 hinsichtlich der Dosimetrie. Es werden Dosimetrieverfahren im Zusammenhang mit der Entwicklung, Validierung und Lenkung der Anwendung eines Strahlensterilisationsverfahrens beschrieben.

Stérilisation des produits de santé - Irradiation - Partie 3: Directives relatives aux aspects dosimétriques (ISO 11137-3:2006)

L'ISO 11137-3:2006 fournit des directives concernant les exigences de l'ISO 11137-1 et de l'ISO 11137-2 relatives à la dosimétrie. Les modes opératoires de dosimétrie relatifs à la mise au point, à la validation et au contrôle de routine d'un procédé de stérilisation par irradiation y sont décrits.

Sterilizacija izdelkov za zdravstveno nego - Sevanje - 3. del: Smernica glede vidikov doziranja (ISO 11137-3:2006)

General Information

• Status: Withdrawn
• Publication Date: 14-Apr-2006
• Withdrawal Date: 25-Jul-2017
• 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
• Completion Date: 26-Jul-2017
• 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 11137-3:2006 - Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects (ISO 11137-3:2006)

Relations

• 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
• Replaces: EN 552:1994 - Sterilization of medical devices - Validation and routine control of sterilization by irradiation
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 11137-3:2017 - Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017)
• Effective Date: 17-Apr-2013

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2006
1DGRPHãþD
OSIST prEN ISO 11137-3:2004
SIST EN 552:2000
SIST EN 552:2000/A1:2000
SIST EN 552:2000/A2:2001
Sterilizacija izdelkov za zdravstveno nego - Sevanje - 3. del: Smernica glede
vidikov doziranja (ISO 11137-3:2006)
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects
(ISO 11137-3:2006)
Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 3: Anleitung zu
dosimetrischen Aspekten (ISO/FDIS 11137-3:2006)
Stérilisation des produits de santé - Irradiation - Partie 3: Directives relatives aux aspects
dosimétriques (ISO 11137-3:2006)
Ta slovenski standard je istoveten z: EN ISO 11137-3:2006
ICS:
11.080.01
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 11137-3
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2006
ICS 11.080.01 Supersedes EN 552:1994
English Version
Sterilization of health care products - Radiation - Part 3:
Guidance on dosimetric aspects (ISO 11137-3:2006)
Stérilisation des produits de santé - Irradiation - Partie 3: Sterilisation von Produkten für die Gesundheitsfürsorge -
Directives relatives aux aspects dosimétriques (ISO 11137- Strahlen - Teil 3: Anleitung zu dosimetrischen Aspekten
3:2006) (ISO/FDIS 11137-3:2006)
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 11137-3:2006: E
worldwide for CEN national Members.

Foreword
This document (EN ISO 11137-3:2006) 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 11137-3:2006 has been approved by CEN as EN ISO 11137-3:2006 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 11137-3
First edition
2006-04-15
Sterilization of health care products —
Radiation —
Part 3:
Guidance on dosimetric aspects
Stérilisation des produits de santé — Irradiation —
Partie 3: Directives relatives aux aspects dosimétriques

Reference number
ISO 11137-3:2006(E)
©
ISO 2006
ISO 11137-3:2006(E)
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ii © ISO 2006 – All rights reserved

ISO 11137-3:2006(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 1
4 Measurement of dose. 1
5 Selection and calibration of dosimetry systems . 2
5.1 General. 2
5.2 Selection of dosimetry systems. 2
5.3 Calibration of dosimetry system . 2
6 Establishing the maximum acceptable dose . 2
7 Establishing the sterilization dose. 3
8 Installation qualification. 4
9 Operational qualification. 4
9.1 General. 4
9.2 Gamma irradiators. 5
9.3 Electron beam irradiators . 6
9.4 X-ray irradiators . 7
10 Performance qualification. 8
10.1 General. 8
10.2 Gamma and X-ray . 9
10.3 Electron beam . 10
11 Routine monitoring and control . 11
11.1 General. 11
11.2 Frequency of dose measurements . 11
Annex A (informative) Mathematical modelling . 12
Bibliography . 15

ISO 11137-3:2006(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 11137-3 was prepared by Technical Committee ISO/TC 198, Sterilization of health care product.
This first edition, together with ISO 11137-1 and ISO 11137-2, cancels and replaces ISO 11137:1995.
ISO 11137 consists of the following parts, under the general title Sterilization of health care products —
Radiation:
⎯ Part 1: Requirements for development, validation and routine control of a sterilization process for medical
devices
⎯ Part 2: Establishing the sterilization dose
⎯ Part 3: Guidance on dosimetric aspects
iv © ISO 2006 – All rights reserved

ISO 11137-3:2006(E)
Introduction
An integral part of radiation sterilization is the ability to measure dose. Dose is measured during all stages of
development, validation and routine monitoring of the sterilization process. It has to be demonstrated that
dose measurement is traceable to a national or International Standard, that the uncertainty of measurement is
known, and that the influence of temperature, humidity and other environmental considerations on dosimeter
response is known and taken into account. Process parameters are established and applied based on dos
...