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)

ISO 11137-3:2017 gives guidance on meeting the requirements in ISO 11137-1 and ISO 11137-2 and in ISO/TS 13004 relating to dosimetry and its use in development, validation and routine control of a radiation sterilization process.

Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 3: Anleitung zu dosimetrischen Aspekten der Entwicklung, Validierung und Lenkung der Anwendung (ISO 11137-3:2017)

Dieses Dokument gibt eine Anleitung zur Erfüllung der Anforderungen von ISO 11137-1 und ISO 11137-2 und ISO/TS 13004 hinsichtlich der Dosimetrie und ihrem Gebrauch bei der Entwicklung, Validierung und Lenkung der Anwendung eines Strahlensterilisationsverfahrens.

Stérilisation des produits de santé - Irradiation - Partie 3: Directives relatives aux aspects dosimétriques de développement, la validation et le contrôle de routine (ISO 11137-3:2017)

L'ISO 11137-3:2017 fournit des préconisations permettant de satisfaire aux exigences de l'ISO 11137‑1, l'ISO 11137‑2 et l'ISO/TS 13004 concernant la dosimétrie et son utilisation dans la mise au point, la validation et le contrôle de routine d'un procédé de stérilisation par irradiation.

Sterilizacija izdelkov za zdravstveno nego - Sevanje - 3. del: Smernice o dozimetričnih vidikih za razvoj, validacijo in rutinski nadzor (ISO 11137-3:2017)

Ta dokument podaja smernice za izpolnjevanje zahtev v standardih ISO 11137-1 in ISO 11137-2 ter
standardu ISO/TS 13004, ki določa zahteve za razvoj, validacijo in rutinski nadzor sterilizacijskega postopka s sevanjem.

General Information

• Status: Published
• Publication Date: 25-Jul-2017
• Withdrawal Date: 30-Jan-2018
• 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: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 26-Jul-2017
• 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 11137-3:2017 - Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017)

Relations

• Replaces: EN ISO 11137-3:2006 - Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects (ISO 11137-3:2006)
• Effective Date: 17-Apr-2013

Standards Content (Sample)

SLOVENSKI STANDARD
01-oktober-2017
1DGRPHãþD
SIST EN ISO 11137-3:2006
6WHULOL]DFLMDL]GHONRY]D]GUDYVWYHQRQHJR6HYDQMHGHO6PHUQLFHR
GR]LPHWULþQLKYLGLNLK]DUD]YRMYDOLGDFLMRLQUXWLQVNLQDG]RU,62
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects
of development, validation and routine control (ISO 11137-3:2017)
Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 3: Anleitung zu
dosimetrischen Aspekten der Entwicklung, Validierung und Lenkung der Anwendung
(ISO 11137-3:2017)
Stérilisation des produits de santé - Irradiation - Partie 3: Directives relatives aux aspects
dosimétriques de développement, la validation et le contrôle de routine (ISO 11137-
3:2017)
Ta slovenski standard je istoveten z: EN ISO 11137-3:2017
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.

EN ISO 11137-3
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2017
EUROPÄISCHE NORM
ICS 11.080.01 Supersedes EN ISO 11137-3:2006
English Version
Sterilization of health care products - Radiation - Part 3:
Guidance on dosimetric aspects of development, validation
and routine control (ISO 11137-3:2017)
Stérilisation des produits de santé - Irradiation - Partie Sterilisation von Produkten für die
3: Directives relatives aux aspects dosimétriques de Gesundheitsfürsorge - Strahlen - Teil 3: Anleitung zu
développement, la validation et le contrôle de routine dosimetrischen Aspekten der Entwicklung, Validierung
(ISO 11137-3:2017) und Lenkung der Anwendung (ISO 11137-3:2017)
This European Standard was approved by CEN on 15 March 2017.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, 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: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11137-3:2017 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 11137-3:2017) 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 January 2018 and conflicting national standards shall
be withdrawn at the latest by January 2018.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 11137-3:2006.
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, Croatia,
Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands,
Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
the United Kingdom.
Endorsement notice
The text of ISO 11137-3:2017 has been approved by CEN as EN ISO 11137-3:2017 without any
modification.
INTERNATIONAL ISO
STANDARD 11137-3
Second edition
2017-06
Sterilization of health care products —
Radiation —
Part 3:
Guidance on dosimetric aspects of
development, validation and routine
control
Stérilisation des produits de santé — Irradiation —
Partie 3: Directives relatives aux aspects dosimétriques de
développement, la validation et le contrôle de routine
Reference number
ISO 11137-3:2017(E)
©
ISO 2017
ISO 11137-3:2017(E)
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, 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.
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ii © ISO 2017 – All rights reserved

ISO 11137-3:2017(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and symbols . 1
3.1 General . 1
3.2 Symbols . 3
4 Measurement of dose. 4
4.1 General . 4
4.1.1 Direct and indirect dose measurements . 4
4.1.2 Dosimetry systems . 4
4.1.3 Best estimate of dose . 4
4.2 Dosimetry system selection and calibration . 5
4.2.1 General. 5
4.2.2 Selection of dosimetry systems . 5
4.2.3 Calibration of dosimetry systems . 5
4.3 Dose measurement uncertainty . 6
4.3.1 General concepts . 6
4.3.2 The Guide to the expression of uncertainty in measurement
(GUM) methodology . 6
4.3.3 Radiation sterilization specific aspects of dose measurement uncertainty . 7
5 Establishing the maximum acceptable dose. 8
6 Establishing the sterilization dose . 9
7 Installation qualification .10
8 Operational qualification .11
8.1 General .11
8.2 Gamma irradiators .11
8.3 Electron beam irradiators .13
8.4 X-ray irradiators .15
9 Performance qualification .17
9.1 General .17
9.2 Gamma irradiators .18
9.2.1 Loading pattern .18
9.2.2 Dosimetry.19
9.2.3 Analysis of dose mapping data .20
9.3 Electron beam irradiators .20
9.3.1 Loading pattern .20
9.3.2 Dosimetry.22
9.3.3 Analysis of dose mapping data .23
9.4 X-ray irradiators .23
9.4.1 Loading pattern .23
9.4.2 Dosimetry.24
9.4.3 Analysis of dose mapping data .25
10 Routine monitoring and control .25
10.1 General .
...