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
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
26-Jul-2017
Completion Date
26-Jul-2017

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11137-3:2017
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
SIST EN ISO 11137-3:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 11137-3:2017

---------------------- Page: 2 ----------------------

SIST EN ISO 11137-3:2017


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.

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SIST EN ISO 11137-3:2017
EN ISO 11137-3:2017 (E)
Contents Page
European foreword . 3

2

---------------------- Page: 4 ----------------------

SIST EN ISO 11137-3:2017
EN ISO 11137-3:2017 (E)
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, Luxemb
...

SLOVENSKI STANDARD
oSIST prEN ISO 11137-3:2015
01-september-2015
6WHULOL]DFLMDL]GHONRY]D]GUDYVWYHQRQHJR6HYDQMHGHO6PHUQLFHR
GR]LPHWULþQLKYLGLNLK]DUD]YRMYDOLGDFLMRLQUXWLQVNLQDG]RU ,62',6
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects
of development, validation and routine control (ISO/DIS 11137-3:2015)
Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 3: Anleitung zu
dosimetrischen Aspekten der Entwicklung, Validierung und Lenkung der Anwendung
(ISO/DIS 11137-3:2015)
Stérilisation des produits de santé - Irradiation - Partie 3: Directives relatives aux aspects
dosimétriques de développement, la validation et le contrôle de routine (ISO/DIS 11137-
3:2015)
Ta slovenski standard je istoveten z: prEN ISO 11137-3 rev
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
oSIST prEN ISO 11137-3:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 11137-3:2015

---------------------- Page: 2 ----------------------
oSIST prEN ISO 11137-3:2015
DRAFT INTERNATIONAL STANDARD
ISO/DIS 11137-3
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
2015-07-02 2015-10-02
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
ICS: 11.080.01
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for
Standardization (ISO), and processed under the ISO lead mode of collaboration
as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member
bodies for a parallel five month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments
received, will be submitted to a parallel two-month approval vote in ISO and
THIS DOCUMENT IS A DRAFT CIRCULATED
formal vote in CEN.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
To expedite distribution, this document is circulated as received from the
IN ADDITION TO THEIR EVALUATION AS
committee secretariat. ISO Central Secretariat work of editing and text
BEING ACCEPTABLE FOR INDUSTRIAL,
composition will be undertaken at publication stage.
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 11137-3:2015(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2015

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oSIST prEN ISO 11137-3:2015
ISO/DIS 11137-3:2015(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, 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.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2015 – All rights reserved

---------------------- Page: 4 ----------------------
oSIST prEN ISO 11137-3:2015
ISO/DIS 11137-3
Contents Page
Foreword . v
Introduction . vi
1 Scope . 1
2 Normative References . 1
3 Terms and definitions . 1
3.1 Definitions . 1
3.2 Terms .
...

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