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EN ISO 11137-3:2006

(Main)

Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects (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Withdrawn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

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11137-3:2006
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
SIST EN ISO 11137-3:2006 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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

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.

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

EN ISO 11137-3:2006 (E)





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.

2

---------------------- Page: 3 ----------------------

EN ISO 11137-3:2006 (E)



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 implantabl
...

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