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CEN ISO/TS 13004:2014

(Main)

Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO/TS 13004:2013)

Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO/TS 13004:2013)

ISO/TS 13004:2013 describes a method for substantiating a selected sterilization dose of 17,5, 20, 22,5, 27,5, 30, 32,5 or 35 kGy that achieves a sterility assurance level (SAL) of 10−6 or less for radiation sterilization of health care products. ISO/TS 13004:2013 also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.

Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Bestätigung der gewählten Sterilisationsdosis: Methode VDmaxSD (ISO/TS 13004:2013)

1.1   Einschlussklauseln
Diese Technische Spezifikation beschreibt ein Verfahren zur Bestätigung einer ausgewählten Sterilisations-dosis von (17,5; 20; 22,5; 27,5; 30; 32,5 oder 35) kGy, bei der ein Sterilitätssicherheits¬niveau (SAL) von höchstens 106 für die Strahlensterilisation von Produkten für die Gesundheitsvorsorge erzielt wird. Die vorliegende Technische Spezifikation legt weiterhin ein Verfahren zur Sterilisationsdosis¬überprüfung fest, auf dessen Grundlage die fortgesetzte Wirksamkeit der bestätigten Sterilisationsdosis nachgewiesen werden kann.
ANMERKUNG   Die Auswahl und Bestätigung der Sterilisationsdosis dient der Erfüllung der Anforderungen an die Festlegung der Sterilisationsdosis im Rahmen der Verfahrensdefinition nach ISO 11137 1.
1.2   Ausschlussklauseln
Dieses Verfahren gilt ausschließlich für die Bestätigung einer ausgewählten Sterilisationsdosis von (17,5; 20; 22,5; 27,5; 30; 32,5 oder 35) kGy und wird nicht für die Bestätigung weiterer Sterilisationsdosen angewendet. Das Verfahren wird nicht für die Bestätigung einer ausgewählten Sterilisationsdosis genutzt, wenn die durchschnittliche Keimbelastung der gesamten Produkteinheit den für die ausgewählte Sterilisationsdosis festgelegten Grenzwert überschreitet (siehe Tabelle 3).
ANMERKUNG   Die Verfahren für die Bestätigung ausgewählter Sterilisationsdosen von 25 kGy und 15 kGy werden nicht von dieser Technischen Spezifikation abgedeckt; sie werden in ISO 11137 2 beschrieben.
1.3   Anwendung
Wird die Entscheidung getroffen, dieses Verfahren zur Festlegung der Sterilisationsdosis anzuwenden, müssen die hier angegebenen Anforderungen (muss) und Anleitungen (sollte) befolgt werden.

Stérilisation des produits de santé - Irradiation - Justification de la dose de stérilisation choisie: méthode VDmaxSD (ISO/TS 13004:2013)

Sterilizacija izdelkov za zdravstveno nego - Sevanje - Utemeljitev izbrane doze sterilizacije: metoda VDmaxSD (ISO/TS 13004:2013)

Standard CEN ISO/TS 13004 opisuje metodo za utemeljitev izbrane doze sterilizacije 17,5, 20, 22,5, 27,5, 30, 32,5 ali 35 kGy za doseganje ravni zagotavljanja sterilnosti (SAL) 10–6 ali manj za sterilizacijo zdravstvenih pripomočkov s sevanjem. Ta tehnična specifikacija določa tudi metodo za revizijo odmerka sterilizacije, ki se uporablja za dokaz stalne učinkovitosti utemeljenega odmerka sterilizacije.

General Information

Status
Withdrawn
Publication Date
27-May-2014
Withdrawal Date
27-Jun-2023
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
Ref Project
SIST-TS CEN ISO/TS 13004:2014 - Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO/TS 13004:2013)

Relations

Replaced By
EN ISO 13004:2023 - Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022)
Effective Date
19-Jan-2023

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST-TS CEN ISO/TS 13004:2014
01-oktober-2014
Sterilizacija izdelkov za zdravstveno nego - Sevanje - Utemeljitev izbrane doze
sterilizacije: metoda VDmaxSD (ISO/TS 13004:2013)
Sterilization of health care products - Radiation - Substantiation of selected sterilization
dose: Method VDmaxSD (ISO/TS 13004:2013)
Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Bestätigung der
gewählten Sterilisationsdosis: Methode VDmaxSD (ISO/TS 13004:2013)
Stérilisation des produits de santé - Irradiation - Justification de la dose de stérilisation
choisie: méthode VDmaxSD (ISO/TS 13004:2013)
Ta slovenski standard je istoveten z: CEN ISO/TS 13004:2014
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
13.280 Varstvo pred sevanjem Radiation protection
SIST-TS CEN ISO/TS 13004:2014 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TS CEN ISO/TS 13004:2014

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SIST-TS CEN ISO/TS 13004:2014

TECHNICAL SPECIFICATION
CEN ISO/TS 13004

SPÉCIFICATION TECHNIQUE

TECHNISCHE SPEZIFIKATION
May 2014
ICS 11.080.01
English Version
Sterilization of health care products - Radiation - Substantiation
of selected sterilization dose: Method VDmaxSD (ISO/TS
13004:2013)
Stérilisation des produits de santé - Irradiation - Justification Sterilisation von Produkten für die Gesundheitsfürsorge -
de la dose de stérilisation choisie: méthode VDmaxSD Strahlen - Bestätigung der gewählten Sterilisationsdosis:
(ISO/TS 13004:2013) Methode VDmaxSD (ISO/TS 13004:2013)
This Technical Specification (CEN/TS) was approved by CEN on 27 May 2014 for provisional application.

The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to submit their
comments, particularly on the question whether the CEN/TS can be converted into a European Standard.

CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS available
promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in parallel to the CEN/TS)
until the final decision about the possible conversion of the CEN/TS into an EN is reached.

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, 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
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 13004:2014 E
worldwide for CEN national Members.

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SIST-TS CEN ISO/TS 13004:2014
CEN ISO/TS 13004:2014 (E)
Contents Page
Foreword .3
2

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SIST-TS CEN ISO/TS 13004:2014
CEN ISO/TS 13004:2014 (E)
Foreword
The text of ISO/TS 13004:2013 has been prepared by Technical Committee ISO/TC 198 “Sterilization of
health care products” of the International Organization for Standardization (ISO) and has been taken over as
CEN ISO/TS 13004:2014 by Technical Committee CEN/TC 204 “Sterilization of medical devices” the
secretariat of which is held by BSI.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to announce this Technical Specification: 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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO/TS 13004:2013 has been approved by CEN as CEN ISO/TS 13004:2014 without any
modification.
3

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SIST-TS CEN ISO/TS 13004:2014

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SIST-TS
...

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