SIST EN ISO 13004:2023
(Main)Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022)
Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022)
This document describes a method for substantiating a selected sterilization dose of 17,5 kGy, 20 kGy,
22,5 kGy, 27,5 kGy, 30 kGy, 32,5 kGy or 35 kGy that achieves a sterility assurance level (SAL) of 10−6
or less for radiation sterilization of health care products. This document also specifies a method
of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated
sterilization dose.
NOTE 1 Selection and substantiation of the sterilization dose is used to meet the requirements for establishing
the sterilization dose within process definition in ISO 11137-1.
This document does not apply to other sterilization doses than the substantiation of a selected
sterilization dose of 17,5 kGy, 20 kGy, 22,5 kGy, 27,5 kGy, 30 kGy, 32,5 kGy or 35 kGy. The method is
not used for the substantiation of a selected sterilization dose if the average bioburden of the entire
product item exceeds the limit specified for the selected sterilization dose (see Table 3).
NOTE 2 The methods for substantiation of selected sterilization doses of 25 kGy and 15 kGy are not included
in this document. They are described in ISO 11137-2.
If the decision is made to use this method of sterilization dose establishment, the method is intended to
be followed in accordance with the requirements (shall) and guidance (should) stipulated herein.
Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Bestätigung der gewählten Sterilisationsdosis: Methode VDmaxSD (ISO 13004:2022)
Dieses Dokument beschreibt ein Verfahren zur Bestätigung einer ausgewählten Sterilisationsdosis von 17,5 kGy, 20 kGy, 22,5 kGy, 27,5 kGy, 30 kGy, 32,5 kGy oder 35 kGy, mit der ein Sterilitätssicherheitsniveau (SAL) von 10−6 oder weniger für die Strahlensterilisation von Produkten für die Gesundheitsvorsorge erreicht wird. Dieses Dokument legt darüber hinaus ein Verfahren zur Sterilisationsdosisüberprüfung fest, die zum Nachweis der beständigen Wirksamkeit der bestätigten Sterilisationsdosis verwendet wird.
ANMERKUNG 1 Auswahl und Bestätigung der Sterilisationsdosis werden angewendet, um die Anforderungen an die Ermittlung der Sterilisationsdosis im Rahmen der Verfahrensdefinition nach ISO 11137 1 zu erfüllen.
Dieses Dokument ist nicht anwendbar für andere Sterilisationsdosen, sondern ausschließlich für die Bestätigung ausgewählter Sterilisationsdosen von 17,5 kGy, 20 kGy, 22,5 kGy, 27,5 kGy, 30 kGy, 32,5 kGy und 35 kGy. Das Verfahren wird nicht zur Bestätigung einer ausgewählten Sterilisationsdosis verwendet, wenn die durchschnittliche mikrobiologische Belastung der gesamten Produkteinheit den für die ausgewählte Sterilisationsdosis festgelegten Grenzwert überschreitet (siehe Tabelle 3).
ANMERKUNG 2 Die Verfahren für die Bestätigung ausgewählter Sterilisationsdosen von 25 kGy und 15 kGy sind in diesem Dokument nicht berücksichtigt. Diese werden in ISO 11137 2 beschrieben.
Wenn die Entscheidung getroffen wird, dieses Verfahren zur Ermittlung der Sterilisationsdosis anzuwenden, ist das Verfahren zur Anwendung in Übereinstimmung mit den hier festgelegten Anforderungen (muss) und Handlungsempfehlungen (sollte) vorgesehen.
Stérilisation des produits de santé - Irradiation - Justification de la dose stérilisante choisie: Méthode DVmaxDS (ISO 13004:2022)
Sterilizacija izdelkov za zdravstveno nego - Sevanje - Utemeljitev izbrane doze sterilizacije: metoda VDmaxSD (ISO 13004:2022)
Ta dokument opisuje metodo za utemeljitev izbrane doze sterilizacije 17,5 kGy, 20 kGy, 22,5 kGy, 27,5 kGy, 30 kGy, 32,5 kGy ali 35 kGy za doseganje ravni zagotavljanja sterilnosti (SAL) 10–6 ali manj za sterilizacijo zdravstvenih pripomočkov s sevanjem. Ta dokument določa tudi metodo za presojo odmerka sterilizacije, ki se uporablja za dokaz stalne učinkovitosti utemeljenega odmerka sterilizacije.
OPOMBA 1: Izbira in utemeljitev odmerka sterilizacije se uporabljata za izpolnitev zahtev za določanje odmerka sterilizacije v sklopu definicije postopka iz standarda ISO 11137-1.
Ta dokument se ne uporablja za druge odmerke sterilizacije, razen za utemeljitev izbranega odmerka sterilizacije 17,5 kGy, 20 kGy, 22,5 kGy, 27,5 kGy, 30 kGy, 32,5 kGy ali 35 kGy. Metoda se ne uporablja za utemeljitev izbranega odmerka sterilizacije, če povprečna biološka obremenitev celotnega izdelka presega mejo, določeno za izbrani odmerek sterilizacije (glej preglednico 3).
OPOMBA 2: Metode za utemeljitev izbranih odmerkov sterilizacije 25 kGy in 15 kGy niso vključene v ta dokument. Opisane so v standardu ISO 11137-2.
Če se sprejme odločitev, da se uporabi ta metoda za določanje sterilizacije odmerka, je predvideno, da se sledi metodi skladno z zahtevami (je treba) in navodili (naj), določenimi v tem dokumentu.
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 13004:2023
01-september-2023
Nadomešča:
SIST-TS CEN ISO/TS 13004:2014
Sterilizacija izdelkov za zdravstveno nego - Sevanje - Utemeljitev izbrane doze
sterilizacije: metoda VDmaxSD (ISO 13004:2022)
Sterilization of health care products - Radiation - Substantiation of selected sterilization
dose: Method VDmaxSD (ISO 13004:2022)
Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Bestätigung der
gewählten Sterilisationsdosis: Methode VDmaxSD (ISO 13004:2022)
Stérilisation des produits de santé - Irradiation - Justification de la dose stérilisante
choisie: Méthode DVmaxDS (ISO 13004:2022)
Ta slovenski standard je istoveten z: EN ISO 13004:2023
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 13004:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 13004:2023
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SIST EN ISO 13004:2023
EN ISO 13004
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2023
EUROPÄISCHE NORM
ICS 11.080.01 Supersedes CEN ISO/TS 13004:2014
English Version
Sterilization of health care products - Radiation -
Substantiation of selected sterilization dose: Method
SD
VD (ISO 13004:2022)
max
Stérilisation des produits de santé - Irradiation - Sterilisation von Produkten für die
Justification de la dose stérilisante choisie: Méthode Gesundheitsfürsorge - Strahlen - Bestätigung der
DS SD
DV (ISO 13004:2022) gewählten Sterilisationsdosis: Methode VD (ISO
max max
13004:2022)
This European Standard was approved by CEN on 26 June 2023.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATIO N
EUROPÄISCHES KOMITEE FÜR NORMUN G
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13004:2023 E
worldwide for CEN national Members.
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SIST EN ISO 13004:2023
EN ISO 13004:2023 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 13004:2023
EN ISO 13004:2023 (E)
European foreword
The text of ISO 13004:2022 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 EN ISO 13004:2023 by 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 December 2023, and conflicting national standards
shall be withdrawn at the latest by December 2023.
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 CEN ISO/TS 13004:2014.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
...
SLOVENSKI STANDARD
oSIST prEN ISO 13004:2023
01-maj-2023
Sterilizacija izdelkov za zdravstveno nego - Sevanje - Utemeljitev izbrane doze
sterilizacije: metoda VDmaxSD (ISO 13004:2022)
Sterilization of health care products - Radiation - Substantiation of selected sterilization
dose: Method VDmaxSD (ISO 13004:2022)
Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Bestätigung der
gewählten Sterilisationsdosis: Methode VDmaxSD (ISO 13004:2022)
Stérilisation des produits de santé - Irradiation - Justification de la dose stérilisante
choisie: Méthode DVmaxDS (ISO 13004:2022)
Ta slovenski standard je istoveten z: prEN ISO 13004
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
oSIST prEN ISO 13004:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 13004:2023
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oSIST prEN ISO 13004:2023
INTERNATIONAL ISO
STANDARD 13004
First edition
2022-10
Sterilization of health care products —
Radiation — Substantiation of
selected sterilization dose: Method
SD
VD
max
Stérilisation des produits de santé — Irradiation — Justification de la
DS
dose stérilisante choisie: Méthode DV
max
Reference number
ISO 13004:2022(E)
© ISO 2022
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oSIST prEN ISO 13004:2023
ISO 13004:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
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or ISO’s member body in the country of the requester.
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Published in Switzerland
ii
© ISO 2022 – All rights reserved
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oSIST prEN ISO 13004:2023
ISO 13004:2022(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Definition and maintenance of product families for sterilization dose substantiation
and sterilization dose auditing.5
4.1 General . 5
4.2 Defining product families . 5
4.3 Designation of product to represent a product family . 6
4.3.1 Product to represent a product family . 6
4.3.2 Master product . 7
4.3.3 Equivalent product . 7
4.3.4 Simulated product . 7
4.
...
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