CEN ISO/TS 13004:2014

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

Contents Page
Foreword .3
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
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.
TECHNICAL ISO/TS
SPECIFICATION 13004
First edition
2013-05-01
Sterilization of health care products —
Radiation — Substantiation of selected
SD
sterilization dose: Method VD
max
Stérilisation des produits de santé — Irradiation — Justification de la
SD
dose de stérilisation choisie: méthode VD
max
Reference number
ISO/TS 13004:2013(E)
©
ISO 2013
ISO/TS 13004:2013(E)
© ISO 2013
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
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2013 – All rights reserved

ISO/TS 13004:2013(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
1.1 Inclusions . 1
1.2 Exclusions . 1
1.3 Application . 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
4.4 Maintaining product families . 7
4.5 Consequence of failure of sterilization dose substantiation or sterilization dose audit . 8
5 Selection and testing of product for substantiating and auditing a selected
sterilization dose. 8
5.1 Nature of product . 8
5.2 Sample item portion (SIP) . 9
5.3 Manner of sampling .10
5.4 Microbiological testing .11
5.5 Irradiation .11
SD
6 Method VD — Substantiation of a selected sterilization dose of 17,5, 20, 22,5, 27,5,
max
30, 32,5, or 35 kGy .11
6.1 Rationale.11
SD
6.2 Procedure for Method VD for multiple production batches .12
max
SD
6.3 Procedure for Method VD for a single production batch .17
max
7 Maintaining process effectiveness .21
7.1 General .21
7.2 Determination of bioburden .22
7.3 Sterilization dose audit .22
SD
8 Tables of values for SIP equal to 1,0 VD , SIP dose reduction factor and augmentation
max
dose corresponding to applicable values of average bioburden for selected sterilization
doses of 17,5, 20, 22,5, 27,5, 30, 32,5 and 35 kGy .27
9 Worked examples .53
9.1 Substantiation of a selected sterilization dose of 17,5 kGy (SIP less than 1,0) .53
9.2 Substantiation of a selected sterilization dose of 30 kGy (SIP equal to 1,0) .54
22,5
9.3 Sterilization dose audit for a sterilization dose substantiated using Method VD , the
max
findings from which necessitated augmentation of the sterilization dose .55
Bibliography .57
ISO/TS 13004:2013(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International
Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies
casting a vote.
In other circumstances, particularly when there is an urgent market requirement for such documents, a
technical committee may decide to publish other types of normative document:
— an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical
experts in an ISO working group and is accepted for publication if it is approved by more than 50 %
of the members of the parent committee casting a vote;
— an ISO Technical Specification (ISO/TS) represents an agreement between the members of a
technical com
...