|
SLOVENSKI STANDARD
01-junij-2023
Sterilizacija izdelkov za zdravstveno nego - Sevanje - 1. del: Zahteve za razvoj,
validacijo in rutinsko kontrolo sterilizacijskih postopkov za medicinske
pripomočke (ISO/DIS 11137-1:2023)
Sterilization of health care products - Radiation - Part 1: Requirements for development,
validation and routine control of a sterilization process for medical devices (ISO/DIS
11137-1:2023)
Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 1:
Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines
Sterilisationsverfahrens für Medizinprodukte (ISO/DIS 11137-1:2023)
Stérilisation des produits de santé - Irradiation - Partie 1: Exigences relatives à la mise
au point, à la validation et au contrôle de routine d'un procédé de stérilisation pour les
dispositifs médicaux (ISO/DIS 11137-1:2023)
Ta slovenski standard je istoveten z: prEN ISO 11137-1
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT INTERNATIONAL STANDARD
ISO/DIS 11137-1
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
2023-04-14 2023-07-07
Sterilization of health care products — Radiation —
Part 1:
Requirements for the development, validation and routine
control of a sterilization process for medical devices
ICS: 11.080.01
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
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 11137-1:2023(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 2023
ISO/DIS 11137-1:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 11137-1
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
Sterilization of health care products — Radiation —
Part 1:
Requirements for the development, validation and routine
control of a sterilization process for medical devices
ICS: 11.080.01
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: +41 22 749 01 11
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: [email protected]
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 11137-1:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023
ISO/DIS 11137-1:2023(E)
Contents Page
Foreword .iv
Introduction . vi
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 General . 9
5 Sterilizing agent characterization .10
5.1 Sterilizing agent . 10
5.2 Microbicidal effectiveness . . 10
5.3 Material effects . 10
5.4 Environmental considerations . 10
6 Process and equipment characterization .10
6.1 Process . 10
6.2 Equipment . 10
7 Product definition .12
8 Process definition .12
8.1 Establishing the maximum acceptable dose, D .12
max,acc
8.2 Establishing the sterilization dose, D . 13
ster
8.3 Specifying the maximum acceptable dose and the sterilization dose .13
8.4 Transference of maximum acceptable, verification or sterilization dose between
radiation sources .13
8.4.1 Transference of maximum acceptable dose .13
8.4.2 Transference of verification dose or sterilization dose . 14
9 Validation . .14
9.1 Installation qualification . 14
9.2 Operational qualification . 14
9.3 Performance qualification.15
9.4 Review and approval of validation . 16
10 Routine monitoring and control.17
11 Product release from sterilization .17
12 Maintaining process effectiveness .18
12.1 Demonstration of continued effectiveness . 18
12.1.1 General . 18
12.1.2 Frequency of determinations of bioburden . 18
12.1.3 Frequency of sterilization dose audits . 18
12.2 Recalibration . 20
12.3 Maintenance of equipment . 20
12.4 Requalification . 20
12.5 Assessment of change . 20
Annex A (informative) Guidance .21
Annex ZA (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered .36
Annex ZB (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be
covered .40
Bibliography .43
iii
ISO/DIS 11137-1:2023(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organizati
...