FprEN ISO 11137-1

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
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NATIONAL REGULATIONS.
ISO/DIS 11137-1:2023(E)
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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
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NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 11137-1:2023(E)
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TO SUBMIT, WITH THEIR COMMENTS,
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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
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