CEN ISO/TS 11137-4:2023

Sterilization of health care products - Radiation - Part 4: Guidance on process control (ISO/TS 11137-4:2020)

This document provides additional guidance to that given in ISO 11137-3 on meeting the requirements specified in ISO 11137-1, ISO 11137-2 and ISO/TS 13004 for the establishment and control of a radiation sterilization process using gamma, electron beam, and X-irradiation.

Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 4: Leitfaden zur Verfahrenssteuerung (ISO/TS 11137-4:2020)

Dieses Dokument liefert einen zusätzlichen Leitfaden zu der Anleitung in ISO 11137 3 zur Erfüllung der in ISO 11137 1, ISO 11137 2 und ISO/TS 13004 festgelegten Anforderungen für die Erarbeitung und Lenkung eines Strahlensterilisationsverfahrens mit Anwendung von Gamma-, Elektronen- oder XRay-Bestrahlung.

Stérilisation des produits de santé - Irradiation - Partie 4: Recommandations sur le contrôle de processus (ISO/TS 11137-4:2020)

Sterilizacija izdelkov za zdravstveno oskrbo - Sevanje - 4. del: Navodila za nadzor procesov (ISO/TS 11137-4:2020)

Ta dokument podaja dodatna navodila poleg navodil iz standarda ISO 11137‑3, ki se nanašajo na izpolnitev zahtev iz standardov ISO 11137‑1, ISO 11137‑2 in ISO/TS 13004, za vzpostavitev in nadziranje postopka sterilizacije z gama žarki, elektronskim žarkom in obsevanjem.

General Information

• Status: Published
• Publication Date: 20-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: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 21-Jun-2023
• Due Date: 20-Aug-2024
• Completion Date: 21-Jun-2023
• Ref Project: SIST-TS CEN ISO/TS 11137-4:2023 - Sterilization of health care products - Radiation - Part 4: Guidance on process control (ISO/TS 11137-4:2020)

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2023
Sterilizacija izdelkov za zdravstveno oskrbo - Sevanje - 4. del: Navodila za nadzor
procesov (ISO/TS 11137-4:2020)
Sterilization of health care products - Radiation - Part 4: Guidance on process control
(ISO/TS 11137-4:2020)
Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 4: Leitfaden zur
Verfahrenssteuerung (ISO/TS 11137-4:2020)
Stérilisation des produits de santé - Irradiation - Partie 4: Recommandations sur le
contrôle de processus (ISO/TS 11137-4:2020)
Ta slovenski standard je istoveten z: CEN ISO/TS 11137-4:2023
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.

CEN ISO/TS 11137-4
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
June 2023
TECHNISCHE SPEZIFIKATION
ICS 11.080.01
English Version
Sterilization of health care products - Radiation - Part 4:
Guidance on process control (ISO/TS 11137-4:2020)
Stérilisation des produits de santé - Irradiation - Partie Sterilisation von Produkten für die
4: Recommandations sur le contrôle de processus Gesundheitsfürsorge - Strahlen - Teil 4: Leitfaden zur
(ISO/TS 11137-4:2020) Verfahrenssteuerung (ISO/TS 11137-4:2020)
This Technical Specification (CEN/TS) was approved by CEN on 28 May 2023 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, 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 NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

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. CEN ISO/TS 11137-4:2023 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
The text of ISO/TS 11137-4:2020 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 11137-4:2023 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 shall not be held responsible for identifying any or all such patent rights.
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, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO/TS 11137-4:2020 has been approved by CEN as CEN ISO/TS 11137-4:2023 without any
modification.
TECHNICAL ISO/TS
SPECIFICATION 11137-4
First edition
2020-06
Sterilization of health care products —
Radiation —
Part 4:
Guidance on process control
Stérilisation des produits de santé — Irradiation —
Partie 4: Recommandations sur le contrôle de processus
Reference number
ISO/TS 11137-4:2020(E)
©
ISO 2020
ISO/TS 11137-4:2020(E)
© ISO 2020
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 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
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Published in Switzerland
ii © ISO 2020 – All rights reserved

ISO/TS 11137-4:2020(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and symbols . 1
3.1 General . 1
3.2 Symbols . 3
4 Principles applied in validating and controlling an irradiation process .4
4.1 General . 4
4.2 Use of the dose measurement at the monitoring location . 4
4.2.1 General. 4
4.2.2 D as an indirect measurement of dose to product . 4
mon
4.2.3 D as a process monitor . 4
mon
4.2.4 D or D as a direct measurement of dose to product . 5
min max
4.3 Monitoring of critical process parameters . 5
5 Establishing process target doses . 6
5.1 Inputs and steps in establishing a process target dose . 6
5.1.1 General. 6
5.1.2 Process validation inputs (installation, operational and performance
qualification) . 7
5.1.3 Additional inputs . 7
5.1.4 Determine σ . 7
process
5.1.5 Product dose specifications . 8
5.1.6 Select coverage factor k . 8
5.1.7 Setting process target doses . 8
5.1.8 Analyse process output . 8
5.1.9 Review . . 8
5.2 Performance qualification outputs . 8
5.2.1 General. 8
5.2.2 Experimental design for PQ. 9
5.2.3 Processing categories . 9
5.3 Components of σ .10
process
5.3.1 General.10
5.3.2 Components related to measurement uncertainty .11
5.3.3 Components related to process variability .12
5.3.4 Combining components of uncertainty .13
5.3.5 Reducing σ .13
process
5.4 Establishing process target doses .16
5.4.1 Coverage factors .16
5.4.2 Process factors .17
5.4.3 Choice of target processing parameters .17
5.4.4 Assessing process capability .18
6 Routine monitoring and control .18
6.1 General .18
6.2 Product handling .19
6.2.1 Receipt of product .19
6.2.2 Loading .19
6.2.3 Unloading .19
6.2.4 Storage .
...