oSIST prEN ISO 11135:2025

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2025)

ISO 11135:2014 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.

Sterilisation von Produkten für die Gesundheitsfürsorge - Ethylenoxid - Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens für Medizinprodukte (ISO/DIS 11135:2025)

Stérilisation des produits de santé - Oxyde d'éthylène - Exigences de développement, de validation et de contrôle de routine d'un processus de stérilisation pour des dispositifs médicaux (ISO/DIS 11135:2025)

L'ISO 11135:2014 spécifie les exigences relatives à la mise au point, à la validation et au contrôle de routine du procédé de stérilisation des dispositifs médicaux à l'oxyde d'éthylène dans l'industrie et dans les établissements de santé, et reconnaît les similitudes et différences entre les deux applications.

Sterilizacija izdelkov za zdravstveno nego - Etilenoksid - Zahteve za razvoj, validacijo in rutinsko kontrolo sterilizacijskih postopkov za medicinske pripomočke (ISO/DIS 11135:2025)

General Information

• Status: Not Published
• Public Enquiry End Date: 16-Sep-2025
• ICS: 11.080.01 - Sterilization and disinfection in general
• Technical Committee: VAZ - Healthcare
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 03-Jul-2025
• Due Date: 20-Nov-2025
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Directive: 2017/746 - Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Ref Project: prEN ISO 11135 - Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2025)

Relations

• Revises: SIST EN ISO 11135:2014/A1:2020 - Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)
• Effective Date: 24-Jul-2024
• Revises: SIST EN ISO 11135:2014 - Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
• Effective Date: 24-Jul-2024

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2025
Sterilizacija izdelkov za zdravstveno nego - Etilenoksid - Zahteve za razvoj,
validacijo in rutinsko kontrolo sterilizacijskih postopkov za medicinske
pripomočke (ISO/DIS 11135:2025)
Sterilization of health-care products - Ethylene oxide - Requirements for the
development, validation and routine control of a sterilization process for medical devices
(ISO/DIS 11135:2025)
Sterilisation von Produkten für die Gesundheitsfürsorge - Ethylenoxid - Anforderungen
an die Entwicklung, Validierung und Lenkung der Anwendung eines
Sterilisationsverfahrens für Medizinprodukte (ISO/DIS 11135:2025)
Stérilisation des produits de santé - Oxyde d'éthylène - Exigences de développement, de
validation et de contrôle de routine d'un processus de stérilisation pour des dispositifs
médicaux (ISO/DIS 11135:2025)
Ta slovenski standard je istoveten z: prEN ISO 11135
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 11135
ISO/TC 198
Sterilization of health-care
Secretariat: ANSI
products — Ethylene oxide —
Voting begins on:
Requirements for the development,
2025-06-25
validation and routine control of
Voting terminates on:
a sterilization process for medical
2025-09-17
devices
Stérilisation des produits de santé — Oxyde d'éthylène —
Exigences de développement, de validation et de contrôle de
routine d'un processus de stérilisation pour des dispositifs
médicaux
ICS: 11.080.01
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
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.
Reference number
ISO/DIS 11135:2025(en)
DRAFT
ISO/DIS 11135:2025(en)
International
Standard
ISO/DIS 11135
ISO/TC 198
Sterilization of health-care
Secretariat: ANSI
products — Ethylene oxide
Voting begins on:
— Requirements for the
development, validation and
Voting terminates on:
routine control of a sterilization
process for medical devices
Stérilisation des produits de santé — Oxyde d'éthylène —
Exigences de développement, de validation et de contrôle de
routine d'un processus de stérilisation pour des dispositifs
médicaux
ICS: 11.080.01
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: [phone]
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 11135:2025(en)
ii
ISO/DIS 11135:2025(en)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
1.1 Inclusions.1
1.2 Exclusions .1
2 Normative references . 1
3 Terms and definitions . 2
4 Quality management system .13
5 Sterilizing agent characterization . 14
5.1 General .14
5.2 Sterilizing agent .14
5.3 Microbicidal effectiveness . .14
5.4 Material effects .14
5.5 Safety and the environment .14
6 Process and equipment characterization .15
6.1 General . 15
6.2 Process characterization . 15
6.3 Equipment characterization .16
7 Product definition .16
7.1 General .16
7.2 Product safety, quality and performance .17
7.3 Microbiological quality .17
7.4 Documentation .17
8 Process definition . 17
9 Validation . .18
9.1 General .18
9.2 Installation qualification (IQ) .19
9.2.1 Equipment .19
9.2.2 Installation qualification (IQ) specifications . .19
9.3 Operational qualification (OQ) .19
9.4 Performance qualification (PQ) . 20
9.4.1 General . 20
9.4.2 Performance qualification (PQ) — Microbiological (MPQ) . 20
9.4.3 Performance qualification (PQ) — Physical (PPQ) .21
9.5 Review and approval of validation . 23
10 Routine monitoring and control.23
11 Product release from sterilization .25
12 Maintaining process effectiveness .25
12.1 General . 25
12.2 Maintenance of equipment . 25
12.3 Requalification . 26
12.4 Assessment of change . . 26
12.5 Assessment of equivalence . 26
12.5.1 Process equivalence . 26
12.5.2 Product equivalence .27
Annex A (informative) Guidance on the application of the requirements in this document .28
Annex B (informative) Guidance on selection of PCD and demonstration of appropriateness for
MPQ .54

iii
ISO/DIS 11135:2025(en)
Annex C (informative) Guidance on the number and placement of PCDs, temperature and
humidity sensors .
...