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 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.

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

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.

General Information

• Status: Published
• Publication Date: 06-Jul-2014
• ICS: 11.080.01 - Sterilization and disinfection in general
• Technical Committee: ISO/TC 198 - Sterilization of health care products
• Drafting Committee: ISO/TC 198/WG 1 - Industrial ethylene oxide sterilization
• Current Stage: 9093 - International Standard confirmed
• Completion Date: 16-May-2024

Relations

• Consolidates: ISO/IEC 13818-1:2000/Cor 2:2002 - Information technology — Generic coding of moving pictures and associated audio information: Systems — Part 1: — Technical Corrigendum 2
• Effective Date: 06-Jun-2022
• Amended By: ISO 11135:2014/Amd 1:2018 - 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
• Effective Date: 01-Jan-2022
• Revises: ISO/TS 11135-2:2008 - Sterilization of health care products — Ethylene oxide — Part 2: Guidance on the application of ISO 11135-1
• Effective Date: 06-Mar-2010
• Revises: ISO 11135-1:2007 - Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
• Effective Date: 06-Mar-2010

Standards Content (Sample)

DRAFT INTERNATIONAL STANDARD ISO/DIS 11135
ISO/TC 198 Secretariat: ANSI
Voting begins on Voting terminates on

2000-09-15 2012-02-15
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION    МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ    ORGANISATION INTERNATIONALE DE NORMALISATION


Sterilization of health-care products — Ethylene oxide —
Requirements for the development, validation and routine
control of a sterilization process for medical devices
Stérilisation des produits de santé — Oxyde d'éthylène — Exigences pour le développement, la validation et
la vérification de routine d'un processus de stérilisation pour les appareils médicaux
[Revision of first edition (ISO 11135-1:2007) and ISO/TS 11135-2:2008]
ICS 11.080.01


ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for Standardization (ISO), and
processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
five-month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments received, will be
submitted to a parallel two-month approval vote in ISO and formal vote in CEN.

In accordance with the provisions of Council Resolution 15/1993 this document is circulated in
the English language only.
Conformément aux dispositions de la Résolution du Conseil 15/1993, ce document est distribué
en version anglaise seulement.

To expedite distribution, this document is circulated as received from the committee
secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at
publication stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.



THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS 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 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.
©  International Organization for Standardization, 2011

---------------------- Page: 1 ----------------------
ISO/DIS 11135

Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as permitted
under the applicable laws of the user’s country, neither this ISO draft nor any extract from it may be
reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic,
photocopying, recording or otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to 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 [e-mail]
Web www.iso.org
Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.

ii © ISO 2011 – All rights reserved

---------------------- Page: 2 ----------------------
ISO/DIS 11135
Contents Page
Foreword . vi
Introduction . vii
1 Scope . 1
1.1 Inclusions . 1
1.2 Exclusions . 1
2 Normative references . 2
3 Terms and definitions . 3
4 Quality management systems . 10
4.1 Documentation .
...

DRAFT INTERNATIONAL STANDARD ISO/DIS 11135.2
ISO/TC 198 Secretariat: ANSI
Voting begins on Voting terminates on

2012-09-20 2012-11-20
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION    МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ    ORGANISATION INTERNATIONALE DE NORMALISATION


Sterilization of health-care products — Ethylene oxide —
Requirements for the development, validation and 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
[Revision of first edition (ISO 11135-1:2007) and ISO/TS 11135-2:2008]
ICS 11.080.01


ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for Standardization (ISO), and
processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
five-month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments received, will be
submitted to a parallel two-month approval vote in ISO and formal vote in CEN.


To expedite distribution, this document is circulated as received from the committee
secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at
publication stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.



THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS 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 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.
©  International Organization for Standardization, 2012

---------------------- Page: 1 ----------------------
ISO/DIS 11135.2

Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as permitted
under the applicable laws of the user’s country, neither this ISO draft nor any extract from it may be
reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic,
photocopying, recording or otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to 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 [e-mail]
Web www.iso.org
Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.

ii © ISO 2012 – All rights reserved

---------------------- Page: 2 ----------------------
ISO/DIS 11135
Contents Page
1 Scope . 1
1.1 Inclusions . 1
1.2 Exclusions . 1
2 Normative references . 2
3 Terms and definitions . 3
4 Quality management systems . 10
4.1 Documentation . 10
4.2 Management responsibility . 10
4.3 Product realization . 11
4.4 Measurement, analysis and improvement — Control of nonconforming product . 11
5 Sterilizing agent characterization .
...

INTERNATIONAL ISO
STANDARD 11135
Second edition
2014-07-15
Sterilization of health-care
products — Ethylene oxide —
Requirements for the development,
validation and 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
Reference number
ISO 11135:2014(E)
©
ISO 2014

---------------------- Page: 1 ----------------------
ISO 11135:2014(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2014
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 [e-mail]
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved

---------------------- Page: 2 ----------------------
ISO 11135:2014(E)

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
1.1 Inclusions . 1
1.2 Exclusions . 1
2 Normative references . 2
3 Terms and definitions . 3
4 Quality management systems .11
4.1 Documentation .11
4.2 Management responsibility .11
4.3 Product realization .11
4.4 Measurement, analysis and improvement — Control of nonconforming product .11
5 Sterilizing agent characterization .11
5.1 General .11
5.2 Sterilizing agent .12
5.3 Microbicidal effectiveness .12
5.4 Material effects.12
5.5 Safety and the environment .12
6 Process and equipment characterization .
...

NORME ISO
INTERNATIONALE 11135
Deuxième édition
2014-07-15
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
Sterilization of health-care products — Ethylene oxide —
Requirements for the development, validation and routine control of a
sterilization process for medical devices
Numéro de référence
ISO 11135:2014(F)
©
ISO 2014

---------------------- Page: 1 ----------------------
ISO 11135:2014(F)

DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2014
Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite ni utilisée
sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie, l’affichage sur
l’internet ou sur un Intranet, sans autorisation écrite préalable. Les demandes d’autorisation peuvent être adressées à l’ISO à
l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.org
Publié en Suisse
ii © ISO 2014 – Tous droits réservés

---------------------- Page: 2 ----------------------
ISO 11135:2014(F)

Sommaire Page
Avant-propos .v
Introduction .vi
1 Domaine d’application . 1
1.1 Inclusions . 1
1.2 Exclusions . 1
2 Références normatives . 2
3 Termes et définitions . 3
4 Systèmes de management de la qualité .11
4.1 Documentation .11
4.2 Responsabilité de la direction .11
4.3 Réalisation du produit .11
4.4 Mesurages, analyse et amélioration — Maîtrise du produit non conforme .11
5 Caractérisation de l’agent stérilisant .11
5.1 Généralités .11
5.2 Agent stérilisant .12
5.3 Efficacité microbicide .12
5.4 Effets sur les matériaux .12
5.5 Sécurité et environnement .12
6 Caractérisation du procédé et de l’équipement .
...