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)

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 11135:2014)

1.1 Im Anwendungsbereich enthalten
Diese Internationale Norm legt Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens mit Ethylenoxid für Medizinprodukte im Rahmen der Industrie sowie in Einrichtungen der Gesundheitsfürsorge fest und erkennt die Ähnlichkeiten und Unterschiede zwischen den beiden Anwendungen an.
ANMERKUNG 1 Zu den Ähnlichkeiten zählen das gemeinsame Erfordernis für Qualitätssysteme, Mitarbeiter-schulungen und die ordnungsgemäßen Sicherheitsmaßnahmen. Die Hauptunterschiede beziehen sich auf die speziellen physikalischen und organisatorischen Bedingungen in Einrichtungen der Gesundheitsfürsorge sowie auf den Ausgangszustand der wiederverwendbaren Medizinprodukte, die zur Sterilisation vorgelegt werden.
ANMERKUNG 2 Einrichtungen der Gesundheitsfürsorge unterscheiden sich von den Herstellern der Medizinprodukte durch die physikalische Gestaltung der Verarbeitungsbereiche, durch die verwendete Ausrüstung und durch die Verfüg-barkeit von Mitarbeitern mit dem entsprechenden Ausbildungsstand und den entsprechenden Erfahrungen. Die primäre Aufgabe von Einrichtungen der Gesundheitsfürsorge besteht in der Pflege von Patienten; das Wiederaufbereiten von Medizinprodukten ist nur eine der zahlreichen Tätigkeiten, die im Rahmen dieser Aufgabe durchgeführt werden.
ANMERKUNG 3 In Bezug auf den Ausgangszustand von Medizinprodukten sterilisieren die Hersteller von Medizin-produkten im Allgemeinen große Stückzahlen ähnlicher Medizinprodukte, die aus Neuware hergestellt wurden. Einrichtungen der Gesundheitsfürsorge müssen andererseits sowohl neue als auch wiederverwendbare Medizinprodukte unterschiedlicher Arten und mit schwankender Keimbelastung handhaben und behandeln. Folglich sehen sie sich vor der Sterilisation mit zusätzlichen Herausforderungen der Reinigung, Bewertung, Vorbereitung und Verpackung eines Medizinprodukts konfrontiert. In der vorliegenden Internationalen Norm werden für Einrichtungen der Gesundheitsfürsorge spezifische alternative Herangehensweisen und Leitlinien entsprechend gekennzeichnet.
ANMERKUNG 4 EO-Gas und dessen Gemische sind wirksame Sterilisationsmittel, die vorrangig bei wärme- und feuchteempfindlichen Medizinprodukten verwendet werden, die nicht dampfsterilisiert werden können.
ANMERKUNG 5 Obgleich der Anwendungsbereich dieser Internationalen Norm auf Medizinprodukte begrenzt ist, legt er Anforderungen fest und liefert Anleitungen, die für andere Produkte für die Gesundheitsfürsorge gelten können.
1.2 Nicht im Anwendungsbereich enthalten
1.2.1 Diese Internationale Norm legt keine Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines Verfahrens der Inaktivierung der Erreger spongiformer Enzephalopathien wie Scrapie, bovine spongiforme Enzephalopathie und Creutzfeldt-Jakob-Krankheit fest. In einigen Ländern wurden spezifische Empfehlungen für die Behandlung möglicherweise mit diesen Erregern kontaminierter Materialien erarbeitet.
ANMERKUNG Siehe ISO 22442-1, ISO 22442-2 und ISO 22442-3.
1.2.2 Diese Internationale Norm enthält keine ausführlichen Angaben zur Festlegung einer Anforderung an die Bezeichnung eines Medizinprodukts, das als steril gekennzeichnet ist.
ANMERKUNG Zu beachten sind nationale oder regionale Anforderungen an die Bezeichnung von Medizinprodukten die als 'steril' gekennzeichnet sind. Siehe zum Beispiel EN 556-1 oder ANSI/AAMI ST67.
1.2.3 Diese Internationale Norm legt kein Qualitätsmanagementsystem für die Lenkung aller Stufen der Herstellung von Medizinprodukten fest.

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 11135:2014)

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 11135:2014)

Standard EN ISO 11135 določa zahteve za razvoj, validacijo in rutinsko kontrolo sterilizacijskih postopkov z etilenoksidom za medicinske naprave v industrijske in zdravstvene namene, in njegovo sprejemanje podobnosti in razlik med tema dvema uporabama.

General Information

Status
Published
Publication Date
15-Jul-2014
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
16-Jul-2014
Completion Date
16-Jul-2014

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SLOVENSKI STANDARD
SIST EN ISO 11135:2014
01-oktober-2014
1DGRPHãþD
SIST EN ISO 11135-1:2007
SIST-TS CEN ISO/TS 11135-2:2008
SIST-TS CEN ISO/TS 11135-2:2008/AC:2009
6WHULOL]DFLMDL]GHONRY]D]GUDYVWYHQRQHJR(WLOHQRNVLG=DKWHYH]DUD]YRM
YDOLGDFLMRLQUXWLQVNRNRQWURORVWHULOL]DFLMVNLKSRVWRSNRY]DPHGLFLQVNH
SULSRPRþNH ,62
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)

Sterilisation von Produkten für die Gesundheitsfürsorge - Ethylenoxid - Anforderungen

an die Entwicklung, Validierung und Lenkung der Anwendung eines
Sterilisationsverfahrens für Medizinprodukte (ISO 11135:2014)
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 (ISO 11135:2014)
Ta slovenski standard je istoveten z: EN ISO 11135:2014
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 11135:2014 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 11135:2014
---------------------- Page: 2 ----------------------
SIST EN ISO 11135:2014
EUROPEAN STANDARD
EN ISO 11135
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2014
ICS 11.080.01 Supersedes CEN ISO/TS 11135-2:2008, EN ISO 11135-
1:2007
English Version
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)

Stérilisation des produits de santé - Oxyde d'éthylène - Sterilisation von Produkten für die Gesundheitsfürsorge -

Exigences de développement, de validation et de contrôle Ethylenoxid - Anforderungen an die Entwicklung,

de routine d'un processus de stérilisation pour des Validierung und Lenkung der Anwendung eines

dispositifs médicaux (ISO 11135:2014) Sterilisationsverfahrens für Medizinprodukte (ISO

11135:2014)
This European Standard was approved by CEN on 28 June 2014.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European

Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national

standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation

under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same

status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United

Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels

© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11135:2014 E

worldwide for CEN national Members.
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SIST EN ISO 11135:2014
EN ISO 11135:2014 (E)
Contents Page

Foreword ..............................................................................................................................................................3

Annex ZA (informative) Relationship between this European Standard and the Essential

Requirements of EU Directive 90/385/EEC ..........................................................................................4

Annex ZB (informative) Relationship between this European Standard and the Essential

Requirements of Directive 93/42/EEC ..................................................................................................5

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SIST EN ISO 11135:2014
EN ISO 11135:2014 (E)
Foreword

This document (EN ISO 11135:2014) has been prepared by Technical Committee ISO/TC 198 “Sterilization of

health care products” in collaboration with Technical Committee CEN/TC 204 “Sterilization of medical devices”

the secretariat of which is held by BSI.

This European Standard shall be given the status of a national standard, either by publication of an identical

text or by endorsement, at the latest by January 2015, and conflicting national standards shall be withdrawn at

the latest by January 2015.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent

rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.

This document supersedes CEN ISO/TS 11135-2:2008, EN ISO 11135-1:2007.

This document has been prepared under a mandate given to CEN by the European Commission and the

European Free Trade Association, and supports essential requirements of EU Directive(s).

For relationship with EU Directive(s), see informative Annex ZA, ZB, which are integral parts of this document.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,

Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,

Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

Endorsement notice

The text of ISO 11135:2014 has been approved by CEN as EN ISO 11135:2014 without any modification.

---------------------- Page: 5 ----------------------
SIST EN ISO 11135:2014
EN ISO 11135:2014 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC

This European Standard has been prepared under a mandate given to CEN by the European Commission

and the European Free Trade Association to provide one means of conforming to Essential Requirements of

the New Approach Directive 90/385/EEC.

Once this standard is cited in the Official Journal of the European Union under that Directive and has been

implemented as a national standard in at least one Member State, compliance with the clauses of this

standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of

conformity with the relevant Essential Requirements of that Directive and associated EFTA regulations.

Table ZA.1 — Correspondence between this European Standard and Directive 90/385/EEC

Clauses of this EN Essential Requirements (ERs) of Qualifying remarks/Notes
Directive 90/385/EEC
4,5,6,7,8,9,10,11,12 7 This relevant Essential
Requirement is only partly
addressed in this European
Standard. Packaging for
maintenance of sterility during
transportation and storage are not
covered

WARNING: Other requirements and other EU Directives may be applicable to the products falling within the scope of this

standard.
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SIST EN ISO 11135:2014
EN ISO 11135:2014 (E)
Annex ZB
(informative)
Relationship between this European Standard and the Essential
Requirements of Directive 93/42/EEC

This European Standard has been prepared under a mandate given to CEN by the European Commission

and the European Free Trade Association to provide one means of conforming to Essential Requirements of

the New Approach Directive 93/42/EEC.

Once this standard is cited in the Official Journal of the European Union under that Directive and has been

implemented as a national standard in at least one Member State, compliance with the clauses of this

standard given in Table ZB.1 confers, within the limits of the scope of this standard, a presumption of

conformity with the relevant Essential Requirements of that Directive and associated EFTA regulations.

Table ZB.1 — Correspondence between this European Standard and Directive 93/42/EEC

Clauses of this EN Essential Requirements (ERs) of Qualifying remarks/Notes
Directive 90/42/EEC
4,5,6,7,8,9,10,11,12 8.3 This relevant Essential
Requirement is only partly
addressed in this European
Standard. Packaging for
maintenance of sterility during
transportation and storage are not
covered
4,5,6,7,8,9,10,11,12 8.4

WARNING: Other requirements and other EU Directives may be applicable to the products falling within the scope of this

standard.
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SIST EN ISO 11135:2014
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SIST EN ISO 11135:2014
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
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SIST EN ISO 11135:2014
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 copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved
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SIST EN ISO 11135:2014
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 ................................................................................................................................12

6.1 General ........................................................................................................................................................................................................12

6.2 Process characterization .............................................................................................................................................................12

6.3 Equipment characterization .....................................................................................................................................................13

7 Product definition ............................................................................................................................................................................................14

7.1 General ........................................................................................................................................................................................................14

7.2 Product safety, quality and performance ......................................................................................................................15

7.3 Microbiological quality .................................................................................................................................................................15

7.4 Documentation ....................................................................................................................................................................................15

8 Process definition .............................................................................................................................................................................................15

9 Validation ..................................................................................................................................................................................................................16

9.1 General ........................................................................................................................................................................................................16

9.2 Installation qualification, IQ .....................................................................................................................................................17

9.3 Operational qualification, OQ ..................................................................................................................................................17

9.4 Performance qualification, PQ ................................................................................................................................................18

9.5 Review and approval of validation .....................................................................................................................................20

10 Routine monitoring and control .......................................................................................................................................................22

11 Product release from sterilization ..................................................................................................................................................23

12 Maintaining process effectiveness

..................................................................................................................................................23

12.1 General ........................................................................................................................................................................................................23

12.2 Maintenance of equipment ........................................................................................................................................................24

12.3 Requalification .....................................................................................................................................................................................24

12.4 Assessment of change ....................................................................................................................................................................24

12.5 Assessment of equivalence ........................................................................................................................................................25

Annex A (normative) Determination of lethal rate of the sterilization process — Biological

indicator/bioburden approach ..........................................................................................................................................................26

Annex B (normative) Conservative determination of lethal rate of the sterilization process —

Overkill approach .............................................................................................................................................................................................27

Annex C (informative) Temperature sensors, RH sensors and biological indicator numbers ..............29

© ISO 2014 – All rights reserved iii
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SIST EN ISO 11135:2014
ISO 11135:2014(E)

Annex D (informative) Guidance on the application of the normative requirements ...................................32

Annex E (normative) Single Lot Release ........................................................................................................................................................74

Bibliography .............................................................................................................................................................................................................................76

iv © ISO 2014 – All rights reserved
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SIST EN ISO 11135:2014
ISO 11135:2014(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. 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. 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 on the meaning of ISO specific terms and expressions related to conformity

assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers

to Trade (TBT), see the following URL: Foreword - Supplementary information

The committee responsible for this document is ISO/TC 198, Sterilization of health care products.

ISO 11135:2014 cancels and replaces ISO 11135-1:2007 and ISO/TS 11135-2:2008, both of which have

been technically revised and condensed into a single standard.
© ISO 2014 – All rights reserved v
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SIST EN ISO 11135:2014
ISO 11135:2014(E)
Introduction

A sterile medical device is one that is free of viable microorganisms. Medical devices produced under

standard manufacturing conditions in accordance with the requirements for quality management

systems (see for example ISO 13485) might, prior to sterilization, have microorganisms on them, albeit

in low numbers. Such medical devices are non-sterile. The purpose of sterilization is to inactivate the

microbiological contaminants and thereby transform the non-sterile medical devices into sterile ones.

The kinetics of inactivation of a pure culture of microorganisms by physical and/or chemical agents

used to sterilize medical devices can generally best be described by an exponential relationship

between the numbers of microorganisms surviving and the extent of treatment with the ethylene

oxide (EO); inevitably this means that there is always a finite probability that a microorganism might

survive regardless of the extent of treatment applied. For a given treatment, the probability of survival

is determined by the number and resistance of microorganisms and by the environment in which the

organisms exist during treatment. It follows that the sterility of any one medical device in a population

subjected to sterilization processing cannot be guaranteed and the sterility of a processed population is

defined in terms of the probability of there being a viable microorganism present on a medical device.

ISO 11135 describes requirements that, if met, will provide an ethylene oxide sterilization process

intended to sterilize medical devices, which has appropriate microbicidal activity. Furthermore,

compliance with the requirements ensures that validations conducted following this International

Standard will provide products that meet the defined requirements for sterile products with a high

degree of confidence. The specification for this probability is a matter for regulatory authorities and can

vary from country to country (see for example EN 556-1 and ANSI/AAMI ST67).

Generic requirements of the quality management systems for design and development, production,

installation and servicing are given in ISO 9001 and particular requirements for quality management

systems for medical device production are given in ISO 13485. The standards for quality management

systems recognize that, for certain processes used in manufacturing or reprocessing, the effectiveness

of the process cannot be fully verified by subsequent inspection and testing of the product. Sterilization

is an example of such a process. For this reason, sterilization processes are validated for use, the

performance of the sterilization process monitored routinely and the equipment maintained.

Exposure to a properly validated, accurately controlled sterilization process is not the only factor

associated with the provision of reliable assurance that the product is sterile and, in this regard, suitable

for its intended use. Attention is therefore given to a number of considerations including:

— the microbiological status of incoming raw materials and/or components;

— the validation and routine control of any cleaning and disinfection procedures used on the product;

— the control of the environment in which the product is manufactured or reprocessed, assembled

and packaged;
— the control of equipment and processes;
— the control of personnel and their hygiene;
— the manner and materials in which the product is packaged;
— the conditions under which product is stored.

The type of contamination on a product to be sterilized varies and this impacts upon the effectiveness

of a sterilization process. Products that have been used in a health care setting and are being presented

for resterilization in accordance with the manufacturer’s instructions (see ISO 17664) are a special case.

There is the potential for such products to possess a wide range of contaminating microorganisms and

residual inorganic and/or organic contamination in spite of the application of a cleaning process. Hence,

it is important to pay particular attention to the validation and control of the cleaning and disinfection

processes used during reprocessing. Mixed product loads are common in health care facilities with

throughput volumes dictated by historical and predicted demand for sterile product.

vi © ISO 2014 – All rights reserved
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SIST EN ISO 11135:2014
ISO 11135:2014(E)

The requirements are the normative parts of ISO 11135 with which compliance is claimed. The guidance

given in the informative annexes is not normative and is not provided as a checklist for auditors. The

guidance in Annex D provides explanations and methods that are regarded as being suitable means for

complying with the requirements for industry and health care facilities.

The guidance, in Annex D, is intended for people who have a basic knowledge of the principles of EO

sterilization. Methods other than those given in the guidance can be used if they are effective in achieving

compliance with the requirements of ISO 11135.

The development, validation and routine control of a sterilization process comprises a number of

discrete but interrelated activities; e.g. calibration, maintenance, product definition, process definition,

installation qualification, operational qualification and performance qualification. While the activities

required by ISO 11135 have been grouped together and are presented in a particular order, ISO 11135

does not require that the activities be performed in the order in which they are presented. The activities

required are not necessarily sequential, as the programme of development and validation may be iterative.

It is possible that performing these different activities will involve a number of separate individuals

and/or organizations, each of whom undertakes one or more of these activities. This International

Standard does not specify the particular individuals or organizations to carry out the activities.

It is important that patient safety be addressed by minimizing exposure to EO and its by-products during

normal product use. ISO 10993-7 specifies limits for EO and ethylene chlorohydrin (ECH); however, no

exposure limits are set for ethylene glycol (EG) because risk assessment indicates that when EO residues

are controlled, it is unlikely that biologically significant residues of EG would be present.

© ISO 2014 – All rights reserved vii
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SIST EN ISO 11135:2014
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SIST EN ISO 11135:2014
INTERNATIONAL STANDARD ISO 11135:2014(E)
Sterilization of health-care products — Ethylene oxide —
Requirements for the development, validation and routine
control of a sterilization process for medical devices
1 Scope
1.1 Inclusions

This International Standard 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.

NOTE 1 Among the similarities are the common need for quality systems, staff training, and proper safety

measures. The major differenc
...

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