Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)

ISO 11137-1:2006 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. Although the scope of ISO 11137-1:2006 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment.
ISO 11137-1:2006 covers radiation processes employing irradiators using the radionuclide 60Co or 137Cs, a beam from an electron generator or a beam from an X-ray generator.
ISO 11137-1:2006 does not:
specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease;
detail specified requirements for designating a medical device as sterile;
specify a quality management system for the control of all stages of production of medical devices;
specify requirements for occupational safety associated with the design and operation of irradiation facilities;
specify requirements for the sterilization of used or reprocessed devices.

Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 1: Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens für Medizinprodukte

1.1   Dieser Teil von ISO 11137 legt Anforderungen für die Entwicklung, Validierung und Lenkung der Anwenduung eines Strahlensterilisationsverfahrens für Medizinprodukte fest.
ANMERKUNG   Obgleich der Anwendungsbereich von diesem Teil von ISO 11137 auf Medizinprodukte begrenzt ist, legt er Anforderungen fest und liefert Anleitungen, die für andere Produkte und Ausrüstungen gelten können.
Durch diesen Teil von ISO 11137 erfasste Strahlensterilisationsverfahren wenden Bestrahlungsanlagen an,
a)   die die Radionuklide 60Co und 137Cs verwenden,
b)   in denen beschleunigte Elektronen erzeugt werden
oder
c)   in denen durch beschleunigte Elektronen X-Rays (Röntgenstrahlen) genutzt werden.
1.2   Dieser Teil von ISO 11137 legt keine Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines Verfahrens zur Inaktivierung der Verursacher spongiformer Enzephalopathien wie Scrapie, bovine spongiforme Enzephalopathie und Creutzfeldt-Jakob-Krankheit fest. In bestimmten Ländern sind spezifische Empfehlungen für die Behandlung möglicherweise mit diesen Erregern kontaminierter Materialien erarbeitet worden.
ANMERKUNG   Siehe zum Beispiel ISO 22442 1, ISO 22442 2 und ISO 22442 3.
1.2.1   Dieser Teil von ISO 11137 legt keine in den Einzelheiten festgelegte Anforderung zur Kennzeichnung eines Medizinprodukts als steril fest.
ANMERKUNG   Zu beachten sind nationale oder regionale Anforderungen für die Kennzeichnung von Medizinprodukten als „steril“. Siehe zum Beispiel EN 556 1 oder ANSI/AAMI ST67.
1.2.2   Dieser Teil von ISO 11137 legt kein Qualitätsmanagementsystem für die Lenkung der Anwendung aller Stufen der Herstellung von Medizinprodukten fest.
ANMERKUNG   Es ist keine Anforderung von diesem Teil von ISO 11137, dass bei der Herstellung ein vollständiges Qualitätsmanagementsystem vorhanden ist, aber die als Minimum erforderlichen Elemente eines Qualitätsmanagement-systems zur Lenkung der Anwendung des Sterilisationsverfahrens werden an geeigneten Stellen im Text als normativ

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 11137-1:2006, y compris Amd 1:2013)

L'ISO 11137-1:2006 spécifie les exigences relatives à la mise au point, à la validation et au contrôle de routine d'un procédé de stérilisation par irradiation pour les dispositifs médicaux. Bien que le domaine d'application de la présente partie de l'ISO 11137 se limite aux dispositifs médicaux, elle spécifie les exigences et fournit des directives qui peuvent être applicables à d'autres produits et équipements.
L'ISO 11137-1:2006 couvre les procédés d'irradiation utilisant des irradiateurs, qui utilisent les radionucléides 60Co ou 137Cs, un faisceau à partir d'un générateur d'électrons ou un faisceau à partir d'un générateur de rayons X.
L'ISO 11137-1:2006
ne spécifie pas les exigences pour la mise au point, la validation et le contrôle de routine d'un procédé pour l'inactivation des agents responsables des encéphalopathies spongiformes telles que la tremblante du mouton (scrapie en anglais), l'encéphalopathie spongiforme bovine et la maladie de Creutzfeldt-Jakob. Des recommandations spécifiques ont été formulées dans certains pays pour le traitement des matériaux potentiellement contaminés par ces agents,
ne détaille pas les exigences spécifiées pour désigner un dispositif médical stérile,
ne spécifie pas de système de management de la qualité pour le contrôle de toutes les étapes de production des dispositifs médicaux,
n'exige ni l'utilisation d'indicateurs biologiques pour la validation ou la surveillance de la stérilisation par radiation, ni qu'un essai de stérilité défini dans la pharmacopée soit réalisé pour la libération du produit.
ne spécifie pas d'exigences relatives à la sécurité du travail associée à la conception et au fonctionnement des installations d'irradiation.
ne spécifie pas d'exigences relatives à la stérilisation de dispositifs usagés ou retraités.

Sterilizacija izdelkov za zdravstveno nego - Sevanje - 1. del: Zahteve za razvoj, validacijo in rutinsko kontrolo sterilizacijskih postopkov za medicinske pripomočke (ISO 11137-1:2006, vključno z dopolnilom Amd 1:2013)

Standard ISO 11137-1:2006 določa zahteve za razvoj, validacijo in rutinsko kontrolo sterilizacijskega postopka s sevanjem za medicinske pripomočke. Čeprav se je obseg standarda ISO 11137-1: 2006 omejena na medicinske pripomočke, določa zahteve in smernice, ki se lahko uporabljajo za druge izdelke in opremo.
Standard ISO 11137-1:2006 zajema postopke sevanja z iradiatorji z uporabo radionuklidov 60Co ali 137Cs, žarka iz generatorja elektronov ali žarka iz generatorja rentgenskega sevanja.
Standard ISO 11137-1:2006 ne določa:
zahtev za razvoj, validacijo in rutinsko kontrolo postopka za inaktivacijo povzročiteljev spongiformne encefalopatije, kot so praskavec, bovina spongiformna encefalopatija in Creutzfeldt-Jakobova bolezen; zahtev za označevanje medicinskega pripomočka kot sterilnega; sistema vodenja kakovosti za nadzor vseh faz proizvodnje medicinskih pripomočkov; zahtev za varnost pri delu, povezanih z načrtovanjem in upravljanjem sredstev za obsevanje; zahtev za sterilizacijo uporabljenih ali predelanih pripomočkov.

General Information

Status
Published
Publication Date
04-Aug-2015
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
02-Jul-2015
Due Date
06-Sep-2015
Completion Date
05-Aug-2015

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SLOVENSKI STANDARD
SIST EN ISO 11137-1:2015
01-september-2015
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SIST EN ISO 11137-1:2006
SIST EN ISO 11137-1:2006/A1:2013

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SULSRPRþNH ,62YNOMXþQR]GRSROQLORP$PG

Sterilization of health care products - Radiation - Part 1: Requirements for development,

validation and routine control of a sterilization process for medical devices (ISO 11137-

1:2006, including Amd 1:2013)
Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 1:
Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines
Sterilisationsverfahrens für Medizinprodukte

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 11137-1:2006, y compris Amd 1:2013)
Ta slovenski standard je istoveten z: EN ISO 11137-1:2015
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 11137-1:2015 en

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

---------------------- Page: 1 ----------------------
SIST EN ISO 11137-1:2015
---------------------- Page: 2 ----------------------
SIST EN ISO 11137-1:2015
EUROPEAN STANDARD
EN ISO 11137-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2015
ICS 11.080.01 Supersedes EN ISO 11137-1:2006
English Version
Sterilization of health care products - Radiation - Part 1:
Requirements for development, validation and routine control of
a sterilization process for medical devices (ISO 11137-1:2006,
including Amd 1:2013)

Stérilisation des produits de santé - Irradiation - Partie 1: Sterilisation von Produkten für die Gesundheitsfürsorge -

Exigences relatives à la mise au point, à la validation et au Strahlen - Teil 1: Anforderungen an die Entwicklung,

contrôle de routine d'un procédé de stérilisation pour les Validierung und Lenkung der Anwendung eines

dispositifs médicaux (ISO 11137-1:2006, y compris Amd Sterilisationsverfahrens für Medizinprodukte (ISO 11137-

1:2013) 1:2006, einschließlich Amd 1:2013)
This European Standard was approved by CEN on 20 May 2015.

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

© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11137-1:2015 E

worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 11137-1:2015
EN ISO 11137-1:2015 (E)
Contents Page

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

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

Requirements of EU Directive 90/385/EEC on active implantable medical devices ......................5

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

Requirements of EU Directive 93/42/EEC on medical devices .........................................................6

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

Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices ...........................7

---------------------- Page: 4 ----------------------
SIST EN ISO 11137-1:2015
EN ISO 11137-1:2015 (E)
Foreword

The text of ISO 11137-1:2006, including Amd 1:2013 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 EN ISO 11137-1:2015 by 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 December 2015, and conflicting national standards shall be withdrawn

at the latest by December 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 EN ISO 11137-1:2006.

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 Directives.

For relationship with EU Directives, see informative Annexes ZA, ZB, ZC, which are an integral part of this

document.

The following referenced documents are indispensable for the application of this document. For undated

references, the edition of the referenced document (including any amendments) listed below applies. For

dated references, only the edition cited applies. However, for any use of this standard within the meaning of

Annex ZA, ZB or ZC, the user should always check that any referenced document has not been superseded

and that its relevant contents can still be considered the generally acknowledged state-of-art.

When an IEC or ISO standard is referred to in the ISO standard text, this should be understood as a

normative reference to the corresponding EN standard, if available, and otherwise to the dated version of the

ISO or IEC standard as listed below.

NOTE The way in which these referenced documents are cited in normative requirements determines the extent (in

whole or in part) to which they apply.
Table — Correlation between normative references and dated EN and ISO standards
Normative references Equivalent dated standard
as listed in Clause 2 of the ISO
EN ISO
standard
ISO 10012-1 EN ISO 10012:2003 ISO 10012:2003
ISO 11137-2 EN ISO 11137-2:2013 ISO 11137-2:2013
ISO 11737-1 EN ISO 11737-1:2006 + AC:2009 ISO 11737-1:2006 + Cor 1:2007
ISO 11737-2 EN ISO 11737-2:2009 ISO 11737-2:2009
ISO 13485 EN ISO 13485:2012 ISO 13485:2003
---------------------- Page: 5 ----------------------
SIST EN ISO 11137-1:2015
EN ISO 11137-1:2015 (E)

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 11137-1:2006, including Amd 1:2013 has been approved by CEN as EN ISO 11137-1:2015

without any modification.
---------------------- Page: 6 ----------------------
SIST EN ISO 11137-1:2015
EN ISO 11137-1:2015 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on active implantable
medical devices

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

Commission and the European Free Trade Association to provide a means of conforming to Essential

Requirements of the New Approach Directive 90/385/EEC on active implantable medical devices.

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 normative 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 corresponding Essential Requirements of that Directive and associated EFTA regulations.

NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk

management process needs to be in compliance with 90/385/EEC, as amended by 2007/47/EC. This means that risks

have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’ or ‘removed’, according

to the wording of the corresponding essential requirement.

NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential requirements

1, 4, 5, 8, 9 and 10 of the Directive.

NOTE 3 This Annex ZA is based on normative references according to the table of references in the European

foreword, replacing the references in the core text.

NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this

European Standard.

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 Only a sterilization process using
ionizing radiation is considered by
this standard.
This relevant Essential
Requirement is only partly
addressed in this European
Standard. Design and packaging
for maintenance of sterility during
transportation and storage are not
covered. Aspects of manufacture
other than those related to
sterilization are not covered.

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within

the scope of this Standard.
---------------------- Page: 7 ----------------------
SIST EN ISO 11137-1:2015
EN ISO 11137-1:2015 (E)
Annex ZB
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices

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

Commission and the European Free Trade Association to provide a means of conforming to Essential

Requirements of the New Approach Directive 93/42/EEC on medical devices.

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 normative 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 corresponding Essential Requirements of that Directive and associated EFTA regulations.

NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk

management process needs to be in compliance with 93/42/EEC, as amended by 2007/47/EC. This means that risks have

to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’ or ‘removed’, according to the

wording of the corresponding essential requirement.

NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential requirements

1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.

NOTE 3 This Annex ZA is based on normative references according to the table of references in the European

foreword, replacing the references in the core text.

NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this

European Standard.

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 93/42/EEC
4,5,6,7,8,9,10,11,12 8.3 Only a sterilization process using
ionizing radiation is considered by
this standard.
This relevant Essential
Requirement is only partly
addressed in this European
Standard. Design and packaging
for maintenance of sterility during
transportation and storage are not
covered. Aspects of manufacture
other than those related to
sterilization are not covered.
4,5,6,7,8,9,10,11,12 8.4 This relevant Essential
Requirement is only partly
addressed in this European
Standard. Aspects of manufacture
other than those related to
sterilization are not covered.

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within

the scope of this Standard.
---------------------- Page: 8 ----------------------
SIST EN ISO 11137-1:2015
EN ISO 11137-1:2015 (E)
Annex ZC
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC on in vitro diagnostic
medical devices

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

Commission and the European Free Trade Association to provide a means of conforming to Essential

Requirements of the New Approach Directive 98/79/EC on in vitro diagnostic medical devices.

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 normative clauses of

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

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

NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk

management process needs to be in compliance with 98/79/EC. This means that risks have to be reduced ‘as far as

possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’ or ‘removed’, according to the wording of the

corresponding essential requirement.

NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential requirements

Part A: 1, 2 and 5; Part B: 1.2, 2, 3, 5, 6, and 7 of the Directive.

NOTE 3 This Annex ZA is based on normative references according to the table of references in the European

foreword, replacing the references in the core text.

NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this

European Standard.

Table ZC.1 — Correspondence between this European Standard and Directive 98/79/EC

Clauses of this EN Essential Requirements (ERs) of Qualifying remarks/Notes
Directive 98/79/EC
4,5,6,7,8,9,10,11,12 B.2.3 Only a sterilization process using
ionizing radiation is considered by
this standard.
This relevant Essential
Requirement is only partly
addressed in this European
Standard. Design and packaging
for maintenance of sterility during
transportation and storage are not
covered. Aspects of manufacture
other than those related to
sterilization are not covered.
---------------------- Page: 9 ----------------------
SIST EN ISO 11137-1:2015
EN ISO 11137-1:2015 (E)
4,5,6,7,8,9,10,11,12 B.2.4 This relevant Essential requirement
is addressed only with regard to:
- sterilization, not covering other
special microbiological state
- devices for which sterilization by
radiation is appropriate

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within

the scope of this Standard.
---------------------- Page: 10 ----------------------
SIST EN ISO 11137-1:2015
INTERNATIONAL ISO
STANDARD 11137-1
First edition
2006-04-15
Sterilization of health care products —
Radiation —
Part 1:
Requirements for development, validation
and routine control of a sterilization
process for medical devices
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
Reference number
ISO 11137-1:2006(E)
ISO 2006
---------------------- Page: 11 ----------------------
SIST EN ISO 11137-1:2015
ISO 11137-1:2006(E)
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ii © ISO 2006 – All rights reserved
---------------------- Page: 12 ----------------------
SIST EN ISO 11137-1:2015
ISO 11137-1:2006(E)
Contents Page

Foreword............................................................................................................................................................ iv

Introduction ........................................................................................................................................................ v

1 Scope ..................................................................................................................................................... 1

2 Normative references ........................................................................................................................... 2

3 Terms and definitions........................................................................................................................... 2

4 Quality management system elements ..............................................................................................8

4.1 Documentation...................................................................................................................................... 8

4.2 Management responsibility ................................................................................................................. 9

4.3 Product realization................................................................................................................................ 9

4.4 Measurement, analysis and improvement — Control of nonconforming product ........................ 9

5 Sterilizing agent characterization ....................................................................................................... 9

5.1 Sterilizing agent .................................................................................................................................... 9

5.2 Microbicidal effectiveness ................................................................................................................... 9

5.3 Material effects...................................................................................................................................... 9

5.4 Environmental considerations .......................................................................................................... 10

6 Process and equipment characterization ........................................................................................ 10

6.1 Process ................................................................................................................................................ 10

6.2 Equipment ........................................................................................................................................... 10

7 Product definition ............................................................................................................................... 11

8 Process definition............................................................................................................................... 12

8.1 Establishing the maximum acceptable dose ................................................................................... 12

8.2 Establishing the sterilization dose.................................................................................................... 12

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

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.................................................................................................... 15

10 Routine monitoring and control ........................................................................................................ 16

11 Product release from sterilization..................................................................................................... 17

12 Maintaining process effectiveness ................................................................................................... 17

12.1 Demonstration of continued effectiveness...................................................................................... 17

12.2 Recalibration ....................................................................................................................................... 20

12.3 Maintenance of equipment ................................................................................................................ 20

12.4 Requalification of equipment ............................................................................................................ 20

12.5 Assessment of change....................................................................................................................... 20

Annex A (informative) Guidance..................................................................................................................... 21

Bibliography ..................................................................................................................................................... 36

© ISO 2006 – All rights reserved iii
---------------------- Page: 13 ----------------------
SIST EN ISO 11137-1:2015
ISO 11137-1:2006(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.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International Standards

adopted by the technical committees are circulated to the member bodies for voting. Publication as an

International Standard requires approval by at least 75 % of the member bodies casting a vote.

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.

ISO 11137-1 was prepared by Technical Committee ISO/TC 198, Sterilization of health care product.

This first edition, together with ISO 11137-2 and ISO 11137-3, cancels and replaces ISO 11137:1995.

ISO 11137 consists of the following parts, under the general title Sterilization of health care products —

Radiation:

⎯ Part 1: Requirements for development, validation and routine control of a sterilization process for medical

devices
⎯ Part 2: Establishing the sterilization dose
⎯ Part 3: Guidance on dosimetric aspects
iv © ISO 2006 – All rights reserved
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SIST EN ISO 11137-1:2015
ISO 11137-1:2006(E)
Introduction

A sterile medical device is one that is free of viable microorganisms. International Standards, which specify

requirements for validation and routine control of sterilization processes, require, when it is necessary to

supply a sterile medical device, that adventitious microbiological contamination of a medical device prior to

sterilization be minimized. Even so, medical devices produced under standard manufacturing conditions in

accordance with the requirements for quality management systems (see, for example, ISO 13485) may, 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 sterilizing agent; inevitably this means that

there is always a finite probability that a microorganism may 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.

This part of ISO 11137 describes requirements that, if met, will provide a radiation sterilization process

intended to sterilize medical devices, that has appropriate microbicidal activity. Furthermore, compliance with

the requirements ensures that this activity is both reliable and reproducible so that predictions can be made,

with reasonable confidence, that there is a low level of probability of there being a viable microorganism

present on product after sterilization. Specification of this probability is a matter for regulatory authorities and

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

Generic requirements of the quality management system 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 recognise that, for

certain processes used in manufacturing, 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 is monitored

routinely and the equipment is maintained.

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

with the provision of reliable assurance that the products are sterile and, in this regard, suitable for its intended

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