Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

This part of ISO 11137 specifies methods for determining the minimum dose needed to achieve a specified
requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization
dose to achieve a sterility assurance level, SAL, of 10−6. This part of ISO 11137 also specifies methods of
sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.
This part of ISO 11137 defines product families for sterilization dose establishment and sterilization
dose audit.

Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 2: Festlegung der Sterilisationsdosis

Im vorliegenden Teil von ISO 11137 werden Verfahren zur Ermittlung der Mindestdosis, die zur Erfüllung einer festgelegten Anforderung an die Sterilität erforderlich ist, sowie Verfahren zur Bestätigung der Anwendung von 25 kGy oder 15 kGy als Sterilisationsdosis zur Erzielung eines Sterilitätssicherheitsniveaus, SAL, von 10−6 festgelegt. Dieser Teil von ISO 11137 legt auch Überprüfungsverfahren für die Sterilisationsdosis zum Nachweis der fortgesetzten Wirksamkeit der Sterilisationsdosis fest.
Dieser Teil von ISO 11137 definiert Produktfamilien für die Festlegung der Sterilisationsdosis und die Überprüfungen der Sterilisationsdosis.

Stérilisation des produits de santé - Irradiation - Partie 2: Établissement de la dose stérilisante (ISO 11137-2:2013)

Sterilizacija izdelkov za zdravstveno nego - Sevanje - 2. del: Določanje odmerka sterilizacije (ISO 11137-2:2013)

Ta del standarda ISO 11137 določa metode za določanje minimalnega odmerka, ki je potreben za doseganje določene zahteve glede sterilnosti, in metode za utemeljitev uporabe 25 kGy ali 15 kGy kot odmerka sterilizacije za doseganje ravni zagotavljanja sterilnosti (SAL) 10–6. Ta del standarda ISO 11137 določa tudi metode za revizijo odmerka sterilizacije, ki se uporabljajo za dokaz stalne učinkovitosti odmerka sterilizacije. Ta del standarda ISO 11137 določa skupine izdelkov za določanje odmerka sterilizacije in revizijo odmerka sterilizacije.

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 11137-2:2015
01-september-2015
1DGRPHãþD
SIST EN ISO 11137-2:2013
6WHULOL]DFLMDL]GHONRY]D]GUDYVWYHQRQHJR6HYDQMHGHO'RORþDQMHRGPHUND
VWHULOL]DFLMH ,62

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization

dose (ISO 11137-2:2013)

Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 2: Festlegung

der Sterilisationsdosis

Stérilisation des produits de santé - Irradiation - Partie 2: Établissement de la dose

stérilisante (ISO 11137-2:2013)
Ta slovenski standard je istoveten z: EN ISO 11137-2:2015
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 11137-2:2015 en

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

---------------------- Page: 1 ----------------------
SIST EN ISO 11137-2:2015
---------------------- Page: 2 ----------------------
SIST EN ISO 11137-2:2015
EUROPEAN STANDARD
EN ISO 11137-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2015
ICS 11.080.01 Supersedes EN ISO 11137-2:2013
English Version
Sterilization of health care products - Radiation - Part 2:
Establishing the sterilization dose (ISO 11137-2:2013)

Stérilisation des produits de santé - Irradiation - Partie 2: Sterilisation von Produkten für die Gesundheitsfürsorge -

Établissement de la dose stérilisante (ISO 11137-2:2013) Strahlen - Teil 2: Festlegung der Sterilisationsdosis (ISO

11137-2:2013)
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 11137-2:2015 E

worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 11137-2:2015
EN ISO 11137-2:2015 (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 ......................4

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

Requirements of EU Directive 93/42/EEC on medical devices .........................................................5

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

Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices ...........................6

---------------------- Page: 4 ----------------------
SIST EN ISO 11137-2:2015
EN ISO 11137-2:2015 (E)
Foreword

The text of ISO 11137-2:2013 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 11137-2:2015 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 11137-2:2013.

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 and ZC, which are integral parts 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 11137 EN ISO 11137-1:2006/A1:2013 ISO 11137-1:2006/A1:2013
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

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 11137-2:2013 has been approved by CEN as EN ISO 11137-2:2015 without any modification.

---------------------- Page: 5 ----------------------
SIST EN ISO 11137-2:2015
EN ISO 11137-2:2015 (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 European Essential Requirements (ERs) of Qualifying remarks/Notes

Standard EU Directive 90/385/EEC
4, 5, 6, 7, 8, 9, 10 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: 6 ----------------------
SIST EN ISO 11137-2:2015
EN ISO 11137-2:2015 (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 EU Directive 93/42/EEC

Clauses of this European Essential Requirements (ERs) Qualifying remarks/Notes
Standard of EU Directive 93/42/EEC
4, 5, 6, 7, 8, 9, 10 8.3 Only a sterilization process using
inoizing radiation is considered by this
standard.
This relevant ER is only partly
addressed in this International
Standard and only in conjunction with
ISO 11137-1. 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 8.4 This relevant ER is only partly
addressed in this International
Standard and only in conjunction with
ISO 11137-1. 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 11137-2:2015
EN ISO 11137-2:2015 (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 European Essential Requirements (ERs) of Qualifying remarks/Notes

Standard EU Directive 98/79/EC
4, 5, 6, 7, 8, 9, 10 B.2.3 Only a sterilization process using
inoizing radiation is considered by
this standard.
This relevant ER is only partly
addressed in this International
Standard and only in conjunction
with ISO 11137-1. 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: 8 ----------------------
SIST EN ISO 11137-2:2015
EN ISO 11137-2:2015 (E)
4, 5, 6, 7, 8, 9, 10 B.2.4 This relevant Essential requirement
is addressed in this International
Standard in conjunction with
ISO 11137-1 and 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: 9 ----------------------
SIST EN ISO 11137-2:2015
---------------------- Page: 10 ----------------------
SIST EN ISO 11137-2:2015
INTERNATIONAL ISO
STANDARD 11137-2
Third edition
2013-06-01
Sterilization of health care
products — Radiation —
Part 2:
Establishing the sterilization dose
Stérilisation des produits de santé — Irradiation —
Partie 2: Établissement de la dose stérilisante
Reference number
ISO 11137-2:2013(E)
ISO 2013
---------------------- Page: 11 ----------------------
SIST EN ISO 11137-2:2015
ISO 11137-2:2013(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2013

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 2013 – All rights reserved
---------------------- Page: 12 ----------------------
SIST EN ISO 11137-2:2015
ISO 11137-2:2013(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

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

2 Normative references ...................................................................................................................................................................................... 1

3 Terms, definitions, and abbreviated terms ............................................................................................................................... 1

3.1 Terms and definitions ....................................................................................................................................................................... 1

3.2 Abbreviated terms ............................................................................................................................................................................... 3

4 Definition and maintenance of product families for dose setting, dose substantiation, and

sterilization dose auditing ......................................................................................................................................................................... 4

4.1 General ........................................................................................................................................................................................................... 4

4.2 Defining product families .............................................................................................................................................................. 4

4.3 Designation of product to represent a product family for performance of a verification

dose experiment or sterilization dose audit .................................................................................................................. 5

4.4 Maintaining product families ..................................................................................................................................................... 6

4.5 Effect of failure of establishment of sterilization dose or of a sterilization dose audit on a

product family.......................................................................................................................................................................................... 7

5 Selection and testing of product for establishing the sterilization dose ...................................................7

5.1 Nature of product ................................................................................................................................................................................. 7

5.2 Sample item portion (SIP) ............................................................................................................................................................. 8

5.3 Manner of sampling ............................................................................................................................................................................ 9

5.4 Microbiological testing ..................................................................................................................................................................... 9

5.5 Irradiation ................................................................................................................................................................................................... 9

6 Methods of dose establishment ............................................................................................................................................................ 9

7 Method 1: dose setting using bioburden information ................................................................................................10

7.1 Rationale....................................................................................................................................................................................................10

7.2 Procedure for Method 1 for product with an average bioburden greater than or equal

to 1,0 for multiple production batches ............................................................................................................................11

7.3 Procedure for Method 1 for product with an average bioburden greater than or equal

to 1,0 for a single production batch ...................................................................................................................................17

7.4 Procedure for Method 1 for product with an average bioburden in the range 0,1 to 0,9 for

multiple or single production batches .............................................................................................................................19

8 Method 2: Dose setting using fraction positive information from incremental dosing to

determine an extrapolation factor .................................................................................................................................................20

8.1 Rationale....................................................................................................................................................................................................20

8.2 Procedure for Method 2A............................................................................................................................................................21

8.3 Procedure for Method 2B ............................................................................................................................................................24

9 Method VD — Substantiation of 25 kGy or 15 kGy as the sterilization dose .............................28

max

9.1 Rationale....................................................................................................................................................................................................28

9.2 Procedure for Method VD for multiple production batches ...........................................................29

max

9.3 Procedure for Method VD for a single production batch ...................................................................34

max

9.4 Procedure for Method VD for multiple production batches ...........................................................37

max

9.5 Procedure for Method VD for a single production batch ...................................................................40

max

10 Sterilization dose audit ...............................................................................................................................................................................43

10.1 Purpose and frequency .................................................................................................................................................................43

10.2 Procedure for auditing a sterilization dose established using Method 1, Method 2A, or

Method 2B ................................................................................................................................................................................................43

10.3 Procedure for auditing a sterilization dose substantiated using Method VD or

max
15 46

Method VD ..................................................................................................................................................................................

max

10.4 Failure of a sterilization dose audit ....................................................................................................................................52

11 Worked examples .............................................................................................................................................................................................52

© ISO 2013 – All rights reserved iii
---------------------- Page: 13 ----------------------
SIST EN ISO 11137-2:2015
ISO 11137-2:2013(E)

11.1 Worked examples for Method 1 ............................................................................................................................................52

11.2 Worked examples for Method 2 ............................................................................................................................................54

11.3 Worked examples for Method VD .................................................................................................................................

max 62

11.4 Worked example of a sterilization dose audit for a dose established using Method 1, the

findings from which necessitated augmentation of the sterilization dose ......................................64

11.5 Worked example of a sterilization dose audit for a dose established using Method 2A, the

findings from which necessitated augmentation of the sterilization dose ......................................64

11.6 Worked example of a sterilization dose audit for a sterilization dose substantiated using

25 65

Method VD ..................................................................................................................................................................................

max

Bibliography .............................................................................................................................................................................................................................67

iv © ISO 2013 – All rights reserved
---------------------- Page: 14 ----------------------
SIST EN ISO 11137-2:2015
ISO 11137-2:2013(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 11137-2 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.

This third edition cancels and replaces the second edition (ISO 11137-2:2012), of which it constitutes a

minor revision with the following changes:
— addition of the word “and” in 9.1, second paragraph, third sentence;
— addition of the word “not” in 10.3.4.1, third paragraph;

— correction of the language used to describe requirements for interpretation of results during a verification

dose experiment in the second paragraph in 7.2.6.2, 7.3.7.2, 9.2.6.3, 9.3.7.3, 9.4.6.3, and 9.5.7.3.

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
© ISO 2013 – All rights reserved v
---------------------- Page: 15 ----------------------
SIST EN ISO 11137-2:2015
ISO 11137-2:2013(E)
Introduction

This part of ISO 11137 describes methods that can be used to establish the sterilization dose in

accordance with one of the two approaches specified in 8.2 of ISO 11137-1:2006. The methods used in

these approaches are:
— dose setting to obtain a product-specific dose;
— dose substantiation to verify a preselected dose of 25 kGy or 15 kGy.

The basis of the dose setting methods described in this part of ISO 11137 (Methods 1 and 2) owe

[19][20][21]
much to the ideas first propounded by Tallentire . Subsequentl
...

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