SIST EN ISO 20857:2013

SLOVENSKI STANDARD
SIST EN ISO 20857:2013
01-september-2013
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Sterilization of health care products - Dry heat - Requirements for the development,
validation and routine control of a sterilization process for medical devices (ISO
20857:2010)
Sterilisation von Produkten für die Gesundheitsfürsorge - Trockene Hitze -
Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines
Sterilisationsverfahrens für Medizinprodukte (ISO 20857:2010)
Stérilisation des produits de santé - Chaleur sèche - Exigences pour l'élaboration, la
validation et le contrôle de routine d'un processus de stérilisation pour dispositifs
médicaux (ISO 20857:2010)
Ta slovenski standard je istoveten z: EN ISO 20857:2013
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 20857:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 20857:2013

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SIST EN ISO 20857:2013


EUROPEAN STANDARD
EN ISO 20857

NORME EUROPÉENNE

EUROPÄISCHE NORM
April 2013
ICS 11.080.01
English Version
Sterilization of health care products - Dry heat - Requirements
for the development, validation and routine control of a
sterilization process for medical devices (ISO 20857:2010)
Stérilisation des produits de santé - Chaleur sèche - Sterilisation von Produkten für die Gesundheitsfürsorge -
Exigences pour l'élaboration, la validation et le contrôle de Trockene Hitze - Anforderungen an die Entwicklung,
routine d'un processus de stérilisation pour dispositifs Validierung und Lenkung der Anwendung von industriellen
médicaux (ISO 20857:2010) Sterilisationsverfahren für Medizinprodukte (ISO
20857:2010)
This European Standard was approved by CEN on 5 April 2013.

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

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 20857:2013: E
worldwide for CEN national Members.

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SIST EN ISO 20857:2013
EN ISO 20857:2013 (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

2

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SIST EN ISO 20857:2013
EN ISO 20857:2013 (E)
Foreword
The text of ISO 20857:2010 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
20857:2013 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 October 2013, and conflicting national standards shall be withdrawn at
the latest by October 2013.
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 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 Annex ZA, B and C, 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 20857:2010 has been approved by CEN as EN ISO 20857:2013 without any modification.
3

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SIST EN ISO 20857:2013
EN ISO 20857:2013 (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 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 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.
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 product(s) falling
within the scope of this Standard.
4

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SIST EN ISO 20857:2013
EN ISO 20857:2013 (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 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 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.
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 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 product(s) falling
within the scope of this Standard.
5

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SIST EN ISO 20857:2013
EN ISO 20857:2013 (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 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 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.
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 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 B.2.4
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this Standard.

6

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SIST EN ISO 20857:2013

INTERNATIONAL ISO
STANDARD 20857
First edition
2010-08-15


Sterilization of health care products —
Dry heat — Requirements for the
development, validation and routine
control of a sterilization process for
medical devices
Stérilisation des produits de santé — Chaleur sèche — Exigences pour
l'élaboration, la validation et le contrôle de routine d'un processus de
stérilisation pour dispositifs médicaux




Reference number
ISO 20857:2010(E)
©
ISO 2010

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SIST EN ISO 20857:2013
ISO 20857:2010(E)
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All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
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ii © ISO 2010 – All rights reserved

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SIST EN ISO 20857:2013
ISO 20857:2010(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 .2
4 Quality management system elements.10
4.1 Documentation .10
4.2 Management responsibility .10
4.3 Product realization .10
4.4 Measurement, analysis and improvement — Control of nonconforming product.10
5 Sterilizing agent characterization.11
5.1 Sterilizing agent.11
5.2 Microbicidal effectiveness.11
5.3 Material effects.11
5.4 Environmental considerations.11
6 Process and equipment characterization .11
6.1 Process characterization.11
6.2 Equipment characterization.11
7 Product definition.13
7.1 General.13
7.2 Product safety and performance .13
7.3 Packaging considerations.14
7.4 Microbiological quality.14
7.5 Product family.14
7.6 Biological safety.14
8 Process definition.15
9 Validation.16
9.1 General.16
9.2 Installation qualification .16
9.3 Operational qualification .16
9.4 Performance qualification.16
9.5 Additional sterilization systems .18
9.6 Review and approval of validation .18
10 Routine monitoring and control.19
10.1 Routine control .19
10.2 Routine monitoring .19
10.3 Process monitoring locations.20
11 Product release from sterilization/depyrogenation .21
12 Maintaining process effectiveness.21
12.1 General.21
12.2 Recalibration.21
12.3 Maintenance of equipment .21
12.4 Requalification.21
12.5 Assessment of change .22
© ISO 2010 – All rights reserved iii

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SIST EN ISO 20857:2013
ISO 20857:2010(E)
Annex A (informative) Guidance on the application of this International Standard .23
Annex B (informative) Process definition based on inactivation of the microbial population in its
natural state (bioburden-based approach) .46
Annex C (informative) Process definition based on the inactivation of reference microorganisms
and knowledge of bioburden (combined bioburden/biological indicator approach) .48
Annex D (informative) Conservative process definition based on inactivation of reference
microorganisms (overkill method).51
Annex E (informative) Process development .54
Bibliography .57

iv © ISO 2010 – All rights reserved

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SIST EN ISO 20857:2013
ISO 20857:2010(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 20857 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
© ISO 2010 – All rights reserved v

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SIST EN ISO 20857:2013
ISO 20857:2010(E)
Introduction
A sterile medical device is one that is free of viable microorganisms. International Standards that specify
requirements for development, 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 products
are non-sterile. The purpose of sterilization is to inactivate the microbiological contaminants and thereby
transform the non-sterile products 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 product 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 product.
This International Standard describes requirements that, if met, will provide a dry heat sterilization process
capable of sterilizing medical devices through appropriate microbicidal activity. This International Standard
also describes requirements that, if met, will provide a dry heat depyrogenation process through an
appropriate denaturation activity. Furthermore, such compliance permits prediction, with reasonable
confidence, that there is a low probability of there being a viable microorganism present on the product after
processing. 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). Additionally, there will be a low probability of
pyrogenic material of bacterial origin being present on the product after the application of a depyrogenation
process.
Generic requirements of the quality management systems for design/development, production, installation and
servicing are given in ISO 9001 and particular requirements for quality management systems for medical
device production in ISO 13485. The standards for quality management systems recognise 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 and depyrogenation are examples of such
processes. For this reason, sterilization and depyrogenation processes are validated for use, the performance
of the processes 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 product is sterile and, in this regard, suitable for its intended
use. Attention is therefore given to a number of factors including:
a) the microbiological status of incoming raw materials and/or components;
b) the validation and routine control of any cleaning and disinfection procedures used on the product;
c) the control of the environment in which the product is manufactured, assembled and packaged;
d) the control of equipment and processes;
e) the control of personnel and their hygiene;
f) the manner and materials in which the product is packaged;
g) the conditions under which product is stored.
vi © ISO 2010 – All rights reserved

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SIST EN ISO 20857:2013
ISO 20857:2010(E)
These factors also need consideration for the provision of reliable assurance of depyrogenation.
The type of contamination on the product to be sterilized varies and this variation influences the effectiveness
of a sterilization and depyrogenation process. Product that has been used in a health care setting and is being
presented for resterilization in accordance with the manufacturer's instructions (see ISO 17664) should be
regarded as a special case. There is potential for such product 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, particular attention has to be given to the validation and control of the cleaning and
disinfection processes used during reprocessing.
The requirements are the normative parts of this International Standard with which compliance is claimed. The
guidance given in the informative annexes is not normative and is not provided as a check list for auditors.
The guidance provides explanations as well as methods that are accepted as being suitable means for
complying with the requirements. Approaches other than those given in the guidance may be used if they are
effective in achieving compliance with the requirements of this International Standard.
The development, validation and routine control of a sterilization process and/or a depyrogenation process
comprise a number of discrete but interrelated activities, for example calibration, maintenance, product
definition, process definition, installation qualification, operational qualification and performance qualification.
While the activities required by this International Standard have been grouped together and are presented in a
particular order, this International Standard does not require that the activities be performed in the order that
they are presented. The activities required are not necessarily sequential, as the programmes of development
and validation might be iterative. It is possible that performing these different activities will involve a number of
separate individuals and/or organizations, each of whom undertake one or more of these activities. This
International Standard does not specify the particular individuals or organizations to carry out the activities.
© ISO 2010 – All rights reserved vii

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SIST EN ISO 20857:2013

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SIST EN ISO 20857:2013
INTERNATIONAL STANDARD ISO 20857:2010(E)

Sterilization of health care products — Dry heat —
Requirements for the development, validation and routine
control of a sterilization process for medical devices
1 Scope
1.1 Inclusions
1.1.1 This International Standard specifies requirements for the development, validation and routine control
of a dry heat sterilization process for medical devices.
NOTE Although the sco
...