Bsi bs en 00556 1 2001 (2006)

BRITISH STANDARD

BS EN
556-1:2001
Incorporating
Corrigendum No. 1

Sterilization of medical
devices —
Requirements for
medical devices to be
designated
“STERILE” —

The European Standard EN 556-1:2001 has the status of a
British Standard

ICS 11.080.01

12&23<,1*:,7+287%6,3(50,66,21(;&(37$63(50,77('%<&23<5,*+7/$:

--`,,`````,`,,`,```,,`,,`,`,,,`,-`-`,,`,,`,`,,`---

Part 1: Requirements for terminally
sterilized medical devices


BS EN 556-1:2001

National foreword
This British Standard was published by BSI. It is the UK implementation of

EN 556-1:2001, including Corrigendum September 2006. It supersedes
BS EN 556:1995 which is withdrawn.
The UK participation in its preparation was entrusted to Technical Committee
CH/67, Sterilization of medical devices.
A list of organizations represented on CH/67 can be obtained on request to its
secretary.
This publication does not purport to include all the necessary provisions of a
contract. Users are responsible for its correct application.
Compliance with a British Standard cannot confer immunity from
legal obligations.

--`,,`````,`,,`,```,,`,,`,`,,,`,-`-`,,`,,`,`,,`---

This British Standard, having
been prepared under the
direction of the Health and
Environmental Sector Policy
and Strategy Committee, was
published under the authority
of the Standards Policy and
Strategy Committee
on 11 December 2001

Amendments issued since publication
Amd. No.

Date

16728

31 October 2006 Correction to the note in 4.1 and
correction to reference 7 to EN 1441

Corrigendum No. 1
© BSI 2006

ISBN 0 580 38311 3

Comments


EUROPEAN STANDARD

EN 556-1

NORME EUROPÉENNE
EUROPÄISCHE NORM

October 2001

ICS 11.080.01

Supersedes EN 556:1994
Incorporating Corrigendum September 2006

English version

Sterilization of medical devices — Requirements for medical
devices to be designated “STERILE” — Part 1: Requirements
for terminally sterilized medical devices

Sterilisation von Medizinprodukten — Anforderungen an
Medizinprodukte, die als “STERIL” gekennzeichnet
werden — Teil 1: Anforderungen an Medizinprodukte, die in
der Endpackung sterilisiert wurden

--`,,`````,`,,`,```,,`,,`,`,,,`,-`-`,,`,,`,`,,`---

Stérilisation des dispositifs médicaux — Exigences
relatives aux dispositifs médicaux en vue d'obtenir
l'étiquetage STERILE — Partie 1: Exigences relatives aux
dispositifs médicaux stérilisés au stade terminal

This European Standard was approved by CEN on 18 August 2001.

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 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: rue de Stassart, 36

© 2001 CEN

All rights of exploitation in any form and by any means reserved
worldwide for CEN national Members.

B-1050 Brussels

Ref. No. EN 556-1:2001 E


EN 556-1:2001 (E)

Contents
Page

Foreword

3

--`,,`````,`,,`,```,,`,,`,`,,,`,-`-`,,`,,`,`,,`---

Introduction

4

1 Scope

4

2 Normative references

4

3 Terms and definitions

4

4 Requirements

6

Annex ZA (informative) Clauses of this European Standard addressing essential
requirements or other provisions of EU Directives

7

Bibliography

8

2


EN 556-1:2001 (E)

Foreword
This European Standard has been prepared 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 April 2002, and conflicting national standards shall be withdrawn at
the latest by April 2002.

This European Standard supersedes EN 556:1994.
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association, and supports essential requirements of EC Directive(s).
--`,,`````,`,,`,```,,`,,`,`,,,`,-`-`,,`,,`,`,,`---

For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this standard.
This standard has been considered by CEN/TC 204 as one of a sequence of European Standards concerned
with sterilization processes and their control. The other standards in this series are:
EN 550, Sterilization of medical devices — Validation and routine control of ethylene oxide sterilization.
EN 552, Sterilization of medical devices — Validation and routine control of sterilization by irradiation.
EN 554, Sterilization of medical devices — Validation and routine control of moist heat sterilization.
prEN 556-2, Sterilization of medical devices — Requirements for medical devices to be designated
“Sterile” — Part 2: Requirements for aseptically processed medical devices (in preparation).
EN 1174, Sterilization of medical devices — Estimation of the population of micro-organisms on product.
EN ISO 14160, Sterilization of single-use medical devices incorporating materials of animal origin —
Validation and routine control of sterilization by liquid chemical sterilants (ISO 14160:1998).
EN ISO 14937, Sterilization of health care products — General requirements for characterization of a
sterilizing agent and the development, validation and routine control of a sterilization process for medical
devices (ISO 14937:2000).
Annexes designated ‘informative’ are given only for information. In this standard annex ZA is informative.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark,
Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal,
Spain, Sweden, Switzerland and the United Kingdom.

3


EN 556-1:2001 (E)

Introduction
A sterile product item is one which is free of viable micro-organisms. European Standards for medical
devices require, when it is necessary to supply a sterile product item, that adventitious microbiological
contamination of a medical device from all sources is minimized by all practical means. Even so, product
items produced under standard manufacturing conditions in accordance with their requirements for quality
systems for medical devices (see EN ISO 13485:2000 or EN ISO 13488:2000) may, prior to sterilization,
have micro-organisms on them, albeit in low numbers. Such product items are non-sterile. The purpose of
sterilization processing is to inactivate the microbiological contaminants and thereby transform the
non-sterile items into sterile ones.
The inactivation of a pure culture of micro-organisms by physical and/or chemical agents used to sterilize
medical devices often approximates to an exponential relationship; inevitably this means that, regardless of
the extent of treatment applied, there is always a finite probability that a micro-organism will survive. For a
given treatment, the probability of survival is determined by the number and resistance of micro-organisms
and by the environment in which the organisms exist during treatment. It follows that the sterility of any one
item subjected to sterilization processing cannot be guaranteed and the sterility of the processed items has to
be defined in terms of the probability of the existence of a surviving micro-organism on/in an item. The
standards for quality management systems recognize that there are processes used which cannot be fully
verified by subsequent inspection and testing of product. Sterilization is an example of such a process.
Sterilization processes have to be validated before use, the performance of the process monitored routinely
and the equipment maintained.
It is important to be aware that exposure to a properly validated and accurately controlled sterilization process
is not the only factor associated with the provision of assurance that the product item is sterile and, in this
respect, suitable for its intended use. Attention has also to be given to a number of factors including the
microbiological status (bioburden) of incoming raw materials and/or components, their subsequent storage
and to the control of the environment in which the product is manufactured, assembled and packaged.

1

Scope

This European Standard specifies the requirements for a terminally-sterilized medical device to be
designated “STERILE”. Part 2 of this European Standard specifies the requirements for an aseptically
processed medical device to be designated “STERILE”.
NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designation of a medical device
as “STERILE” is only permissible when a validated sterilization process has been applied. Requirements for validation
and routine control of processes for the sterilization of medical devices are specified in EN 550, EN 552, EN 554,
EN ISO 14160 and EN ISO 14937.

2

Normative references

This European Standard incorporates, by dated or undated reference, provisions from other publications.
These normative references are cited at the appropriate places in the text and the publications are listed
hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to
this European Standard only when incorporated in it by amendment or revision. For undated references the
latest edition of the publication referred to applies (including amendments).
EN ISO 13485:2000, Quality systems — Medical devices — Particular requirements for the application of
EN/ISO 9001 (revision of EN 46001:1996) (identical to ISO 13485:1996).
EN ISO 13488:2000, Quality systems — Medical devices — Particular requirements for the application of
EN/ISO 9002 (revision of EN 46002:1996) (identical to ISO 13488:1996).

3

Terms and definitions

For the purposes of this standard, the following terms and definitions apply.
NOTE

4

Terms defined in this clause are set in Italic type throughout the text of this standard.


EN 556-1:2001 (E)
3.1
bioburden
population of viable micro-organisms on a product and/or package

--`,,`````,`,,`,```,,`,,`,`,,,`,-`-`,,`,,`,`,,`---

3.2
medical device
any instrument, apparatus, appliance, material or other article, whether used alone or in combination,
including the software necessary for its proper application, intended by the manufacturer to be used for
human beings for the purpose of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease;
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;
— investigation, replacement or modification of the anatomy or of a physiological process;
— control of conception;
and which does not achieve its principal intended action in or on the human body by pharmacological,
immunological or metabolic means, but which may be assisted in its function by such means.
3.3
sterility
state of being free from viable micro-organisms
3.4
sterile
condition of a medical device that is free from viable micro-organisms
3.5
terminally-sterilized

condition of a medical device which has been exposed to a sterilization process in a packaged or assembled
form that maintains the sterility of the medical device or a defined portion thereof

5


EN 556-1:2001 (E)

4

Requirements

4.1
For a terminally-sterilized medical device to be designated “STERILE”, the theoretical probability of
-6
there being a viable micro-organism present on/in the device shall be equal to or less than 1 ´ 10 .
NOTE Permission for acceptance of a probability greater than that specified in 4.1 may be sought through the
appropriate regulatory bodies. Such permission depends on the individual situation, including consideration
of the risk management activites (see, for example, EN ISO 14971) undertaken by the manufacturer of the
medical device.

4.2
Compliance shall be shown by the manufacturer or supplier through provision of documentation and
records which demonstrate that the devices have been subjected to a validated sterilization process
fulfilling 4.1.
The documentation and records shall be retained as specified in EN ISO 13485:2000, 4.5 and 4.16 or
EN ISO 13488:2000, 4.5 and 4.16.
NOTE 1 Evidence that a medical device is sterile comes from: i) the initial validation of the sterilization process and
subsequent revalidations that demonstrate the acceptability of the process; and ii) information gathered during routine
control and monitoring which demonstrates that the validated process has been delivered in practice.

--`,,`````,`,,`,```,,`,,`,`,,,`,-`-`,,`,,`,`,,`---

NOTE 2 The achievement of sterility is predicted from the bioburden level on products, the resistance of the
micro-organisms comprising that bioburden and the extent of treatment imposed during sterilization.

6


EN 556-1:2001 (E)

Annex ZA
(informative)
Clauses of this European Standard addressing essential requirements or other
provisions of EU Directives
This European Standard has been prepared under a mandate given to CEN/CENELEC by the European
Commission and the European Free Trade Association and supports essential requirements of EU Directive
93/42/EEC.
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the
scope of this standard.
The following clauses of this standard, as detailed in Table ZA.1, are likely to support requirements of
Directives 90/385/EEC, 93/42/EEC and 98/79/EC.
Compliance with the clauses of this standard provides one means of conforming with the specific essential
requirements of the Directive concerned and associated EFTA regulations.

Table ZA.1 — Correspondence between this European Standard and EU Directives
Clauses/sub-clauses
of this European
Standard

Essential
requirements
(ER:s) of Directive
93/42/EEC,
Annex I

Essential
requirements
(ER:s) of Directive
90/385/EEC,
Annex I

4.1

1, 8.1, 13.3 (c)

1, 7, 14.1 7 dash

1, 2.1, 8.4 (c)

4.2

8.4

—

2.4

th

Essential
requirements
(ER:s) of Directive
98/79/EC,
Annex I

7


EN 556-1:2001 (E)

Bibliography
[1]

EN ISO 9001:1994, Quality systems — Model for quality assurance in design/development, production,
installation and servicing (ISO 9001:1994).

[2]

EN ISO 9002:1994, Quality systems — Model for quality assurance in production, installation and
servicing (ISO 9002:1994).

[3]

EN 550, Sterilization of medical devices — Validation and routine control of ethylene oxide sterilization.

[4]

EN 552, Sterilization of medical devices — Validation and routine control of sterilization by irradiation.

[5]

EN 554, Sterilization of medical devices — Validation and routine control sterilization by moist heat.

[6]

EN 980, Graphical symbols for use in the labelling of medical devices.

[7]

EN ISO 14971:2000, Medical devices — Application of risk management to medical devices
(ISO 14971:2000).

[8]

EN ISO 14160:1998, Sterilization of single-use medical devices incorporating materials of animal
origin — Validation and routine control of sterilization by liquid chemical sterilants (ISO 14160:1998).

[9]

EN ISO 14937:2000, Sterilization of health care products — General requirements for characterization of
a sterilizing agent and the development, validation and routine control of a sterilization process for
medical devices (ISO 14937:2000).

[10] 90/385/EEC, Council Directive of 20 June 1990 on the approximation of the laws of the Member States
relating to active implantable medical devices.
[11] 93/42/EEC, Council Directive of 14 June 1993 concerning medical devices
[O.J.L 169 pp 1.43 (12 July 1993)].

8

--`,,`````,`,,`,```,,`,,`,`,,,`,-`-`,,`,,`,`,,`---

[12] 98/79/EC, Council Directive of 27 October 1998 on in vitro diagnostic medical devices.


--`,,`````,`,,`,```,,`,,`,`,,,`,-`-`,,`,,`,`,,`---


BS EN
556-1:2001

BSI — British Standards Institution
BSI is the independent national body responsible for preparing
British Standards. It presents the UK view on standards in Europe and at the
international level. It is incorporated by Royal Charter.
Revisions
British Standards are updated by amendment or revision. Users of
British Standards should make sure that they possess the latest amendments or
editions.
It is the constant aim of BSI to improve the quality of our products and services.
We would be grateful if anyone finding an inaccuracy or ambiguity while using
this British Standard would inform the Secretary of the technical committee
responsible, the identity of which can be found on the inside front cover.
Tel: +44 (0)20 8996 9000. Fax: +44 (0)20 8996 7400.
BSI offers members an individual updating service called PLUS which ensures
that subscribers automatically receive the latest editions of standards.
Buying standards
Orders for all BSI, international and foreign standards publications should be
addressed to Customer Services. Tel: +44 (0)20 8996 9001.

Fax: +44 (0)20 8996 7001. Email: Standards are also
available from the BSI website at .
In response to orders for international standards, it is BSI policy to supply the
BSI implementation of those that have been published as British Standards,
unless otherwise requested.
Information on standards
BSI provides a wide range of information on national, European and
international standards through its Library and its Technical Help to Exporters
Service. Various BSI electronic information services are also available which give
details on all its products and services. Contact the Information Centre.
Tel: +44 (0)20 8996 7111. Fax: +44 (0)20 8996 7048. Email:
Subscribing members of BSI are kept up to date with standards developments
and receive substantial discounts on the purchase price of standards. For details
of these and other benefits contact Membership Administration.
Tel: +44 (0)20 8996 7002. Fax: +44 (0)20 8996 7001.
Email:

--`,,`````,`,,`,```,,`,,`,`,,,`,-`-`,,`,,`,`,,`---

BSI
389 Chiswick High Road
London
W4 4AL

Information regarding online access to British Standards via British Standards
Online can be found at />Further information about BSI is available on the BSI website at
.
Copyright
Copyright subsists in all BSI publications. BSI also holds the copyright, in the
UK, of the publications of the international standardization bodies. Except as

permitted under the Copyright, Designs and Patents Act 1988 no extract may be
reproduced, stored in a retrieval system or transmitted in any form or by any
means – electronic, photocopying, recording or otherwise – without prior written
permission from BSI.
This does not preclude the free use, in the course of implementing the standard,
of necessary details such as symbols, and size, type or grade designations. If these
details are to be used for any other purpose than implementation then the prior
written permission of BSI must be obtained.
Details and advice can be obtained from the Copyright & Licensing Manager.
Tel: +44 (0)20 8996 7070. Fax: +44 (0)20 8996 7553.
Email: