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12347:1998
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Biotechnology Ð Performance |
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criteria for steam sterilizers |
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and autoclaves |
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The European Standard EN 12347:1998 has the status of a |
British Standard |
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ICS 07.080; 11.080 |
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NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW
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BS EN 12347:1998

National foreword
This British Standard is the English language version of EN 12347:1998.
The UK participation in its preparation was entrusted to Technical Committee
CII/58, Biotechnology, which has the responsibility to:

Ð aid enquirers to understand the text;

Ð present to the responsible European committee any enquiries on the
interpretation, or proposals for change, and keep the UK interests informed;
Ð monitor related international and European developments and promulgate
them in the UK.

A list of organizations represented on this committee can be obtained on request to

its secretary.
Cross-references
The British Standards which implement international or European publications
referred to in this document may be found in the BSI Standards Catalogue under the
section entitled ªInternational Standards Correspondence Indexº, or by using the
ªFindº facility of the BSI Standards Electronic Catalogue.
A British Standard does not purport to include all the necessary provisions of a
contract. Users of British Standards are responsible for their correct application.
Compliance with a British Standard does not of itself confer immunity
from legal obligations.

Summary of pages
This document comprises a front cover, an inside front cover, the EN title page,
pages 2 to 8, an inside back cover and a back cover.

This British Standard, having Amendments issued since publication

been prepared under the
direction of the Sector Board for Amd. No. Date Text affected
Materials and Chemicals, was
published under the authority of
the Standards Board and comes
into effect on 15 August 1998

 BSI 1998

ISBN 0 580 29944 9

EUROPEAN STANDARD EN 12347
NORME EUROPEÂENNE
EUROPAÈISCHE NORM March 1998

ICS 07.080; 07.100.99; 11.080

Descriptors: Biotechnology, autoclaves, microorganisms, noxious microorganisms, accident prevention, hazards, definitions,
characteristics, leaktightness, cleaning, sterilization, classifications, specifications, verification

English version

Biotechnology Ð Performance criteria for steam

sterilizers and autoclaves

Biotechnologie Ð CriteÁres de performance pour les Biotechnik Ð Leistungskriterien fuÈr

steÂrilisateurs aÁ la vapeur d'eau et les autoclaves Dampf-Sterilisatoren und Autoklaven

This European Standard was approved by CEN on 15 February 1998.

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 Central Secretariat 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 Central Secretariat 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.

CEN
European Committee for Standardization
Comite EuropeÂen de Normalisation
EuropaÈisches Komitee fuÈr Normung

Central Secretariat: rue de Stassart 36, B-1050 Brussels

 1998 CEN Ð All rights of exploitation in any form and by any means reserved worldwide for CEN national
members
Ref. No. EN 12347:1998 E
Page 2
EN 12347:1998

Foreword Contents
This European Standard has been prepared by Page
Technical Committee CEN/TC 233, Biotechnology, the
secretariat of which is held by AFNOR. Foreword 2
This European Standard has been prepared under a Introduction 3
mandate given to CEN by the European Commission 1 Scope 3
and the European Free Trade Association. 2 Normative references 3
This European Standard shall be given the status of a 3 Definitions 4
national standard, either by publication of an identical
text or by endorsement, at the latest by 4 Hazards 4
September 1998, and conflicting national standards 5 Performance classification 5
shall be withdrawn at the latest by September 1998.
6 Classification of steam sterilizers and
According to the CEN/CENELEC Internal Regulations, autoclaves 6
the national standards organizations of the following
countries are bound to implement this European 7 Verification of performance 7
Standard: Austria, Belgium, Czech Republic, Denmark, 8 Marking and packaging 7
Finland, France, Germany, Greece, Iceland, Ireland, 9 Documents 7
Italy, Luxembourg, Netherlands, Norway, Portugal,
Spain, Sweden, Switzerland and the United Kingdom. Annex A (informative) Bibliography 8

 BSI 1998

Introduction
Steam sterilizers and autoclaves are used to destroy
microorganisms by subjecting them to steam (steam
sterilizers) or to steam at elevated temperatures and
pressure (autoclaves). They are, for example, used for:
± sterilizing materials and units of equipment before
they are used in laboratories or/and factories;
± eliminating the risk associated with material which
requires inactivation and/or sterilization prior to
disposal in waste treatment operations;
± making equipment safe for (re)use.
It is important to consider the performance of steam
sterilizers and autoclaves used for these purposes with
regard to the potential hazard posed by the
microorganism in use. For some microorganisms
additional measures are needed to prevent their release
from the autoclave before or after sterilization and to
treat exhaust gases and/or condensates which can be
released during or after the process. Consideration
should be given to workers, the environment and the
public in general. See also EN 285 for general
requirements for large steam sterilizers and autoclaves.
1 Scope
This European Standard specifies performance criteria
for steam sterilizers and autoclaves used for the
destruction and prevention of release of
microorganisms used in biotechnological processes.
This European Standard applies if the intended use of
steam sterilizers or autoclaves includes hazardous or
potentially hazardous microorganisms used in
biotechnological processes, or if exposure of the
worker or the environment to such microorganisms is
restricted for reasons of safety.
Additional criteria for individual components of a
steam sterilizer or autoclave, such as filters, couplings,
pipes, are given in European Standards on
biotechnology pertaining to performance criteria for
filter elements, filtration equipment, tubes and pipes
and couplings, which are being prepared.
 BSI 1998
Page 3
EN 12347:1998
2 Normative references
This European Standard incorporates by dated or
undated references, 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.
EN 285, Sterilization Ð Steam sterilizers Ð Large
sterilizers
EN 554, Sterilization of medical devices Ð Validation
and routine control of sterilization by moist heat
EN 866-1, Biological systems for testing sterilizers and
sterilization processes Ð Part 1: General requirements
EN 866-3, Biological systems for testing sterilizers and
sterilization processes Ð Part 3: Particular systems
for use in moist heat sterilizers
prEN 866-7, Biological systems for testing sterilizers
and sterilization processes Ð Part 7: Particular
requirements for self-contained biological indicator
systems for use in moist heat sterilizers
EN 867-1, Non-biological systems for use in
sterilizers Ð Part 1: General requirements
EN 867-2, Non-biological systems for use in
sterilizers Ð Part 2: Process indicators (Class A)
EN 1619, Biotechnology Ð Large-scale process and
production Ð General requirements for management
and organization for strain conservation procedures
EN 1620, Biotechnology Ð Large-scale process and
production Ð Plant building according to the degree
of hazard
EN 1672-2, Food processing machinery Ð Safety and
hygiene requirements Ð Basic concepts Ð Part 2:
Hygiene requirements
prEN 12296, Biotechnology Ð Equipment Ð Guidance
for testing procedures for cleanability
prEN 12297, Biotechnology Ð Equipment Ð Guidance
for testing procedures for sterilizability
prEN 12298, Biotechnology Ð Equipment Ð Guidance
for testing procedures for leaktightness
ISO 4287-1, Surface roughness Ð Terminology Ð
Part 1: Surface and its parameters
ISO 4288, Geometrical Product Specifications (GPS) Ð
Surface texture: Profile method Ð Rules and
procedures for the assessment of surface texture
Page 4
EN 12347:1998

3 Definitions 3.9
For the purposes of this standard, the following sterile
definitions apply. state of being free from viable microorganisms
NOTE 1 In practice no such absolute statement regarding the
3.1 absence of viable microorganisms can be proven. However, sterile
autoclave conditions can be regarded as established by using an accepted or
recognized method of sterilization.
apparatus designed to sterilize materials and/or
NOTE 2 The process of inactivation of viable microorganisms
equipment by exposure to steam at a pressure above during a sterilization procedure is usually described by an
the atmospheric pressure empirical mathematical function, commonly an exponential
function. By their mathematical nature, such functions can be
3.2 reduced to very low numbers, but not to zero. However, these
cleanability empirical functions can be applied to control or assess the
process parameters of a sterilization procedure to realize a desired
ability to be made clean degree of inactivation of viable microorganisms.
3.3 3.10
hazard sterilizability
intrinsic property or ability of something (e.g. any ability of components of equipment, units of equipment
agent, equipment, material or process) to cause harm or plants to be sterilized
[EN 1620]
3.11
NOTE Harm is an injury or damage to health of people and/or
the environment. sterilization
3.4 process used to reach a sterile state
leakage 3.12
egress from equipment target microorganism
3.5 process microorganism and/or other microorganisms
relevant for the specific process
leaktightness NOTE For safety testing procedures, non-pathogenic
ability of component of equipment or unit of microorganisms should be used where possible.
equipment to limit egress
3.6 4 Hazards
microorganism The following hazards shall be considered:
any microbiological entity, cellular or non-cellular, ± release of microorganisms after operation due to
capable of replication or of transferring genetic insufficient inactivation and/or removal of
material microorganisms when the equipment is opened or
[EN 1619] dismantled;
NOTE For the purposes of this standard, the term ± release of microorganisms by leakage during or
microorganism covers the term of biological agent, according to after operation;
the Directive 90/679/EEC: microorganisms, including those which
have been genetically modified, cell cultures and human ± release of microorganisms by exhaust gases or
endoparasites which can provoke any infection, allergy or toxicity. condensate.
3.7
risk
probability of occurrence of a hazard causing harm
and the degree of severity of the harm
3.8
steam sterilizer
apparatus designed to sterilize materials and/or
equipment by exposure to steam

 BSI 1998
 Page 5
EN 12347:1998

5 Performance classification 5.3 Cleanability

The performance class for cleanability of the steam
5.1 General
sterilizer or autoclave shall be determined in
With regard to the contained use of microorganisms in accordance with Table 2.
the steam sterilizer or autoclave, the steam sterilizer or
autoclave shall be classified for the following Table 2 Ð Cleanability performance
performance criteria:
Performance class for Description of
± leaktightness; cleanability performance class
± cleanability; Cleanability Index (CI)
± sterilizability. CI-A Visible soil or cleanliness not
The performance of the steam sterilizer or autoclave defined
shall be determined for each of these criteria. The
equipment shall be classified in accordance with CI-B Cleanability tested and
Tables 1, 2 and 3. For each criterion the equipment shall quantified under defined
be classified independently. conditions or designed with
NOTE Equipment can for example be in class SI-A for
regard to specified technical
sterilizability, but in class LI-C for leaktightness. criteria
5.2 Leaktightness CI-C Cleanability tested and
quantified under defined
The performance class for leaktightness of the steam
conditions and soil below
sterilizer or autoclave shall be determined in
detection limit or threshold
accordance with Table 1.
value1)
1) Based on assessment by BATNEEC (best available techniques
Table 1 Ð Leaktightness performance
not entailing excessive costs)*
Performance class for Description of
leaktightness performance class
NOTE Cleanability applies as a performance criterion for the
Leaktightness Index (LI) equipment where:

LI-A Leakage not defined ± deposits of soil in the equipment could jeopardize
the sterilization procedure if the sterilization media
LI-B Leakage detected and do not reach all parts of the equipment or if the
quantified under defined required temperature is not reached;
conditions1)
± cleaning procedures are intended to remove and
LI-C Leakage tested under inactivate microorganisms to make the equipment
defined conditions and safe for handling, without using any other
leakage below prescribed sterilization or inactivation procedure.
threshold value2)
1) Based on leakage assessment by BATNEEC (best available
techniques not entailing excessive costs)*
2) Prescribed threshold value can for example be the detection
limit of an approved BATNEEC.

NOTE Leaktight means tight for target microorganisms.

* Use of BATNEEC does not mean that financial issues moderate the degree of safety. Where several methods are available, the user
may choose the most convenient, provided that it gives results of the necessary quality.

 BSI 1998
Page 6
EN 12347:1998

5.4 Sterilizability 6.2 Type II steam sterilizers and autoclaves

The performance class for sterilizability of the steam A steam sterilizer or autoclave meeting the following
sterilizer or autoclave shall be determined in requirements, in addition to those given in 6.1, shall be
accordance with Table 3. This criterion covers all classified as type II:
methods of inactivation up to sterilization. The ± the steam sterilizer or autoclave has additional
sterilizability performance is therefore usually containment features which prevent release of living
combined with the cleanability criterion. microorganisms to the environment during or after
the operating cycle;
Table 3 Ð Sterilizability performance NOTE 1 Release of microorganisms can occur when air is
Performance class for Description of removed from the autoclave chamber while operating
sterilizability performance class temperature and pressure are being reached, or when
condensate, e.g. from the holding chamber or from exhaust
Sterilizability Index (SI) filters, is released during or after the operating cycle.
SI-A Equipment not suited or NOTE 2 Appropriate measures to prevent loss of containment
tested for reduction of viable can include provision of filters able to sterilize exhaust air, and
discharge of condensate to equipment such as vessels
target microorganisms containing sterilizing liquids.
SI-B Equipment can be treated ± the steam sterilizer or autoclave has a minimum
for a specified reduction of performance class as given in Table 4.
viable target microorganisms
SI-C Equipment can be sterilized
NOTE In this table, the result (performance) of an inactivation
procedure is described, and not the way or means of achieving
the result.

6 Classification of steam sterilizers and

autoclaves
6.1 Type I steam sterilizers and autoclaves
A steam sterilizer or autoclave meeting the following
requirements shall be classified as type I:
± the steam sterilizer or autoclave is capable of
bringing all parts of the holding chamber to
conditions that will cause a specified reduction of
the amount of viable microorganisms in the load, in
accordance with the procedures given in EN 554;
NOTE Conditions that are known to reduce the number of
viable microorganisms in a load are generally combinations of
time, elevated temperature, elevated pressure and/or addition of
chemicals.
± the steam sterilizer or autoclave has a minimum
performance class as given in Table 4.

Table 4 Ð Minimum performance classification for type I and type II steam

sterilizers and autoclaves
Performance criterion Type I steam sterilizers and autoclaves Type II steam sterilizers and autoclaves
Holding chamber Auxiliary equipment Holding chamber Auxiliary equipment
(piping, etc.) (piping, etc.)
Sterilizability SI-C SI-A SI-C SI-C
Cleanability CI-B 1) CI-B 1) CI-B 1) CI-B1)
Leaktightness LI-A LI-A LI-C LI-C
1) Residual soil should not negatively affect sterilizability. In general, this will require CI-B for cleanability, but CI-A is also acceptable if
it is validated that the residual soil does not affect the sterilization result.

 BSI 1998

7 Verification of performance
7.1 General
Verification of the classification shall be done in
accordance with Tables 1, 2 and 3. The performance of
the equipment is classified and verified by the
manufacturer or by the user. If the equipment is
manufactured in accordance with an already classified
prototype, it is classified in the same class as the
prototype, if:
± there is no change in design or materials used; or
± there are only minor and not biosafety-relevant
changes.
If there are only minor and not biosafety-relevant
changes, the manufacturer shall document the changes
and shall make evident to the user that no
reclassification is expected following these changes.
NOTE Verification of classification can, for example, be done by
operating an appropriate quality assurance system.
7.2 Leaktightness
The steam sterilizer or autoclave shall be classified
LI-A if no test methods are executed to determine the
leaktightness.
To be classified LI-B or LI-C, the steam sterilizer or
autoclave shall be tested according to the guidance
given in prEN 12298. Tests shall be performed under
representative process conditions.
7.3 Cleanability
The steam sterilizer or autoclave shall be classified
CI-A if no test methods are executed to determine the
cleanability. The equipment shall be classified CI-A if
there is visible soil after a cleaning procedure.
To be classified CI-B or CI-C, the steam sterilizer or
autoclave shall be tested according to the guidance
given in prEN 12296. Tests shall be performed under
representative process conditions.
Alternatively, the steam sterilizer or autoclave can be
classified CI-B if it is designed according to
EN 1672-2 and if the surface roughness of the metallic
material applied in the steam sterilizer or autoclave is
less than or equal to Ra = 1,6 mm, defined according to
ISO 4287-1 and measured according to ISO 4288 or
equivalent, on internal product contact areas.
NOTE An electrochemical surface treatment of the metallic
materials is preferred to a mechanical polish because it produces
a smoother surface, even if the Ra values are the same. During
this type of surface treatment, sharp peaks and valley contours
will be reduced preferentially because of high current rates at
these particular parts of the surface. Applicability of
electrochemical treatment can depend on the type of material in
use.
Documentation containing information about surface
roughness for different surfaces and drawings showing
how well the design complies with EN 1672-2 shall be
included. Deviations from the design requirements
above shall be pointed out and the reasons for the
deviations shall be explained.
 BSI 1998
Page 7
EN 12347:1998
7.4 Sterilizability
For type I and type II steam sterilizers or autoclaves,
the holding chamber shall be classified SI-C. The
holding chamber shall be tested according to the
guidance given in prEN 12297.
The auxiliary equipment of a type I steam sterilizer or
autoclave shall be classified SI-A if no test methods are
executed to determine the sterilizability.
To be classified SI-B or SI-C, the auxiliary equipment of
a type I steam sterilizer or autoclave shall be tested
according to the guidance given in prEN 12297 and in
EN 285. The indicators used in these tests shall fulfil
the requirements given in EN 866-1, EN 866-3,
prEN 866-7 or EN 867-1 and EN 867-2. Tests shall be
performed at representative process conditions.
8 Marking and packaging
Each steam sterilizer and autoclave shall be identified
in such a way that its performance with regard to
cleanability, sterilizability and leaktightness can be
checked.
If it is not practical to mark a steam sterilizer or
autoclave or a component of it (e.g. due to its size or
nature), the packaging shall be marked. An unmarked
autoclave or package shall be classified LI-A, SI-A and
CI-A.
NOTE This identification could be, for example, trade mark, type
number, year of production.
Additional information on marking of equipment in
relation to sterilizability is given in EN 556 (see
annex A [4]).
9 Documents
The manufacturer or supplier shall provide a written
manual which details the operating procedures which
enable the equipment to perform to its specified
classification for cleanability, sterilizability and
leaktightness.
The user shall have documentation on the
classification and its verification available.
NOTE Under certain circumstances, the user can reclassify the
equipment. If, for example, the equipment could comply with
sterilizability class SI-C, but is classified SI-B because of testing by
the manufacturer, then the user can reclassify the equipment to
SI-C if he executes and documents an appropriate test.
Page 8
EN 12347:1998

Annex A (informative)
Bibliography
[1] Council Directive 90/219/EEC of 23 April 1990 on
the contained use of genetically modified
microorganisms. OJEC 08.05.1990, no. L 117, p 1.
[2] Council Directive 90/679/EEC of 26 November 1990
on the protection of workers from risks related to
exposure to biological agents at work (seventh
individual Directive within the meaning of
Article 16, paragraph 1, of Directive 89/391/EEC).
OJEC 31.12.1990, no. L 374, p 1.
[3] EN 61010-1, Safety requirements for electrical
equipment for measurement, control and
laboratory use Ð Part 1: General requirements
[4] EN 556, Sterilization of medical devices Ð
Requirements for medical devices to be labelled
`Sterile'

 BSI 1998
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