EN 13060:2004

SLOVENSKI STANDARD
01-januar-2005
Mali parni sterilizatorji
Small steam sterilizers
Dampf-Klein-Sterilisatoren
Petits stérilisateurs a la vapeur d'eau
Ta slovenski standard je istoveten z: EN 13060:2004
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 13060
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2004
ICS 11.080.10
English version
Small steam sterilizers
Petits stérilisateurs à la vapeur d'eau Dampf-Klein-Sterilisatoren
This European Standard was approved by CEN on 16 April 2004.
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, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
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COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 13060:2004: E
worldwide for CEN national Members.

Contents
page
Foreword.3
Introduction .4
1 Scope .5
2 Normative references .5
3 Terms and definitions .6
4 General technical requirements.13
5 Performance requirements .29
6 Safety .30
7 Categories of tests.30
8 Test equipment .32
9 Test programme.40
10 Test methods.41
Annex A (informative)  Clarification of the definition of hollow space A and hollow space B (see 3.19
and 3.20) .57
Annex B (informative)  Process evaluation system .59
Annex C (informative)  Suggested maximum limits of contaminants in and specification for water for
steam sterilization.60
Annex D (informative)  Example of a table to be supplied with pre-purchase documentation and with
the instructions for use.61
Annex E (informative)  Load support systems .62
Annex F (informative)  Rationale for the tests.63
Annex ZA (informative)  Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42 EEC on medical devices .65
Bibliography .66

Foreword
This document (EN 13060:2004) has been prepared by Technical Committee CEN/TC 102 “Sterilizers for medical
purposes”, the secretariat of which is held by DIN.
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 2004, and conflicting national standards shall be withdrawn at the latest
by December 2004.
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 Directive(s).
For relationship with EU Directive(s), see informative annex ZA which is an integral part of this document.
The annexes A, B, C, D, E and F are informative.
This document includes a Bibliography.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark,
Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

Introduction
Small steam sterilizers are widely used for medical purposes, e.g. in general medical practices, dentistry, facilities
for personal hygiene and beauty care and also veterinary practices. They are also used for materials and
equipment, which are likely to come into contact with blood or body fluids, e.g. implements used by beauty
therapists, tattooists, body piercers and hairdressers. The very specific sterilizer loads used within these fields of
application call for different performance requirements for the sterilization cycles and different corresponding test
methods.
This European Standard specifies the general requirements for small steam sterilizers and test methods for
specified sterilizer loads according to Table 1. These loads include unwrapped solid products, full porous load,
small porous load, small porous items, hollow loads A, hollow loads B, single wrapped products and double
wrapped products. The performance tests specified in this standard can also be used by device manufacturers to
specify the appropriate performance for decontamination processes according to the requirements for information
to be given by medical device manufacturers according to EN ISO 17664:2004. This will enable users to identify
the specific sterilizer performance required to safely process their devices.
Table 1 — Types of sterilization cycles
Type Description of intended use
B The sterilization of all wrapped or non-wrapped, solid, hollow load products type A and porous
products as represented by the test loads in this standard.
N The sterilization of non wrapped solid products.
S The sterilization of products as specified by the manufacturer of the sterilizer including non
wrapped solid products and at least one of the following: porous products, small porous items,
hollow load products type A, hollow load products B, single wrapped products, multiple-layer
wrapped products.
NOTE 1 The description identifies ranges of products and test loads.
NOTE 2 Non wrapped sterilized instruments are intended either for immediate use or for non sterile storage, transport and
application (e.g. to prevent cross infection).
It is essential that the sterilizer and associated equipment is used only for the sterilization of the type of products for
which it is designed. The choice of sterilizer, sterilization cycle or quality of services provided can be inappropriate
for a particular load. Therefore the suitability of a sterilization procedure for a particular product needs to be verified
by validation.
1 Scope
This European Standard specifies the performance requirements and test methods for small steam sterilizers and
sterilization cycles which are used for medical purposes or for materials that are likely to come into contact with
blood or body fluids.
This European Standard applies to automatically controlled small steam sterilizers that generate steam using
electrical heaters or use steam that is generated by a system external to the sterilizer.
This European Standard applies to small steam sterilizers used primarily for the sterilization of medical devices and
unable to accommodate a sterilization module (300 mm × 300 mm × 600 mm) and with a chamber volume not
exceeding 60 litres.
This European Standard does not apply to small steam sterilizers that are used to sterilize liquids or
pharmaceutical products.
This European Standard does not specify safety requirements related to risks associated with the zone in which the
sterilizer is used (e.g. flammable gases).
This European Standard does not specify requirements for the validation and routine control of sterilization by moist
heat.
NOTE Requirements for the validation and routine control of sterilization by moist heat are given in EN 554, which may
also be applied for small steam sterilizers.
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 285:1996, Sterilization — Steam sterilizers — Large sterilizers.
EN 475, Medical devices — Electrically-generated alarm signals.
EN 866-3, Biological systems for testing sterilizers and sterilization processes — Part 3: Particular systems for use

in moist heat sterilizers.
EN 867-1:1997, Non-biological systems for use in sterilizers — Part 1: General requirements.
EN 867-5:2001, Non-biological systems for use in sterilizers — Part 5: Specification for indicator systems and
process challenge devices for use in performance testing for small sterilizers Type B and Type S.
EN 868 (all parts), Packaging materials and systems for medical devices which are to be sterilized.
EN 10088-1, Stainless steels — Part 1: List of stainless steels.
EN 60529, Degrees of protection provided by enclosures (IP code) (IEC 60529:1989).

Currently under revision by CEN/TC 102.
EN 867-1 is currently under revision by ISO/TC 198 and CEN/TC 102 (Vienna Agreement).
EN 868-1 is currently under revision by ISO/TC 198 and CEN/TC 102 (Vienna Agreement).
EN 61010-1, Safety requirements for electrical equipment for measurement, control and laboratory use — Part 1:
General requirements (IEC 61010-1:2001).
EN 61010-2-041, Safety requirements for electrical equipment for measurement, control and laboratory use - Part
2-041: Particular requirements for autoclaves using steam for the treatment of medical materials, and for laboratory
processes (IEC 61010-2-041:1996).
EN 61326, Electrical equipment for measurement, control and laboratory use — EMC requirements
(IEC 61326:1997).
EN ISO 228-1, Pipe threads where pressure-tight joints are not made on the threads — Part 1: Dimensions,
tolerances and designation (ISO 228-1:2000).
EN ISO 3746, Acoustics — Determination of sound power levels of noise sources using sound pressure — Survey
method using and enveloping measurement surface over a reflecting plane (ISO 3746:1995).
EN ISO 4017, Hexagon head screws — Product grades A and B (ISO 4017:1999).
EN ISO 4126-1, Safety devices for protection against excessive pressure — Part 1: Safety valves (ISO 4126-
1:2004).
EN ISO 13485:2003, Medical devices — Quality management systems — Requirements for regulatory purposes
(ISO 13485:2003).
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).
3 Terms and definitions
For the purposes of this European Standard, the following terms and definitions apply.
NOTE Other definitions relevant to steam sterilization and its validation are given in EN 285 and EN 554.
3.1
absolute pressure
pressure for which the zero value is associated with absolute vacuum
[EN 764-1:2004, definition 4.5]
3.2
active drain of small steam sterilizers
drain through which fluids present in the chamber are discharged during the process
3.3
air removal
removal of air from the sterilizer chamber and sterilizer load sufficient to facilitate steam penetration
...