oSIST prEN 13060:2023
(Main)Sterilizers for medical purposes - Small steam sterilizers - Requirements and testing
Sterilizers for medical purposes - Small steam sterilizers - Requirements and testing
This document 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 document 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 document applies to small steam sterilizers used primarily for the sterilization of medical devices with a chamber volume of less than 60 l and unable to accommodate a sterilization module (300 mm × 300 mm × 600 mm).
The requirements concerning the quality management and risk management are addressed by other standards (e.g. EN ISO 13485, EN ISO 14971).
This document does not apply to small steam sterilizers that are used to sterilize liquids or pharmaceutical products.
This document does not specify safety requirements related to risks associated with the zone in which the sterilizer is used (e.g. flammable gases).
This document 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 ISO 17665.
This document does not specify requirements for other sterilization processes that also employ moist heat as part of the process (i.e. formaldehyde, ethylene oxide).
Sterilisatoren für medizinische Zwecke - Dampf-Klein-Sterilisatoren - Anforderungen und Prüfung
Dieses Dokument legt die Leistungsanforderungen und Prüfverfahren für Dampf-Klein-Sterilisatoren und deren Sterilisationszyklen fest, die für medizinische Zwecke oder für Materialien verwendet werden, die mit Blut oder Körperflüssigkeiten in Kontakt kommen können.
Dieses Dokument gilt für automatisch geregelte Dampf-Klein-Sterilisatoren, die zur Dampferzeugung elektrische Heizungen verwenden oder die Dampf benutzen, der in einem System außerhalb des Sterilisators erzeugt wird.
Dieses Dokument gilt für Dampf-Klein-Sterilisatoren mit einem Kammervolumen unter 60 l, die in erster Linie für die Sterilisation von Medizinprodukten verwendet werden, und die nicht in der Lage sind, eine Sterilisiereinheit (300 mm × 300 mm × 600 mm) aufzunehmen.
Die Anforderungen bezüglich des Qualitäts- und Risikomanagements sind durch andere Normen berücksichtigt (z. B. EN ISO 13485, EN ISO 14971).
Dieses Dokument gilt nicht für Dampf-Klein-Sterilisatoren, die für die Sterilisation von Flüssigkeiten oder pharmazeutischen Produkten verwendet werden.
Dieses Dokument legt keine Sicherheitsanforderungen fest, die mit den Risiken in dem Bereich zusammen-hängen, in dem der Sterilisator verwendet wird (z. B. entzündliche Gase).
Dieses Dokument legt keine Anforderungen für die Validierung und Routineüberwachung der Sterilisation mit feuchter Hitze fest.
ANMERKUNG Anforderungen an die Validierung und Routineüberwachung der Sterilisation mit feuchter Hitze sind in EN ISO 17665 enthalten.
Dieses Dokument legt keine Anforderungen für andere Sterilisationsverfahren fest, bei denen feuchte Hitze als Teil des Prozesses eingesetzt wird (d. h. Formaldehyd, Ethylenoxid).
Stérilisateurs à usage médical - Petits stérilisateurs à la vapeur d'eau - Exigences et essais
Le présent document spécifie les exigences de performance et les méthodes d'essai relatives aux petits stérilisateurs à la vapeur d'eau et aux cycles de stérilisation utilisés à des fins médicales ou pour des matériels susceptibles d'entrer en contact avec du sang ou des fluides corporels.
Le présent document s'applique aux petits stérilisateurs à la vapeur d'eau à commande automatique qui produisent de la vapeur d'eau à l'aide d'éléments chauffants électriques, ou qui utilisent la vapeur d'eau produite par un système externe au stérilisateur.
Le présent document s'applique aux petits stérilisateurs à la vapeur d'eau employés essentiellement pour la stérilisation de dispositifs médicaux, dont le volume de la chambre est inférieur à 60 l et qui ne peuvent pas loger une unité de stérilisation (300 mm x 300 mm x 600 mm).
Les exigences relatives au management de la qualité et à la gestion des risques sont traitées dans d'autres normes (par exemple, EN ISO 13485, EN ISO 14971).
Le présent document ne s'applique pas aux petits stérilisateurs à la vapeur d'eau qui sont utilisés pour stériliser des liquides ou des produits pharmaceutiques.
Le présent document ne précise pas les exigences de sécurité en rapport avec les risques associés à la zone dans laquelle le stérilisateur est utilisé (par exemple, gaz inflammables).
Le présent document ne spécifie pas les exigences relatives à la validation et au contrôle de routine de la stérilisation à la chaleur humide.
NOTE Les exigences relatives à la validation et au contrôle de routine d'un procédé de stérilisation à la chaleur humide sont indiquées dans l'EN ISO 17665.
Le présent document ne définit pas d'exigences relatives à d'autres procédés de stérilisation qui utilisent également de la chaleur humide (à savoir : stérilisation au formaldéhyde, à l'oxyde d'éthylène).
Sterilizatorji za uporabo v medicini - Mali parni sterilizatorji - Zahteve in preskušanje
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN 13060:2023
01-julij-2023
Nadomešča:
SIST EN 13060:2015+A1:2019
Sterilizatorji za uporabo v medicini - Mali parni sterilizatorji - Zahteve in
preskušanje
Sterilizers for medical purposes - Small steam sterilizers - Requirements and testing
Sterilisatoren für medizinische Zwecke - Dampf-Klein-Sterilisatoren - Anforderungen und
Prüfung
Stérilisateurs à usage médical - Petits stérilisateurs à la vapeur d'eau - Exigences et
essais
Ta slovenski standard je istoveten z: prEN 13060
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
oSIST prEN 13060:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN 13060:2023
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oSIST prEN 13060:2023
DRAFT
EUROPEAN STANDARD
prEN 13060
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2023
ICS 11.080.10 Will supersede EN 13060:2014+A1:2018
English Version
Sterilizers for medical purposes - Small steam sterilizers -
Requirements and testing
Stérilisateurs á usage médical - Petits stérilisateurs á la Sterilsatoren für medizinische Zwecke - Dampf-Klein-
vapeur d'eau - Exigences et essais Sterilisatoren - Anforderungen und Prüfung
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 102.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 13060:2023 E
worldwide for CEN national Members.
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oSIST prEN 13060:2023
prEN 13060:2023 (E)
Contents Page
European foreword . 6
Introduction . 7
1 Scope . 8
2 Normative references . 8
3 Terms and definitions .10
4 General .22
4.1 Product definition .22
4.2 Equipment development .23
4.3 Calibration .23
5 Equipment design and construction .24
5.1 Safety and security .24
5.1.1 General requirements .24
5.1.2 Electromagnetic interference .25
5.1.3 Risk control and usability .25
5.2 Chamber .25
5.2.1 Dimensions .25
5.2.2 Doors .26
5.2.3 Chamber integrity .26
5.2.4 Pressure vessels .27
5.2.5 Uniformity of conditions.27
5.2.6 Ancillary equipment and components .27
5.3 Materials .28
5.4 Interlocks .28
5.5 Test connections .29
5.6 Vibration .29
5.7 User interfaces .30
5.8 Transport .30
6 Indicating, monitoring, controlling and recording .31
6.1 General .31
6.2 Automatic control .31
6.3 Software .32
6.4 Control and monitoring system .33
6.5 Failure .34
6.5.1 General .34
6.5.2 Fault .35
6.5.3 Power failure .35
6.5.4 Other failures .35
6.6 Instrumentation .36
6.7 Indicating devices .37
6.7.1 General .37
6.7.2 Sterilizer chamber temperature indicating instrument .37
6.7.3 Sterilizer chamber pressure instrument .37
6.7.4 Jacket pressure indicating instrument .38
6.7.5 Loading side of the sterilizer .38
6.7.6 Double ended sterilizer .39
6.7.7 Cycle counter .39
6.7.8 Air leak indication .39
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6.8 Recorders . 40
6.8.1 General . 40
6.8.2 Recorders producing analogue records . 41
6.8.3 Recorders producing digital records . 42
6.9 Process. 45
6.9.1 General . 45
6.9.2 Sterilization temperature, sterilization temperature band, holding time . 45
6.9.3 Time-temperature relationships . 45
6.9.4 Equilibration time . 45
7 Services and local environment . 45
7.1 General . 45
7.2 Sterilizing agent and sterilant . 46
7.3 Electrical supply . 46
7.4 Water . 46
7.4.1 Water supply for steam generation in the sterilizer . 46
7.4.2 Water used other than for steam generation . 47
7.5 Steam . 47
7.5.1 Non-condensable gases of external steam supply . 47
7.6 Vacuum . 47
7.7 Drains . 47
7.8 Lighting . 47
7.9 Compressed air . 47
7.10 Air and inert gases. 48
7.11 Ventilation . 48
8 Emissions . 48
8.1 Electromagnetic emissions . 48
8.2 Noise . 48
8.3 Heat emission . 49
9 Test instrumentation . 49
10 Performance and assessment . 50
10.1 General . 50
10.2 Chamber integrity . 50
10.2.1 General . 50
10.2.2 Air leakage rate . 51
10.3 Attainment of conditions . 51
10.4 Performance verification . 51
10.5 Drying . 52
10.6 Microbiological performance . 52
10.7 Pressure change . 52
10.7.1 General . 52
10.7.2 Dynamic sterilizer chamber pressure test . 52
11 Information supplied by the manufacturer . 53
11.1 General . 53
11.2 Information to be made available prior to purchase . 53
11.3 Marking . 58
11.3.1 Marking of the pressure vessel . 58
11.3.2 Marking of the sterilizer and the packaging . 58
11.4 Label . 59
11.5 Instructions for use . 59
11.6 Technical description . 59
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Annex A (normative) Test programme .60
A.1 Categories of tests .60
A.2 Type tests .60
A.3 Works test .61
A.4 Installation tests .61
A.5 Test programme .61
A.6 Rationale for the tests (informative) .63
Annex B (normative) Test equipment .66
B.1 Test equipment .66
B.2 Temperature sensors .66
B.3 Thermometric recording instrument .66
B.4 Pressure measurement and recording instrument .67
B.5 Test equipment for the performance of the air leakage test .68
B.6 Process challenge device (PCD) and chemical indicator for narrow lumen .69
B.7 Process challenge device and chemical indicator for simple hollow item .69
B.8 Balance for load dryness test .70
Annex C (normative) Test loads .71
C.1 Test loads .71
C.2 Porous load .71
C.3 Solid load, unwrapped .73
C.4 Solid load, single wrapped .73
C.5 Solid load, double wrapped .73
C.6 Clarification of the definition of narrow lumens and simple hollow items (see 3.31
and 3.49) (informative) .74
Annex D (normative) Test procedures .76
D.1 Test procedures .76
D.2 Air leakage test .76
D.3 Dynamic sterilizer chamber pressure test.78
D.4 Empty chamber test .79
D.5 Solid load test .79
D.6 Narrow lumen test .79
D.7 Simple hollow item test.80
D.8 Small porous load test .81
D.9 Full porous load test (single and double wrapped) .82
D.10 Small porous items test (single and double wrapped) .83
D.11 Solid load dryness test.84
D.12 Porous load dryness test (small and full, single and double wrapped) .84
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D.13 Small porous items dryness test (single and double wrapped) . 85
D.14 Microbiological test for solid loads . 85
D.15 Microbiological test for narrow lumens . 86
D.16 Microbiological test for simple hollow item . 86
D.17 Microbiological test for small porous loads . 86
D.18 Microbiological test for full porous loads . 87
D.19 Microbiological test for small porous items . 87
Annex E (informative) Monitoring system . 88
Annex F (informative) Suggested maximum limits of contaminants in and specifications for
water for steam sterilization . 89
F.1 Suggested maximum limits of contaminants in and specifications for water for steam
sterilization . 89
Annex G (informative) Load support systems . 90
Annex H (informative) Illustrations of the interrelationship between control and recording
. 91
H.1 Overview . 91
H.2 Illustration 1 . 91
H.3 Illustration 2 . 93
H.4 Illustration 3 . 94
H.5 Illustration 4 . 96
Annex ZA (informative) Relationship between this European Standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered . 97
Bibliography . 115
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oSIST prEN 13060:2023
prEN 13060:2023 (E)
European foreword
This document (prEN 13060:2023) has been prepared by Technical Committee CEN/TC 102 “Sterilizers
and associated equipment for processing of medical devices”, the secretariat of which is held by DIN.
This document is currently submitted to the CEN Enquiry.
This document will supersede EN 13060:2014+A1:2018.
In comparison with the previous edition, the following technical modifications have been made:
— the structure of the main text has been widely adopted to the structure of ISO/TS 22421:2021;
— update of normative references;
— update of terms and definitions to align with EN ISO 11139:2018;
— for requirement on non-condensable gases test, reference is made to EN 285:2015+A1:2021.
This document has been prepared under a Standardization Request given to CEN by the European
Commission and the European Free Trade Association, and supports essential requirements of EU
Directive(s) / Regulation(s).
For relationship with EU Directive(s) / Regulation(s), see informative Annex ZA, which is an integral part
of this document.
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oSIST prEN 13060:2023
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Introduction
Small steam sterilizers are widely used for medical purposes, e.g. in general medical practice, dentistry,
podiatry, facilities for personal hygiene and beauty care and also veterinary practice. They are also used
for materials and equipment which are likely to come into contact with blood or bodily fluids, e.g.
implements used by beauty therapists, tattooists, body piercers and hairdressers. The specific nature of
such loads used within these fields of application call for different performance requirements for the
sterilization cycles and hence different corresponding test methods.
This document specifies the general requirements for small steam sterilizers and associated test
methods. Performance is defined by reference to standard test loads. These are used to define a basic
minimum performance and are not necessarily related to specific medical devices. It is the responsibility
of the user and the manufacturer of the device to be sterilized to determine that any particular cycle is
suitable for sterilizing a particular device. The performance tests specified in this document can also be
used by the manufacturer of the device to be sterilized 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 17664-1. This will enable users to identify the specific sterilizer
performance required to safely process their devices.
The performance requirements specified in this document are not intended for the process to be effective
in inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform
encephalopathy and Creutzfeldt-Jakob disease. However, some national regulations require the use of
modified steam processes as part of a general prion decontamination programme.
It is essential that the sterilizer and ancillary equipment is used only for the sterili
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