SIST EN 13060:2025
(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 Werkstoffe verwendet werden, die mit Blut oder Körperflüssigkeiten in Kontakt kommen können.
Dieses Dokument ist anwendbar 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 ist anwendbar für Dampf-Klein-Sterilisatoren mit einem Kammervolumen unter 60 l, die in erster Linie für die Sterilisation von Medizinprodukten verwendet werden, und die keine Sterilisiereinheit (300 mm × 300 mm × 600 mm) aufnehmen können.
Die Anforderungen bezüglich des Qualitäts- und Risikomanagements sind durch andere Normen berücksichtigt (z. B. EN ISO 13485, EN ISO 14971).
Dieses Dokument ist nicht anwendbar 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
Ta dokument določa zahteve za delovanje in preskusne metode za male parne sterilizatorje in sterilizacijske cikle, ki se uporabljajo za medicinske namene ali za materiale, ki lahko pridejo v stik s krvjo ali telesnimi tekočinami. Ta dokument se uporablja za avtomatsko nadzorovane male parne sterilizatorje, ki paro proizvajajo z električnimi grelci ali uporabljajo paro, ki jo proizvaja sistem zunaj sterilizatorja. Ta dokument se uporablja za male parne sterilizatorje, ki se uporabljajo predvsem za sterilizacijo medicinskih pripomočkov s prostornino komore manj kot 60 litrov in v katere ni mogoče namestiti sterilizacijskega modula (300 mm × 300 mm × 600 mm). Zahteve glede vodenja kakovosti in obvladovanja tveganj so obravnavane v drugih standardih (npr. EN ISO 13485, EN ISO 14971). Ta dokument se ne uporablja za male parne sterilizatorje, ki so namenjeni sterilizaciji tekočin ali farmacevtskih izdelkov. Ta dokument ne določa varnostnih zahtev v zvezi s tveganji, povezanimi z območjem, na katerem se uporablja sterilizator (npr. vnetljivi plini). Ta dokument ne določa zahtev za validacijo in rutinsko kontrolo sterilizacije z vlažno toploto. OPOMBA: Zahteve za validacijo in rutinsko kontrolo sterilizacije z vlažno toploto so podane v standardu EN ISO 17665. Ta dokument ne določa zahtev za druge sterilizacijske postopke, ki prav tako uporabljajo vlažno toploto (tj. formaldehid, etilenoksid).
General Information
- Status
- Published
- Public Enquiry End Date
- 18-Jul-2023
- Publication Date
- 07-Sep-2025
- Technical Committee
- VAZ - Healthcare
- Current Stage
- 6060 - National Implementation/Publication (Adopted Project)
- Start Date
- 04-Sep-2025
- Due Date
- 09-Nov-2025
- Completion Date
- 08-Sep-2025
Relations
- Effective Date
- 01-Oct-2025
Overview
SIST EN 13060:2025 (identical to EN 13060:2025) sets the requirements and test methods for small steam sterilizers used for medical purposes or for materials likely to contact blood or body fluids. It applies to automatically controlled small steam sterilizers that either generate steam with internal electrical heaters or use an external steam supply. The standard covers sterilizers with a chamber volume of less than 60 L and that cannot accommodate a sterilization module of 300 × 300 × 600 mm. It supersedes earlier editions and was approved by CEN on 23 June 2025.
Key technical topics and requirements
SIST EN 13060:2025 addresses design, performance and testing aspects essential for safe and effective sterilization. Major topics include:
- Product definition and equipment development - scope of device categories and design lifecycle considerations.
- Equipment design and construction - chamber design, doors, pressure vessels, materials, interlocks and transport.
- Control, monitoring and recording - automatic control systems, software considerations, instrumentation, indicating devices and digital/analogue recorders.
- Performance and assessment - chamber integrity, air leakage, attainment of sterilization conditions, drying and microbiological performance.
- Test programmes and test instrumentation - type tests, works tests, installation tests and required sensors/recorders.
- Services and local environment - requirements for steam, water, vacuum, electrical supply and ventilation.
- Information and labelling - manufacturer’s instructions for use, marking, technical descriptions and pre-purchase information.
Note: Validation and routine control of moist heat sterilization are outside this document and are covered by EN ISO 17665. Quality management and risk management are handled by standards such as EN ISO 13485 and EN ISO 14971.
Practical applications and users
This standard is intended for stakeholders involved in the design, manufacture, testing, procurement and use of small steam sterilizers:
- Manufacturers - to design and verify compliance of small medical steam sterilizers.
- Test laboratories and notified bodies - to perform type and performance testing, including air-leak and microbiological assessments.
- Biomedical engineers and sterile services departments - to assess suitability for clinical use, installation requirements and maintenance.
- Procurement teams in clinics and dental practices - to compare products against standardized requirements.
SIST EN 13060:2025 is specifically useful where small-capacity, automatically controlled steam sterilizers are deployed for medical instruments and devices.
Related standards (selected)
- EN ISO 17665 - validation and routine control of moist heat sterilization
- EN ISO 13485 - medical device quality management systems
- EN ISO 14971 - medical device risk management
Keywords: SIST EN 13060:2025, EN 13060:2025, small steam sterilizers, medical sterilizers, sterilization requirements and testing, steam sterilizers, sterilization cycles.
Frequently Asked Questions
SIST EN 13060:2025 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Sterilizers for medical purposes - Small steam sterilizers - Requirements and testing". This standard covers: 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).
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).
SIST EN 13060:2025 is classified under the following ICS (International Classification for Standards) categories: 11.080.10 - Sterilizing equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN 13060:2025 has the following relationships with other standards: It is inter standard links to SIST EN 13060:2015+A1:2019. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN 13060:2025 is associated with the following European legislation: EU Directives/Regulations: 2006/42/EC, 2017/745; Standardization Mandates: M/575, M/575 AMD 2. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
You can purchase SIST EN 13060:2025 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of SIST standards.
Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2025
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: EN 13060:2025
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN 13060
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2025
EUROPÄISCHE NORM
ICS 11.080.10 Supersedes EN 13060:2014+A1:2018
English Version
Sterilizers for medical purposes - Small steam sterilizers -
Requirements and testing
Stérilisateurs à usage médical - Petits stérilisateurs à la Sterilisatoren für medizinische Zwecke - Dampf-Klein-
vapeur d'eau - Exigences et essais Sterilisatoren - Anforderungen und Prüfung
This European Standard was approved by CEN on 23 June 2025.
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, 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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 13060:2025 E
worldwide for CEN national Members.
Contents Page
European foreword . 6
Introduction . 8
1 Scope . 9
2 Normative references . 9
3 Terms and definitions .11
4 General .23
4.1 Product definition .23
4.2 Equipment development .24
4.3 Calibration .24
5 Equipment design and construction .25
5.1 Safety and security .25
5.1.1 General requirements .25
5.1.2 Electromagnetic interference .26
5.1.3 Risk control and usability .26
5.2 Chamber .27
5.2.1 Dimensions .27
5.2.2 Doors .27
5.2.3 Chamber integrity .28
5.2.4 Pressure vessels .28
5.2.5 Uniformity of conditions.28
5.2.6 Ancillary equipment and components .28
5.3 Materials .29
5.4 Interlocks .29
5.5 Test connections .30
5.6 Vibration .30
5.7 User interfaces .31
5.8 Transport .31
6 Indicating, monitoring, controlling and recording .32
6.1 General .32
6.2 Automatic control .32
6.3 Software .33
6.4 Control and monitoring system .34
6.5 Failure .35
6.5.1 General .35
6.5.2 Fault .36
6.5.3 Power failure .36
6.5.4 Other failures .36
6.6 Instrumentation .37
6.7 Indicating devices .38
6.7.1 General .38
6.7.2 Sterilizer chamber temperature indicating instrument .38
6.7.3 Sterilizer chamber pressure instrument .38
6.7.4 Jacket pressure indicating instrument .39
6.7.5 Loading side of the sterilizer .39
6.7.6 Double ended sterilizer .40
6.7.7 Cycle counter .40
6.7.8 Air leak indication .41
6.8 Recorders . 41
6.8.1 General . 41
6.8.2 Recorders producing analogue records . 42
6.8.3 Recorders producing digital records . 43
6.9 Process. 46
6.9.1 General . 46
6.9.2 Sterilization temperature, sterilization temperature band, holding time . 46
6.9.3 Time-temperature relationships . 46
6.9.4 Equilibration time . 46
7 Services and local environment . 47
7.1 General . 47
7.2 Sterilizing agent and sterilant . 47
7.3 Electrical supply . 47
7.4 Water . 47
7.4.1 General . 47
7.4.2 Water supply for steam generation in the sterilizer . 47
7.4.3 Water used other than for steam generation . 48
7.5 Steam . 48
7.5.1 External steam supply . 48
7.6 Vacuum . 48
7.7 Drains . 48
7.8 Lighting . 49
7.9 Compressed air . 49
7.10 Air and inert gases. 49
7.11 Ventilation . 49
8 Emissions . 49
8.1 Electromagnetic emissions . 49
8.2 Noise . 49
8.3 Heat emission . 50
9 Test instrumentation . 50
10 Performance and assessment . 51
10.1 General . 51
10.2 Chamber integrity . 52
10.2.1 General . 52
10.2.2 Air leakage rate . 52
10.3 Attainment of conditions . 52
10.4 Performance verification . 53
10.5 Drying . 53
10.6 Microbiological performance . 53
10.7 Pressure change . 53
10.7.1 General . 53
10.7.2 Dynamic sterilizer chamber pressure test . 54
11 Information supplied by the manufacturer . 54
11.1 General . 54
11.2 Information to be made available prior to purchase . 54
11.3 Marking . 59
11.3.1 Marking of the pressure vessel . 59
11.3.2 Marking of the sterilizer and the packaging . 59
11.4 Label . 60
11.5 Instructions for use . 60
11.6 Technical description . 61
Annex A (normative) Test programme .62
A.1 Categories of tests .62
A.2 Type tests .62
A.3 Works test .63
A.4 Installation tests .63
A.5 Test programme .63
A.6 Rationale for the tests (informative) .65
Annex B (normative) Test equipment .68
B.1 Test equipment .68
B.2 Temperature sensors .68
B.3 Thermometric recording instrument .68
B.4 Pressure measurement and recording instrument .69
B.5 Test equipment for the performance of the air leakage test .70
B.6 Process challenge device (PCD) and chemical indicator for narrow lumen .71
B.7 Process challenge device and chemical indicator for simple hollow item .71
B.8 Balance for load dryness test .72
Annex C (normative) Test loads .73
C.1 Test loads .73
C.2 Porous load .73
C.3 Solid load, unwrapped .75
C.4 Solid load, single wrapped .75
C.5 Solid load, double wrapped .75
Annex D (normative) Test procedures .76
D.1 Test procedures .76
D.2 Air leakage test .77
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
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
E.1 General . 88
E.2 Principle . 88
E.3 Equipment . 89
Annex F (informative) Suggested maximum limits of contaminants in and specifications for
water for steam sterilization . 92
F.1 Suggested maximum limits of contaminants in and specifications for water for steam
sterilization . 92
Annex G (informative) Load support systems . 93
Annex H (informative) Illustrations of the interrelationship between control and recording
................................................................................................................................................................... 94
H.1 Overview . 94
H.2 Illustration 1 . 94
H.3 Illustration 2 . 96
H.4 Illustration 3 . 97
Annex I (informative) Environmental aspects . 100
I.1 Environmental impact . 100
I.2 Steam . 100
I.3 Product life cycle . 101
Annex ZA (informative) Relationship between this European Standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered . 102
Bibliography . 120
European foreword
This document (EN 13060:2025) 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 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 February 2026, and conflicting national standards shall
be withdrawn at the latest by February 2026.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes 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 and EN ISO 11139:2018/A1:2024;
— for requirement on non-condensable gases test, reference is made to EN 285:2015+A1:2021;
— considerations of aspect of standardization in moist heat sterilization to align with
EN ISO 17665:2024.
This document has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this
document.
In this document, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates a possibility or capability; and
— “must” is used to express an external constraint.
In this document notes are used for giving additional information intended to assist the understanding
or use of the text of document. The document shall be usable without the notes.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organisations of the
following countries are bound to implement this European Standard: 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 the United
Kingdom.
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 provides minimum 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 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 product. Therefore, the suitability of a sterilization
procedure for a particular product is verified by validation, see EN ISO 17665. Conformance with these
requirements for development, validation and routine control of sterilization process ensures that the
sterilization process is both reliable and reproducible so that predictions can be made, with reasonable
confidence, that there is low probability of there being a viable microorganism present on a health care
product after sterilization.
1 Scope
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).
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
EN 285:2015+A1:2021, Sterilization — Steam sterilizers — Large sterilizers
EN 556-1:2024, Sterilization of medical devices — Requirements for medical devices to be designated
“STERILE” — Part 1: Requirements for terminally sterilized medical devices
EN 764-7:2002, Pressure equipment — Part 7: Safety systems for unfired pressure equipment
EN 868-2:2025, Packaging for terminally sterilized medical devices — Part 2: Sterilization wrap —
Requirements and test methods
EN 868-4:2025, Packaging for terminally sterilized medical devices — Part 4: Paper bags — Requirements
and test methods
EN 868-5:2018, Packaging for terminally sterilized medical devices — Part 5: Sealable pouches and reels of
porous materials and plastic film construction — Requirements and test methods
EN 10088-1:2023, Stainless steels — Part 1: List of stainless steels
This document is impacted by corrigendum EN 764-7:2002/AC:2006.
EN 13445-1:2021, Unfired pressure vessels — Part 1: General
EN 13445-2:2021+A1:2023, Unfired pressure vessels — Part 2: Materials
EN 13445-3:2021, Unfired pressure vessels — Part 3: Design
EN 13445-4:2021+A1:2023, Unfired pressure vessels — Part 4: Fabrication
EN 13445-5:2021+A1:2024, Unfired pressure vessels — Part 5: Inspection and testing
EN 13445-8:2021, Unfired pressure vessels — Part 8: Additional requirements for pressure vessels of
aluminium and aluminium alloys
EN 60529:1991, Degrees of protection provided by enclosures (IP Code)
EN 61010-1:2010, Safety requirements for electrical equipment for measurement, control, and laboratory
use — Part 1: General requirements (IEC 61010-1:2010)
EN 62366-1:2015, Medical devices — Part 1: Application of usability engineering to medical devices
EN IEC 60751:2022, Industrial platinum resistance thermometers and platinum temperature sensors
(IEC 60751:2022)
EN IEC 61010-2-040:2021, Safety requirements for electrical equipment for measurement, control, and
laboratory use — Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat
medical materials (IEC 61010-2-040:2020)
EN IEC 61326-1:2021, Electrical equipment for measurement, control and laboratory use — EMC
requirements — Part 1: General requirements (IEC 61326-1:2020)
EN ISO 228-1:2003, Pipe threads where pressure-tight joints are not made on the threads — Part 1:
Dimensions, tolerances and designation (ISO 228-1:2000)
EN ISO 4017:2022, Fasteners — Hexagon head screws — Product grades A and B (ISO 4017:2022)
EN ISO 4126-1:2013, Safety devices for protection against excessive pressure — Part 1: Safety valves
(ISO 4126-1:2013)
EN ISO 11138-3:2017, Sterilization of health care products — Biological indicators — Part 3: Biological
indicators for moist heat sterilization processes (ISO 11138-3:2017)
EN ISO 11140-1:2014, Sterilization of health care products — Chemical indicators — Part 1: General
requirements (ISO 11140-1:2014)
This document is impacted by amendment EN 60529:1991/A1:2000 and EN 60529:1991/A2:2013, with
corrigendum EN 60529:1991/A2:2013/AC:2019-02, and corrigendum EN 60529:1991/AC:2016-12.
This document is impacted by amendment EN 61010-1:2010:2010/A1:2019 and corrigendum EN 61010-
1:2010/A1:2019/AC:2019.
This document is impacted by corrigenda EN 62366-1:2015/AC:2015 and EN 62366-1:2015/AC:2016-09 and
amendment EN 62366-1:2015/A1:2020.
This document is impacted by amendments EN ISO 4126-1:2013/A1:2016 and EN ISO 4126-1:2013/A2:2019.
EN ISO 11140-6:2022, Sterilization of health care products — Chemical indicators — Part 6: Type 2
indicators and process challenge devices for use in performance testing of small steam sterilizers
(ISO 11140-6:2022)
EN ISO 14971:2019, Medical devices — Application of risk management to medical devices
(ISO 14971:2019)
EN ISO 17665:2024, Sterilization of health care products — Moist heat — Requirements for the
development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024)
EN ISO 20417:2021, Medical devices — Information to be supplied by the manufacturer (ISO 20417:2021,
Corrected version 2021-12)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at https://www.electropedia.org/
3.1
access device
means by which entry to restricted parts of equipment is achieved
Note 1 to entry: This can be by dedicated key, code, or tool.
[SOURCE: EN ISO 11139:2018, 3.4]
3.2
active drain
drain through which fluids present in the chamber are discharged during the process
3.3
automatic controller
device that directs the equipment sequentially through required stages of the cycle in response to
programmed cycle parameters
[SOURCE: EN ISO 11139:2018, 3.18]
3.4
biological indicator
test system containing viable microorganisms providing a specified resistance to a specified sterilization
process
[SOURCE: EN ISO 11139:2018, 3.29]
This document is impacted by amendment EN ISO 14971:2019/A11:2021.
3.5
calibration
operation that, under specified conditions, in a first step, establishes a relation between the quantity
values with measurement uncertainties provided by measurement standards and corresponding
indications with associated measurement uncertainties and, in a second step, uses this information to
establish a relation for obtaining a measurement result from an indication
[SOURCE: EN ISO 11139:2018, 3.31]
3.6
chamber
part of equipment in which a load is processed
[SOURCE: EN ISO 11139:2018, 3.36]
3.7
chemical indicator
test system that reveals change in one or more pre-specified process variables based on a chemical or
physical change resulting from exposure to a process
Note 1 to entry: An indicator intended to be used only in combination with a specific test load is also termed an
indicator (both together becoming an indicator system).
[SOURCE: EN ISO 11139:2018, 3.43, modified – Note 1 to entry has been added]
3.8
control
regulation of variables within specified limits
[SOURCE: EN ISO 11139:2018, 3.63]
3.9
cycle complete
message from the automatic controller that the operating cycle has ended successfully
[SOURCE: EN ISO 11139:2018, 3.71]
3.10
cycle parameter
value of a cycle variable including its tolerance used for control, monitoring, indication, and recording of
an operating cycle
[SOURCE: EN ISO 11139:2018, 3.72]
3.11
cycle variable
property used to control, monitor, indicate, or record an operating cycle
[SOURCE: EN ISO 11139:2018, 3.74]
3.12
double-ended
having separate doors for loading and unloading in separate areas
[SOURCE: EN ISO 11139:2018, 3.92]
3.13
equilibration time
period between the attainment of defined sterilization process parameters at
the reference measurement point and the attainment of the specified sterilization process parameters at
all points within the load
Note 1 to entry: For the purpose of this document, the process parameter to which this definition refers is
temperature.
Note 2 to entry: Independent of the specific load, for the purpose of this document, the allocation of all points is
inside the usable chamber space.
[SOURCE: EN ISO 11139:2018, 3.105, modified – Note 1 and 2 to entry have been added]
3.14
equipment maintenance
combination of all technical and associated administrative actions intended to keep equipment at a state
in which it can perform its required function, or restore it to such a state
[SOURCE: EN ISO 11139:2018, 3.106]
3.15
exposure phase
cycle stage between the introduction of the sterilizing agent or disinfecting agent into the chamber and
when the agent is removed
Note 1 to entry: Disinfecting agent does not concern steam sterilization. For the purpose of this document the
sterilizing agent is moist heat and the exposure phase corresponds to the plateau period which is used in EN 13060.
[SOURCE: EN ISO 11139:2018, 3.111, modified – Note 1 to entry has been added]
3.16
fault
situation in which one or more of the process or cycle parameters is/are outside its/their specified
tolerance(s)
[SOURCE: EN ISO 11139:2018, 3.116]
3.17
hazard
potential source of harm
[SOURCE: EN ISO 11139:2018, 3.130]
3.18
hazardous situation
circumstance in which people, property, or the environment is/are exposed to one or more hazards
[SOURCE: EN ISO 11139:2018, 3.131]
3.19
holding time
period for which the temperatures at the reference measurement point, and at
all points within the load, are continuously within the sterilization temperature band
Note 1 to entry: The holding time follows immediately after the equilibration time. The extent of the holding time
is related to the sterilization temperature.
Note 2 to entry: Independent of the specific loads, for the purpose of this document, the allocation of all points is
inside the usable chamber space.
[SOURCE: EN ISO 11139:2018/A1:2024, 3.133.1, modified – Note 1 and 2 to entry have been added]
3.20
installation test
series of checks and tests performed during installation of the sterilizer in the place of use
3.21
load
product, equipment, or materials to be processed together within an operating cycle
[S
...
SIST EN 13060:2025 표준은 의료 목적으로 사용되는 소형 증기 멸균기에 대한 성능 요구사항 및 시험 방법을 명확히 규정하고 있습니다. 이 표준의 범위는 혈액이나 체액과 접촉할 가능성이 있는 재료를 포함하여, 의료 기기를 멸균하기 위한 소형 증기 멸균기의 기능적 성능을 포함합니다. 이 표준의 주요 강점은 자동 조정되는 소형 증기 멸균기의 성능 및 멸균 사이클에 대한 구체적인 요구사항을 제시함으로써, 의료 기기가 안전하고 효과적으로 멸균될 수 있도록 하는 데 기여한다는 점입니다. 또한, 60 리터 이하의 챔버 용적을 가진 멸균기를 대상으로 하여, 소형 장비의 특정 요구를 충족시키고 있습니다. 표준은 품질 관리 및 위험 관리를 위한 요구사항을 다른 기준서와 연계하여 다루고 있으며(예: EN ISO 13485, EN ISO 14971), 따라서 다른 표준과의 연계성을 통해 포괄적인 품질 보장을 가능하게 하고 있습니다. 그러나 SIST EN 13060:2025는 액체나 의약품의 멸균에 사용되는 소형 증기 멸균기에는 적용되지 않으며, 멸균기 사용 시의 안전 요구사항(예: 인화성 가스와 관련된 위험)도 다루지 않습니다. 또한, 습열을 이용한 멸균의 검증 및 정기적 관리를 위한 요구사항은 EN ISO 17665에 명시되어 있어, 보다 세밀한 규정을 원할 경우 해당 문서를 참고해야 합니다. 결론적으로, SIST EN 13060:2025 표준은 소형 증기 멸균기에 대한 중요한 기준을 제시하여 의료 기기의 안전성과 효율성을 보장하는 데 필수적인 역할을 수행하고 있습니다.
La norme SIST EN 13060:2025 fournit un cadre clair et précis concernant les exigences de performance et les méthodes d'essai des petits stérilisateurs à vapeur utilisés à des fins médicales. Son domaine d'application se concentre exclusivement sur les stérilisateurs à vapeur de petite taille, spécifiquement conçus pour des dispositifs médicaux dont le volume de chambre est inférieur à 60 litres. Cela en fait un document crucial pour les établissements de santé qui manipulent des instruments en contact avec le sang ou des fluides corporels. Parmi les points forts de cette norme, sa définition précise des cycles de stérilisation et des exigences applicables aux stérilisateurs qui utilisent des chauffages électriques ou de la vapeur générée par un système externe. Cela garantit que les utilisateurs peuvent s'assurer que leurs stérilisateurs fonctionnent conformément à des critères de performance bien établis, favorisant ainsi la sécurité des patients et du personnel médical. En outre, il est important de noter que la norme ne couvre pas les stérilisateurs destinés à la stérilisation de liquides ou de produits pharmaceutiques, ni les exigences spécifiques de validation et de contrôle de routine de la stérilisation par chaleur humide, lesquelles sont abordées dans d'autres normes comme l'EN ISO 17665. Cela permet de souligner le caractère ciblé et spécialisé de SIST EN 13060:2025. La norme aborde également, de manière indirecte, les exigences de gestion de la qualité et de gestion des risques, en précisant que ces sujets sont traités par d'autres standards tels que l'EN ISO 13485 et l'EN ISO 14971. Cela met en lumière l'importance d'une approche intégrée et systémique pour garantir la qualité et la sécurité des dispositifs médicaux. En somme, la norme SIST EN 13060:2025 s'avère être un document essentiel pour les professionnels de la santé et les fabricants de stérilisateurs, renforçant la conformité aux exigences de performance tout en assurant la sécurité et l’efficacité des processus de stérilisation à vapeur dans un cadre clinique.
Die Norm SIST EN 13060:2025 legt klare Anforderungen und Tests für kleine Dampfst sterilizer fest, die im medizinischen Bereich eingesetzt werden. Der Geltungsbereich dieser Norm ist präzise definiert und konzentriert sich auf Dampfst sterilizer mit einem Kammervolumen von weniger als 60 Litern, die automatisch gesteuert werden und entweder durch elektrische Heizungen Dampf erzeugen oder auf extern erzeugten Dampf zugreifen. Dies stellt sicher, dass die Norm für eine spezifische, aber wesentliche Klasse von Geräten relevant und anwendbar bleibt. Ein wesentlicher Vorteil dieser Norm ist die umfassende Festlegung der Leistungsanforderungen und der Testmethoden, die notwendig sind, um eine sichere und effektive Sterilisation von medizinischen Geräten zu gewährleisten. Durch die Einschränkung auf kleine Dampfst sterilizer trägt die Norm dazu bei, dass der Standard nicht nur praktikabel, sondern auch umsetzbar ist, indem sie spezifische Geräte ins Visier nimmt, die in der Praxis weit verbreitet sind. Die SIST EN 13060:2025 behandelt nicht die Anforderungen des Qualitäts- und Risikomanagements, da diese durch andere Standards, wie zum Beispiel EN ISO 13485 und EN ISO 14971, abgedeckt werden. Dies sorgt dafür, dass die Norm sich auf die direkt relevantesten Aspekte der Dampfst steriliserung konzentriert, und vermeidet Überschneidungen mit bereits etablierten Regelungen. Ein weiterer wichtiger Punkt ist, dass diese Norm nicht für die Sterilisation von Flüssigkeiten oder pharmazeutischen Produkten gilt. Dieses gezielte Anforderungsprofil sorgt dafür, dass die Norm für ihren spezifischen Anwendungsbereich prägnant bleibt und keine Verwirrung bezüglich ihrer Anwendung auf andere Sterilisationsmethoden, die feuchte Wärme verwenden, entsteht. Zusammenfassend lässt sich sagen, dass die SIST EN 13060:2025 von großer Relevanz für die Sicherheits- und Leistungsstandards von kleinen Dampfst sterilizers im medizinischen Bereich ist, da sie spezifische Anforderungen und Testmethoden definiert, die für die Gewährleistung der Sterilisation von medizinischen Geräten unerlässlich sind.
The SIST EN 13060:2025 standard provides a comprehensive framework for the performance requirements and testing methods for small steam sterilizers, specifically tailored for medical purposes. Its scope is critical as it ensures that sterilizers designed for medical devices-particularly those with a chamber volume of less than 60 liters-meet stringent performance criteria, which is essential for maintaining the safety and efficacy of medical practices. One of the strengths of this standard lies in its detailed specification of the sterilization cycles and the operational mechanisms for automatically controlled small steam sterilizers. By delineating that these devices can utilize steam generated by either internal electrical heaters or external systems, the standard appreciates the diverse technological solutions available within the field, thereby enhancing its relevance among manufacturers and healthcare facilities alike. The exclusion of applications for sterilizing liquids and pharmaceutical products is also a noteworthy aspect of the standard. This clarity helps prevent misapplication and ensures that users leverage the appropriate standards applicable to their specific sterilization needs. Furthermore, by referencing other standards such as EN ISO 13485 and EN ISO 14971 for quality and risk management, SIST EN 13060:2025 positions itself within a broader framework of regulatory compliance, emphasizing a holistic approach to medical device safety. However, it is important to note that the standard does not address safety requirements related to specific environmental risks, such as flammable gases, nor does it set forth requirements for the validation and routine control of sterilization by moist heat processes, which are covered in EN ISO 17665. This delineation helps users identify which standards are relevant depending on their specific sterilization processes, thus facilitating a more targeted compliance pathway. Overall, SIST EN 13060:2025 stands out as a relevant and robust standard for small steam sterilizers, reflecting the necessary performance metrics critical for the healthcare industry's reliance on effective sterilization methods. Its focus on medical applications, combined with clear boundaries on its applicability and interconnections with other standards, underscores its significance in promoting safe and effective medical practices.
SIST EN 13060:2025は、医療目的のための小型蒸気滅菌器に関する重要な標準です。この文書は、小型蒸気滅菌器の性能要件と試験方法を明確に定義しており、特に血液や体液に接触する可能性のある材料の滅菌に関連しています。このような明確な基準は、医療機器の安全性と効果を確保するために不可欠です。 この標準の強みの一つは、自動制御される小型蒸気滅菌器に対して適用されることです。指定されたリトルなスチーム・スタンダードは、電気ヒーターを使用して蒸気を生成するか、滅菌器外部のシステムによって生成された蒸気を使用することをカバーしています。この柔軟性は、さまざまな医療環境において、ニーズに応じた適切な滅菌器を選定する助けとなります。また、滅菌チャンバーの容量が60リットル未満で、300 mm x 300 mm x 600 mmの滅菌モジュールを収容できない機器に特化しているため、特定の市場セグメントに対する明確なガイダンスを提供しています。 SIST EN 13060:2025は、リスク管理や品質管理に関して他の標準（例：EN ISO 13485、EN ISO 14971）に依存しているため、全体的な医療機器の管理体系の中にスムーズに組み込むことができます。しかし、液体や医薬品の滅菌に関しては適用外であり、これにより標準の焦点がより明確になります。 また、湿熱による滅菌の承認や定期的な管理に関する要件については、EN ISO 17665に記載されているため、これらの複雑なプロセスに関しても適切なガイダンスが存在します。さらに、滅菌器が使用されるゾーンに関連するリスクについての安全要件は明示されていないため、使用者は別のガイドラインを参考にする必要があります。 全体として、SIST EN 13060:2025は、小型蒸気滅菌器のための明確かつ包括的な要件を提供することで、医療分野における安全性と効率性を向上させる重要な文書です。その明確な焦点と他の標準との整合性は、医療機関が高い滅菌基準を維持するのに寄与します。
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