EN 13060:2014
(Main)Small steam sterilizers
Small steam sterilizers
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 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 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 ISO 17665 1.
This European Standard does not specify requirements for other sterilization processes that also employ moist heat as part of the process (i.e. formaldehyde, ethylene oxide).
Dampf-Klein-Sterilisatoren
Diese Europäische Norm 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.
Diese Europäische Norm 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.
Diese Europäische Norm gilt für Dampf-Klein-Sterilisatoren mit einem Kammervolumen unter 60 Liter, 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).
Diese Europäische Norm gilt nicht für Dampf-Klein-Sterilisatoren, die für die Sterilisation von Flüssigkeiten oder pharmazeutischen Produkten verwendet werden.
Diese Europäische Norm legt keine Sicherheitsanforderungen fest, die mit den Risiken in dem Bereich zusammenhängen, in dem der Sterilisator verwendet wird (z. B. entzündliche Gase).
Diese Europäische Norm legt keine Anforderungen für die Validierung und Routineüberwachung der Sterilisa-tion mit feuchter Hitze fest.
ANMERKUNG Anforderungen an die Validierung und Routineüberwachung der Sterilisation mit feuchter Hitze sind in EN ISO 17665 1 enthalten.
Diese Europäische Norm legt keine Anforderungen für andere Sterilisationsverfahren fest, bei denen feuchte Hitze als Teil des Prozesses eingesetzt wird (d. h. Formaldehyd, Ethylenoxid).
Petits stérilisateurs à la vapeur d'eau
La présente Norme européenne 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.
La présente Norme européenne 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.
La présente Norme européenne 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 300 mm 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).
La présente Norme européenne ne s’applique pas aux petits stérilisateurs à la vapeur d’eau qui sont utilisés pour stériliser des liquides ou des produits pharmaceutiques.
La présente Norme européenne 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).
La présente Norme européenne 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 1.
La présente Norme européenne 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).
Mali parni sterilizatorji
Ta evropski standard 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 evropski standard velja za avtomatsko nadzorovane male parne sterilizatorje, ki paro proizvajajo z uporabo električnih grelcev ali uporabljajo paro, ki jo proizvaja sistem zunaj sterilizatorja.
Ta evropski standard velja za male parne sterilizatorje, ki se uporabljajo predvsem za sterilizacijo medicinskih pripomočkov in se vanje ne more namestiti sterilizacijski modul (300 mm × 300 mm × 600 mm), s prostornino komore pod 60 litrov.
Zahteve glede vodenja kakovosti in obvladovanja tveganj so obravnavane z normativnim sklicevanjem na druge standarde (npr. EN ISO 13485, EN ISO 14971).
Ta evropski standard ne velja za male parne sterilizatorje, ki se uporabljajo za sterilizacijo tekočin ali
farmacevtskih izdelkov.
Ta evropski standard ne določa varnostnih zahtev v zvezi s tveganji, povezanimi z območjem, na katerem se uporablja sterilizator (npr. vnetljivi plini).
Ta evropski standard ne določa zahtev za validacijo in rutinsko kontrolo sterilizacije z vlažno toploto.
OPOMBA Zahteve za validacijo in rutinsko kontrolo sterilizacije z vlažno toploto so določene v standardu EN ISO 17665-1, točkah 9 in 10, ki se uporabljata za postopke, ki se izvajajo z malimi parnimi sterilizatorji. Ta evropski standard ne določa zahtev za druge sterilizacijske postopke, ki prav tako uporabljajo vlažno toploto (tj. formaldehid, etilenoksid).
General Information
- Status
- Withdrawn
- Publication Date
- 16-Dec-2014
- Withdrawal Date
- 20-Jan-2026
- Technical Committee
- CEN/TC 102 - Sterilizers for medical purposes
- Drafting Committee
- CEN/TC 102/WG 5 - Small sterilizers
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 07-Nov-2018
- Completion Date
- 21-Jan-2026
- Ref Project
SIST EN 13060:2015 - Small steam sterilizers
Relations
- Effective Date
- 24-Dec-2014
- Effective Date
- 19-Jan-2023
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
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Frequently Asked Questions
EN 13060:2014 is a standard published by the European Committee for Standardization (CEN). Its full title is "Small steam sterilizers". This standard covers: 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 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 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 ISO 17665 1. This European Standard does not specify requirements for other sterilization processes that also employ moist heat as part of the process (i.e. formaldehyde, ethylene oxide).
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 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 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 ISO 17665 1. This European Standard does not specify requirements for other sterilization processes that also employ moist heat as part of the process (i.e. formaldehyde, ethylene oxide).
EN 13060:2014 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.
EN 13060:2014 has the following relationships with other standards: It is inter standard links to EN 13060:2004+A2:2010, EN 13060:2014+A1:2018, EN 868-8:2018, EN 868-9:2018, EN 868-1:1997, EN 868-6:2025, EN ISO 3746:2010, EN 868-2:2025, EN 13445-6:2021, EN 13445-4:2021+A1:2023, EN 868-3:2025, EN 13445-10:2021, EN ISO 11138-3:2017, EN 10088-1:2023, EN ISO 4126-1:2013. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 13060:2014 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/023. 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.
EN 13060:2014 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Mali parni sterilizatorjiDampf-Klein-SterilisatorenPetits stérilisateurs à la vapeur d'eauSmall steam sterilizers11.080.10Sterilizacijska opremaSterilizing equipmentICS:Ta slovenski standard je istoveten z:EN 13060:2014SIST EN 13060:2015en,fr,de01-marec-2015SIST EN 13060:2015SLOVENSKI
STANDARDSIST EN 13060:2005+A2:20101DGRPHãþD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 13060
December 2014 ICS 11.080.10 Supersedes EN 13060:2004+A2:2010English Version
Small steam sterilizers
Petits stérilisateurs à la vapeur d'eau
Dampf-Klein-Sterilisatoren This European Standard was approved by CEN on 15 November 2014.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13060:2014 ESIST EN 13060:2015
Clarification of the definition of narrow lumens and simple hollow items (see 3.18 and 3.30) . 63 Annex B (informative)
Process evaluation system. 65 Annex C (informative)
Suggested maximum limits of contaminants in and specification for water for steam sterilization . 66 Annex D (informative)
Example of a table to be supplied with pre-purchase documentation and with the instructions for use . 67 Annex E (informative)
Load support systems . 68 Annex F (informative)
Rationale for the tests . 69 Annex G (informative)
Example of a process challenge device for narrow lumen . 72 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42 EEC on medical devices . 73 Bibliography . 77
— term “hollow load A” has been changed to become “narrow lumen” ( 3.18) — term “hollow load B” has been changed to become “simple hollow items” ( 3.30) c) In Clause 4 various sub-clauses and relevant requirements have been added, such as: — General requirements for design and construction (4.3.1), — Vibrations (4.3.5) — Noise (4.3.6) — Steam penetration test (4.5.1.6) — Software (4.5.4); d) Sub-clause 4.8 has been divided into two subsections: — 4.8 Information to be provided — 4.9 Marking e) Requirements in 5.3 on Attainment of the sterilization conditions have been revised; f) Requirements in Clause 6 Safety, risk control and usability have been revised, e.g. requirements on electromagnetic compatibility (EMC), Pressure Equipment and risk control were added g) Requirements on Sound power level (7.2.6) were added; SIST EN 13060:2015
1) Under revision. 2) EN 868-1 has been replaced by EN ISO 11607-1. SIST EN 13060:2015
[SOURCE: prEN 285:2014, definition 3.25] 3.25 process challenge device PCD item designed to constitute a defined resistance to a sterilization process and used to assess performance of the process [SOURCE: ISO/TS 11139:2006, definition 2.33] 3.26 reference measurement point point where the temperature sensor used for the operating cycle control is located [SOURCE: prEN 285:2014, definition 3.26, modified: "probes" replaced by "sensor"] SIST EN 13060:2015
Table 1 — Types of sterilization cycles Type Description of intended use B The sterilization of products as represented by the test loads in the standard. For products that lie within the limits specified for the relevant test loads, this includes solid products, porous products and lumen devices, wrapped (single- and multiple-layer) or non-wrapped. 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, lumen devices, bowls and receivers, single-layer 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 for immediate use. NOTE 3 These categories are demonstrated by compliance with relevant tests listed in this standard. 3.38 sterilization load product to be, or that has been, sterilized together using a given sterilization process [SOURCE: ISO/TS 11139:2006, definition 2.48] 3.39 sterilization module rectangular parallelepiped of dimensions 300 mm (height) × 600 mm (length) × 300 mm (width) [SOURCE: prEN 285:2014, definition 3.33] 3.40 sterilization process fault one or more of the cycle parameters lying outside of its/their specified tolerance(s) 3.41 sterilization temperature minimum temperature on which the evaluation of the sterilization efficacy is based SIST EN 13060:2015
k) have a response time 90τ ≤ 5 s when tested according to EN 60751:2008, 6.5.2. 4.4.2.3 Sterilizer chamber pressure instrument The sterilizer chamber pressure instrument shall: a) be either digital or analogue; b) be graduated in kilopascals or bars; c) when the sterilization cycle includes a vacuum phase, have a scale which includes the range 0 kPa and 1,3 times the maximum allowable pressure or –1 bar and 1,3 times the maximum allowable pressure, given as absolute pressure value with a zero reading at absolute vacuum or ambient pressure respectively; d) when the sterilization cycle does not include a vacuum phase, have a scale which includes the range 100 kPa and 1,3 times the maximum allowable pressure or 0 bar and 1,3 times the maximum allowable pressure, given as absolute pressure value; e) have an accuracy of better than or equal to ± 5 kPa (0,05 bar) over the scale range; f) for analogue instruments, be graduated in divisions not greater than 20 kPa (0,2 bar); SIST EN 13060:2015
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