SIST EN 13060:2015
(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 litres 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 normative
reference to 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,
clauses 9 and 10 which are applicable to processes conducted by small steam sterilizers.
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 normative Verweisungen auf 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 den Abschnitten 9 und 10 von EN ISO 17665-1 enthalten, die auch für die mit Dampf-Klein-Sterilisatoren durchgeführten Verfahren anwendbar sind. 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
Relations
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
SIST EN 13060:2015
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
EN 13060:2014 (E) 2 Contents Page Foreword .4 Introduction .6 1 Scope .7 2 Normative references .7 3 Terms and definitions .8 4 General technical requirements . 15 4.1 Dimensions . 15 4.2 Materials . 15 4.3 Design and construction . 16 4.4 Instrumentation, indication and registration devices . 17 4.5 Control systems . 25 4.6 Process . 26 4.7 Services and local environment . 27 4.8 Information to be provided . 28 4.9 Marking . 32 4.10 Accessories . 33 5 Performance requirements . 33 5.1 General . 33 5.2 Air leakage rate . 34 5.3 Attainment of the sterilization conditions . 34 5.4 Product compatibility . 34 5.5 Drying . 35 5.6 Microbicidal efficacy . 35 5.7 Non-condensable gases . 35 6 Safety, risk control and usability . 35 6.1 General requirements . 35 6.2 Requirements for EMC . 36 6.3 Requirements for pressure equipment . 36 6.4 Requirements for risk control . 37 7 Categories of tests. 37 7.1 General . 37 7.2 Type tests . 37 7.3 Works test . 38 7.4 Installation tests. 38 8 Test equipment . 39 8.1 General . 39 8.2 Temperature sensors . 39 8.3 Thermometric recording instrument. 39 8.4 Pressure measurement and recording instrument . 40 8.5 Test equipment for the performance of the air leakage test . 41 8.6 Porous load . 42 8.7 Solid load, unwrapped . 43 8.8 Solid load, single wrapped . 44 8.9 Solid load, double wrapped . 44 8.10 Process challenge device (PCD) and chemical indicator for narrow lumen . 44 SIST EN 13060:2015
EN 13060:2014 (E) 3 8.11 Process challenge device and chemical indicator for simple hollow item . 44 8.12 Balance for load dryness test . 45 9 Test programme . 46 10 Test methods . 47 10.1 General requirements on technical tests . 47 10.2 Air leakage test . 48 10.3 Dynamic sterilizer chamber pressure test . 49 10.4 Empty chamber test . 50 10.5 Solid load test . 50 10.6 Narrow lumen test . 50 10.7 Simple hollow item test . 51 10.8 Small porous load test . 52 10.9 Full porous load test (single and double wrapped) . 53 10.10 Small porous items test (single and double wrapped) . 54 10.11 Solid load dryness test . 54 10.12 Porous load dryness test (small and full, single and double wrapped) . 55 10.13 Small porous items dryness test (single and double wrapped) . 56 10.14 Non-condensable gases test . 56 10.15 Microbiological test for solid loads . 60 10.16 Microbiological test for narrow lumens . 60 10.17 Microbiological test for simple hollow item. 60 10.18 Microbiological test for small porous loads . 61 10.19 Microbiological test for full porous loads . 61 10.20 Microbiological test for small porous items . 62 Annex A (informative)
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
SIST EN 13060:2015
EN 13060:2014 (E) 4 Foreword This document (EN 13060:2014) 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 June 2015 and conflicting national standards shall be withdrawn at the latest by December 2015. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 13060:2004+A2:2010. 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 following amendments have been made in comparison with EN 13060:2004+A2:2010: a) The scope of the standard has been revised with the aim to define small and large sterilizers on the chamber volume; b) Normative references, terms and definitions have been updated, e.g.
— 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
EN 13060:2014 (E) 5 h) Requirements in 8.6 Porous load have been revised; i) Requirements for Process challenge device (PCD) and chemical indicators for products with narrow lumen were revised; j) Annex A has been revised, e.g. the defined hollow load A and B replaced by products with narrow lumen or simple hollow items; k) Example for process challenge device for narrow lumen (PCD) has been moved to a new Annex G. l) Annex ZA including Table ZA.1 on medical device directive and Table ZA.2 on machinery directive have been updated due to the changes made in the standard; m) Standard has been editorially revised; n) Updated 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, 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 the United Kingdom. SIST EN 13060:2015
EN 13060:2014 (E) 6 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 sterilization loads used within these fields of application call for different performance requirements for the sterilization cycles and hence different corresponding test methods. This European Standard 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 standard 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. 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 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 product. Therefore the suitability of a sterilization procedure for a particular product needs to be verified by validation (see EN ISO 17665-1). SIST EN 13060:2015
EN 13060:2014 (E) 7 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 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). 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. prEN 285:20141), Sterilization — Steam sterilizers — Large sterilizers EN 285: 2006+A2:2009, Sterilization — Steam sterilizers — Large sterilizers 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 for terminally sterilized medical devices 2) EN 1041, Information supplied by the manufacturer of medical devices EN 10088-1, Stainless steels — Part 1: List of stainless steels
1) Under revision. 2) EN 868-1 has been replaced by EN ISO 11607-1. SIST EN 13060:2015
EN 13060:2014 (E) 8 EN 13060:2004+A2:2010, Small steam sterilizers EN 13445 (all parts), Unfired pressure vessels EN 60529, Degrees of protection provided by enclosures (IP Code)(IEC 60529) EN 60751:2008, Industrial platinum resistance thermometers and platinum temperature sensors (IEC 60751:2008) EN 61010-1:2010, Safety requirements for electrical equipment for measurement, control, and laboratory use — Part 1: General requirements (IEC 61010-1:2010) EN 61010-2-040:2005, 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 61010-2-040:2005) EN 61326-1:2013, Electrical equipment for measurement, control and laboratory use — EMC requirements — Part 1: General requirements (IEC 61326-1:2012) 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) EN ISO 3746, Acoustics — Determination of sound power levels and sound energy levels of noise sources using sound pressure — Survey method using an enveloping measurement surface over a reflecting plane (ISO 3746) EN ISO 4017, Hexagon head screws — Product grades A and B (ISO 4017) EN ISO 4126-1, Safety devices for protection against excessive pressure — Part 1: Safety valves (ISO 4126-1) EN ISO 11138-3, Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3) EN ISO 11140-1, Sterilization of health care products — Chemical indicators — Part 1: General requirements (ISO 11140-1) EN ISO 14971:2012, Medical devices — Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) EN ISO 17665-1:2006, Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006) 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 active drain drain through which fluids present in the chamber are discharged during the process 3.2 automatic controller ÃsterilizationÄ device that, in response to cycle parameters, operates the apparatus sequentially through the operating cycle(s) SIST EN 13060:2015
EN 13060:2014 (E) 9 3.3 biological indicator test system containing viable microorganisms providing a defined resistance to a specified sterilization process [SOURCE: ISO/TS 11139:2006, definition 2.3] 3.4 calibration set of operations that establish, under specified conditions, the relationship between values of a quantity indicated by a measuring instrument or measuring system, or values represented by a material measure or a reference material, and the corresponding values realised by standards [SOURCE: ISO/TS 11139:2006, definition 2.4] 3.5 chemical indicator combination of the indicator agent and its substrate that reveals change in one or more 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). 3.6 cycle parameter physical value including its tolerances used for control, monitoring, indication and recording of the operating cycle [SOURCE: prEN 285:2014, definition 3. 8, modified: “including its tolerances” was added] 3.7 double ended with separate doors for loading and unloading 3.8 equilibration time period which elapses between the attainment of the sterilization temperature in the usable chamber space and the attainment of the sterilization temperature at all points within the load [SOURCE: EN ISO 17665-1:2006, definition 3.13, modified: ”at the reference measurement point” replaced by “in the usable chamber space” ] 3.9 hazard potential source of harm [SOURCE: ISO/IEC Guide 51:1999, definition 3.5] 3.10 hazardous situation circumstance in which people, property or the environment are exposed to one or more hazard(s) [SOURCE: ISO/IEC Guide 51:1999, definition 3.6] 3.11 holding time period for which the temperatures at all points within the useable chamber space and the load are continuously within the sterilization temperature band SIST EN 13060:2015
EN 13060:2014 (E) 10 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. [SOURCE: EN ISO 17665-1:2006, definition 3.19, modified: “” added, ”at the reference measurement point and” deleted and “within the sterilization load” replaced by “within the usable chamber space and the load] 3.12 installation test series of checks and tests performed during installation of the sterilizer in the place of use 3.13 instructions for use instructions intended for the user (operator) of the sterilizer to enable safe and appropriate use 3.14 locked with the locking device(s) fully engaged 3.15 maximum allowable pressure maximum pressure for which the equipment is designed as specified by the manufacturer Note 1 to entry: See Pressure Equipment Directive 97/23/EC, Article 1, sub-clause 2.3. [SOURCE: EN 764-1:2004, definition 3.8, modified: addition of new Note 1 to entry] 3.16 medical device any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of — diagnosis, prevention, monitoring, treatment or alleviation of disease, — diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury, — investigation, replacement, modification or support of the anatomy or of a physiological process, — supporting or sustaining life, — control of conception, — disinfection of medical devices, — providing information for medical purposes by means of in vitro examination of specimens derived from the human body, and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means [SOURCE: EN ISO 13485:2012, definition 3.7] 3.17 monitoring checking against specifications SIST EN 13060:2015
EN 13060:2014 (E) 11 3.18 narrow lumen hollow device which is beyond the range defined for a simple hollow item (see 3.30 and Figure A.3), and which is neither solid (see 3.32) nor porous (see 3.22) Note 1 to entry: See Annex A. EXAMPLES Long tubes, mating surfaces, hinged devices. 3.19 non-condensable gas air and other gas which will not liquefy under the conditions of a saturated steam process 3.20 operating pressure fluid pressure occurring during specified operating conditions [SOURCE: EN 764-1:2004, definition 3.6] Note 1 to entry: For the purposes of steam sterilization operating pressure is specified for the plateau period of a sterilization cycle. 3.21 plateau period equilibration time plus the holding time [SOURCE: prEN 285:2014, definition 3.23] 3.22 porous permeable to water, air or other fluids 3.23 pre-purchase information information necessary for prospective purchasers to enable them to make an informed purchasing decision 3.24 pressure vessel housing and its direct attachments up to the coupling point connection it to other equipment, designed and built to contain fluids under pressure Note 1 to entry: A vessel can be composed of more than one chamber.
[SOURCE: prEN 285:2014, definition 3.25] 3.25 process challenge device PCD item designed to constitute a defined resistance to a
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SLOVENSKI STANDARD
oSIST prEN 13060:2012
01-september-2012
Mali parni sterilizatorji
Small steam sterilizers
Dampf-Klein-Sterilisatoren
Ta slovenski standard je istoveten z: prEN 13060 rev
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
oSIST prEN 13060:2012 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN 13060:2012
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oSIST prEN 13060:2012
EUROPEAN STANDARD
DRAFT
prEN 13060 rev
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2012
ICS 11.080.10 Will supersede EN 13060:2004+A2:2010
English Version
Small steam sterilizers
Petits stérilisateurs à la vapeur d'eau Dampf-Klein-Sterilisatoren
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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey 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
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 13060 rev:2012: E
worldwide for CEN national Members.
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oSIST prEN 13060:2012
prEN 13060:2012 (E)
Contents Page
Foreword .4
Introduction .6
1 Scope .8
2 Normative references .8
3 Terms and definitions .9
4 General technical requirements . 16
4.1 Dimensions . 16
4.2 Materials . 16
4.3 Design and construction . 16
4.4 Instrumentation, indication and registration devices . 18
4.5 Control systems . 27
4.6 Process . 28
4.7 Services and local environment . 29
4.8 Information to be provided . 30
4.9 Marking . 34
4.10 Accessories . 35
5 Performance requirements . 35
5.1 General . 35
5.2 Air leakage rate . 35
5.3 Attainment of the sterilization conditions . 35
5.4 Product compatibility . 36
5.5 Drying . 36
5.6 Microbicidal efficacy . 36
5.7 Non-condensable gases . 36
6 Safety, risk control and usability . 36
6.1 General requirements . 36
6.2 Requirements for EMC . 37
6.3 Requirements for pressure equipment . 37
6.4 Requirements for risk control . 37
7 Categories of tests. 38
7.1 General . 38
7.2 Type tests . 38
7.3 Works test . 39
7.4 Installation tests. 39
8 Test equipment . 40
8.1 General . 40
8.2 Temperature sensors . 40
8.3 Thermometric recording instrument. 40
8.4 Pressure measurement and recording instrument . 41
8.5 Test equipment for the performance of the air leakage test . 42
8.6 Porous load . 43
8.7 Solid load, unwrapped . 44
8.8 Solid load, single wrapped . 45
8.9 Solid load, double wrapped . 45
8.10 Process challenge device (PCD) and chemical indicator system for narrow lumen . 45
8.11 Process challenge device and chemical indicator system for simple hollow item . 45
8.12 Balance for load dryness test . 46
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9 Test programme . 46
10 Test methods . 48
10.1 General requirements on technical tests . 48
10.2 Air leakage test . 49
10.3 Dynamic sterilizer chamber pressure test . 50
10.4 Empty chamber test . 50
10.5 Solid load test . 51
10.6 Narrow lumen test . 51
10.7 Simple hollow item test . 52
10.8 Small porous load test . 53
10.9 Full porous load test (single and double wrapped) . 54
10.10 Small porous items test (single and double wrapped) . 54
10.11 Solid load dryness test . 55
10.12 Porous load dryness test (small and full, single and double wrapped) . 56
10.13 Small porous items dryness test (single and double wrapped) . 57
10.14 Non-condensable gases test . 57
10.15 Microbiological test for solid loads . 61
10.16 Microbiological test for narrow lumens . 61
10.17 Microbiological test for simple hollow item . 61
10.18 Microbiological test for small porous loads . 62
10.19 Microbiological test for full porous loads . 62
10.20 Microbiological test for small porous items . 63
Annex A (informative) Clarification of the definition of narrow lumens and simple hollow items
(see 3.10 and 3.11) . 64
Annex B (informative) Process evaluation system . 66
Annex C (informative) Suggested maximum limits of contaminants in and specification for water
for steam sterilization . 67
Annex D (informative) Example of a table to be supplied with pre-purchase documentation and
with the instructions for use . 68
Annex E (informative) Load support systems . 69
Annex F (informative) Rationale for the tests . 70
F.1 Air leakage test . 70
F.2 Dynamic sterilizer chamber pressure test . 70
F.3 Empty chamber test . 70
F.4 Small porous load test . 70
F.5 Full porous load test . 70
F.6 Solid load test . 70
F.7 Small porous items . 70
F.8 Narrow lumen test . 71
F.9 Simple hollow item test . 71
F.10 Solid load dryness test . 71
F.11 Porous load dryness test. 71
F.12 Non-condensable gases test . 71
F.13 Microbiological test for small porous loads . 71
F.14 Microbiological test for full porous loads . 71
F.15 Microbiological test for small porous items . 71
Annex G (informative) . 73
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42 EEC on medical devices . 74
Bibliography . 78
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Foreword
This document (prEN 13060:2012) has been prepared by Technical Committee CEN/TC 102 “Sterilizers for
medical purposes”, the secretariat of which is held by DIN.
This document is currently submitted to the CEN Enquiry.
This document will supersede EN 13060:2004+A2:2010.
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.
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.
The main changes with respect to the previous edition are listed below:
–— Update of Normative references
–—Update of Terms and definitions (certain definitions no longer referenced in the standard have been
erased)
–— Addition of Clause 4.3.1 (General requirements for design and construction)
–— Addition of Clause 4.3.5 (Vibrations)
–— Addition of Clause 4.3.6 (Noise)
–— Addition of Clause 4.5.4 (Software)
–— Deletion of Clause 4.7. (Electromagnetic compatibility)
–— Modifications to Clause 4.8:
Clause 4.8 in EN 13060:2004 + A2:2010 (Marking and accompanying documents) was divided into two
separate clause in PR EN 13060: Clause 4.8 (Information to be provided) and Clause 4.9 (Marking)
–— Modifications to Clause 5.3
–— Modifications to Clause 6 notably addition of requirements for EMC, pressure equipment and risk control
–— Addition of Clause 7.2.6 (Sound power level)
–— Modifications to Clause 8.6.1 (relative humidity required in point e)
–— Deletion of Clause 8.6.2.2 (Reduced test pack)
–— Deletion of Clause 8.6.3.2
–— Modifications to Clause 8.10
–— Modifications to Annex A to include both the definition for narrow lumens and for simple hollow items
–— Addition of informative Annex G (Example of a PCD for narrow lumen)
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–— Modifications to Annex ZA.1 relating to the "Medical Devices" Directive 93/42/EC (and modifying texts)
–— Modifications to Annex ZA.2 relating to the "Machinery" Directive 2006/42/EC (and modifying texts)
Limited modifications have also been made to the following sections in order to clarify:
–— Introduction, scope
–— 4.4.3.3 (erased normative reference to EN 475)
–— Modifications to Clauses 7.1, 7.2.1, 7.3.1, 7.3.2, 7.4.1, 8.1, 8.11 for clarification
–— Updated Bibliography
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Introduction
Small steam sterilizers are widely used for medical purposes, e.g. in general medical practice, dentistry,
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 sterilizer loads used
within these fields of application call for different performance requirements for the sterilization cycles and
hence different corresponding test methods.
This European Standard 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 process cycle is
suitable for sterilizing a particular device.
Test loads are:
narrow lumen (formerly hollow loads A);
simple hollow item (formerly hollow loads B);
standard test pack for porous loads (wrapped);
small porous items (wrapped);
composition of metal bolts (wrapped or unwrapped).
These test loads are intended in general to represent kinds of real products having characteristics such as
those of:
solid products;
hinged devices;
porous loads;
small porous items;
lumen devices;
bowls and receivers;
unwrapped products; and
wrapped products.
NOTE For wrapped products, single-layer or multiple-layer packaging systems should provide a sterile barrier system
which conforms to EN ISO 11607-1.
The performance tests specified in this standard 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 17664:2004. This will
enable users to identify the specific sterilizer performance required to safely process their devices.
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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 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 (see EN ISO 17665-1).
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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 with a chamber volume of less than 60 litres 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 normative
reference to 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,
clauses 9 and 10 which are applicable to processes conducted by small steam sterilizers.
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).
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
EN 285 + A2:2009, Sterilization — Steam sterilizers — Large sterilizers.
EN ISO 11138-3:2009, Sterilization of health care products — Biological indicators — Part 3: Biological
indicators for moist heat sterilization processes (ISO 11138-3:2006).
EN ISO 11140-1:2009, Sterilization of health care products — Chemical indicators — Part 1: General
requirement (ISO 11140-1:2005).
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.
1
EN 868:2009 (parts 2-10), Packaging for terminally sterilized medical devices .
EN 10088-1:2005, Stainless steels — Part 1: List of stainless steels.
1
EN 868-1 has been replaced by EN ISO 11607-1.
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EN ISO 14971:2009, Medical devices — Application of risk management to medical devices.
EN 60529:1992, 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.
EN 61010-2-040:2005, 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.
EN 61326-1:2006, Electrical equipment for measurement, control and laboratory use — EMC requirements —
General requirements (IEC 61326-1:2005).
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 1041:2008, Information supplied by the manufacturer of medical devices.
EN ISO 3746:2010, Acoustics — Determination of sound power levels of noise sources using sound
pressure — Survey method using and enveloping measurement surface over a reflecting plane
(ISO 3746:2010).
EN ISO 4017:2001, Hexagon head screws — Product grades A and B (ISO 4017:1999).
EN ISO 4126-1:2004, 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 14937:2009, 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 14937:2009).
EN ISO 17665-1:2006, Sterilization of health care products — Moist heat — Part 1: Requirements for the
development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006).
EN 13445:2009 (all parts), Unfired pressure vessels.
EN ISO 11607-1:2009, Packaging for terminally sterilized medical devices — Part 1: Requirements for
materials, sterile barrier systems and packaging systems (ISO 11607-1:2006).
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
active drain of small steam sterilizers
drain through which fluids present in the chamber are discharged during the process
3.2
automatic controller
device that, in response to pre-determined operating cycle variables, operates the sterilizer
sequentially through the required stages of the cycle(s)
[SOURCE: EN ISO 17665-1:2006, 3.2]
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3.3
calibration
set of operations that establish, under specified conditions, the relationship between values of a quantity
indicated by a measuring instrument or measuring system, or values represented by a material measure or a
reference material, and the corresponding values realised by standards
3.4
double ended sterilizer
sterilizer in which there is a door at each end of the sterilizer chamber
[SOURCE:EN 285: 2006, 3.11]
3.5
equilibration time
period which elapses between the attainment of the sterilization temperature in the sterilizer chamber and the
attainment of the sterilization temperature at all points within the load
[SOURCE:EN ISO 17665-1:2006, 3.13]
3.6
fault
one or more of the process parameters lying outside its/their specified tolerance(s)
[SOURCE:ISO/TS 11139:2006, 2.19]
3.7
hazard
potential source of harm
[SOURCE: ISO/IEC Guide 51:1999, 3.5]
3.8
hazardous situation
circumstance in which people, property or the environment are exposed to one or more hazard(s)
[SOURCE: ISO/IEC Guide 51:1999, 3.6]
3.9
holding time (small steam sterilizers)
period for which the temperature of all points within the usable space including the temperature measurement
reference position is held 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.
3.10
installation test
series of checks and tests performed after installation of the sterilizer in the place
...
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