SIST EN 13060:2005+A2:2010

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 13060:2004+A2:2010SIST EN 13060:2005+A2:2010en,fr,de01-junij-2010SIST EN 13060:2005+A2:2010SLOVENSKI
STANDARD



SIST EN 13060:2005+A2:2010



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 13060:2004+A2
March 2010 ICS 11.080.10 Supersedes EN 13060:2004+A1:2009English Version
Small steam sterilizers
Petits stérilisateurs à la vapeur d'eau
Dampf-Klein-Sterilisatoren This European Standard was approved by CEN on 16 April 2004 and includes Amendment 1 approved by CEN on 12 April 2009 and Amendment 2 approved by CEN on 6 February 2010.
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 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 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 and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13060:2004+A2:2010: ESIST EN 13060:2005+A2:2010



EN 13060:2004+A2:2010 (E) 2 Contents page Foreword . 3Introduction . 41Scope . 52Normative references . 53Terms and definitions . 64General technical requirements . 135Performance requirements . 286Safety . 307Categories of tests. 308Test equipment . 329Test programme . 4010Test methods . 41Annex A (informative)
Clarification of the definition of hollow space A and hollow space B (see 3.19 and 3.20) . 57Annex B (informative)
Process evaluation system . 59Annex C (informative)
Suggested maximum limits of contaminants in and specification for water for steam sterilization. 60Annex D (informative)
Example of a table to be supplied with pre-purchase documentation and with the instructions for use . 61Annex E (informative)
Load support systems . 62Annex F (informative)
Rationale for the tests . 63Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42 EEC on medical devices . 65Bibliography . 68
SIST EN 13060:2005+A2:2010



EN 13060:2004+A2:2010 (E) 3 Foreword This document (EN 13060:2004+A2:2010) 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 September 2010, and conflicting national standards shall be withdrawn at the latest by September 2010. 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 includes Amendment 1, approved by CEN on 2009-04-12 and Amendment 2, approved by CEN on 2010-02-06. This document supersedes #EN 13060:2004+A1:2009$. The start and finish of text introduced or altered by amendment is indicated in the text by tags !" and # $. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. The annexes A, B, C, D, E and F are informative. This document includes a Bibliography. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, 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 and United Kingdom.
SIST EN 13060:2005+A2:2010



EN 13060:2004+A2:2010 (E) 4 Introduction Small steam sterilizers are widely used for medical purposes, e.g. in general medical practices, dentistry, facilities for personal hygiene and beauty care and also veterinary practices. They are also used for materials and equipment, which are likely to come into contact with blood or body fluids, e.g. implements used by beauty therapists, tattooists, body piercers and hairdressers. The very specific sterilizer loads used within these fields of application call for different performance requirements for the sterilization cycles and different corresponding test methods. This European Standard specifies the general requirements for small steam sterilizers and test methods for specified sterilizer loads according to Table 1. These loads include unwrapped solid products, full porous load, small porous load, small porous items, hollow loads A, hollow loads B, single wrapped products and double wrapped products. The performance tests specified in this standard can also be used by device manufacturers to specify the appropriate performance for decontamination processes according to the requirements for information to be given by medical device manufacturers according to EN ISO 17664:2004. This will enable users to identify the specific sterilizer performance required to safely process their devices. Table 1 — Types of sterilization cycles Type Description of intended use B The sterilization of all wrapped or non-wrapped, solid, hollow load products type A and porous products as represented by the test loads in this standard. N The sterilization of non wrapped solid products. S The sterilization of products as specified by the manufacturer of the sterilizer including non wrapped solid products and at least one of the following: porous products, small porous items, hollow load products type A, hollow load products B, single wrapped products, multiple-layer wrapped products. NOTE 1 The description identifies ranges of products and test loads. NOTE 2 Non wrapped sterilized instruments are intended either for immediate use or for non sterile storage, transport and application (e.g. to prevent cross infection). #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 prior 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. SIST EN 13060:2005+A2:2010



EN 13060:2004+A2:2010 (E) 5 1 Scope This European Standard specifies the performance requirements and test methods for small steam sterilizers and sterilization cycles which are used for medical purposes or for materials that are likely to come into contact with blood or body fluids. This European Standard applies to automatically controlled small steam sterilizers that generate steam using electrical heaters or use steam that is generated by a system external to the sterilizer. This European Standard applies to small steam sterilizers used primarily for the sterilization of medical devices and unable to accommodate a sterilization module (300 mm × 300 mm × 600 mm) and with a chamber volume not exceeding 60 litres. This European Standard does not apply to small steam sterilizers that are used to sterilize liquids or pharmaceutical products. This European Standard does not specify safety requirements related to risks associated with the zone in which the sterilizer is used (e.g. flammable gases). This European Standard does not specify requirements for the validation and routine control of sterilization by moist heat. NOTE Requirements for the validation and routine control of sterilization by moist heat are given in EN 554, which may also be applied for small steam sterilizers. 2 Normative references !The following referenced documents are indispensable for the application 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 285:1996, Sterilization — Steam sterilizers — Large sterilizers1 EN 475, Medical devices — Electrically-generated alarm signals EN 866-3, Biological systems for testing sterilizers and sterilization processes — Part 3: Particular systems for use in moist heat sterilizers
EN 867-1:1997, Non-biological systems for use in sterilizers — Part 1: General requirements2 EN 867-5:2001, Non-biological systems for use in sterilizers — Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S EN 868 (all parts), Packaging materials and systems for medical devices which are to be sterilized3 EN 10088-1, Stainless steels — Part 1: List of stainless steels EN 60529, Degrees of protection provided by enclosures (IP code) (IEC 60529:1989) EN 61010-1, Safety requirements for electrical equipment for measurement, control and laboratory use — Part 1: General requirements (IEC 61010-1:2001)
1
Currently under revision by CEN/TC 102. 2
EN 867-1 is currently under revision by ISO/TC 198 and CEN/TC 102 (Vienna Agreement). 3
EN 868-1 is currently under revision by ISO/TC 198 and CEN/TC 102 (Vienna Agreement). SIST EN 13060:2005+A2:2010



EN 13060:2004+A2:2010 (E) 6 EN 61010-2-041, Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-041: Particular requirements for autoclaves using steam for the treatment of medical materials, and for laboratory processes (IEC 61010-2-041:1996)4
EN 61326, Electrical equipment for measurement, control and laboratory use — EMC requirements (IEC 61326:1997) EN ISO 228-1, Pipe threads where pressure-tight joints are not made on the threads — Part 1: Dimensions, tolerances and designation (ISO 228-1:2000) EN ISO 3746, Acoustics — Determination of sound power levels of noise sources using sound pressure — Survey method using and enveloping measurement surface over a reflecting plane (ISO 3746:1995) EN ISO 4017, Hexagon head screws — Product grades A and B (ISO 4017:1999) EN ISO 4126-1, Safety devices for protection against excessive pressure — Part 1: Safety valves (ISO 4126-1:2004) EN ISO 13485:2003, Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003) EN ISO 14937, Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000) 3 Terms and definitions !For the purposes of this document, the following terms and definitions apply." NOTE Other definitions relevant to steam sterilization and its validation are given in EN 285 and EN 554. 3.1 absolute pressure pressure for which the zero value is associated with absolute vacuum [EN 764-1:2004, definition 4.5] 3.2 active drain of small steam sterilizers drain through which fluids present in the chamber are discharged during the process 3.3 air removal removal of air from the sterilizer chamber and sterilizer load sufficient to facilitate steam penetration [EN 285:1996, definition 3.2] 3.4 automatic controller device that, in response to pre-determined cycle variables, operates the sterilizer sequentially through the required stages of the cycle(s) [EN 285:1996, definition 3.3] 3.5 biological indicator inoculated carrier contained within its primary pack ready for use
4
Currently under revision by IEC/TC 66/WG 7. SIST EN 13060:2005+A2:2010



EN 13060:2004+A2:2010 (E) 7 [EN 866-1:1997, definition 3.1] 3.6 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 [VIM:1993, definition 6.11] 3.7 chamber temperature lowest temperature prevailing in the sterilizer chamber [EN 554:1994, definition 3.3] 3.8 chemical indicator chemical indicator system in the form in which it is intended to be used 3.9 chemical indicator system combination of the chemical indicator reagent and its substrate 3.10 closed door door which is in the position required for it to be locked 3.11 cycle complete indication indication that the sterilization cycle has been satisfactorily completed as specified and that the sterilized load is ready for removal from the sterilizer chamber 3.12 cycle parameters specified physical properties, for example time, temperature and pressure, that influence the efficacy of the sterilization process 3.13 defined end-point visible change occurring after exposure to the specified variable(s) at a level equal to or greater than that specified for the indicator [EN 867-1:1997, definition 3.2] 3.14 door lid or a similar device provided as a means of closing and sealing the sterilizer chamber [EN 285:1996, definition 3.12] 3.15 double ended sterilizer sterilizer in which there is a door at each end of the sterilizer chamber [EN 285:1996, definition 3.13] 3.16 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 SIST EN 13060:2005+A2:2010



EN 13060:2004+A2:2010 (E) 8 [EN 554:1994, definition 3.5] NOTE The sterilizer chamber temperature is usually called chamber temperature. 3.17 fault recognition by the automatic controller that the pre-set cycle variables for the sterilization cycle have not been attained [EN 285:1996, definition 3.17] 3.18 holding time of small steam sterilizers period for which the temperature of all points within the usable space considering the temperature measurement reference position is held within the sterilization temperature band NOTE The holding time follows immediately after the equilibration time. The extent of the holding time is related to the sterilization temperature. 3.19 hollow load A single ended open space where the ratio of length to diameter of the cavity is greater than or equal to 1 and less than/or equal to 750 (1 ≤ L/D ≤ 750) and where the length of the cavity is not greater than 1 500 mm
(L ≤ 1 500 mm) or double ended open space where the ratio of length to diameter of the cavity is greater than/or equal to 2 and less than or equal to 1 500 (2 ≤ L/D
≤1 500) and where the length of the cavity is not greater than 3 000 mm (L ≤ 3 000 mm) and which is not hollow load B NOTE See annex A. 3.20 hollow load B single ended open space where the ratio of length to diameter of the cavity is greater than or equal to 1 and less than/or equal to 5 (1 ≤ L/D
≤ 5) and where the diameter is greater than or equal to 5 mm (D ≥ 5 mm) or double ended open space where the ratio of length to diameter of the cavity is greater than/or equal to 2 and less than/or equal to 10 (2 ≤ L/D ≤ 10) and where the diameter is greater than or equal to 5 mm (D ≥ 5 mm) NOTE See annex A. 3.21 inoculated carrier carrier on which a defined number of test organisms has been deposited [EN 866-1:1997, definition 3.8] 3.22 installation test
series of checks and tests performed after installation of the sterilizer in the place of use [EN 554:1994, definition 3.9] 3.23 locked door door with the locking device(s) fully engaged and where separate actions are required to unlock and open the door ####3.24 maximum allowable pressure maximum pressure for which the equipment is designed as specified by the manufacturer [EN 764-1:2004, definition 3.8] NOTE See Pressure Equipment Directive 97/23/EC, article 1, sub-clause 2.3.$ SIST EN 13060:2005+A2:2010



EN 13060:2004+A2:2010 (E) 9 3.25 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 [EN ISO 13485:2003, definition 3.7] 3.26 monitoring function of a device or person to check the attainment of the pre-set cycle parameters essential to the efficacy of the operating cycle ####3.27 non-condensable gas air and/or gas which will not liquefy under the conditions of a saturated steam process$ 3.28 operating pressure fluid pressure occurring during specified operating conditions #[EN 764-1:2004, definition 3.6]$ NOTE For the purposes of steam sterilization operating pressure is specified for the plateau period of a sterilization cycle. 3.29 plateau period equilibration time plus the holding time [EN 285:1996, definition 3.24] 3.30 porous ability of a material or configuration of material(s) to absorb fluids 3.31 pressure vessel vessel describing the sterilizer chamber, jacket (if fitted), door(s) and components that are in permanent open connection with the sterilizer chamber [EN 285:1996, definition 3.25] SIST EN 13060:2005+A2:2010



EN 13060:2004+A2:2010 (E) 10 3.32 process challenge device (PCD) object which simulates the worst case of conditions for attainment of the specified sterilization conditions within the items to be sterilized [EN 867-5:2001, definition 3.2] NOTE The device is so constructed that a biological or non-biological indicator system can be placed within the device in the position which it is most difficult for the sterilizing agent to reach. The design of the process challenge device depends on the nature of the goods to be sterilized and the sterilization procedure. 3.33 hazard potentially detrimental effect on persons or the surroundings arising directly from either the sterilizer or its load 3.34 saturated steam water vapour at a temperature corresponding to the boiling point of the source liquid [EN 554:1994, definition 3.20] 3.35 small steam sterilizer steam sterilizer which is unable to accommodate a sterilization module and has a chamber volume not exceeding 60 litres 3.36 solid product that is not made from porous material and which has no recesses or features which present a greater or equal challenge to steam penetration than hollow load B 3.37 sterile condition of a medical device that is free from viable micro-organisms [EN 556-1:2001, definition 3.4] 3.38 sterilization process undertaken to render a sterilizer load sterile [EN 285:1996, definition 3.31] 3.39 sterilization cycle automatic sequence of operating stages performed in a sterilizer for the purpose of sterilization [EN 285:1996, definition 3.32] 3.40 sterilization cycle type classification of a sterilization process based on the performance of the cycle NOTE 1 These categories are demonstrated by compliance with relevant tests listed in this standard NOTE 2 This standard defines three sterilization cycle types: B, N and S. Other claims may be made, but should not make reference to the sterilization cycle type listed. SIST EN 13060:2005+A2:2010



EN 13060:2004+A2:2010 (E) 11 3.41 sterilization module imaginary rectangular parallelepiped of dimensions 300 mm × 300 mm × 600 mm used to express the usable space of sterilizers 3.42 sterilization temperature minimum temperature of the sterilization temperature band [EN 554:1994, definition 3.24] 3.43 sterilization temperature band range of temperatures expressed as the sterilization temperature and the maximum allowable temperature which may prevail throughout the load during the holding time [EN 554:1994, definition 3.25] NOTE These temperatures are usually stated in whole degrees Celsius. 3.44 sterilizer apparatus designed to achieve sterilization [EN 285:1996, definition 3.36] 3.45 sterilizer chamber part of the sterilizer which receives the sterilizer load [EN 554:1994, definition 3.27] 3.46 sterilizer load goods that are to be sterilized simultaneously in the same sterilizer chamber [EN 554:1994, definition 3.28] 3.47 temperature measurement reference position position for temperature measurement as identified by the manufacturer to represent the conditions in the usable space 3.48 theoretical steam temperature temperature of saturated steam expressed in Kelvin, calculated from the measured pressure, using the following equation: T = A + B (lnP + C)-15)
(1) where T is the theoretical steam temperature in Kelvin; P is the measured pressure in megapascals, time averaged to result in a time constant between 1 s and 2,5 s; A is 42,677 6 K;
5 IRVINE TH.F., LILEY, P.E., Steam and Gas tables with computer equations. Academic Press, 1984. SIST EN 13060:2005+A2:2010



EN 13060:2004+A2:2010 (E) 12 B is –3 892,70 K; C is –9,486 54 3.49 type test series of checks and tests for a particular design of sterilizer to demonstrate compliance with the requirements of this standard 3.50 unloading door door in a double ended sterilizer through which the sterilized load is removed from the sterilizer chamber after a sterilization cycle [EN 285:1996, definition 3.42] 3.51 usable space of small steam sterilizers space inside the sterilizer chamber which is not restricted by fixed parts or the appropriate furniture as specified by the manufacturer of the sterilizer for the intended use and which is consequently available to accept the sterilizer load 3.52 validation documented procedure for obtaining, recording and interpreting data required to show that a process will consistently comply with pre-determined specifications [EN 554:1994, definition 3.29] 3.53 water charge volume of the water in the vessel from which the steam for the sterilization cycle is generated 3.54 works test series of tests performed at the manufacturer's works to demonstrate compliance of each sterilizer with its specification [EN 285:1996, definition 3.44] SIST EN 13060:2005+A2:2010



EN 13060:2004+A2:2010 (E) 13 4 General technical requirements 4.1 Dimensions The usable space shall be insufficient in size to accommodate a sterilization module. 4.2 Materials The materials used for components in contact with steam, including instrumentation, shall:  resist the attack of steam and condensate;  not lead to deterioration of the quality of the steam;  not release any substances in such quantities that they could constitute an environmental or health risk. NOTE 1 EN 285:1996, annex A suggests materials and combinations of materials that are suitable for specified applications in the construction of steam sterilizers. NOTE 2 Materials should be assessed in accordance with the principles of EN ISO 10993. 4.3 Design and construction 4.3.1 Doors and locking devices 4.3.1.1 The door shall be capable of being closed without being locked, so that it can be re-opened and closed before a sterilization cycle is initiated. 4.3.1.2 When fitted, the door seal shall permit ease of cleaning of the contact surfaces and seal replacement. 4.3.1.3 After cycle start it shall not be possible to open a sterilizer door before cycle complete is indicated, except through special intervention that will lead to a fault indication. 4.3.1.4 For double ended sterilizers it shall not be possible for more than one door to be open at a time, except for maintenance purposes. 4.3.1.5 For double ended sterilizers it shall not be possible to open the unloading door before cycle complete is indicated. 4.3.2 Test connection(s) 4.3.2.1 The sterilizer shall be equipped with at least one standard test connection. 4.3.2.2 The test connection(s) shall have a female pipe thread conforming to EN ISO 228-G¼ according to
EN ISO 228-1. 4.3.2.3 The test connection(s) shall be at a point of easy access to the chamber. The test connection(s) shall be clearly marked. 4.3.2.4 The steam inlet or vacuum ports and pipelines shall not be used for test connections. 4.3.3 Air filter 4.3.3.1 The air admitted to return the sterilizer chamber to atmospheric pressure after a vacuum assisted drying stage shall be admitted through a filter. SIST EN 13060:2005+A2:2010



EN 13060:2004+A2:2010 (E) 14 NOTE Air filters should be constructed from material resistant to corrosion and biodegradation. The filter material should be supported in a manner which minimizes damage to it. 4.3.3.2 The filter unit shall be readily accessible. 4.3.3.3 The filter shall be protected from any influence that may impair its proper function. 4.3.3.4 The filter shall retain not less than 99,5 % of particles greater than 0,30 µm. 4.4 Instrumentation, indication and registration devices 4.4.1 General All instruments and indicating devices specified in 4.4 shall be located where they can be viewed readily by the operator under normal operation of the sterilizer and their function shall be identified. Unless otherwise specified in this standard, the required instruments and gauges shall be readable by normal or corrected vision from a distance of 1 m and with a minimum illumination of (215 ± 15) lx. 4.4.2 Instruments and indicators 4.4.2.1 General Sterilizers shall be provided with the following instruments: a) sterilizer chamber temperature indicating instrument; b) sterilizer chamber pressure indicating instrument; c) jacket pressure indicating instrument (if the sterilizer is fitted with a pressurised jacket). NOTE The instrumentation listed in this clause may be subjected to additional national
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