EN 14180:2003+A2:2009

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Sterilizatorji za uporabo v medicini - Sterilizatorji s paro nizke temperature in s formaldehidom - Zahteve in preskušanjeSterilisatoren für medizinische Zwecke - Niedertemperatur-Dampf-Formaldehyd-Sterilisatoren - Anforderungen und PrüfungStérilisateurs à usage médical - Stérilisateurs à la vapeur et au formaldéhyde à basse température - Exigences et essaisSterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing11.080.10Sterilizacijska opremaSterilizing equipmentICS:Ta slovenski standard je istoveten z:EN 14180:2003+A2:2009SIST EN 14180:2003+A2:2009en,fr,de01-november-2009SIST EN 14180:2003+A2:2009SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 14180:2003+A2
July 2009 ICS 11.080.10 Supersedes EN 14180:2003+A1:2009English Version
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
Stérilisateurs à usage médical - Stérilisateurs à la vapeur et au formaldéhyde à basse température - Exigences et essais
Sterilisatoren für medizinische Zwecke - Niedertemperatur-Dampf-Formaldehyd-Sterilisatoren - Anforderungen und Prüfung This European Standard was approved by CEN on 16 May 2003 and includes Amendment 1 approved by CEN on 12 April 2009 and Amendment 2 approved by CEN on 13 June 2009.
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, 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 © 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 14180:2003+A2:2009: ESIST EN 14180:2003+A2:2009

2 Contents page Foreword . 3Introduction . 41Scope . 42Normative references . 43Terms and definitions . 54Technical requirements . 105Process control . 196Performance requirements . 227Sound power . 238Marking and labelling . 249Information to be supplied by the manufacturer . 2410Service and local environment . 26Annex A (normative)
Test methods . 29Annex B (normative)
Sterilizer classification and testing . 34Annex C (normative)
Test equipment . 37Annex D (normative)
Determination of formaldehyde residuals in a filter indicator . 40Annex E (informative)
Formaldehyde residues on medical devices . 43Annex F (informative)
Environmental aspects . 45Annex ZA (informative)
!!!!Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC"""" . 48Bibliography . 51 SIST EN 14180:2003+A2:2009

3 Foreword This document (EN 14180:2003+A2:2009) 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 January 2010, and conflicting national standards shall be withdrawn at the latest by March 2010. This document includes Amendment 1, approved by CEN on 2009-04-12 and Amendment 2, approved by CEN on 2009-06-13. This document supersedes #EN 14180:2003+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. Annexes A, B, C and D are normative and form part of this European Standard. Annexes E, F and ZA are for information only. 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, 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.
4 Introduction This European Standard specifies minimum requirements and test methods for sterilizers working below ambient atmospheric pressure performing a low temperature steam and formaldehyde (LTSF) process. LTSF sterilizers are primarily used for the sterilization of medical devices in health care facilities, but may also be used during the commercial production of medical devices. LTSF processes are specified by physical parameters and verified using physical, chemical and microbiological means. The sterilizers operate automatically using pre-set cycles. The test methods and test equipment given may also be applicable to validation and routine control. #Validation and routine control of sterilization processes are essential to ensure their efficacy. This standard does not cover validation and routine control of a LTSF process. Criteria for validation and routine control of LTSF sterilization processes are given in EN 15424. At the present state of knowledge, LTSF sterilizers should not be assumed to deliver processes effectively inactivating the causative agents of spongiform encephalopathies such as scrapie, Bovine Spongiform Encephalophaty and Creutzfeld-Jakob Disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents. (See also EN 15424:2007 1.2.1).$ Planning and design of products applying to this standard should consider not only technical issues but also the environmental impact from the product during its life-cycle. Environmental aspects are addressed in annex F of this standard. NOTE Risk analysis methods, e. g. in EN ISO 14971, pay attention to environmental aspects. Specifications on operator safety are addressed in EN 61010–1, #EN 61010–2–040$ and are not repeated in this standard. EN 60204–1 may also give valuable guidelines. 1 Scope This European Standard specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only. These sterilizers are primarily used for the sterilization of heat labile medical devices in health care facilities. This European Standard specifies minimum requirements:  for the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices;  for the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes. 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." #deleted text$ SIST EN 14180:2003+A2:2009

5 EN 867–5, 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 868–5, Packaging materials and systems for medical devices which are to be sterilized — Parts 5: Heat and self-sealable pouches and reels of paper and plastic film construction — Requirements and test methods. EN 60584–2, Thermocouples — Part 2: Tolerances (IEC 60584–2:1982 + A1:1989). EN 60751, Industrial platinum resistance thermometer sensors (IEC 60751:1983 + A1:1986). EN 61010–1, Safety requirements for electrical equipment for measurement, control and laboratory use — Part 1: General requirements (IEC 61010-1:2001). #EN 61010-2-040, 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 61326:1997, Electrical equipment for measurement, control and laboratory use — EMC requirements (IEC 61326:1997). EN ISO 3746, Acoustics — Determination of sound power levels of noise sources using sound pressure — Survey method using an enveloping measurement surface over a reflecting plane (ISO 3746:1995). #EN ISO 11138-1, Sterilization of health care products — Biological indicators — Part 1: General requirements (ISO 11138-1:2006)$ #EN ISO 11138-5, Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2006)$ ISO 228–1, Pipe threads where pressure-tight joints are not made on the threads — Part 1: Dimensions, tolerances and designation. 3 Terms and definitions !For the purposes of this document, the following terms and definitions apply." 3.1 access device means used to enable access to restricted parts of equipment
NOTE This may be a dedicated key, code or tool. 3.2 aeration a part or parts of the sterilization process in which defined conditions are used such that formaldehyde and its reaction products are desorbed from the medical device, and which can be performed within the sterilizer, within a separate room or chamber, or by a combination of the two
3.3 air removal removal of air from the sterilizer chamber and sterilization load to facilitate sterilant penetration 3.4 automatic controller device that, in response to pre-determined cycle variables, operates the sterilizer sequentially through the required stages of the operating cycle
# 3.5 biological indicator test system containing viable microorganisms providing a defined resistance to a specified sterilization process SIST EN 14180:2003+A2:2009

6 [ISO/TS 11139:2006, definition 2.3]$ 3.6 chamber pre-heating the heating of inner sterilizer-chamber surfaces to achieve predetermined temperatures prior to the commencement of a sterilization cycle 3.7 conditioning treatment of product within the sterilization cycle, but prior to the holding time, to attain a predetermined temperature and humidity throughout the sterilization load 3.8 cycle complete indication that the operating cycle has been satisfactorily completed and that the sterilized load is ready for removal from the sterilizer chamber [EN 285:1996, definition 3.10]
3.9 cycle parameter specified value for a cycle variable
3.10 cycle variables the physical properties that influence the efficacy of the sterilization cycle NOTE For LTSF-sterilizers, the cycle variables include, but may not be limited to temperature, pressure, time, sterilant concentration. 3.11 desorption removal of the sterilant from the chamber and the load at the end of the exposure time 3.12 double-ended sterilizer sterilizer in which there is a door at each end of the sterilizer chamber [EN 285:1996, definition 3.13] 3.13 equilibration time period which elapses between the attainment of the sterilization temperature at the reference measuring point and the attainment of the sterilization temperature at all points within the load 3.14 exposure time time between introducing the sterilant into the chamber and the start of the desorption phase 3.15 holding time period for which the temperature, the steam pressure and the formaldehyde concentration of the steam are held within pre-set values and their tolerances to achieve the required inactivation efficacy in the sterilizer chamber
NOTE The holding time follows immediately after the equilibration time. SIST EN 14180:2003+A2:2009

7 3.16 inoculated carrier a carrier on which a defined number of test organisms has been deposited [EN 866-1:1997, definition 3.8] 3.17
installation qualification
IQ obtaining and documenting evidence that equipment has been provided and installed in accordance with its specification [EN ISO 14937:2000, definition 3.9] 3.18 loading door door in a double-ended sterilizer through which the sterilizer load is put into the sterilizer chamber prior to sterilization [EN 285:1996, definition 3.21] (See also 3.43 unloading door) 3.19 medical device any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:  diagnosis, prevention, monitoring, treatment or alleviation of, disease,  diagnosis, monitoring, treatment, alleviation of or compensation for, an injury or handicap,  investigation, replacement or modification of the anatomy or of a physiological process,  control of conception, and which does not achieve its principal 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 13485:2000, definition 3.1] 3.20 microbicidal solution aqueous solution containing formaldehyde to feed the vaporiser for generating sterilant in the sterilizer 3.21 operating cycle the automatic sequence of operating stages performed in a sterilizer [EN 1422:1997, definition 3.24] 3.22 operational qualification
OQ process of obtaining and documenting evidence that installed equipment operates within predetermined limits when used in accordance with its operational procedures [EN ISO 14937:2000, definition 3.12] 3.23 operator person operating equipment for its intended purpose SIST EN 14180:2003+A2:2009

8 3.24 override means intended only for maintenance or safety, by which the operating cycle can be interrupted or modified 3.25 post-cycle flushing stage after "cycle complete" indication, during which the sterilization load is left in the closed chamber and the internal chamber atmosphere is exchanged 3.26 pressure vessel a vessel consisting of the sterilizer chamber, door(s) and other components that form a permanent unit with the sterilizer chamber and that are pressurised by the same pressure 3.27 process challenge device item designed to simulate product and used to assess the penetration performance of the sterilization cycle NOTE The device is so constituted that a biological or chemical indicator can be put in the place which is the most difficult to reach by sterilizing agent(s).The indicator should not interfere with the function of the process challenge device. 3.28 production test series of tests performed to demonstrate compliance of each sterilizer with its type test performance 3.29 reference measuring point the point where the temperature sensor for the sterilization cycle control is located 3.30 requalification repetition of part of validation for the purpose of confirming the continued acceptability of a specified process [EN ISO 14937:2000, definition 3.20] 3.31 sterilant microbicidal agent composed of steam containing formaldehyde 3.32 sterilant injection single or repeated stage beginning with the introduction of sterilant into the evacuated sterilizer chamber and ending when the set operating pressure has been attained 3.33 sterile free from viable micro-organisms [EN ISO 14937:2000, definition 3.23] 3.34 sterilization validated process used to render a product free from viable micro-organisms
NOTE In a sterilization process the nature of microbial inactivation is described by an exponential function. Therefore the presence of a viable micro-organism on any individual item can be expressed in terms of probability. This probability may be reduced to a very low number, it can never be reduced to zero. 3.35 sterilizer apparatus designed to achieve sterilization [EN 285:1996, 3.36] SIST EN 14180:2003+A2:2009

9 3.36 sterilizer chamber that part of the sterilizer, which receives the sterilizer load [EN 285:1996, definition 3.37] 3.37 sterilization cycle predetermined sequence of operating stages performed in a sterilizer for the purpose of sterilization and desorption 3.38 sterilization load items that are to be, are being or have been sterilized simultaneously in one sterilizer chamber
3.39 sterilization process series of actions or operations to achieve the specified requirements for sterility and for reduction of sterilant residues to an acceptable level NOTE This series of actions or operations includes pre-treatment (if necessary), exposure to the sterilizing agent under defined conditions, and any necessary post-treatment. It does not include any necessary operations preceding the sterilization process, such as cleaning, disinfection or packaging. 3.40 sterilization temperature minimum temperature of the sterilization temperature band on which the evaluation of the sterilization efficacy is based 3.41 sterilization temperature band temperature tolerance range for the load and the reference measuring point, the minimum of which is the sterilization temperature 3.42 theoretical sterilant temperature the temperature of the sterilant, calculated from the temperature versus vapour pressure relationship of the sterilant NOTE This value is calculated from the beginning of the exposure time until the beginning of aeration. 3.43 unloading door door in a double-ended sterilizer through which the sterilizer load is removed from the sterilizer chamber after a sterilization cycle [EN 285:1996, definition 3.42] (See also 3.18 loading door) 3.44 usable space space inside the sterilizer chamber, which is not restricted by fixed parts and which is, according to the manufacturer’s specification, available to accept the sterilization load 3.45 validation documented procedure for obtaining recording and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications [EN ISO 14937:2000, definition 3.32] SIST EN 14180:2003+A2:2009

10 4 Technical requirements 4.1 Sterilizer chamber 4.1.1 Materials 4.1.1.1 The surfaces of the materials for the pressure vessel (including, for example, welds) that can come into contact with process chemicals shall be of materials which, under the designed operating conditions, are not impaired by these chemicals. They shall not release any substances known to be toxic in such quantities that can create a health or environmental hazard. NOTE In the selection of materials for pressure parts and their integral attachments, due attention should be paid to the effects of contact corrosion and differential expansion when dissimilar metals are used in contact. 4.1.1.2 Materials for sterilizer furniture including load supporting systems shall be selected to avoid corrosion and galvanic attack. 4.1.2 Chamber size For the usable space the following dimensions shall be specified in millimetres, as applicable: a) For cylindrical horizontal or cylindrical vertical usable spaces: 000 x 000 in which:  the first three digits give the diameter of the usable space; and  the last three digits give the depth of the usable space. b) For rectangular parallelepiped usable spaces: 000 x 000 x 000 in which:  the first three digits give the width of the usable space;  the next three digits give the height of the usable space; and  the final three digits give the depth of the usable space. c) For other configurations the usable space shall be specified in analogy to a) or b). d) If any dimension exceeds 1000 mm then four digits shall be used, without a decimal point. 4.1.3 Doors and interlocks of the sterilizer chamber 4.1.3.1 Sterilizer chambers shall be provided with one or two doors. 4.1.3.2 After closing the sterilizer door, it shall be possible to open it before a cycle has been started. 4.1.3.3 It shall not be possible to open a sterilizer door(s) during a cycle. 4.1.3.4 In case of an interrupted cycle (e. g. due to a fault), opening of the sterilizer door e. g. to gain access to the load shall require the use of an access device. 4.1.3.5 Means shall be provided to allow access to sealing surfaces for cleaning purposes and for replacing the door seal(s). 4.1.3.6 For double-ended sterilizers it shall not be possible to open the unloading door until a "cycle complete" indication is obtained. 4.1.3.7 For operating cycles dedicated for test or maintenance purposes only, the cycle complete indication shall be different from that of a normal sterilization cycle. For double-ended sterilizers such cycle complete indications shall not permit the unloading door to be opened. 4.1.3.8 The control used to start the automatic operating cycle shall be located at the loading side of the sterilizer. SIST EN 14180:2003+A2:2009

11 4.1.3.9 Except for maintenance purposes it shall not be possible to open both doors simultaneously on double-ended sterilizers. 4.1.3.10 For double-ended sterilizers both ends of the sterilizer shall be fitted with a device to indicate whether the door at that end can be opened. 4.1.3.11 The indication "cycle complete" shall be cancelled when a door is opened. For double-ended sterilizers the loading door shall remain locked until the unloading door has been opened, closed and locked again. 4.1.4 Heating the sterilizer chamber Inner sterilizer chamber surfaces shall be heated to achieve pre-set temperatures. Initiation of the sterilization cycle shall not be possible until this condition has been fulfilled. 4.1.5 Test connections 4.1.5.1 The sterilizer chamber shall be provided with a test connection, which is used for the connection of a test pressure measuring instrument. This connection shall be at a point of easy access, but not in a pipe for media transport or evacuation, and shall terminate in a pipe thread ISO 228 –G1/2A. An example is given Figure 1. The test connection shall be provided with a cap marked PT (Pressure Test) and sealed with a sterilant proof and mechanically resistant O-ring seal or flat seal. NOTE If national regulations require the calibration of all pressure instruments connected to the pressure vessel, test tees and valve cocks with sealing plugs may be required to permit connection of reference instruments. SIST EN 14180:2003+A2:2009

12 Dimensions in millimetres
apipe thread ISO 228-G1/2A Figure 1 — Example of the connection for test instruments
4.1.5.2 The sterilizer chamber shall be provided with a straight thermometry entry connection. An example is given in Figure 2. This connection shall be at a point of easy access. The connection shall be provided with a cap marked TT (Temperature Test) and sealed with a sterilant proof and mechanically resistant O-ring seal or flat seal. Dimensions in millimetres
apipe thread ISO 228-G1A Figure 2 — Example of thermometry entry connection 4.2 Design and construction 4.2.1 General A Council Directive on the approximation of the laws of the member states concerning pressure equipment was released on 29 May 1997 (97/23/EC) and corresponding European Standards EN 13445 and EN 14222, may apply. 4.2.2 Pipework and fittings 4.2.2.1 Pipeworks and fittings (including e. g. seals) which may come into contact with process chemicals shall be of materials which, under the designed operating conditions, are not impaired by these chemicals. They shall not release any substances known to be toxic in such quantities that can create a health or environmental hazard. NOTE To avoid heat loss or condensation, all pipework carrying media to the sterilizer should be isolated except where this will interfere with the function of the sterilizer. SIST EN 14180:2003+A2:2009

13 4.2.2.2 Connections for water and steam supply and drainage shall be provided with means to prevent the ingress of particles which could affect the performance of a sterilizer. NOTE For connections to potable water supply and draining, national or local regulations may apply. 4.2.2.3 Pipework shall be designed to prevent accumulation of condensate. 4.2.2.4 All control valves in the pipework shall be marked with permanent identification in relation to their functions (see 8.4). 4.2.3 Evacuation system 4.2.3.1 Sterilizers shall be provided with a vacuum system to remove air, water and sterilant. The lowest absolute pressure needed for fulfilling the requirements of clause 6 when tested according to A.3 shall be specified. NOTE Vacuum systems mostly operate by means of water. Attention should be paid to optimise the use of water in such systems, as there could be a balance between the use of resources and diluting of formaldehyde into concentrations harmless to environment (See also annex F). 4.2.3.2 The sterilizer shall be provided with a means for leaktesting which shall include the sterilizer chamber and all relevant connected pipework and fittings.
At leak testing the chamber and relevant pipework shall be evacuated to or below the lowest process pressure. The pressure rise shall not exceed 0,1 kPa/min over a period of not less than 5 min and not more than 15 min after obtaining the lowest pressure. 4.2.4 Electrical and mechanical safety 4.2.4.1 For general design, EN 61010–1 and #EN 61010–2–040$ shall apply.
NOTE For guidance regarding specific design aspects, EN 60204–1 may apply. The guidance in EN 60204–1 may reduce testing. # 4.2.4.2 Sterilizers shall comply with EN 61326 regarding electromagnetic compatibility (EMC). Sterilizers operating either in areas in which medical electrical equipment is intended to be used or in the vicinity of other sensitive equipment shall be regarded as class B equipment as specified in EN 61326. For immunity, the requirements of EN 61326:2006, Table 2 shall apply. The selected immunity performance criteria shall ensure that the sterilizer performance as specified in 5.2 will be met during normal operation, when exposed to disturbance phenomena given in EN 61326:2006, Table 2.$ 4.2.5 Aeration system 4.2.5.1 When the sterilizer chamber is ventilated during the aeration for the purpose of desorption and to release the vacuum at the end of the process, microbial recontamination of the sterilization load shall be prevented. 4.2.5.2 When a filter is fitted to the sterilizer to prevent microbial recontamination during aeration or pressure equalization, it shall be readily accessible for replacement. The filter shall be capable of retaining at least 99,5 % of particles with a diameter of 0,3 µm at a pressure difference of 1 bar and at maximum airflow. Means shall be provided between the filter and the sterilisation chamber to prevent fluid flow from the sterilizer chamber into the filter. 4.2.6 Framework and panelling 4.2.6.1 If the sides of the sterilizer need not to be accessible for normal operation, they shall be enclosed with panelling. SIST EN 14180:2003+A2:2009

14 NOTE 1 Sterilizers designed to be recessed into existing walls providing continuous joint with the sterilizer front panelling, do not need to be provided with side panelling. The panelling shall be long-term corrosion-resistant. Instructions for cleaning of the panelling shall be provided. NOTE 2 Ventilation openings may be provided in the panelling. 4.2.6.2 The panelling of sterilizers shall allow access for maintenance work. #NOTE The access for maintenance should be positioned so that it will not compromise the safety of either the product or persons. Requirements for access are specified in EN 61010–2–040.$ 4.3 Indicating, measuring, operating and recording devices 4.3.1 General 4.3.1.1 Indicating and operating devices shall be identified as to their function. They shall be readily accessible, clearly and durably marked with their function and designed to be easy to operate and read. 4.3.1.2 The devices shall be positioned and/or protected such that their performance is within the specified tolerances during the operation of the sterilizer. 4.3.1.3 If an indicating instrument is connected in turn to more than one sensing point, there shall be a continuous indication of the active sensor that is being monitored. 4.3.1.4 Indicating and operating devices shall be readable when viewed at a distance of (1±0,15) m with normal or corrected vision in an illumination of (215±15) lx. 4.3.1.5 Indicating, measuring and recording devices shall have means to adjust in situ by the use of an access device without dismantling the instrument. For analogue indicating instruments that are not easily demountable, means for adjustment in situ shall be provided. NOTE Where digital pressure indicators are used, an additional mechanically attached indicator may be required to comply with national pressure vessel regulations. Where an analogue instrument is provided only for this purpose, the requirement for adjustment in situ is waived. 4.3.1.6 Additional functions fitted at recording or indicating devices shall not jeopardize the accuracy of registration or indication.
4.3.2 Temperature measuring devices 4.3.2.1 When used for process control, monitoring or registration purposes, temperature measuring devices shall have maximum permissible errors of 1 K or less over the scale range 20 °C to 100 °C and be adjusted to ± 0,5 K or less at the sterilization temperature. 4.3.2.2 Temperature control systems shall be protected against unauthorised operation by the use of an access device. 4.3.2.3 At least two independent sensors shall be used for the measurement of the chamber temperature, being dedicated to indication, control and registration. The sensors shall be located in the most representative position in the chamber specified as being the reference measuring point. 4.3.2.4 The registration and monitoring/controlling devices shall be mutually independent as given by any of the arrangements shown in Figure 3. 4.3.2.5 The temperature sensor including the measuring system it is connected to shall have a response time τ0,9 < 5 s when tested in flowing water according to EN 60751. 4.3.2.6 Temperature control systems shall have a function which causes a fault to be indicated if a sensor fails. SIST EN 14180:2003+A2:2009

15 4.3.3 Temperature indicating devices In addition to the requirements in 4.3.2.1, the temperature indicating devices shall:  be graduated in degrees Celsius;
 have a scale, which includes 0 °C to 100 °C;  for analogue instruments be graduated in divisions not greater than 2 °C;  for digital instruments have a resolution of
at least 0,1 °C.
Key
1 Chamber
Temperature indicating instrument Temperature recorder Temperature controller
Pressure indicating instrument Pressure recorder Pressure controller Figure 3 — Arrangements for temperature and pressure sensors 4.3.4 Pressure measuring and indicating devices 4.3.4.1 When used for control, monitoring or registration purposes, pressure measuring and indicating systems shall be protected against unauthorised operation by the use of an access device. 4.3.4.2 When used for process control, monitoring or registration purposes, absolute pressure measuring systems shall be used. 4.3.4.3 At least two independent sensors shall be used for the measurement of the chamber pressure, being dedicated to indication, control and registration. 4.3.4.4 The registration and monitoring/controlling devices shall be mutually independent as given by any of the arrangements shown in Figure 3. SIST EN 14180:2003+A2:2009

16 4.3.4.5 When used for process control, monitoring or registration purposes, pressure measuring and indicating chain shall have maximum permissible errors of 1 % or less over the scale range, and be adjusted to
± 0,8 kPa (± 0,008 bar) or less over the range from 0 kPa (0 bar) up to the sterilization pressure. 4.3.4.6 When used for process control, monitoring or registration purposes, pressure measuring systems shall have a function which causes a fault to be indicated if a sensor fails. 4.3.4.7 Pressure indicating devices shall:  be graduated in kilopascals or bars;  have a scale which includes the range 0 kPa (0 bar) to at least 10 % above the maximum process operating pressure when used for process control or monitoring purposes;
 have maximum permissible errors as specified in 4.3.4.5 when used for process control or monitoring purposes or have maximum permissible errors of 1,6 % or less over the scale range at others;  for analogue instruments, be graduated in divisions not greater than 5 kPa (0,05 bar) when used for process control or monitoring purposes and in divisions not greater than 20 kPa (0,2 bar) at others;
 for analogue instruments indicating overpressure, have the maximum allowable operating pressure legibly identified;  for digital instruments, have a resolution of not greater than 0,5 kPa (0,005 bar) and be adjusted to better than 0,8 kPa (0,008 bar) from 0 kPa (0 bar) to the sterilization pressure. 4.3.5 Timers and time indicating devices 4.3.5.1 A timer shall control the holding time. 4.3.5.2 Time periods within the process shall have an uncertainty of measurement of ±1,0 s or less. 4.3.5.3 If dates and times are indicated, the formats yy:mm:dd and hh:mm:ss shall be used as applicable. 4.3.5.4 The time period of each time controlled part of the sterilization cycle shall be adjustable by the means of an access device. 4.3.5.5 Means shall be provided, independent of the process control, to verify the time period of each stage of the sterilization cycle. 4.3.6 Sterilizing cycle counter A counter shall be provided to indicate the cumulative number of all operating cycles started, including those cycles in which a fault occurred. The cycle counter shall display a minimum of four digits and shall not be capable of being reset inadvertently or deliberately. 4.3.7 Recording instruments 4.3.7.1 General requirements 4.3.7.1.1 The recorder shall be independent such that the measuring chain as well as value data processing and printed values are separate from the automatic controller. NOTE 1 This does not exclude the transfer of informative data from the automatic controller to the recorder and vice versa, via a combined system for data transfer. NOTE 2 Sterilizer identification, cycle number and load identification may be recorded automatically. SIST EN 14180:2003+A2:2009

17 4.3.7.1.2 For operational inspection as well as for batch documentation, analogue or digital recorders shall record pressure and temperature data versus time. The records shall allow evaluation of the data for compliance with specified temperature and pressure profiles throughout the operating cycle (see 9.2 a)). NOTE The data printed may consist of digital records, analogue curves or both. 4.3.7.1.3 The recorder shall produce a record, which shall be readable as defined in 4.3.7.1.6 when stored in specified conditions for a period of not less than 10 years. 4.3.7.1.4 Unless the power supply is interrupted or the instrument itself malfunctions, the instrument shall continue to operate after a fault occurs. 4.3.7.1.5 Recorders shall have a sampling interval of 2 s or lower for each channel. 4.3.7.1.6 Records shall be readable when viewed at a distance of (250±25) mm with a normal or corrected vision in an illumination of (215±15) lx. 4.3.7.1.7 If times are marked, units shall be either in seconds, minutes or hours or multiples thereof. Time periods up to 5 min shall have an uncertainty of measurement of ±2,5 % or less and for periods above 5 min of ±1 % or less. 4.3.7.1.8 Means shall be provided to adjust the recorder in situ by the use of an access device. 4.3.7.2 Recorders producing analogue records 4.3.7.2.1 Recorders producing analogue records shall have a chart speed of not less than 2 mm/min. 4.3.7.2.2 If two or more variables are recorded on the same chart, the printed scale markings on the chart shall be common for all the variables recorded and the major marked interval shall be marked sequentially for each of the variables recorded. 4.3.7.2.3 Recorders producing analogue records shall have a minimum scale width of 100 mm. 4.3.7.2.4 Temperature recorders producing analogue records shall:  have a chart graduated in degrees Celsius;  have a scale, which includes the range 0 °C to 100 °C;  have maximum permissible errors
of 1 % or less over the scale range 0
°C to 100 °C;  be adjusted to
±1 °C or less at the sterilization temperature. 4.3.7.2.5 Pressure recorders producing analogue records shall:  have a chart graduated in bars or kilopascals;  have a scale which includes the range 0 kPa (0 bar) up to the maximum process operating pressure;  have maximum permissible errors
of the record of 1,6 % or
less over the scale range  be adjusted to 1,0 kPa (0,01 bar) or better over the scale range. 4.3.7.3 Recorders producing digital records 4.3.7.3.1 Recorders producing digital records shall use alphanumeric characters and define data by text. 4.3.7.3.2 Recorders producing digital records shall have a paper width with a space for a minimum of 15 characters/line. SIST EN 14180:2003+A2:2009

18 4.3.7.3.3 Temperature recorders producing digital records shall:  have a range which includes 0 °C to 100 °C;  have maximum permissible errors of 1 K or less over the range 20°C to 100°C. 4.3.7.3.4 Pressure recorders producing digital records shall:  have a range which includes 0 kPa (0 bar) to at least 10 % above the maximum process
operating pressure;  have maximum permissible errors
of the record of 1,0 % or less over the scale range. 4.3.8 Indications and registrations 4.3.8.1 Sterilizer instrumentation shall make available to the operator at least the following visual information: a) indication of the chamber pressure; b) indication of the chamber temperature; c) registration of the chamber temperature independent from the automatic controller; d) registration of the chamber pressure independent from the automatic controller; e) indication of the chamber wall temperature; f) indication of the pressure or temperature of the formaldehyde vaporizer (for indication of the vaporization ability); g) indication of the jacket pressure if the sterilizer is fitted with a pressurized jacket; h) indication of steam supply pressure if dedicated steam generator is used; i) indication of the sterilizer being in the state of alert (standby); j) indication of
sterilizer “door(s) locked”; k) indication of the sterilization cycle selected; l) indication of sterilizer “in progress”; m) indication of the sterilization cycle stage; n) indication of "cycle complete"; o) indication of "fault" when occurring (see 5.4); p) indication of when the sterilizer door can be opened; q) cycle counter. NOTE 1 Items c), d) and q) may be incorporated into a single recording system. #NOTE 2 Except if required in EN 61010–2–040 the items a), b), e), f), g) and h) may be incorporated into a system whereby the user may select the display of any measurement.$ NOTE 3 Item m) cycle stage indication may incorporate items i), j), l), n) and p). 4.3.8.2 In addition, instrumentation at double-ended sterilizers shall provide the following visual information at the unloading side: a) indication of the chamber pressure; SIST EN 14180:2003+A2:2009

19 b) indication of sterilizer “in progress”; c) indication of "cycle complete"; d) indication of when the unloading door can be opened; e) indication of "fault". 5 Process control 5.1 General 5.1.1 The sterilizer shall be operated by an automatic controller, which has one or more pre-set sterilization cycles. 5.1.2 The sterilizer shall operate with pre-set programmes permanently stored in the automatic controller. Any change of the pre-set programme or its parameters shall require the use of an access device. NOTE Automatic loading and unloading may be initiated without the use of an access device. 5.1.3 The variables and parameters programmed into the automatic controller and the tolerable limits that will still enable the performance requirements of clause 6 to be met shall be specified. (See also 9.2 a)). 5.1.4 The automatic controller shall be protected against short circuit in components or equipment, which are directly or indirectly connected to the controller. NOTE 1 Guidance is given in EN 60204–1. NOTE 2 Verification may be achieved by assessing compliance with EN 60204–1. 5.1.5 The automatic controller shall be located such that the maximum values of temperature and humidity specified for the automatic controller are not exceeded. NOTE Normally the temperature and humidity in the vicinity of the control system should not exceed 50 °C and 85 % relative humidity respectively. 5.1.6 The automatic controller shall have status indicators for each digital inputs and outputs. NOTE These can be located within the enclosure of the controller. 5.1.7 The reference measuring point shall be selected in such a way that throughout the holding time the temperature at this point correlates with the temperature in the usable space. 5.2 Sterilization cycle and automatic control 5.2.1 Leak testing shall be performed either during the first vacuum phase or during the complete holding time. For process control, if the test is carried out during the first vacuum phase, a pressure stabilising time not exceeding 15 min may precede the test period.
The pressure change measured shall be ≤ 50 Pa (0,5 mbar) per minute when tested over a period of 10 min. A pressure rise due to media injection during the holding time shall not be considered as a leak for the evaluation of the leak rate. There shall be a visual
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