1、BRITISH STANDARDBS EN61010-2-040:2005Safety 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 The European Standard EN 61010-2-040:2005 has the status of a Brit
2、ish StandardICS 19.080; 71.040.10g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN 61010-2-040:2005This British Standard was published under the
3、 authority of the Standards Policy and Strategy Committee on 31 July 2006 BSI 2006ISBN 0 580 49012 2National forewordThis British Standard is the official English language version of EN 61010-2-040:2005. It is identical with IEC 61010-2-040:2005. It supersedes BS EN 61010-2-041:1997, BS EN 61010-2-0
4、42:1997, BS EN 61010-2-043:1998 and BS EN 61010-2-045:2001 which are withdrawn.The UK participation in its preparation was entrusted to Technical Committee EPL/66, Safety of measuring, control and laboratory equipment, which has the responsibility to: A list of organizations represented on this comm
5、ittee can be obtained on request to its secretary.Cross-referencesThe British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Se
6、arch” facility of the BSI Electronic Catalogue or of British Standards Online.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal o
7、bligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep UK interests informed; monitor related international and European developments and promulgate them in the UK.Summary of
8、 pagesThis document comprises a front cover, an inside front cover, the EN title page, pages 2 to 32, an inside back cover and a back cover.The BSI copyright notice displayed in this document indicates when the document was last issued.Amendments issued since publicationAmd. No. Date CommentsEUROPEA
9、N STANDARD EN 61010-2-040 NORME EUROPENNE EUROPISCHE NORM July 2005 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B - 1050 Brussels 2005 CENELEC
10、 - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 61010-2-040:2005 E ICS 19.080; 71.040.10 Supersedes EN 61010-2-041:1996 NOTES: in small roman type; conformity and tests: italic type; terms used throughout this standard which have been de
11、fined in Clause 3: SMALL ROMAN CAPITALS; 2) subclauses, figures, tables and notes which are additional to those in Part 1 are numbered starting from 101. The following dates were fixed: latest date by which the EN has to be implemented at national level by publication of an identical national standa
12、rd or by endorsement (dop) 2006-03-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2008-06-01 Annex ZA has been added by CENELEC. _ 3 EN 61010-2-040:2005 CONTENTS 1 Scope and object4 2 Normative references .5 3 Terms and definitions .5 4 Tests6 5 Mar
13、king and documentation 7 6 Protection against electric shock.12 7 Protection against mechanical HAZARDS 13 7 Protection against mechanical HAZARDS and against HAZARDS related to mechanical functions 13 8 Mechanical resistance to shock and impact.17 9 Protection against the spread of fire17 10 Equipm
14、ent temperature limits and resistance to heat.17 11 Protection against HAZARDS from fluids18 12 Protection against radiation, including laser sources, and against sonic and ultrasonic pressure .21 13 Protection against liberated gases, explosion and implosion21 14 Components.28 15 Protection by inte
15、rlocks 29 16 Test and measurement equipment 29 Annexes .30 Annex G (informative) Leakage and rupture from fluids under pressure30 Annex H (informative) Index of defined terms .30 Annex ZA (normative) Normative references to international publications with their corresponding European publications32
16、Bibliography .31 EN 61010-2-040:2005 4 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 1 Scope and object This clause of Part 1 is applicable except as
17、 follows: 1.1.1 Equipment included in scope Replacement: This International Standard specifies safety requirements for electrical equipment intended for sterilization, washing, and disinfection of medical materials in the medical, veterinary, pharmaceutical and laboratory fields, when used under the
18、 environmental conditions of 1.4. Examples of such equipment are: a) STERILIZERS and disinfectors using steam; b) STERILIZERS and disinfectors using toxic gas, toxic aerosol or toxic vapour; c) STERILIZERS and disinfectors using hot air or hot inert gas, and d) washer disinfectors. 1.1.2 Equipment e
19、xcluded from scope Add the following note to item g) NOTE IEC 60601-1(definition 2.2.15 modified) defines medical electrical equipment as follows: Electrical equipment, provided with not more than one connection to a particular supply MAINS and intended by its manufacturer to be used in the diagnosi
20、s, treatment, or monitoring of a patient; and that makes physical or electrical contact with the patient or transfers energy to or from the patient or detects such energy transfer to or from the patient. Add the following new second paragraph: This standard also does not apply to the following types
21、 of equipment: aa) equipment for use in hazardous gas atmospheres (see IEC 60079) except for an atmosphere created inside equipment by the use of a flammable sterilizing agent (see 13.0); bb) environmental cabinets (see IEC 61010-1); cc) laboratory equipment for the heating of materials for other pu
22、rposes than sterilization or disinfection (see IEC 61010-2-010); dd) laundry equipment (see IEC 60335, Parts 2-4, 2-7, and 2-11, and ISO 10472), unless designed for disinfecting medical materials; ee) dishwashers (see IEC 60335, Parts 2-5 and 2-58). 5 EN 61010-2-040:2005 1.2.1 Aspects included in sc
23、ope Replacement: Replace item g) and the note by the following new text and note: g) liberated gases (including the non-intentional escape of toxic gas), pathogenic substances, explosion and implosion (see Clause 13). NOTE Attention is drawn to the existence of additional requirements which may be s
24、pecified by national authorities responsible for the health and safety of labour forces. In particular, national and other regulations or codes apply for the safety of automatic loading and unloading systems. 1.2.2 Aspects excluded from scope Add the following two new items: aa) special requirements
25、 for protection against chemical and high-risk micro-biological HAZARDS associated with the LOAD; bb) general requirements for the design of calorifiers, shell boilers and PRESSURE VESSELS. NOTE National and other regulations or codes apply for the safety of calorifiers, shell boilers and PRESSURE V
26、ESSELS. 2 Normative references This clause of Part 1 is applicable except as follows: Additions: IEC 60079 (all parts), Electrical apparatus for explosive gas atmospheres IEC 61770, Electrical appliances connected to the water MAINS Avoidance of back-siphonage and failure of hose-sets ISO 3585, Boro
27、silicate glass 3.3 Properties ISO 6718, Bursting discs and bursting disc devices 3 Terms and definitions This clause of Part 1 is applicable except as follows: Addition: 3.2.101 CHAMBER the part of the equipment which receives the LOAD 3.2.102 LOAD equipment or materials put into a CHAMBER to be pro
28、cessed through an OPERATING CYCLE EN 61010-2-040:2005 6 3.2.103 STERILIZER equipment designed to achieve sterilization and which can also be used to deliver a sub-lethal process for the treatment of materials 3.2.104 PRESSURE VESSEL assembly comprising the jacket (if fitted), doors, and all other co
29、mponents in permanent open connection with the CHAMBER NOTE The PRESSURE VESSEL does not include parts from which it can be isolated, such as steam generators, pipework, and fittings. 3.2.105 OPERATING CYCLE the complete set of stages of the process that is carried out, in a specified sequence NOTE
30、Loading and unloading are not part of the OPERATING CYCLE. 3.5.2 HAZARD Add the following new note: NOTE In the context of this standard, the term HAZARD relates only to potential sources of harm to the OPERATOR and surroundings (see 1.2.1), and does not include potential sources of harm related to
31、the efficacy of the process. 4 Tests This clause of Part 1 is applicable except as follows: Additions: 4.3.2.3 Covers and removable parts Add the following new second paragraph: Covers which do not require the use of a TOOL for removal need not be removed if they have interlocks which meet the requi
32、rements of Clause 15, and which automatically de-activate all parts which would otherwise present a HAZARD when the cover is opened. 4.3.2.11 Duty cycle Add the following new second paragraph: Equipment which can be operated continuously shall also be tested without any interval between consecutive
33、OPERATING CYCLES. Add the following new subclause 4.3.2.101 Non-electrical supplies and systems These shall be set to the least favourable RATED values. 7 EN 61010-2-040:2005 4.4.2.4 Motors Add the following new second paragraph: If it is impracticable to test a motor in place, a separate identical
34、motor shall be tested. 4.4.2.10 Heating devices Add the following new item: aa) loss of feed-water shall be simulated. 4.4.2.12 Interlocks Add the following new third paragraph: If an interlock provides protection against accidental contact with a toxic substance, it is tested using a non-toxic subs
35、tance. Add the following three new subclauses: 4.4.2.101 Pressure controllers Pressure controllers, except for overpressure safety devices meeting the requirements of 11.7.4, shall be overridden to supply the system continuously. 4.4.2.102 Failure, or partial failure, of the MAINS supply The equipme
36、nt shall be operated at 90 % and 110 % of the RATED voltage for one cycle. The voltage shall then be set to 90 % of the RATED voltage for 5 min. The voltage shall then be reduced gradually at a rate of approximately 10 V per minute until the equipment fails to operate normally. The voltage shall the
37、n be reset to the RATED voltage with the equipment still switched on. 4.4.2.103 Failure, or partial failure, of other supplies and services In turn, each non-electrical supply and service shall be interrupted, or partially interrupted, whichever is less favourable. NOTE Examples include air, steam,
38、sterilant gas, detergent, disinfectant, and systems for drainage, exhaust, and ventilation. 5 Marking and documentation This clause of Part 1 is applicable except as follows: Add the following new subclause: 5.1.101 Overpressure safety device The device (see 11.7.4) shall be marked with the name of
39、the manufacturer, the model number, and the pressure to which it is set. If a bursting disc is located between the CHAMBER and the overpressure safety device, the disc shall be marked with its specified bursting pressure and associated temperature. EN 61010-2-040:2005 8 5.2 Warning markings Replace
40、the fifth paragraph by the following new paragraph: Warning markings are specified in 5.1.5.1 c), 5.4.3 r), 6.1.2 b), 6.5.1.2 g), 6.6.2, 7.2 c), 7.3, 7.102 b), 7.102c), 10.1, the third paragraph (the first new additional paragraph) of Clause 9, 13.2.2, and 14.103. 5.4.1 General Add the following two
41、 new items to the first paragraph, after item g): aa) if a PRESSURE VESSEL is an integral part of the equipment, a declaration that it complies with the PRESSURE VESSEL regulations and codes applicable in the country of intended use, as specified in 14.101; bb) if NORMAL USE involves the handling of
42、 hazardous substances, documentation shall include necessary information on its constituents. 5.4.2 Equipment ratings Add the following new item to the first paragraph, after item e): aa) for each non-electrical supply, the RATED ranges of pressure and flow-rate. 5.4.3 Equipment installation Replace
43、ment: Replace the text of the subclause by the following: Instructions shall include details of the following, if applicable: a) location and mounting instructions, including the space required for safe and efficient maintenance; b) individual weights of principal heavy subassemblies; c) overall wei
44、ght and floor loading requirements; d) assembly instructions; e) MAINS supply requirements and connections, including the temperature RATING of any cable required to meet 5.1.8; f) for PERMANENTLY CONNECTED EQUIPMENT, requirements for any external switch or circuit-breaker (see 6.11.2.1) and externa
45、l overcurrent protection devices (see 9.5.1) and a recommendation that the switch or circuit-breaker be near the equipment; g) ventilation and drainage requirements (see 11.101, 13.1.103.1 and Note 2 to 13.1.101.4); h) instructions for protective earthing; i) sound power data and requirements (see 1
46、2.5.1); j) requirements for special services, for example air, cooling liquid; k) requirements related to hazardous gas atmospheres (see 13.0); l) instructions to position the equipment so that it is not difficult to operate the disconnecting device; 9 EN 61010-2-040:2005 m) instructions relating to
47、 the handling and containment of hazardous substances, including any need for additional equipment that may be required to control emissions (see 11.101, 13.1.101.3. and the note to 13.1.104); n) a warning if a HAZARD could be caused by hot items falling from the equipment (see the third paragraph (
48、the first new paragraph) of Clause 9); o) requirements for material used in the installation of the STERILIZER which may come in contact with sterilant (see 13.1.103.4 and 13.2.101). Conformity is checked by inspection. Add the following new subclause: 5.4.3.101 Special systems Installation instruct
49、ions shall include details of the following special systems, if needed to protect against possible HAZARDS: a) non-recirculating ventilation system for the room in which the equipment is installed (also see 13.1.103.3); NOTE Such a ventilation system should normally give a minimum of 10 air changes per hour, but for large installations this may need to be increased. b) for equipment using toxic sterilant, means to protect against HAZARDS arising from failure of the room ventilation system (see 13.1.103.3); c) a non-recirculati
