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; 71.040.10g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58Licensed Copy: Wang Bin, na, Mon Sep 18 08:19:52 BST 2006, Uncontro
3、lled Copy, (c) BSIBS EN 61010-2-040:2005This British Standard was published under the 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 ident
4、ical with IEC 61010-2-040:2005. It supersedes BS EN 61010-2-041:1997, BS EN 61010-2-042:1997, BS EN 61010-2-043:1998 and BS EN 61010-2-045:2001 which are withdrawn.The UK participation in its preparation was entrusted to Technical Committee EPL/66, Safety of measuring, control and laboratory equipme
5、nt, which has the responsibility to: A list of organizations represented on this committee 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
6、 section entitled “International Standards Correspondence Index”, or by using the “Search” 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 applicatio
7、n. Compliance with a British Standard does not of itself confer immunity from legal obligations. 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 rel
8、ated international and European developments and promulgate them in the UK.Summary of 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 docu
9、ment was last issued.Amendments issued since publicationAmd. No. Date CommentsLicensed Copy: Wang Bin, na, Mon Sep 18 08:19:52 BST 2006, Uncontrolled Copy, (c) BSIEUROPEAN STANDARD EN 61010-2-040 NORME EUROPENNE EUROPISCHE NORM July 2005 CENELEC European Committee for Electrotechnical Standardizatio
10、n Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B - 1050 Brussels 2005 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 61010-2-040:2005 E
11、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 defined in Clause 3: SMALL ROMAN CAPITALS; 2) subclauses, figures, tables and notes which are additional to those in Part 1 are numb
12、ered 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 standard or by endorsement (dop) 2006-03-01 latest date by which the national standards conflicting with the EN have to be withdrawn (do
13、w) 2008-06-01 Annex ZA has been added by CENELEC. _ Licensed Copy: Wang Bin, na, Mon Sep 18 08:19:52 BST 2006, Uncontrolled Copy, (c) BSI 3 EN 61010-2-040:2005 CONTENTS 1 Scope and object4 2 Normative references .5 3 Terms and definitions .5 4 Tests6 5 Marking and documentation 7 6 Protection agains
14、t 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 Equipment temperature limits and resistance to hea
15、t.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 interlocks 29 16 Test and measurement equipment
16、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 Bibliography .31 Licensed Copy: Wang Bin, na
17、, Mon Sep 18 08:19:52 BST 2006, Uncontrolled Copy, (c) BSIEN 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
18、 clause of Part 1 is applicable except as 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 a
19、nd laboratory fields, when used under the 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
20、d) washer disinfectors. 1.1.2 Equipment excluded 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 it
21、s manufacturer to be used in the diagnosis, 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 a
22、lso does not apply to the following types 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
23、for the heating of materials for other purposes 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). Licensed
24、Copy: Wang Bin, na, Mon Sep 18 08:19:52 BST 2006, Uncontrolled Copy, (c) BSI 5 EN 61010-2-040:2005 1.2.1 Aspects included in scope 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 substanc
25、es, explosion and implosion (see Clause 13). NOTE Attention is drawn to the existence of additional requirements which may be specified 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 autom
26、atic loading and unloading systems. 1.2.2 Aspects excluded from scope Add the following two new items: aa) special requirements 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 P
27、RESSURE VESSELS. NOTE National and other regulations or codes apply for the safety of calorifiers, shell boilers and PRESSURE VESSELS. 2 Normative references This clause of Part 1 is applicable except as follows: Additions: IEC 60079 (all parts), Electrical apparatus for explosive gas atmospheres IE
28、C 61770, Electrical appliances connected to the water MAINS Avoidance of back-siphonage and failure of hose-sets ISO 3585, Borosilicate 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
29、.101 CHAMBER the part of the equipment which receives the LOAD 3.2.102 LOAD equipment or materials put into a CHAMBER to be processed through an OPERATING CYCLE Licensed Copy: Wang Bin, na, Mon Sep 18 08:19:52 BST 2006, Uncontrolled Copy, (c) BSIEN 61010-2-040:2005 6 3.2.103 STERILIZER equipment des
30、igned 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 components in permanent open connection with the CHAMBER NOTE The PRESSURE VESSEL does not
31、 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 Loading and unloading are not part of the OPERATING CYCLE. 3.5.2 HAZARD Add the followin
32、g 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 the efficacy of the process. 4 Tests This clause of Part 1 is applicable except as follo
33、ws: 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 requirements of Clause 15, and which automatically de-activate all parts which would otherwis
34、e 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 OPERATING CYCLES. Add the following new subclause 4.3.2.101 Non-electrical supplies and
35、systems These shall be set to the least favourable RATED values. Licensed Copy: Wang Bin, na, Mon Sep 18 08:19:52 BST 2006, Uncontrolled Copy, (c) BSI 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 mo
36、tor 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 substa
37、nce. 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 equipment
38、 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 then
39、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, st
40、erilant 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 th
41、e 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. Licensed Copy: Wang Bin, na, Mon Sep 18 08:19:52 BST
42、2006, Uncontrolled Copy, (c) BSIEN 61010-2-040:2005 8 5.2 Warning markings Replace 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 additio
43、nal paragraph) of Clause 9, 13.2.2, and 14.103. 5.4.1 General Add the following two 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
44、of intended use, as specified in 14.101; bb) if NORMAL USE involves the handling of 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 suppl
45、y, the RATED ranges of pressure and flow-rate. 5.4.3 Equipment installation Replacement: 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
46、maintenance; b) individual weights of principal heavy subassemblies; c) overall weight 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,
47、 requirements for any external switch or circuit-breaker (see 6.11.2.1) and external 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
48、) instructions for protective earthing; i) sound power data and requirements (see 12.5.1); 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
49、operate the disconnecting device; Licensed Copy: Wang Bin, na, Mon Sep 18 08:19:52 BST 2006, Uncontrolled Copy, (c) BSI 9 EN 61010-2-040:2005 m) instructions relating to 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 (the first new paragraph) of Clause 9); o) requirements for material
