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1、TR 61010-3-043 O IEC:2001(E) - 3 - Committee draft INTERNAT I O NAL E LECTROTEC H N I CAL COM M ISS I ON Report on voting SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - Part 3-043: Conformity verification report for IEC 61 O 1 O-2-043:1997- Particular req
2、uirements for dry heat sterilizers using either hot air or hot inert gas for treatment of medical materials and for laboratory processes FOREWORD 1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising all national electrotechnical committees
3、 (IEC National Committees). The object of the IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, the IEC publishes International Standards. Their preparation is entrusted t
4、o technical committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation. The IEC collaborates closely with the Internati
5、onal Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisions or agreements of the IEC on technical matters express, as nearly as possible, an international consensus of opinion on the relevant subjects since
6、each technical committee has representation from all interested National Committees. 3) The documents produced have the form of recommendations for international use and are published in the form of standards, technical specifications, technical reports or guides and they are accepted by the Nationa
7、l Committees in that sense. 4) In order to promote international unification, IEC National Committees undertake to apply IEC International Standards transparently to the maximum extent possible in their national and regional standards. Any divergence between the IEC Standard and the corresponding na
8、tional or regional standard shall be clearly indicated in the latter. 5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any equipment declared to be in conformity with one of its standards. 6) Attention is drawn to the possibility that some of t
9、he elements of this International Standard may be the subject of patent rights. The IEC shall not be held responsible for identifying any or all such patent rights. The main task of IEC technical committees is to prepare International Standards. However, a technical committee may propose the publica
10、tion of a technical report when it has collected data of a different kind from that which is normally published as an International Standard, for example “state of the art“. Technical reports do not necessarily have to be reviewed until the data they provide are considered to be no longer valid or u
11、seful. IEC 61010-3-043, which is a technical report, has been prepared by IEC technical com- mittee 66: Safety of measuring, control, and laboratory equipment. I 661223lCDV I 661230lRVC I Full information on the voting for the approval of this technical report can be found in the report on voting in
12、dicated in the above table. Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/09/2007 07:02:45 MSTNo reproduction or networking permitted without license from IHS -,-,- - 4 - TR 61010-3-04
13、3 O IEC:2001(E) This publication has been drafted in accordance with the ISO/IEC Directives, Part 3. This report is a Technical Report and is of a purely informative nature and is therefore by itself not to be regarded as an International Standard. It is for use by test houses and other users to ass
14、ist them with determining and recording verification of conformity of the equipment under test with the requirements of: IEC 61010-2-043: 1997 and IEC 61010-1:1990 + amendment 1:1992 + amendment 2:1995 The protocol for completion of this report is contained in publication IEC 61010-3:1997 The IEC se
15、lls read-only PDF files as a general rule. In the present instance, and quite exceptionally, to enable the user to fill in the forms, a revisable file is included in a pocket affixed to the back cover of this publication. This file can also be downloaded from the Web as a PDF file. There is, however
16、, at the end of the document, a revisable file containing the forms. Please use the zip/unzip function. A bilingual version will not be issued. A French version may be issued. The committee has decided that the contents of this publication will remain unchanged until 2004. At this date, the publicat
17、ion will be reconfirmed; withdrawn; amended. replaced by a revised edition, or Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/09/2007 07:02:45 MSTNo reproduction or networking permitted
18、 without license from IHS -,-,- TR 61010-3-043 O IEC:2001(E) -5- Conformity Verification Report Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-043: Particular requirements for dry heat sterilizers using either hot air or hot inert gas for treatment
19、 of medical materials. and for laboratorv Drocesses IEC 61010-2-043 Report reference No : Compiled by (+ signature) . : Approved by (+ signature) . : Date of issue .: Testing organization : Address . .: Testing location . : Applicant : Address .: Standard : IEC 61 010-2-04311997 and IEC 61010-1:1990
20、 + amendment 1:1992 + amendment 2:1995 Copyright blank test rep0 rt. : This report has been prepared by IECITC 66, which retains responsibility for any changes or corrections required. Test procedure . : Procedure deviation : Non-standard test method . : Type of item tested : 0 Laboratory Trademark
21、: Modelltype reference . .: Manufacturer . : Rating : Copy of rating plate: Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/09/2007 07:02:45 MSTNo reproduction or networking permitted wi
22、thout license from IHS -,-,- - 6 - TR 61010-3-043 O IEC:2001(E) Description of equipment function : INSTALLATION/OVERVOLTAGE CATEGORY: POLLUTION DEGREE: Environmental rating: u Standard Equipment mobility: uportable u Built in u Other (specify): UHand-held u Floorstanding u Fixed UBenchmounted UOthe
23、r (specify): Connection to mains supply: u Permanent UDetachable u Non-detachable u None Operating conditions: ucontinuous UShort-time u Intermittent Overall size of the equipment (Length x Width x Height): Mass of the equipment (kg): Marked degree of protection to IEC 60529: IP- - Accessories and d
24、etachable parts included in the evaluation: Options: NOTE “(see form A.X)“ refers to a form appended to the report. Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/09/2007 07:02:45 MSTNo
25、 reproduction or networking permitted without license from IHS -,-,- TR 61010-3-043 O IEC:2001(E) Document No - 7 - Document description Number of pages Table 1 - Documents attached to this report Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=IHS
26、Employees/1111111001, User=Wing, Bernie Not for Resale, 03/09/2007 07:02:45 MSTNo reproduction or networking permitted without license from IHS -,-,- -8- Table 2 - Test equipment list TR 61010-3-043 O IEC:2001(E) 1) or interval between calibrations. Copyright International Electrotechnical Commissio
27、n Provided by IHS under license with IECLicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/09/2007 07:02:45 MSTNo reproduction or networking permitted without license from IHS -,-,- TR 61010-3-043 O IEC:2001(E) h aa Q cn O E O W aa c b L b .- - t cn E aa E O c E O o O cn J I m a
28、a Q k b c .- z -9- Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/09/2007 07:02:45 MSTNo reproduction or networking permitted without license from IHS -,-,- - 10- Requirement Result TR
29、61010-3-043 O IEC:2001(E) Comments Clause Subclause I i.1.1 i.l.2 i.l.3 F I I General Required equipment markings are: a) visible: - from the exterior or - after removing a cover or - opening a door or - after removal from a rack or panel b) not put on parts which can be removed by an OPERATOR c) Le
30、tter symbols (IEC 60027) used d) Graphic symbols (EC 61010-1; Table 1) used Identification Equipment is identified by: - manufacturers name or registered I I or input current If more than one voltage range: - separate values marked or - values differ by less than 20 % (see Form A.3) d) OPERATOR - Se
31、t for different RATED supply voltages: - indicates the equipment set voltage - PORTABLE EQUIPMENT indication is visible from the exterior - indication changing the setting changes the trade mark - Mains supply Equipment is marked as follows: a) nature of supply: - frequencies - d.c. with symbol 1 b)
32、 RATED supply voltage(s) or range model number, name or other means a.c. RATED mains frequency or range of C) - maximum RATED power (w Or VA) Result: P = Pass F = Fail NA = Not Applicable Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=IHS Employees
33、/1111111001, User=Wing, Bernie Not for Resale, 03/09/2007 07:02:45 MSTNo reproduction or networking permitted without license from IHS -,-,- TR 61010-3-043 O IEC:2001(E) - 11 - Clause Subclause F i.l.4 i.l.5 i.l.6 5.1.7 2) Accessory mains socket-outlets accepting standard mains plugs are na rked : -
34、 with the voltage, if it is different from he mains supply voltage - for use only with specific equipment f not marked for specific equipment, it is narked with: - the maximum RATED current or power, md maximum permitted leakage current i r - symbol 14 with full details in the jocumentation The meas
35、ured value not more than 110 % (see Form A.3) Fuses PERATOR replaceable fuse marking (see also 5.4.5) Measuring circuit TERMINALS rERMiNALs and operating devices Where necessary for safety, indication of and indicators Mains supply TERMINALS identified Power supply switch on or off position marked i
36、f used as disconnecting device TERMINAL marking: a) FUNCTIONAL EARTH TERMINALS b) PROTECTIVE CONDUCTOR TERMINALS: - or - part of appliance inlet c) TERMINALS of measuring and control circuits symbol 6 is placed close to or on the TERM I NAL d) TERMINALS supplied from the interior e) ACCESSIBLE FUNCT
37、IONAL EARTH TERMINALS aa) NORMAL USE setting a control could cause a hazard, an indicating device is provided Equipment protected by DOUBLE INSULATION or REINFORCED INSULATION Protected throughout (symbol 11 used) Only partially protected (symbol 11 not used) Not applicable 71 I I purpose of TERMNAL
38、S, connectors, controls $ $ $ S B . . . . . . . . . . . . . . . . . . . . . li Result: P = Pass F = Fail NA = Not Applicable Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/09/2007 07:02
39、:45 MSTNo reproduction or networking permitted without license from IHS -,-,- - 12- - to warn against the charging of non- .echargeable batteries - to indicate the type of rechargeable iattery used Narning markings - visible when ready for NORMAL USE - if necessary, marked with symbol 14 - are near
40、or on applicable parts - statement to isolate or disconnect - advice how to avoid contact with 4CCESSIBLE HAZARDOUS LIVE parts - symbol 13) - - load type easily touched high temperature parts if lockable door, to lock and retain key TR 61010-3-043 O IEC:2001(E) instructions shall include a warning E
41、quipment operation Instructions include: a) operating controls: i) interconnection i) use b) positioned so that disconnection is difficult c) accessories: i) interconnection i) suitability individual weights of principle heavy iii) detachable parts and special materials I I Result: P = Pass F = Fail
42、 NA = Not Applicable Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/09/2007 07:02:45 MSTNo reproduction or networking permitted without license from IHS -,-,- - 14- TR 61010-3-043 O IEC
43、:2001(E) Clause Subclause 5.4.5 6 6.1 6.1.1 6.2 6.3 6.3.1 6.3.1.2 6.3.2 6.3.2.2 6.4 e) explanation of symbols used f) cleaning g) lockable door closure stop: - correct use - retain key h) safe use of override key i) action in case of malfunction Equipment maintenance Instructions include: i) mainten
44、ance on threaded parts ii) safety devices fitted - replacement of hoses, etc. - specific battery type - any manufacturer specified parts - Protection against electric shock (see Form A.5) General RATING and characteristics of fuses Conformity is checked by the determination of 6.2 and 6.3 followed b
45、y the tests of 6.4 to 6.12 Abestos is not used Exceptions CaDacitance test (see Forms A.6 and A.7) Determination of ACCESSIBLE parts (see Form A.6) Permissible limits for ACCESSIBLE parts Values in NORMAL CONDITION I I (see Form A.7) Levels Of PERMANENTLY CONNECTED equipment are 1.5 times the values
46、 (see Form A.7) Values in SINGLE FAULT CONDITION (see Form A.8) II Levels Of PERMANENTLY CONNECTED equipment are 1,5 times the values (see Form A.8) Protection in NORMAL CONDITION I I (see 6.8 and 8.1) Result: P = Pass F = Fail NA = Not Applicable Copyright International Electrotechnical Commission
47、Provided by IHS under license with IECLicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/09/2007 07:02:45 MSTNo reproduction or networking permitted without license from IHS -,-,- TR 61010-3-043 O IEC:2001(E) - 15- Clause Subclause 6.5 6.5.1 6.5.1.1 6.5.1.2 6.5.1.3 6.5.1.4 6.5.2
48、 6.5.3 6.5.4 6.6 6.6.1 Additional protection is provided by: - one or more of 6.5.1 to 6.5.3 or - automatic disconnection of the supply R Protective earthing ACCESSIBLE conductive parts: - bonded to the protective conductor terminal or - separated by screen or BARRIER from parts which are HAZARDOUS LIVE (For indirect bonding of measurement and test equipment, see 6.5.1.4