EN 61010-2-081-2015 en Safety requirements for electrical equipment for measurement control and laboratory use - Part 2-081 Particular requirements for automatic and semi-automatic.pdf

1、BSI Standards PublicationSafety requirements for electrical equipment for measurement, control and laboratory usePart 2-081: Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposesBS EN 61010-2-081:2015National forewordThis British Standard is th

2、e UK implementation of EN 61010-2-081:2015. It is identical to IEC 61010-2-081:2015. It supersedes BS EN 61010-2-081:2002which will be withdrawn on 27 February 2018.The UK participation in its preparation was entrusted to TechnicalCommittee EPL/66, Safety of measuring, control and laboratory equipme

3、nt.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisions ofa contract. Users are responsible for its correct application. The British Standards Institution 2015.Published by BSI Stand

4、ards Limited 2015ISBN 978 0 580 79881 8ICS 19.080; 71.040.10Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 April 2015.Amendments/corrigenda issued since public

5、ationDate Text affectedBRITISH STANDARDBS EN 61010-2-081:2015EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 61010-2-081 March 2015 ICS 19.080; 71.040.10 Supersedes EN 61010-2-081:2002 English Version Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2

6、-081: Particular requirementsfor automatic and semi-automatic laboratory equipment foranalysis and other purposes (IEC 61010-2-081:2015) Rgles de scurit pour appareils lectriques de mesurage, de rgulation et de laboratoire - Partie 2-081: Exigences particulires pour les appareils de laboratoire, aut

7、omatiqueset semi-automatiques, destins lanalyse et autres usages(IEC 61010-2-081:2015) Sicherheitsbestimmungen fr elektrische Mess-, Steuer-,Regel- und Laborgerte - Teil 2-081: BesondereAnforderungen an automatische und semiautomatische Laborgerte fr Analysen und andere Zwecke (IEC 61010-2-081:2015)

8、 This European Standard was approved by CENELEC on 2015-02-27. CENELEC 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

9、references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CENELEC member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility

10、 of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, Former

11、 Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. European Committee for Electrotechnical

12、Standardization Comit Europen de Normalisation ElectrotechniqueEuropisches Komitee fr Elektrotechnische Normung CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members. Ref. No. EN 61

13、010-2-081:2015 E EN 61010-2-081:2015 - 2 - Foreword The text of document 66/544/FDIS, future edition 2 of IEC 61010-2-081, prepared by IEC/TC 66 “Safety of measuring, control and laboratory equipment“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 61010-2-081:2015. The

14、following dates are fixed: latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2015-11-27 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2018-02-27 Thi

15、s document supersedes EN 61010-2-081:2002. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC and/or CEN shall not be held responsible for identifying any or all such patent rights. This standard covers the Principle Elements

16、 of the Safety Objectives for Electrical Equipment Designed for Use within Certain Voltage Limits (LVD - 2006/95/EC). Endorsement notice The text of the International Standard IEC 61010-2-081:2015 was approved by CENELEC as a European Standard without any modification. BS EN 61010-2-081:2015- 3 - EN

17、 61010-2-081:2015 Annex ZA (normative) Normative references to international publications with their corresponding European publications Annex ZA of EN 61010-1:2010 applies. BS EN 61010-2-081:2015 2 IEC 61010-2-081:2015 IEC 2015 CONTENTS 1 Scope and object . 6 2 Normative references. 7 3 Terms and d

18、efinitions 7 4 Tests . 7 5 Marking and documentation . 7 6 Protection against electric shock 9 7 Protection against mechanical HAZARDS 9 8 Resistance to mechanical stresses . 9 9 Protection against the spread of fire . 9 10 Equipment temperature limits and resistance to heat 10 11 Protection against

19、 hazards from fluids 10 12 Protection against radiation, including laser sources, and against sonic and ultrasonic pressure 10 13 Protection against liberated gases and substances, explosion and implosion 10 14 Components and subassemblies 10 15 Protection by interlocks 10 16 HAZARDS resulting from

20、application. 11 17 RISK assessment . 11 Annexes . 11 Bibliography . 11 Table 1 Symbols 7 BS EN 61010-2-081:2015 6 IEC 61010-2-081:2015 IEC 2015 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE Part 2-081: Particular requirements for automatic and semi-automat

21、ic laboratory equipment for analysis and other purposes 1 Scope and object This clause of part 1 is applicable except as follows: 1.1.1 Equipment included in scope Replacement: Replace the text by the following: This part of IEC 61010 applies to automatic and semi-automatic laboratory equipment for

22、analysis and other purposes. Automatic and semi-automatic laboratory equipment consists of instruments or systems for measuring or modifying one or more characteristics or parameters of samples, performing the complete process or parts of the process without manual intervention. Equipment forming pa

23、rt of such a system is within the scope of this standard. Examples of equipment within the scope of this standard include: analytical equipment; automatic sampler (pipettor, aliquoter); equipment for sample replication and amplification. NOTE 1 In the case of analytical equipment the complete proces

24、s usually includes the following steps: taking a specific quantity of the sample; preparing the sample by chemical, thermal, mechanical or other means; measurement; display, transmission or printing of the results of measurement. NOTE 2 If all or part of the equipment falls within the scope of one o

25、r more other part 2 standards of IEC 61010 as well as within the scope of this standard, considerations have to be given to those other part 2 standards. 1.1.2 Equipment excluded from scope Addition: Add the following item: aa) IEC 61010-2-101 (IVD Equipment) 1.2 Object 1.2.1 Aspects included in sco

26、pe Addition: Add the following items: BS EN 61010-2-081:2015IEC 61010-2-081:2015 IEC 2015 7 aa) biohazards; bb) hazardous chemical substances. 1.2.2 Aspects excluded from scope Addition: Add the following item and note: aa) handling or manipulation of material outside the equipment. NOTE Requirement

27、s covering these subjects are the responsibility of committees preparing the relevant standards. 2 Normative references This clause of Part 1 is applicable. 3 Terms and definitions This clause of Part 1 is applicable 4 Tests This clause of Part 1 is applicable. 5 Marking and documentation This claus

28、e of Part 1 is applicable except as follows: Table 1 Symbols Additions: Add the following symbol to Table 1: Number Symbol Publication Description 101 Background colour optional; Symbol colour optional; Outline / outline colour optional; ISO 7000-0659 (2004-01) Biological risks Add the following sub

29、clause: 5.1.5.101 Gas and liquid connections If necessary for safety, the equipment shall be clearly marked near to the connector on the equipment with a) a means of identifying the gas or liquid to be used. Where no internationally recognized symbol (including chemical formulae) exists, the equipme

30、nt shall be marked with symbol 14 of Table 1; BS EN 61010-2-081:2015 8 IEC 61010-2-081:2015 IEC 2015 b) the maximum permitted pressure, or alternatively symbol 14 of Table 1 (see 5.4.3); c) flow direction of the gas and liquid, if applicable. Conformity is checked by inspection. 5.2 Warning markings

31、 Replacement: Replace the first paragraph by the following: Warning markings specified in 5.1.5.1, 5.1.5.2 c), 5.1.5.101, 6.1.2 b), 7.3.2 b) 3), 7.4, 10.1, 13.2.2 and 13.101 shall meet the following requirements. 5.3 Durability of markings Replacement: Replace the first paragraph by the following pa

32、ragraph: Markings required by 5.1.2 to 5.2 shall be removable only with a TOOL or by appreciable force and shall remain clear and legible under conditions of NORMAL USE, and resist the effects of temperature and rubbing, and of solvent and reagents likely to be encountered in NORMAL USE, including c

33、leaning and decontaminating agents specified by the manufacturer. Addition: Add the following paragraph after the second paragraph: If a solvent or reagent specified for use with the equipment could affect the durability of particular marking, that marking is also rubbed for 30 s with the most frequ

34、ently used and/or aggressive solvent or reagent to which the equipment is likely to be exposed in NORMAL USE. A representative sample of groups of solvents or reagents likely to have a similar effect can optionally be used. 5.4.1 General Deletion: Delete note 2 in the second paragraph. 5.4.4 Equipme

35、nt operation Replacement: Replace the text in item h) by the following item h) and note: h) a statement listing any potentially poisonous or injurious gases or substances that can be liberated from the equipment, and possible quantities; NOTE Manufacturers can find valuable details in the internatio

36、nally recognized Laboratory Biosafety Manual, published by the World Health Organization. This gives information on decontaminants, their use, dilutions and potential applications. There are also national guidelines that cover these areas. Addition: Add the following subclauses: BS EN 61010-2-081:20

37、15IEC 61010-2-081:2015 IEC 2015 9 5.4.101 Removal of equipment from use for repair or disposal Instructions shall be provided for the RESPONSIBLE BODY for eliminating or reducing HAZARDS involved in removal from use, transportation or disposal, or appropriate contact information shall be provided in

38、 the instructions. NOTE Regional or international requirements can apply. Conformity is checked by inspection of the documentation. 6 Protection against electric shock This clause of Part 1 is applicable. 7 Protection against mechanical HAZARDS This clause of Part 1 is applicable except as follows:

39、7.3.2 Exceptions Replacement: Replace the text in item b) 3) by the following: there are warning markings prohibiting access by untrained OPERATORS. Markings shall be placed within the area requiring maintenance where they can alert the OPERATOR to the HAZARD. As an alternative, symbol 14 of Table 1

40、 can be used, with the warnings included in the documentation. Addition: Add the following item: b) 4) There are OPERATOR maintenance instructions that specify safe maintenance procedures. 8 Resistance to mechanical stresses This clause of Part 1 is applicable except as follows: 8.1 General Replacem

41、ent: Replace the text of item 3) by the following: 3) except for FIXED EQUIPMENT, for equipment with a mass over 100 kg, or for equipment whose size and weight make unintentional movement unlikely and which is not moved in NORMAL USE, the appropriate test of 8.3. The equipment is not operated during

42、 the tests. 9 Protection against the spread of fire This clause of Part 1 is applicable. BS EN 61010-2-081:2015 10 IEC 61010-2-081:2015 IEC 2015 10 Equipment temperature limits and resistance to heat This clause of Part 1 is applicable. 11 Protection against HAZARDS from fluids This clause of Part 1

43、 is applicable: 12 Protection against radiation, including laser sources, and against sonic and ultrasonic pressure This clause of Part 1 is applicable. 13 Protection against liberated gases and substances, explosion and implosion This clause of Part 1 is applicable except as follows Addition: Add t

44、he following subclause: 13.101 Biohazardous substances Equipment that can be potentially biohazardous due to the use of biohazardous substances shall be prominently marked with symbol 101 of Table 1, or the appropriate international symbol, or (if none is available) symbol 14 of Table 1. At minimum,

45、 a biohazard symbol shall be near the sampling area and visible in NORMAL USE. Biohazard symbols shall be near biohazardous areas accessed during OPERATOR maintenance visible only during this maintenance. Any part of the equipment that contains biohazardous waste material which can be removed from t

46、he equipment during NORMAL USE or a biohazardous drain connection shall be marked with an appropriate biohazard symbol. 14 Components and subassemblies This clause of Part 1 is applicable. 15 Protection by interlocks This clause of Part 1 is applicable except as follows. 15.1 General Addition: Add t

47、he following text after the first sentence As an alternative method, for interlock systems containing electric/electronic or programmable components (E/E/P components) the reliability and design requirements can be determined by BS EN 61010-2-081:2015IEC 61010-2-081:2015 IEC 2015 11 applying e.g. IE

48、C 62061 (SIL) or ISO 13849 (PL) or other solutions providing equivalent functional safety. 16 HAZARDS resulting from application This clause of Part 1 is applicable. 17 RISK assessment This clause of Part 1 is applicable. Annexes The annexes of Part 1 are applicable. Bibliography Addition: Add the f

49、ollowing reference: World Health Organization, Laboratory biosafety manual _ BS EN 61010-2-081:2015This page deliberately left blankBSI is the national body responsible for preparing British Standards and other standards-related publications, information and services.BSI is incorporated by Royal Charter. British Standards and other standardization products are published by BSI Standards Limited.British Standards Institution (BSI)BSI Group Headquarters389 Chiswick High Road Lon