IEC 61010-2-101-2002 Particular requirements for in vitro diagnostic (IVD) medical equipment.pdf

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1、NORMEINTERNATIONALECEIIECINTERNATIONALSTANDARD61010-2-101Premire ditionFirst edition2002-01Rgles de scurit pour appareils lectriquesde mesurage, de rgulation et de laboratoire Partie 2-101:Prescriptions particulires pour les appareilsmdicaux de diagnostic in vitro (DIV)Safety requirements for electr

2、ical equipmentfor measurement, control and laboratory use Part 2-101:Particular requirements for in vitro diagnostic(IVD) medical equipmentNumro de rfrenceReference numberCEI/IEC 61010-2-101:2002PUBLICATION GROUPE DE SCURITGROUPED SAFETY PUBLICATION61010-2-101 IEC:2002 3 CONTENTSFOREWORD.51 Scope an

3、d object.92 Normative references .113 Terms and definitions .114 Tests .135MARKING and documentation.156 Protection against electric shock .237 Protection against mechanical HAZARDS.238 Mechanical resistance to shock and impact .239 Protection against the spread of fire .2510 Equipment temperature l

4、imits and resistance to heat.2511 Protection against HAZARDS from fluids .2512 Protection against radiation, including laser sources, and against sonic andultrasonic pressure .2513 Protection against liberated gases, explosion and implosion.2714 Components .2715 Protection by interlocks .2716 Measur

5、ing circuits .27Annex H Index of defined terms.29Annex AA (normative) Risk management .31Annex BB (normative) Instructions for use for self-test IVD medical equipment.35Bibliography.4361010-2-101 IEC:2002 5 INTERNATIONAL ELECTROTECHNICAL COMMISSION_SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FORMEA

6、SUREMENT, CONTROL AND LABORATORY USE Part 2-101: Particular requirements for in vitro diagnostic (IVD)medical equipmentFOREWORD1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprisingall national electrotechnical committees (IEC National Commi

7、ttees). The object of the IEC is to promoteinternational co-operation on all questions concerning standardization in the electrical and electronic fields. Tothis end and in addition to other activities, the IEC publishes International Standards. Their preparation isentrusted to technical committees;

8、 any IEC National Committee interested in the subject dealt with mayparticipate in this preparatory work. International, governmental and non-governmental organizations liaisingwith the IEC also participate in this preparation. The IEC collaborates closely with the InternationalOrganization for Stan

9、dardization (ISO) in accordance with conditions determined by agreement between thetwo organizations.2) The formal decisions or agreements of the IEC on technical matters express, as nearly as possible, aninternational consensus of opinion on the relevant subjects since each technical committee has

10、representationfrom all interested National Committees.3) The documents produced have the form of recommendations for international use and are published in the formof standards, technical specifications, technical reports or guides and they are accepted by the NationalCommittees in that sense.4) In

11、order to promote international unification, IEC National Committees undertake to apply IEC InternationalStandards transparently to the maximum extent possible in their national and regional standards. Anydivergence between the IEC Standard and the corresponding national or regional standard shall be

12、 clearlyindicated in the latter.5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for anyequipment declared to be in conformity with one of its standards.6) Attention is drawn to the possibility that some of the elements of this International Standa

13、rd may be the subjectof patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.International Standard IEC 61010-2-101 has been prepared by IEC technical committee 66:Safety of measuring, control and laboratory equipment.This standard has been prepared in c

14、lose collaboration with Working Group CENELECBTTF 88.1.It has the status of a group safety function, as specified in IEC Guide 104.The text of this standard is based on the following documents:FDIS Report on voting66/261/FDIS 66/271/RVDFull information on the voting for the approval of this standard

15、 can be found in the report onvoting indicated in the above table.This publication has been drafted in accordance with the ISO/IEC Directives, Part 3.This part 2 is intended to be used in conjunction with IEC 61010-1. It was established on thebasis of the second edition (2001). Consideration may be

16、given to future editions of, oramendments to, IEC 61010-1.61010-2-101 IEC:2002 7 This part 2 supplements or modifies the corresponding clauses in IEC 61010-1 so as toconvert that publication into the IEC standard: Safety requirements for in vitro diagnostic(IVD) medical equipment.Where a particular

17、subclause of part 1 is not mentioned in this part 2, that subclause appliesas far as is reasonable. Where this part states “addition”, “modification”, “replacement”, or“deletion” the relevant requirement, test specification or note in part 1 should be adaptedaccordingly.In this standard:1) the follo

18、wing print types are used: requirements: in roman type; NOTES: in smaller roman type; conformity and test: in italic type; terms used throughout this standard which have been defined in clause 3: SMALLROMAN CAPITALS;2) subclauses or figures which are additional to those in part 1 are numbered starti

19、ng from101; the additional annexes are lettered AA and BB.Annexes AA and BB form integral parts of this standard.The committee has decided that the contents of this publication remain valid until 2004-12. Atthis date, in accordance with the committees decision, the publication will be: reconfirmed;

20、withdrawn; replaced by a revised edition, or amended.61010-2-101 IEC:2002 9 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FORMEASUREMENT, CONTROL AND LABORATORY USE Part 2-101: Particular requirements for in vitro diagnostic (IVD)medical equipment1 Scope and objectThis clause of part 1 is applicable

21、except as follows:1.1 ScopeReplacement:This part 2 applies to equipment intended for in vitro diagnostic (IVD) medical purposes,including self-test IVD medical purposes.IVD medical equipment, whether used alone or in combination, is intended by themanufacturer to be used in vitro for the examination

22、 of specimens, including blood and tissuesamples, derived from the human body, solely or principally for the purpose of providinginformation concerning one or more of the following: a physiological or pathological state; or a congenital abnormality; the determination of safety and compatibility with

23、 potential recipients; the monitoring of therapeutic measures.Self-test IVD medical equipment is intended by the manufacturer for use by lay persons in ahome environment.NOTE If all or part of the equipment falls within the scope of one or more other part 2 standards of IEC 61010 aswell as within th

24、e scope of this standard, it will also need to meet the requirements of those other part 2 standards.1.1.2 Equipment excluded from scopeAddition:Add the following second paragraph:Products for general laboratory use are not IVD medical devices unless such products, inview of their characteristics, a

25、re specifically intended by their manufacturer to be used for invitro diagnostic examination.61010-2-101 IEC:2002 11 1.2 Object1.2.1 Aspects included in scopeReplacement:Replace the first sentence by the following:The purpose of the requirements of this standard is to ensure that the design and them

26、ethods of construction used provide a high degree of protection at a TOLERABLE RISK forthe OPERATOR and the surrounding area, using RISK management where appropriate (seeannex AA).Addition:Add two new items:h) biohazards;i) hazardous chemical substances.1.2.2 Aspects excluded from scopeAddition:Add

27、a new item and the following note:g) the handling or manipulation outside the equipment of material under analysis.NOTE Requirements covering these subjects are the responsibility of committees preparing relevant standards.2 Normative referencesThis clause of part 1 is applicable except as follows:A

28、dditions:ISO 14971:2000, Medical devices Application of risk management to medical devices3 Terms and definitionsThis clause of part 1 is applicable except as follows:3.1 Equipment and states of equipmentAdditional definitions:3.101HARMphysical injury or damage to the health of people, or damage to

29、property or the environmentISO/IEC Guide 51:1999, definition 3.361010-2-101 IEC:2002 13 3.102RISKcombination of the probability of occurrence of HARM and the severity of that HARMISO/IEC Guide 51:1999, definition 3.23.103TOLERABLE RISKRISK which is accepted in a given context based on the current va

30、lues of societyISO/IEC Guide 51:1999, definition 3.7NOTE 1 TOLERABLE RISK is the result of a balance between the ideal of absolute safety, the demands to be met bya product, process or service, and factors such as benefit to the user, suitability of purpose, cost effectiveness,RISK evaluation, conve

31、ntions of the society concerned, and the state of the art.NOTE 2 The term “acceptable risk” is used in ISO 14971 in the same sense as TOLERABLE RISK.3.104REASONABLY FORESEEABLE MISUSEuse of a product, process or service in a way not intended by the supplier, but which mayresult from readily predicta

32、ble human behaviourISO/IEC Guide 51:1999, definition 3.143.105PERMANENTLY AFFIXEDremovable only with a TOOL or by appreciable force and able to withstand the effects oftemperature, rubbing, common solvents, reagents and vapours encountered during normaluse3.106MARKINGinscription, in writing or as a

33、graphical symbol, PERMANENTLY AFFIXED to a product4 TestsThis clause of part 1 is applicable except as follows:4.4.1 GeneralReplacement:Replace item a) of the first paragraph by:a) Equipment and circuit diagrams shall be examined to determine the fault con-ditions which could arise in NORMAL USE and

34、 REASONABLY FORESEEABLE MISUSE,and which could cause a HAZARD.Deletion:Delete the first dash.61010-2-101 IEC:2002 15 Addition:Additional subclause:4.4.2.101 Incorrect voltage selectionMultivoltage equipment that can be set by the OPERATOR to different supply voltages shall beset to each voltage in t

35、urn and then connected to all other RATED supply voltages in turn.5 MARKING and documentationThis clause of part 1 is applicable except as follows:5.1.1 GeneralReplacement:Replace the third paragraph by the following:Letter symbols for quantities and units shall be in accordance with IEC 60027. Inte

36、rnationallyrecognized symbols, including those of Table 1, shall be used as far as possible. If otheradditional symbols are required, it shall not be possible to confuse them with theinternationally recognized symbols. There are no colour requirements for symbols, except forsymbol 101 (see table 1).

37、 Graphic symbols shall be explained in the documentation.Table 1 SymbolsAddition:Add the following new symbols:Number Symbol Publication Description101Background colour yellow;symbol and outline black.ISO 7000 0659 Biohazard102LOTEN 980, subclause 4 Batch code5.1.2 IdentificationReplacement:Equipmen

38、t shall, as a minimum, be marked with the following information:a) manufacturers name or trade mark, and the address. The address shall include at leastthe city and country;b) model number, name, or other means of identifying the equipment;c) where this is required by regulation, the name and addres

39、s of the authorized represen-tative of the manufacturer;NOTE For example, in the EU this is the natural or legal person as established within the EC.61010-2-101 IEC:2002 17 The following additional information shall be marked on the equipment or packaging or inthe instructions for use:1) the serial-

40、number, for example SN XXXX or alternatively the batch code, preceded byLOT, using symbol 102 of Table 1;2) the following information:i) a clear indication that the equipment is IVD medical equipment;ii) if applicable, a clear indication that the equipment is self-test IVD medicalequipment;iii) if a

41、 potential RISK is posed, the identification of detachable components bymanufacturer and part identification, and where appropriate the batch code, etc.iv) any expiry date of consumable parts, expressed as the year, the month and (whererelevant) the day, in that order.Addition:Additional subclause:5

42、.1.101 Transport and storagePackaging shall be labelled to indicate any special conditions for transport or storage.Conformity is checked by inspection.5.2 Warning MARKINGSReplacement:Replace the fifth paragraph by the following four paragraphs:Equipment that can be potentially infectious due to the

43、 samples or reagents used shall beprominently marked with symbol 101 of Table 1.Equipment that can be hazardous due to the use of chemical substances shall be marked withthe appropriate symbol, or (if none is available) symbol 14 of Table 1.Containers or bags for biohazardous waste material which can be removed from theequipment during NORMAL USE shall be marked with symbol 101 of Table 1.Other warning ma