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1、BRITISH STANDARD BS EN 60601-2-2:2001 Medical electrical equipment Part 2-2: Particular requirements for the safety of high frequency surgical equipment The European Standard EN 60601-2-2:2000 has the status of a British Standard ICS 11.040.30 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY
2、 COPYRIGHT LAW BS EN 60601-2-2:2001 This British Standard, having been prepared under the direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 April 2001 BSI 04-2001 ISBN 0 580 37008 9 National foreword Thi
3、s British Standard is the official English language version of EN 60601-2-2:2000. It is identical with IEC 60601-2-2:1998. It supersedes BS EN 60601-2-2:1993 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/97, Electrosurgical equipment, which has t
4、he responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. From 1 January 1997, all IEC publications have the number 6000 added to the old number. For instance, IEC 27-1 has been renumbered as IEC 60027-1. For a period of time during the
5、change over from one numbering system to the other, publications may contain identifiers from both systems. Cross-references Attention is drawn to the fact that CEN and CENELEC Standards normally include an annex which lists normative references to international publications with their corresponding
6、 European publications. The British Standards which implement these international or European publications may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue.
7、 A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; pr
8、esent to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, a
9、n inside front cover, the EN title page, pages 2 to 41 and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments EUROPEAN STANDARDEN 60601-2-2 NORME EUROPENNE EUROPISCHE NORMNovember 2000
10、 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 2000 CENELEC -All rights of exploitation in any form and by any means reserved
11、worldwide for CENELEC members. Ref. No. EN 60601-2-2:2000 E ICS 11.040.30Supersedes EN 60601-2-2:1993 English version Medical electrical equipment Part 2-2: Particular requirements for the safety of high frequency surgical equipment (IEC 60601-2-2:1998) Appareils lectromdicaux Partie 2-2: Rgles part
12、iculires de scurit pour des appareils dlectrochirurgie courant haute frquence (CEI 60601-2-2:1998) Medizinische elektrische Gerte Teil 2-2: Besondere Festlegungen fr die Sicherheit von Hochfrequenz- Chirurgiegerten (IEC 60601-2-2:1998) This European Standard was approved by CENELEC on 2000-08-01. CE
13、NELEC 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 references concerning such national standards may be obtained on
14、 application to the Central Secretariat 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 of a CENELEC member into its own language and notified to the Central Sec
15、retariat has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and Unite
16、d Kingdom. Foreword The text of document 62D/291/FDIS, future edition 3 of IEC 60601-2-2, prepared by SC 62D, Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-2 on 2000-08-01. Th
17、is European Standard supersedes EN 60601-2-2:1993. 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) 2001-05-01 latest date by which the national standards conflicting with the E
18、N have to be withdrawn(dow) 2003-08-01 Annexes designated “normative“ are part of the body of the standard. Annexes designated “informative“ are given for information only. In this standard, annex ZA is normative and annexes AA and ZB are informative. Annexes ZA and ZB have been added by CENELEC. _
19、Endorsement notice The text of the International Standard IEC 60601-2-2:1998 was approved by CENELEC as a European Standard without any modification. _ Page 2 EN 6060122:2000 BSI 04-2001 CONTENTS Page INTRODUCTION .5 Clause SECTION ONE GENERAL 1Scope and object 6 2Terminology and definitions.7 3Gene
20、ral requirements8 4General requirements for tests 9 5Classification 9 6Identification, marking and documents.9 7Power input.12 SECTION TWO ENVIRONMENTAL CONDITIONS SECTION THREE PROTECTION AGAINST ELECTRICAL SHOCK HAZARDS 14Requirements related to classification .13 17Separation 13 18Protective eart
21、hing, functional earthing and potential equalization13 19Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS.13 20Dielectric strength.16 SECTION FOUR PROTECTION AGAINST MECHANICAL HAZARDS SECTION FIVE PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION 36Electromagnetic compatibil
22、ity17 SECTION SIX PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES 39Common requirements for CATEGORY AP and CATEGORY APG EQUIPMENT.18 Page 3 EN 6060122:2000 BSI 04-2001 SECTION SEVEN PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS 42Excessive temperatures
23、18 44Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfection and compatibility.18 46Human errors19 SECTION EIGHT ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT 50Accuracy of operating data20 51Protection against hazardous output21 SECTION
24、NINE ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS 52Abnormal operation and fault conditions 23 SECTION TEN CONSTRUCTIONAL REQUIREMENTS 56Components and general assembly.23 59Construction and layout.25 Figures 101 to 109 2832 Appendix L References Publications mentioned in this standa
25、rd33 Annex AA (informative) Guidance and rationale for particular clauses and subclauses .34 Annex ZA (normative) Normative references to international publications with their corresponding European publications 41 Annex ZB (informative) Other international publications mentioned in this standard wi
26、th the reference of the relevant European publications 41 Page 4 EN 6060122:2000 BSI 04-2001 INTRODUCTION The revisions for this third edition of the Particular Standard refer mainly to the following: Split NEUTRAL ELECTRODES are dealt with in more detail. Limitation of incorrect output power in SIN
27、GLE FAULT CONDITION. The requirements for AP EQUIPMENT are revised. White indicator lamps on coloured backgrounds for CUTTING and COAGULATION mode are no longer allowed. Limitation of monitoring current to 100 ?A for HF SURGICAL EQUIPMENT with BF or CF APPLIED PARTS. Revised requirements for CREEPAG
28、E DISTANCE and AIR CLEARANCE of APPLIED PARTS. Simultaneous activation of more than one PATIENT CIRCUIT is dealt with in more detail and a compliance test method is now defined. Page 5 EN 6060122:2000 BSI 04-2001 MEDICAL ELECTRICAL EQUIPMENT Part 2-2: Particular requirements for the safety of high f
29、requency surgical equipment SECTION ONE GENERAL The clauses and subclauses of this section of the General Standard apply except as follows: 1 Scope and object This clause of the General Standard applies except as follows: *1.1 Scope Addition: This Particular Standard specifies requirements for the s
30、afety of HIGH FREQUENCY SURGICAL EQUIPMENT used in medical practice, as defined in 2.1.101 and hereinafter referred to as HF SURGICAL EQUIPMENT. HF SURGICAL EQUIPMENT having a RATED OUTPUT POWER not exceeding 50 W (for example for micro-coagulation, or for use in dentistry or ophthalmology) is exemp
31、t from certain of the requirements of this Particular Standard. These exemptions are indicated in the relevant requirements. 1.2 Object Replacement: The object of this Particular Standard is to establish particular requirements for the safety of HF SURGICAL EQUIPMENT. 1.3 Particular Standards Additi
32、on: This Particular Standard amends and supplements a set of IEC publications consisting of IEC 60601-1:1988, Medical electrical equipment Part 1: General requirements for safety Amendment 1 (1991) Amendment 2 (1995) IEC 60601-1-1:1992, Medical electrical equipment Part 1: General requirements for s
33、afety 1: Collateral Standard: Safety requirements for medical electrical systems IEC 60601-1-2:1993, Medical electrical equipment Part 1: General requirements for safety 2: Collateral Standard: Electromagnetic compatibility Requirements and tests IEC 60601-1-4:1996, Medical electrical equipment Part
34、 1: General requirements for safety 4: Collateral Standard: Programmable electrical medical systems Page 6 EN 6060122:2000 BSI 04-2001 For brevity, IEC 60601-1 is referred to, in this Particular Standard, either as the “General Standard” or as the “General Requirement(s)”, IEC 60601-1-1, IEC 60601-1
35、-2, and IEC 60601-1-4 as the Collateral Standard(s). The term “this Standard“ covers the Particular Standard used together with the General Standard and any Collateral Standards. The numbering of sections, clauses and subclauses of this Particular Standard corresponds to that of the General Standard
36、. The changes to the text of the General Standard are specified by the use of the following words: “Replacement” means that the clause or subclause of the General Standard is replaced completely by the text of this Particular Standard. “Addition” means that the text of this Particular Standard is ad
37、ditional to the requirements of the General Standard. “Amendment” means that the clause or subclause of the General Standard is amended as indicated by the text of this Particular Standard. Subclauses or figures which are additional to those of the General Standard are numbered starting from 101, ad
38、ditional annexes are lettered AA, BB, etc., and additional items aa), bb), etc. Clauses and subclauses for which there is a rationale are marked with an asterisk*. These rationales can be found in an informative annex AA. Annex AA should be used in determining the relevance of the requirements addre
39、ssed but should never be used to establish additional test requirements. Where there is no corresponding section, clause or subclause in this Particular Standard, the section, clause or subclause of the General Standard or of Collateral Standards applies without modification. Where it is intended th
40、at any part of the General Standard or Collateral Standards, although possibly relevant, is not to be applied, a statement to that effect is given in this Particular Standard. A requirement of this Particular Standard, replacing or modifying requirements of the General Standard or Collateral Standar
41、ds, takes precedence over the corresponding General Requirement(s). 2 Terminology and definitions This clause of the General Standard applies except as follows: Additional definitions: *2.1.101 HF SURGICAL EQUIPMENT MEDICAL ELECTRICAL EQUIPMENT including its associated ACCESSORIES intended for the p
42、erformance of surgical operations, such as the CUTTING or COAGULATION of biological tissue by means of high frequency (h.f.) currents. Page 7 EN 6060122:2000 BSI 04-2001 2.1.102 ACTIVE ELECTRODE Electrode intended to produce certain physical effects required in electrosurgery, for example CUTTING an
43、d COAGULATION. 2.1.103 BIPOLAR ELECTRODE Assembly of two ACTIVE ELECTRODES on the same support, so constructed that, when energized, the h.f. current flows mainly between these two electrodes. 2.1.104 NEUTRAL ELECTRODE Electrode of a relatively large area for connection to the body of the PATIENT, i
44、ntended to provide a return path for the high frequency current with such a low current density in the body tissue that physical effects such as unwanted burns are avoided. NOTE The NEUTRAL ELECTRODE is also known as plate, plate electrode, passive, return or dispersive electrode. 2.1.105 ENDOSCOPIC
45、ALLY USED ACCESSORY See definition in IEC 60601-2-18:1996. NOTE The reader is referred to IEC 60601-2-18 to ensure that a consistent definition is used. 2.12.101 RATED OUTPUT POWER The power in watts produced when the h.f. output is fed into the RATED LOAD. 2.12.102 CUTTING Resection or dissection o
46、f body tissue caused by the passage of high frequency current of high current density at the ACTIVE ELECTRODE(S). 2.12.103 COAGULATION Sealing of small blood vessels or of body tissue caused by the passage of high frequency current at the ACTIVE ELECTRODE(S). 2.12.104 RATED LOAD The value of non-rea
47、ctive load resistance that results in the maximum h.f. output power from each operating mode of the HF SURGICAL EQUIPMENT. 3 General requirements This clause of the General Standard applies except as follows: 3.6 Additional SINGLE FAULT CONDITIONS: aa) failure in the NEUTRAL ELECTRODE monitoring cir
48、cuit which would result in a SAFETY HAZARD (see 59.101); bb) a defect in the output switching circuit resulting in an excessive low frequency PATIENT LEAKAGE CURRENT (see 56.11); Page 8 EN 6060122:2000 BSI 04-2001 cc) any defect which results in the unwanted energization of the PATIENT CIRCUIT (see
49、59.102); dd) any defect which results in a significant increase in output power relative to the output setting (see 51.5). 4 General requirements for tests This clause of the General Standard applies except as follows: 4.6 Other conditions Additional item: aa) Where reference is made in test specifications to electrode cables and/or electrodes, those supplied or recommended by the manufacturer shall be used. 5 Classification This clause of the General Stand