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1、BRITISH STANDARD BS EN 60601-2-20: 1997 BS 5724-2.120: 1997 IEC 601-2-20: 1990 (including IEC amendment 1:1996) Medical electrical equipment Part 2: Particular requirements for safety Specification for transport incubators The European Standard EN 60601-2-20:1996 has the status of a British Standard
2、 ICS 11.040.10 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 02:51:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 60601-2-20:1997 This British Standard, having been prepared under the direction of the Health and Environment Sector Board, was published under the authority of the Standar
3、ds Board and comes into effect on 15 June 1997 BSI 09-1999 The following BSI references relate to the work on this standard: Committee reference CH/91 Draft for comment 95/560384 DC ISBN 0 580 27368 7 Committees responsible for this British Standard The preparation of this British Standard was entru
4、sted to Technical Committee CH/91, Incubators, upon which the following bodies were represented: Association of British Health-care Industries Association of Manufacturers of Domestic Electrical Appliances British Anaesthetic and Respiratory Equipment Manufacturers Association British Surgical Trade
5、s Association Department of Health Institution of Physics and Engineering in Medicine and Biology Royal College of Midwives Royal College of Paediatrics and Child Health Amendments issued since publication Amd. No.DateComments Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 02:51:42 GMT+00:00
6、 2006, Uncontrolled Copy, (c) BSI BS EN 60601-2-20:1997 BSI 09-1999i Contents Page Committees responsibleInside front cover National forewordii Foreword2 Text of EN 60601-2-205 List of referencesInside back cover Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 02:51:42 GMT+00:00 2006, Uncontr
7、olled Copy, (c) BSI BS EN 60601-2-20:1997 ii BSI 09-1999 National foreword This Section of BS EN 60601 has been prepared by Technical Committee CH/91. It is the English language version of EN 60601-2-20:1996 Medical electrical equipment Part 2: Particular requirements for the safety of transport inc
8、ubators published by the European Committee for Electrotechnical Standardization (CENELEC). It is identical with IEC 601-2-20:1990 including Amendment 1:1996, published by the International Electrotechnical Commission (IEC). It supersedes BS 5724-2.120:1991 which is withdrawn. This particular Standa
9、rd amends and supplements BS EN 60601-11) hereinafter called the General Standard. As stated in 1.3 of the General Standard, the requirements of the Particular Standard take precedence over those of the General Standard. A Rational for the most important requirements is given in Annex AA. It is cons
10、idered that a knowledge of the reasons for the requirements will not only facilitate the proper application of the standard, but will expedite any subsequent revision. Annex AA does not form part of the requirements of the standard. 1) Also numbered BS 5724-1 Cross-references Publication referred to
11、Corresponding British Standard BS 5724 Medical electrical equipment EN 60601-1:1990Part 1:1989 General requirements for safety (IEC 601-1:1988) BS EN 60601 Medical electrical equipment Part 1 General requirements for safety EN 60601-1-1:1993 (IEC 601-1-1:1992) Section 1.1:1993 Collateral standard. S
12、afety requirements for medical electrical systems EN 60601-1-2:1993 (IEC 601-1-2:1993) Section 1.2:1993 Collateral standard. Electromagnetic compatibility. Requirements and tests EN 60601-1-3:1994 (IEC 601-1-3:1994) Section 1.3:1995 Collateral standard. General requirements for radiation protection
13、in diagnostic X-ray equipment EN 60601-1-4:1996 (IEC 601-1-4:1994) Section 1.4:1997 Collateral standard. Programmable electrical medical systems EN 60601-2-19:1996 (IEC 601-2-19:1990) BS EN 60601-2-19:1997 Medical electrical equipment Part 2 Particular requirements for safety. Specification for baby
14、 incubators EN 60651:1993 (IEC 651:1979) BS EN 60651:1994 Specification for sound level meters ISO 32:1977 and ISO 407:1991 BS 1319:1976 Specification for medical gas cylinders, valves and yoke connections ISO 7767:1988BS 5724 Medical electrical equipment Part 2 Particular requirements for safety Se
15、ction 2.27:1993 Specification for oxygen analysers for monitoring patient breathing mixtures Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 02:51:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 60601-2-20:1997 BSI 09-1999iii A British Standard does not purport to include all the necessar
16、y 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. Summary of pages This document comprises a front cover, an inside front cover, pages i to iv, the EN tit
17、le page, pages 2 to 24, an inside back cover and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 02:51:42 GMT+00
18、:00 2006, Uncontrolled Copy, (c) BSI iv blank Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 02:51:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 60601-2-20 December 1996 ICS 11.040.10Supersedes HD 395.2.20 S1:1992 Descriptors: Medical elec
19、trical equipment, incubator, transport incubator, safety requirements, protection against electric shock, protection against mechanical hazard, radiation protection, fire protection, environmental conditions English version Medical electrical equipment Part 2: Particular requirements for the safety
20、of transport incubators (IEC 601-2-20:1990 + A1:1996) Appareils lectromdicaux Partie 2: Rgles particulires de scurit des incubateurs de transport (CEI 601-2-20:1990 + A1:1996) Medizinische elektrische Gerte Teil 2: Besondere Festlegungen fr die Sicherheit von Transportinkubatoren (IEC 601-2-20:1990
21、+ A1:1996) This European Standard was approved by CENELEC on 1996-10-01. 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 bibli
22、ographical references concerning such national standards may be obtained on 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 responsibilit
23、y of a CENELEC member into its own language and notified to the Central Secretariat has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherla
24、nds, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. 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 1996 Copyrig
25、ht reserved to CENELEC members Ref. No. EN 60601-2-20:1996 E Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 02:51:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 60601-2-20:1996 BSI 09-1999 2 Foreword The text of the International Standard IEC 601-2-20:1990, prepared by SC 62D, Electromedic
26、al equipment, of IEC TC 62, Electrical equipment in medical practice, was approved by CENELEC as HD 395.2.20 S1 on 1992-03-24. This Harmonization Document was submitted to the formal vote for conversion into a European Standard and was approved by CENELEC as EN 60601-2-20 on 1996-10-01. The text of
27、document 62D/194/FDIS, future amendment 1 to IEC 60601-2-20:1990, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC for inclusion in EN 60601-2-20 on 1996-10-01. The following dates were fixed: Annexes designated “normative” are part of the body of the standard. Annexes desi
28、gnated “informative” are given for information only. In this standard, Annex ZA is normative and Annex AA and Annex ZB are informative. Annex ZA and Annex ZB have been added by CENELEC. latest date by which the EN has to be implemented at national level by publication of an identical national standa
29、rd or by endorsement(dop) 1997-06-01 latest date by which the national standards conflicting with the EN have to be withdrawn(dow) 1998-06-13 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 02:51:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 60601-2-20:1996 BSI 09-19993 Contents Page Forew
30、ord2 Introduction5 Section 1. General 1Scope and object5 2Terminology and definitions6 3General requirements6 4General requirements for tests7 5Classification7 6Identification, marking and documents7 7Power input8 Section 2. Safety requirements 10Special environmental conditions8 Section 3. Protecti
31、on against electric shock hazards 20Dielectric strength8 Section 4. Protection against mechanical hazards 21Mechanical strength9 22Moving parts9 23Surfaces, corners and edges9 24Stability and transportability9 Section 5. Protection against hazards from unwanted or excessive radiation Section 6. Prot
32、ection against hazards of explosions in medically used rooms Section 7. Protection against excessive temperatures, fire and other hazards, such as human errors 42Excessive temperatures10 43Fire prevention10 44Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disi
33、nfection11 45Pressure vessels and parts subject to pressure12 46Human errors12 49Interruption of the power supply12 Section 8. Accuracy of operating data and protection against incorrect output 50Accuracy of operating data12 51Protection against incorrect output14 Section 9. Fault conditions causing
34、 overheating and/or mechanical damage; environmental tests Section 10. Constructional requirements 54General14 Page 55Enclosures and covers14 56Components and general assembly14 Section 11. Additional requirements 101Alarms15 102Sound pressure level16 103Humidifying unit16 104Maximum air velocity in
35、 the enclosure16 105Concentration of carbon dioxide (CO2)16 106Provision of oxygen17 107Electrical power supply17 Appendix L References Publications mentioned in this standard19 Annex AA (informative) Rationale19 Annex ZA (normative) Normative references to international publications with their corr
36、esponding European publications23 Annex ZB (informative) Normative references to international publications with their corresponding European publications23 Figure 10217 Figure 104 Illustration of the main requirements of this standard18 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 02:51:4
37、2 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 4 blank Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 02:51:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 60601-2-20:1996 BSI 09-19995 Introduction This Particular Standard concerns the safety of TRANSPORT INCUBATORS. It amends and supplements
38、 IEC 601-1 (second edition 1988): Medical electrical equipment Part 1: General requirements for safety. Where it is intended that any part of the General Standard, although possibly relevant, is not to be applied, a statement to that effect is given in this Particular Standard. The numbering of sect
39、ions, clauses and sub-clauses of this Particular Standard corresponds with that of the General Standard. Sub-clauses or figures which are additional to those of the General Standard are numbered starting from 101; additional appendices are lettered AA, BB, etc., and additional items aa), bb), etc. I
40、n this standard, the following print types are used: requirements, compliance with which can be tested, and definitions: in roman type; explanations, advice, introductions, general statements, exceptions and references: in smaller type; test specifications: in italic type; TERMS DEFINED IN CLAUSE2 O
41、F THE GENERAL STANDARD OR THIS PARTICULAR STANDARD: SMALL CAPITALS. The requirements are followed by specifications for the relevant tests. A rationale for the more important requirements, where appropriate, is given in Annex AA. It is considered that a knowledge of the reasons for these requirement
42、s will not only facilitate the proper application of the standard but will, in due course, expedite any revision necessitated by changes in clinical practice or as a result of developments in technology. However this appendix does not form part of the requirements of this standard. The sub-clauses w
43、hich have corresponding rationale statements are marked with an * after their number. Section 1. General 1 Scope and object This clause of the General Standard applies except as follows: 1.1 Scope Addition: This Particular Standard specifies safety requirements for TRANSPORT INCUBATORS, as defined i
44、n 2.1.101 of this standard. This standard does not apply to baby incubators (see IEC 601-2-19). 1.2 Object Addition: The object of this Particular Standard is to establish requirements for TRANSPORT INCUBATORS, which minimize hazards to PATIENT and USER, and to specify tests by which compliance with
45、 the requirements can be verified. 1.3 Particular Standards Addition: This Particular Standard refers to IEC 601-1:1988, Medical electrical equipment Part 1: General requirements for safety with its amendments 1 (1991) and 2 (1995). For brevity, IEC 601-1 is referred to in this Particular Standard e
46、ither as the “General Standard” or as the “General Requirements”. The term “this Standard” is used to make reference to the General Standard and this Particular Standard taken together. The numbering of sections, clauses and subclauses of this Particular Standard corresponds with that of the General
47、 Standard. 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 Stand
48、ard is additional 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 fro
49、m 101, additional annexes are lettered AA, etc., and additional items aa), bb), etc. Where there is no corresponding section, clause or subclause in this Particular Standard, the section, clause or subclause of the General Standard applies without modification. A requirement of this Particular Standard replacing or modifying requirements of the General Standard takes precedence over the corresponding General Requirement(s). 1.5 Collateral Standards The following Collateral Standards apply: IEC 601-1-1:1992, Medical electrical equipment Pa