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1、BRITISH STANDARD BS EN 60601-2-19: 1997 BS 5724-2.119: 1997 IEC 601-2-19: 1990 (including IEC Amendment 1:1996) Medical electrical equipment Part 2: Particular requirements for safety Specification for baby incubators The European Standard EN 60601-2-19:1996 with the incorporation of amendment A1:19
2、96 has the status of a British Standard ICS 11.040.10 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 02:51:41 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 60601-2-19:1997 This British Standard, having been prepared under the direction of the Health and Environment Sector Board, was publi
3、shed under the authority of the Standards Board and comes into effect on 15 June 1997 BSI 10-1999 The following BSI references relate to the work on this standard: Committee reference CH/91 Draft for comment 95/560383 DC ISBN 0 580 27370 9 Committees responsible for this British Standard The prepara
4、tion of this British Standard was entrusted 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 Manufactu
5、rers Association British Surgical Trades 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 sheffie
6、ldun, na, Wed Nov 08 02:51:41 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 60601-2-19:1997 BSI 10-1999i Contents Page Committees responsibleInside front cover National forewordii Foreword2 Text of EN 60601-2-195 List of referencesInside back cover Licensed Copy: sheffieldun sheffieldun, na, Wed
7、Nov 08 02:51:41 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 60601-2-19:1997 ii BSI 10-1999 National foreword This Section of BS EN 60601 has been prepared by Technical Committee CH/91. It is the English language version of EN 60601-2-19:1996 Medical electrical equipment Part 2: Particular requi
8、rements for the safety of baby incubators, including Amendment A1:1996 published by the European Committee for Electrotechnical Standardization (CENELEC). It is identical with IEC 601-2-19:1990 including Amendment 1:1996, published by the International Electrotechnical Commission (IEC). It supersede
9、s BS 5724-2.119:1991 which is withdrawn. This particular Standard 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 t
10、he most important requirements is given in Annex AA. It is considered 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) A
11、lso numbered BS 5724-1 Cross-references Publication referred toCorresponding British Standard BS 5724 Medical electrical equipment EN 60601-1:1990 (IEC 601-1:1988) Part 1:1989 General requirements for safety BS EN 60601 Medical electrical equipment Part 1 General requirements for safety EN 60601-1-1
12、:1993 (IEC 601-1-1:1992) Section 1.1:1993 Collateral standard. Safety 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 Col
13、lateral standard. General requirements for radiation protection 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 60601-2-20:1996 (IEC 601-2-20:1990) BS EN 60601-2-20:1997 Medical electrical equipment P
14、art 2: Particular requirements for safety. Specification for transport incubators EN 60651:1993 (IEC 651:1979) BS EN 60651:1994 Specification for sound level meters ISO 7767:1988BS 5724 Medical electrical equipment Part 2 Particular requirements for safety Section 2.27:1993 Specification for oxygen
15、analysers for monitoring patient breathing mixtures Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 02:51:41 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 60601-2-19:1997 BSI 10-1999iii A British Standard does not purport to include all the necessary provisions of a contract. Users of Brit
16、ish 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 title page, pages 2 to 24, an inside back co
17、ver 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 02:51:41 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv b
18、lank Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 02:51:41 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 60601-2-19 December 1996 + A1 December 1996 UDC 615.478.5:618.39:616-053.3:614.8 ICS 11.040.10 Supersedes HD 395.2.19 S1:1992 Descripto
19、rs: Medical electrical equipment, incubator, baby 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
20、the safety of baby incubators (including amendment A1:1996) (IEC 601-2-19:1990 + A1:1996) Appareils lectromdicaux Partie 2: Rgles particulires de scurit des incubateurs pour bbs (inclut lamendement A1:1996) (CEI 601-2-19:1990 + A1:1996) Medizinische elektrische Gerte Teil 2: Besondere Festlegungen f
21、r die Sicherheit von Suglingsinkubatoren (enthlt nderung A1:1996) (IEC 601-2-19:1990 + A1:1996) This European Standard was approved by CENELEC on 1996-10-01; amendment A1 was approved by CENELEC on 1996-10-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipul
22、ate 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 application to the Central Secretariat or to any CENELEC member. This European Standard
23、 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 Secretariat has the same status as the official versions. CENELEC members are the national
24、electrotechnical committees of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisatio
25、n Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B-1050 Brussels 1996 Copyright reserved to CENELEC members Ref. No. EN 60601-2-19:1996 + A1:1996 E Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 02:51:41 GMT+00:00 2006, Uncontrolled
26、 Copy, (c) BSI EN 60601-2-19:1996 BSI 10-1999 2 Foreword The text of the International Standard IEC 601-2-19:1990, prepared by SC 62D, Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, was approved by CENELEC as HD 395.2.19 S1 on 1992-03-24. This Harmonization Documen
27、t was submitted to the formal vote for conversion into a European Standard and was approved by CENELEC as EN 60601-2-19 on 1996-10-01. The following dates were fixed: Foreword to amendment A1 The text of document 62D/193/FDIS, future amendment 1 to IEC 601-2-19:1990, prepared by SC 62D, Electromedic
28、al equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as amendment A1 to EN 60601-2-19:1996 on 1996-10-01. The following dates were fixed: Annexes designated “normative” are part of the body of the standard. A
29、nnexes designated “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 nati
30、onal standard or by endorsement(dop) 1997-09-01 latest date by which the amendment has to be implemented at national level by publication of an identical national standard or by endorsement(dop) 1997-09-01 latest date by which the national standards conflicting with the amendment have to be withdraw
31、n(dow) 1998-06-13 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 02:51:41 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 60601-2-19:1996 BSI 10-19993 Contents Page Foreword2 Introduction5 Section 1. General 1Scope and object5 2Terminology and definitions8 3General requirements6 4General requi
32、rements for tests6 5Classification6 6Identification, marking and documents7 7Power input7 Section 2. Safety requirements 10Special environmental conditions8 11Special measures with respect to safety8 Section 3. Protection against electric shock hazards 20Dielectric strength8 Section 4. Protection ag
33、ainst mechanical hazards 21Mechanical strength8 22Moving parts8 23Surfaces, corners and edges8 24Stability and transportability9 Section 5. Protection against hazards from unwanted or excessive radiation 36Electromagnetic compatibility9 Section 6. Protection against hazards of explosions in medicall
34、y used rooms Section 7. Protection against excessive temperatures, fire and other hazards, such as human errors 42Excessive temperatures9 43Fire prevention10 44Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection10 45Pressure vessels and parts subject t
35、o pressure11 46Human errors11 49Interruption of the power supply11 Section 8. Accuracy of operating data and protection against incorrect output 50Accuracy of operating data11 Page Section 9. Fault conditions causing overheating and/or mechanical damage; environmental tests Section 10. Constructiona
36、l requirements 54General13 55Enclosures and covers13 56Components and general assembly13 Section 11. Additional requirements 101Alarms15 102Sound pressure level17 103Humidifying unit17 104Maximum air velocity in the enclosure17 105Concentration of carbon dioxide (CO2)17 Appendix L References Publica
37、tions mentioned in this standard19 Annex AA (informative) Rationale19 Annex ZA (normative) Normative references to international publications with their corresponding European publications23 Annex ZB (informative) Normative references to international publications with their corresponding European p
38、ublications23 Figure 10116 Figure 10217 Figure 103 Illustration of the main requirements of this standard18 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 02:51:41 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 4 blank Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 02:51:41 GMT+00:00 200
39、6, Uncontrolled Copy, (c) BSI EN 60601-2-19:1996 BSI 10-19995 Introduction This Particular Standard concerns the safety of baby incubators. It amends and supplements IEC 601-1 (second edition 1988): Medical electrical equipment Part 1: General requirements for safety. Where it is intended that any p
40、art 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 sections, clauses and sub-clauses of this Particular Standard corresponds with that of the General Standard. Sub-clauses or figures which a
41、re 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. In this standard, the following print types are used: requirements, compliance with which can be tested and definitions: in roman type;
42、explanations, advice, introductions, general statements, exceptions and references: in smaller type; test specifications: in italic type; TERMS DEFINED IN CLAUSE2 OF THE GENERAL STANDARD OR THIS PARTICULAR STANDARD:SMALL CAPITALS. The requirements are followed by specifications for the relevant test
43、s. 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 requirements will not only facilitate the proper application of the standard but will, in due course, expedite any revision necessitated by changes
44、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 which have corresponding rationale statements are marked with an * after their number. Section 1. General 1 Scope and object This clause o
45、f the General Standard applies except as follows: 1.1 Scope Addition: This Particular Standard specifies safety requirements for INCUBATORS, as defined in 2.1.101 of this standard. This standard does not apply to transport incubators used for the transportation of babies (see IEC 601-2-20). 1.2 Obje
46、ct Addition: The object of this Particular Standard is to establish requirements for INCUBATORS which minimize hazards to PATIENT and USER, and to specify tests by which compliance with the requirements can be verified. 1.3 Particular Standards With this amendment to the Particular Standard for baby
47、 INCUBATORS the following documents are to be taken into consideration: IEC 601-1:1988, Medical electrical equipment Part 1: General requirements for safety. Amendment 1 (1991) Amendment 2 (1995) The requirements of this Particular Standard take priority over the above-mentioned standard and its ame
48、ndments, hereinafter referred to as the General Standard. 1.5 Collateral Standards The following Collateral Standards apply: IEC 601-1-1:1992, Medical electrical equipment Part 1: General requirements for safety 1. Collateral standard: Safety requirements for medical electrical systems. IEC 601-1-2:
49、1993, Medical electrical equipment Part 1: General requirements for safety 2. Collateral Standard: Requirements and tests. IEC 601-1-3:1994, Medical electrical equipment Part 1: General requirements for safety 3. Collateral Standard: General requirements for radiation protection in diagnostic X-ray equipment. IEC 601-1-4:1996, Medical electrical equipment Part 1: General requirements for safety 4. Collateral Standard: Programmable electrical medical systems. 2 Terminology and definitions This clause of the General