BS-EN-60601-2-19-1997 BS-5724-2.119-1997 IEC-60601-2-19-1990.pdf
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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
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