BS-EN-50072-1992 BS-5724-2.29-1992.pdf
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1、BRITISH STANDARD BS EN 50072:1992 BS 5724-2.29: 1992 Medical electrical equipment Part 2: Particular requirements for safety Section 2.29 Specification for peritoneal dialysis equipment The European Standard EN 50072:1992 has the status of a British Standard UDC 615.84:616.61-78:614.8 Licensed Copy:
2、 sheffieldun sheffieldun, na, Mon Nov 06 02:03:32 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 50072:1992 This British Standard, having been prepared under the direction of the Health Care Standards Policy Committee, was published under the authority of the Standards Board and comes into effect
3、on 15 December1992 BSI 10-1999 The following BSI references relate to the work on this standard: Committee reference HCC/23 Draft for comment 89/53820 DC ISBN 0 580 21460 5 Cooperating organizations The European Committee for Electrotechnical Standardization (CENELEC), under whose supervision this E
4、uropean Standard was prepared, comprises the national committees of the following countries: AustriaItaly BelgiumLuxembourg DenmarkNetherlands FinlandNorway FrancePortugal GermanySpain GreeceSweden IcelandSwitzerland IrelandUnited Kingdom Amendments issued since publication Amd. No.DateComments Lice
5、nsed Copy: sheffieldun sheffieldun, na, Mon Nov 06 02:03:32 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 50072:1992 BSI 10-1999i Contents Page Cooperating organizationsInside front cover National forewordii Foreword2 Introduction3 Section 1. General 1Scope and object3 2Terminology and definition
6、s3 3General requirements3 4General requirements for tests4 5Identification, marking and documentation4 Section 2. Environmental conditions Section 3. Protection against electric shock hazards Section 4. Protection against mechanical hazards Section 5. Protection against hazards from unwanted or exce
7、ssive radiation Section 6. Protection against hazards of ignition of flammable anaesthetic mixtures Section 7. Protection against excessive temperatures and other safety hazards5 44Overflow, spillage, leakage, humidity, ingress of liquids cleaning, sterilization and disinfection Section 8. Accuracy
8、of operating data and protection against hazardous output 51Protection against hazardous output6 Section 9. Abnormal operation and fault conditions; environmental tests Section 10. Constructional requirements 54General7 59Construction and layout7 National annex NA (informative) Committees responsibl
9、eInside back cover National annex NB (informative) Cross-referencesInside back cover Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 06 02:03:32 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 50072:1992 ii BSI 10-1999 National foreword This British Standard has been prepared under the directio
10、n of the Health Care Standards Policy Committee and is the English language version of EN 50072:1992, Medical electrical equipment Particular requirements for the safety of peritoneal dialysis equipment, published by the European Committee for Electrotechnical Standardization (CENELEC). This Particu
11、lar Standard amends and supplements BS 5724-1 hereinafter called the General Standard. The changes from the text of the General Standard are specified by the use of the following words. “Replacement” means that the clause, subclause or specified paragraph of the General Standard is replaced by the t
12、ext of this standard. “Amendment” means that the clause, subclause or specified paragraph of the General Standard is amended as indicated by the text of this standard. “Addition” means that the text of this standard is additional to the requirements of the General Standard. A British Standard does n
13、ot 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. Summary of pages This document comprises a front cover, an inside
14、front cover, pages i and ii, the EN title page, pages 2 to 8, 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 sheff
15、ieldun, na, Mon Nov 06 02:03:32 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 50072 September 1992 UDC 615.84:616.61-78:614.8 Descriptors: Medical electrical equipment, peritoneal dialysis equipment, safety requirements, radiations, particular specif
16、ications, tests, terminology English version Medical electrical equipment Particular requirements for the safety of peritoneal dialysis equipment Appareils lectromdicaux Rgles particulires de scurit pour le matriel de dialyse pritonale Medizinische elektrische Gerte Besondere Festlegungen fr die Sic
17、herheit von Peritoneal-Dialyse-Gerte This European Standard was approved by CENELEC on 24 March 1992. 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 alteratio
18、n. 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 exists in three official versions (English, French, German). A version in any other language made by transl
19、ation 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 electrotechnical committees of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland
20、, Italy, Luxembourg, Netherlands, 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,
21、 B-1050 Brussels 1992 Copyright reserved to CENELEC members Ref. No. EN 50072:1992 E Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 06 02:03:32 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 50072:1992 BSI 10-1999 2 Foreword This standard was prepared by the working group for peritoneal dialysis
22、 equipment of TC 62, Electrical equipment in medical practice. The draft standard was submitted to the CENELEC Unique Acceptance Procedure in July 1991 and was approved by CENELEC as EN 50072 on 24 March 1992. The following dates are applicable: For products which have complied with the relevant nat
23、ional standard before 1993-03-01, as shown by the manufacturer or by a certification body, this previous standard may continue to apply for production until 1998-03-01. latest date of publication of an identical national standard(dop) 1993-03-01 latest date of withdrawal of conflicting national stan
24、dards(dow) 1993-03-01 Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 06 02:03:32 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 50072:1992 BSI 10-19993 Introduction The minimum safety requirements specified in this Particular Standard are considered to provide for a practical degree of safety in
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