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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 793:1998 The Europe
2、an Standard EN 793:1997 has the status of a British Standard ICS 11.040.01 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Particular requirements for safety of medical supply units Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:55:38 GMT+00:00 2006, Uncontrolled Co
3、py, (c) BSI This British Standard, having been prepared under the direction of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 15 April 1998 BSI 1998 ISBN 0 580 29655 5 BS EN 793:1998 Amendments issued since publication Amd.
4、No.DateText affected National foreword This British Standard is the English language version of EN 793:1997. The UK participation in its preparation was entrusted by Technical Committee CH/44, Anaesthetic machines, breathing attachments, medical gas pipeline systems and hose assemblies, to Subcommit
5、tee CH/44/2, Medical gas supply systems, which has the responsibility to: aid enquirers to understand the text; present to the responsible European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European d
6、evelopments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards C
7、atalogue under the section entitled International Standards Correspondence Index, or by using the Find facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their c
8、orrect 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, the EN title page, pages 2 to 22, an inside back cover and a back cover. Licensed Copy: sheffieldun sheffie
9、ldun, na, Tue Nov 07 02:55:38 GMT+00:00 2006, Uncontrolled Copy, (c) BSI CEN European Committee for Standardization Comite Europe en de Normalisation Europa isches Komitee fu r Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1997 CEN All rights of exploitation in any form and by any
10、 means reserved worldwide for CEN national Members. Ref. No. EN 793:1997 E EUROPEAN STANDARDEN 793 NORME EUROPE ENNE EUROPA ISCHE NORM December 1997 ICS 11.040.01 Descriptors: Electromedical equipment, electric power supply, lighting, gas supply, medical gases, gaseous effluent disposal, safety requ
11、irements, accident prevention, protection against electric shocks, protection against mechanical hazards, radiation protection, fire protection, performance evaluation, equipment specification, marking, colour codes English version Particular requirements for safety of medical supply units Prescript
12、ions particulie res relatives a la se curite des gaines techniques a usage me dical Besondere Anforderungen fu r die Sicherheit von medizinischen Versorgungseinheiten This European Standard was approved by CEN on 30 October 1997. CEN members are bound to comply with the CEN/CENELEC Internal Regulati
13、ons 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 application to the Central Secretariat or to any CEN member. This Europ
14、ean Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the natio
15、nal standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:55:38 GMT+00:00 2006, Unco
16、ntrolled Copy, (c) BSI Page 2 EN 793:1997 BSI 1998 Foreword This European Standard has been prepared by Technical Committee CEN/TC 215, Anaesthetics and respiratory equipment, the secretariat of which is held by BSI. For special national conditions for clauses 6.1bb) and 6.2aa) see annex AA. This Eu
17、ropean Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association and supports essential requirements of EU Directive(s). For relationship with EU Directives, see informative annex ZA which is an integral part of this standard. Annex AA
18、 is a normative part, and annexes BB, CC and ZA are informative parts, of this standard. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by May 1998, and conflicting national standards shall be withd
19、rawn at the latest by May 1998. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxe
20、mbourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Contents Page Foreword2 Introduction4 Section one General 1Scope4 2Normative references4 3Terms and definitions4 4General requirements and requirements for tests8 5Classification8 6Identification, marking and d
21、ocuments8 7Power input10 Section two Environmental conditions 8Basic safety categories10 9Removable protection means10 10Environmental conditions10 11Not used10 12Not used10 Page Section three Protection against electric shock hazards 13General10 14Requirements related to classification10 15Limitati
22、on of voltage and/or energy10 16Enclosures and protective covers10 17Separation10 18Protective earthing, functional earthing and potential equalization10 19Continuous leakage currents and patient auxiliary currents10 20Dielectric strength10 Section four Protection against mechanical hazard 21Mechani
23、cal strength10 22Moving parts12 23Surfaces, corners and edges12 24Stability in normal use12 25Expelled parts12 26Vibration and noise12 27Pneumatic and hydraulic power12 28Suspended masses12 Section five Protection against hazards from unwanted or excessive radiation 29X-radiation12 30Alpha, beta, ga
24、mma, neutron radiation and other particle radiation12 31Microwave radiation12 32Light radiation (including lasers)12 33Infra-red radiation12 34Ultraviolet radiation12 35Acoustical energy (including ultrasonics)12 36Electromagnetic compatibility12 Section six Protection against hazards of ignition of
25、 flammable anaesthetic mixtures 37Locations and basic requirements12 38Marking, accompanying documents12 39Common requirements for category AP and category APG equipment12 40Requirements and tests for category AP equipment, parts and components thereof12 41Requirements and tests for category APG equ
26、ipment, parts and components thereof13 Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:55:38 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 3 EN 793:1997 BSI 1998 Page Section seven Protection against excessive temperatures and other safety hazards 42Excessive temperatures13 43Fire preven
27、tion13 44Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection13 45Pressure vessels and parts subject to pressure13 46Human errors13 47Electrostatic charges13 48Material in applied parts in contact with the body of the patient13 49Interruption of the pow
28、er supply13 Section eight Accuracy of operating data and protection against hazardous output 50Accuracy of operating data13 51Protection against hazardous output13 Section nine Abnormal operation and fault conditions: environmental tests 52Abnormal operation and fault conditions13 53Environmental te
29、sts13 Section ten Constructional requirements 54General13 55Enclosures and covers13 56Components and general assembly14 57Mains parts, components and layout14 58Protective earthing - terminals and connections14 59Construction and layout14 Annex AA (normative) Special national conditions19 Annex BB (
30、informative) Bibliography19 Annex CC (informative) Rationale19 Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions of EU Directives21 Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:55:38 GMT+00:00 2006, Uncontrolled Copy, (c) BSI
31、Page 4 EN 793:1997 BSI 1998 Introduction This Particular Standard amends EN 60601-1:1990 Medical electrical equipment, Part 1: General requirements for safety. As stated in EN 60601-1:1990 the requirements of this Particular Standard take priority over those of EN 60601-1:1990. As in EN 60601-1:1990
32、 the requirements are followed by the relevant tests. The structure of this Particular Standard corresponds to that of EN 60601-1:1990 and the sections, clauses and subclauses refer to those of EN 60601-1:1990. Clauses, subclauses, tables and figures additional to those in EN 60601-1:1990 are number
33、ed beginning at 101. Additional annexes are lettered beginning at AA except for annex ZA. Additional items in lettered lists are lettered beginning aa). Rationales for some of the requirements of this standard are given in annex CC. Such requirements are indicated by the letter R after the clause nu
34、mber. Section one General 1 Scope Clause 1 of EN 60601-1:1990 applies with the following addition: This standard applies to medical supply units as defined in 3.4. 1.3 Particular Standards This Particular Standard amends EN 60601-1:1990. The requirements of this Particular Standard take priority ove
35、r those of EN 60601-1:1990. 2 Normative references This European Standard incorporates by dated or undated reference, provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references subsequ
36、ent amendment to or revisions of any of these apply to this European Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies. Appendix L of EN 60601-1:1990 applies with the following additions: EN 737-1, Medical
37、 gas pipeline systems Part 1: Terminal units for compressed medical gases and vacuum prEN 737-2, Medical gas pipeline systems Part 2: Anaesthetic gas scavenging disposal systems Basic requirements prEN 737-3, Medical gas pipeline systems Part 3: Pipelines for compressed medical gases and vacuum Basi
38、c requirements EN 737-4, Medical gas pipeline systems Part 4: Terminal units for anaesthetic gas scavenging systems EN 739:1998, Low-pressure hose assemblies for use with medical gases EN 1441, Medical devices Risk analysis EN ISO 3744, Acoustics Determination of sound power levels of noise sources
39、using sound pressure Engineering method in an essentially freefield condition over a reflecting plane (ISO 3744:1994) EN 60598-1, Luminaires Part 1: General requirements and tests (IEC 598-1:1992, modified) EN 60601-1:1990, Medical electrical equipment Part 1: General requirements for safety EN 6060
40、1-1-2, Medical electrical equipment Part 1: General requirements for safety Electromagnetic compatibility Requirements and tests EN 60669-1, Switches for household and similar fixed electrical installations Part 1: General requirements (IEC 669-1:1993, modified) IEC 79-4, Electrical apparatus for ex
41、plosive gas atmospheres Part 4: Method of test for ignition temperature IEC 884-1, Plugs and socket-outlets for household and similar purposes General requirements 3 Terms and definitions Clause 2 of EN 60601-1:1990 applies with the following additions: 3.1 equipment single self-contained unit or co
42、mbination of units provided with one or more permanently fixed connections to the building services, e.g. electricity, medical gas(es), liquid(s) or anaesthetic gas scavenging systems 3.2 junction point connection point between the medical supply unit and the fixed building services 3.3 medical gas
43、any gas or mixture of gases intended to be administered to patients for therapeutic, diagnostic or prophylactic purposes, or for surgical tool applications 3.4 medical supply unit prefabricated permanently installed equipment of Class I, Type B for application in medical areas such as general wards
44、and special purpose areas, e.g. operating theatres, induction rooms, recovery wards, intensive care of therapy units and other intermediate care areas. It is intended to supply electric power and/or medical gases and/or liquids NOTE Medical supply units can include medical electrical equipment or sy
45、stems or parts of such equipment or systems which might be applied to diagnosis, therapeutics and communications. Medical supply units can consist of modular sections for electrical supply, lighting for therapy or illumination, communication, supply of medical gases and liquids, anaesthetic gas scav
46、enging systems. Typical examples of medical supply units are given in Figures 101, 102 and 103. Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:55:38 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 5 EN 793:1997 BSI 1998 1 2 3 4 5 Ambient lighting fitting Electrical socket Mains supply Int
47、ercommunication, safety extra-low voltage Recessed equipment 6 7 8 9 10 Barrier Terminal unit Pipeline installation Reading light Safety distance as distance from centre to centre Figure 101 Sectional drawing of typical medical supply unit for patient care rooms Licensed Copy: sheffieldun sheffieldu
48、n, na, Tue Nov 07 02:55:38 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 6 EN 793:1997 BSI 1998 1 2 3 4 Electrical socket Mains supply Intercommunication, safety extra-low voltage Recessed equipment 5 6 7 8 Barrier Terminal unit Pipeline installation Safety distance as distance from centre to cent
49、re Figure 102 Sectional drawing of typical medical supply unit for intensive care rooms and operating theatres Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:55:38 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 7 EN 793:1997 BSI 1998 1 2 3 4 Barrier Terminal units Recessed equipment, low current electro installation, intercommunication safety extra-low voltage Electrical socket 5 6 7 8 Safety distance measured on the surface as distance from centre to centre Flexible hoses