BS-EN-ISO-11197-2004.pdf
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1、BRITISH STANDARD BS EN ISO 11197:2004 Medical supply units The European Standard EN ISO 11197:2004 has the status of a British Standard ICS 11.040.01 ? BS EN ISO 11197:2004 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 January 2005 BSI 3
2、1 January 2005 ISBN 0 580 45366 9 National foreword This British Standard is the official English language version of EN ISO 11197:2004. It is identical with ISO 11197:2004. It supersedes BS EN 793:1998 which is withdrawn. The UK participation in its preparation was entrusted by Technical Committee
3、CH/121, Anaesthetic and respiratory equipment, to Subcommittee CH/121/6, Medical gas supply systems, which has the responsibility to: A list of organizations represented on this subcommittee can be obtained on request to its secretary. Cross-references The British Standards which implement internati
4、onal or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport
5、to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee an
6、y enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN ISO title page, pages 2 to 46,
7、an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11197 December 2004 ICS 11.040.01 Supersedes EN 7
8、93:1997 English version Medical supply units (ISO 11197:2004) Gaines techniques usage mdical (ISO 11197:2004) Medizinische Versorgungseinheiten (ISO 11197:2004) This European Standard was approved by CEN on 23 September 2004. CEN members are bound to comply with the CEN/CENELEC Internal Regulations
9、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 European
10、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 national
11、standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN
12、 COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2004 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11197:2004: E EN ISO 11197
13、:2004 (E) 2 Contents page Foreword5 Introduction.6 SECTION ONE - GENERAL 7 1 Scope 7 2 Normative references7 3 Terms and definitions .8 4 General requirements and requirements for tests.8 5 Classification9 6 Identification, marking and documents.9 7 Power input 13 SECTION TWO - ENVIRONMENTAL CONDITI
14、ONS14 8 Basic safety categories.14 9 Removable protection means.14 10 Environmental conditions.14 11 Not Used .14 12 Not Used .14 SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS.15 13 General15 14 Requirements related to classification15 15 Limitation of voltage and/or energy.15 16 Enclosu
15、res and protective covers.15 17 Separation 15 18 Protective earthing, functional earthing and potential equalization15 19 Continuous leakage current and patient auxiliary currents15 20 Dielectric strength .16 SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS 17 21 Mechanical strength17 22 Moving
16、parts.17 23 Surfaces, corners and edges17 24 Stability in normal use 17 25 Expelled parts 18 26 Vibration and noise18 27 Pneumatic and hydraulic power.18 28 Suspended masses .18 EN ISO 11197:2004 (E) 3 SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION.19 29 X-Radiation.1
17、9 30 Alpha, beta, gamma, neutron radiation and other particle radiation .19 31 Microwave radiation19 32 Light radiation (including lasers).19 33 Infra-red radiation19 34 Ultraviolet radiation.19 35 Acoustical energy (including ultrasonics)19 36 Electromagnetic compatibility .19 SECTION SIX - PROTECT
18、ION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES 21 37 Locations and basic requirements 21 38 Marking and accompanying documents.21 39 Common requirements for Category AP and Category APG Equipment21 40 Requirements and tests for Category AP Equipment, parts and components thereof .
19、21 41 Requirements and tests for Category APG Equipment, parts and components thereof.21 SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS .22 42 Excessive temperatures22 43 R Fire prevention.22 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning,
20、sterilization and disinfection.22 45 Pressure vessels and parts subject to pressure22 46 Human errors .23 47 Electrostatic charges 23 48 Material in applied parts in contact with the body of the patient .23 49 Interruption of the power supply .23 SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTEC
21、TION AGAINST HAZARDOUS OUTPUT24 50 Accuracy of operating data 24 51 Protection against hazardous output24 SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS, ENVIRONMENTAL TESTS25 52 Abnormal operation and fault conditions.25 53 Environmental tests 25 SECTION TEN - CONSTRUCTIONAL REQUIREMENTS25
22、54 General25 55 Enclosures and covers .25 56 Components and general assembly25 57 Mains parts, components and layout25 58 Protective earthing - terminals and connections.26 59 Construction and layout .27 Annexes.39 EN ISO 11197:2004 (E) 4 Annex A A (normative) Special National Conditions.40 Annex B
23、B (informative) Rationale.41 Annex ZA (Informative) Clauses of this European Standard addressing essential requirements or other provisions of EU Directives43 Annex ZB (Informative) Normative references to international publications with their relevant European publications45 Bibliography46 EN ISO 1
24、1197:2004 (E) 5 Foreword This document (EN ISO 11197:2004) has been prepared by CEN /TC 215, “Respiratory and anaesthetic equipment“, the secretariat of which is held by BSI, in collaboration with ISO/TC121/SC6 “Medical gas systems“. This European Standard shall be given the status of a national sta
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