BS-EN-60601-2-12-2006.pdf
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1、BRITISH STANDARD BS EN 60601-2-12: 2006 Medical electrical equipment Part 2-12: Particular requirements for the safety of lung ventilators Critical care ventilators The European Standard EN 60601-2-12:2006 has the status of a British Standard ICS 11.040.10 ? Licensed Copy: sheffieldun sheffieldun, n
2、a, Thu Nov 09 01:11:30 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 60601-2-12: 2006 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 October 2006 BSI 2006 ISBN 0 580 49391 1 National foreword This British Standard was published by BSI.
3、 It is the UK implementation of EN 60601-2-12: 2006. It is identical with IEC 60601-2-12: 2006. It supersedes BS EN 794-1:1997 which is withdrawn. The UK participation in its preparation was entrusted by Technical Committee CH/121, Anaesthetic and respiratory equipment, to Subcommittee CH/121/3, Lun
4、g ventilators and related equipment. A list of organizations represented on CH/121/3 can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Stan
5、dard cannot confer immunity from legal obligations. Amendments issued since publication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 09 01:11:30 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD EN 60601-2-12 NORME EUROPENNE EUROPISCHE NORM June 2006 CENELEC E
6、uropean Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B - 1050 Brussels 2006 CENELEC - All rights of exploitation in any form and by any means reserved worldwide
7、 for CENELEC members. Ref. No. EN 60601-2-12:2006 E ICS 11.040.10 English version Medical electrical equipment Part 2-12: Particular requirements for the safety of lung ventilators Critical care ventilators (IEC 60601-2-12:2001) Appareils lectromdicaux Partie 2-12: Rgles particulires de scurit pour
8、ventilateurs pulmonaires Ventilateurs pour utilisation en soins intensifs (CEI 60601-2-12:2001) Medizinische elektrische Gerte Teil 2-12: Besondere Festlegungen fr die Sicherheit von Beatmungsgerten fr den medizinischen Gebrauch Beatmungsgerte fr die Intensivpflege (IEC 60601-2-12:2001) This Europea
9、n Standard was approved by CENELEC on 2006-05-01. 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 alteration. Up-to-date lists and bibliographical references c
10、oncerning 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 translation under the responsibility of a CENELEC member i
11、nto 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, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Ital
12、y, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 09 01:11:30 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Foreword The text of the Inte
13、rnational Standard IEC 60601-2-12:2001, prepared by SC 62D, Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, and ISO TC 121/SC 3, Lung ventilators and related equipment, was submitted to the Unique Acceptance Procedure and was approved by CENELEC as EN 60601-2-12 on
14、2006-05-01. The following dates were fixed: - latest date by which the EN has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2007-05-01 - latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2009-
15、05-01 This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and covers essential requirements of EC Directive 93/42/EEC. See Annex ZZ. This European Standard replaces EN 794-1:1997, Lung ventilators - Part 1: Part
16、icular requirements for critical care ventilators, which was prepared by CEN/TC 215 and will be withdrawn by CEN. Other European Standards which may be of interest relating to lung ventilators prepared by CEN/TC 215 are: EN 794-3:1998, Lung ventilators Part 3: Particular requirements for emergency a
17、nd transport ventilators EN ISO 10651-2:2004, Lung ventilators for medical use - Particular requirements for basic safety and essential performance Part 2: Home care ventilators for ventilator-dependent patients EN ISO 10651-4:2002, Lung ventilators Part 4: Particular requirements for operator-power
18、ed resuscitators EN ISO 10651-6:2004, Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices. In this standard, the following print types are used: requirements, compliance with which can be tested, and de
19、finitions: roman type; explanations, advice, notes, general statements, exceptions and references: small roman type; test specifications: italic type; TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD OR OF THIS PARTICULAR STANDARD: SMALL CAPITALS. Annexes ZA, ZB and ZZ have been added by CENELEC. _
20、 Endorsement notice The text of the International Standard IEC 60601-2-12:2001 was approved by CENELEC as a European Standard without any modification. 2 EN 60601-2-12:2006 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 09 01:11:30 GMT+00:00 2006, Uncontrolled Copy, (c) BSI CONTENTS SECTION ONE
21、 GENERAL 1 2 3 4 5 6 7 SECTION TWO ENVIRONMENTAL CONDITIONS 8 9 10 SECTION THREE PROTECTION AGAINST ELECTRIC SHOCK HAZARDS 13 14 15 16E 17 18 19 20 SECTION FOUR PROTECTION AGAINST MECHANICAL HAZARDS 21 22 23 24Stability in 25 26 27 28 SECTION FIVE PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIV
22、E RADIATION 29 30 31 32 33 34 3 EN 60601-2-12:2006 35 36 FOREWORD.2 INTRODUCTION.5 Scope and object6 Terminology and definitions 7 General requirements .11 General requirements for tests11 Classification11 Identification, marking and documents 11 Power input 15 Basic safety categories.15 Removable p
23、rotective means 15 Environmental conditions 15 General 16 Requirements related to classification.16 Limitation of voltage and/or energy16 NCLOSURES and PROTECTIVE COVERS16 Separation17 Protective earthing, functional earthing and potential equalization17 Continuous LEAKAGE CURRENTS and PATIENT AUXIL
24、IARY CURRENTS.17 Dielectric strength.17 Mechanical strength17 Moving parts.17 Expelled parts.17 Surfaces, corners and edges 17 NORMAL USE17 Vibration and noise.17 Pneumatic and hydraulic power.18 Suspended masses 18 X-radiation18 Alpha, beta, gamma, neutron radiation and other particle radiation18 M
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- BS EN 60601 12 2006
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