BS-EN-60601-2-31-1995 BS-5724-2.31-1995.pdf
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1、BRITISH STANDARD BS EN 60601-2-31: 1995 BS 5724-2.31: 1995 IEC 601-2-31: 1994 Implementing Amendment No. 1 not published separately Medical electrical equipment Part 2: Particular requirements for safety Section 2.31 Specification for external cardiac pacemakers with internal power source The Europe
2、an Standard EN 60601-2-31:1995 with the incorporation of amendment A1:1998 has the status of a British Standard ICS 11.040.40 BS EN 60601-2-31:1995 This British Standard, having been prepared under the direction of the Health and Environment Sector Board, was published under the authority of the Sta
3、ndards Board and comes into effect on 15 June 1995 BSI 06-1999 The following BSI references relate to the work on this standard: Committee reference HCC/92 Draft for comment 91/53412 DC ISBN 0 580 24315 X Committees responsible for this British Standard The preparation of this British Standard was e
4、ntrusted to Technical Committee HCC/92, Active implants, upon which the following bodies were represented: Association of British Health-care Industries Biological Engineering Society British Cardiac Society British Pacing and Electrophysiology Group British Surgical Trades Association Department of
5、 Health Electricity Association Institute of Physical Sciences in Medicine (IPSM) Institution of Electrical Engineers Medical Research Council Ministry of Defence National Heart and Lung Institute National Radiological Protection Board Royal College of Physicians of London Society of Cardiothoracic
6、Surgeons of Great Britain and Ireland Amendments issued since publication Amd. No.DateComments 10132November 1998 Indicated by a sideline in the margin BS EN 60601-2-31:1995 BSI 06-1999i Contents Page Committees responsibleInside front cover National forewordii Foreword2 Text of EN 60601-2-315 List
7、of referencesInside back cover BS EN 60601-2-31:1995 ii BSI 06-1999 National foreword This section of BS EN 60601 has been prepared by Technical Committee HCC/92 and is the English language version of EN 60601-2-31 Medical electrical equipment Part 2: Particular requirements for the safety of extern
8、al pacemakers with internal power source, including Amendment A1:1998 published by the European Committee for Electrotechnical Standardization (CENELEC). It is identical with IEC 601-2-31:1994 including Amendment 1:1998 published by the International Electrotechnical Commission (IEC). This Particula
9、r Standard amends and supplements BS 5724-1:1989 hereinafter called the General Standard. As stated in 1.3 of the General Standard, the requirements of this Particular Standard take precedence over those of the General Standard. As in the General Standard, the requirements are followed by compliance
10、 tests. The numbers of the sections and clauses in this standard refer to the related sections and clauses in the General Standard. Clauses, subclauses or figures that are additional to those of the General Standard are numbered starting from 101; additional appendices are lettered AA, BB, etc. and
11、additional items are lettered aa), bb) etc. 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 text of this standard. “Amendment” means tha
12、t 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. General guidance in the application of this Particular Standard and
13、a rationale for the more important requirements are 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. Neither this annex nor Annex BB form a part of this
14、standard. Cross-references Additional information. The following print types are used in this standard. Requirements, compliance with which can be tested, and definitions: in roman type. Explanations, advice and general statements: in small roman type Test procedures : in italic type. Terms defined
15、in clause 2 of BS 5724-1: in SMALL CAPITALS. For the purposes of this British Standard, any references to IEC page numbers in the text should be ignored. Textual errors. When adopting text of the international standard, the textual errors listed below were discovered. They have been marked in the te
16、xt and have been reported to IEC in a proposal to amend the text of the international standard. International standardCorresponding British Standard EN 60601-1:1990 (IEC 601-1:1988) EN 60601-1-2:1993 (IEC 601-1-2:1993) EN 60801-2:1993 (IEC 801-2:1991) BS 5724 Medical electrical equipment Part 1:1989
17、 General requirements for safety BS EN 60601 Medical electrical equipment Part 1 General requirements for safety Section 1.2:1993 Collateral standard. Electromagnetic compatibility. Requirements and tests BS EN 60801 Electromagnetic compatibility for industrial-process measurement and control equipm
18、ent Part 2:1993 Electrostatic discharge requirements BS EN 60601-2-31:1995 BSI 06-1999iii In Table AA.1, the first two lines of text should be deleted and replaced by the following. In clause 6.1 aa) of Annex AA, last line, delete “white and blue” and substitute with “white and a contrasting colour”
19、. Also, re-number this clause as “6.1 aa), bb)” and re-number “6.1 bb)” as “6.1 cc)”. A British Standard does not 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 it
20、self confer immunity from legal obligations. Failure to paceLow batteryBattery indicator49.101 Poor connectionTest of connection6.8.2 aa) 12) 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 cover and a bac
21、k 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. iv blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 60601-2-31 January 1995 + A1 April 1998 ICS 11.040.40 Descript
22、ors: Medical electrical equipment, external cardiac pacemaker, safety requirements, protection against electric shock, protection against mechanical hazard, radiation protection, fire protection, environmental conditions English version Medical electrical equipment Part 2-31: Particular requirements
23、 for the safety of external cardiac pacemakers with internal power source (includes amendment A1:1998) (IEC 60601-2-31:1994 + A1:1998) Appareils lectromdicaux Partie 2-31: Rgles particulires de scurit des stimulateurs cardiaques externes source dnergie interne (inclut lamendement A1:1998) (CEI 60601
24、-2-31:1994 + A1:1998) Medizinische elektrische Gerte Teil 2-31: Besondere Festlegungen fr die Sicherheit von externen Herzschrittmachern mit interner Stromversorgung (enthlt nderung A1:1998) (IEC 60601-2-31:1994 + A1:1998) This European Standard was approved by CENELEC on 1994-12-06; amendment A1 wa
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