BS-EN-61010-2-101-2002.pdf
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1、BRITISH STANDARD BS EN 61010-2-101: 2002 Safety requirements for electrical equipment for measurement, control, and laboratory use Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment The European Standard EN 61010-2-101:2002 has the status of a British Standard ICS 11
2、.040.55; 19.080 ? BS EN 61010-2-101:2002 This British Standard, having been prepared under the direction of the Materials and Chemicals Sector Policy and Strategy Committee, was published under the authority of the Standards Policy and Strategy Committee on 9 December 2002 BSI 9 December 2002 ISBN 0
3、 580 40819 1 National foreword This British Standard is the official English language version of EN 61010-2-101:2002. It was derived by CENELEC from IEC 61010-2-101:2002. The CENELEC common modifications have been implemented at the appropriate places in the text and are indicated by tags (e.g. ?).
4、The UK participation in its preparation was entrusted to Technical Committee LBI/40, Electrical laboratory equipment, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. This British Standard is to be read in conjunction
5、 with BS EN 61010-1:2001 Safety requirements for electrical equipment for measurement, control, and laboratory use, Part 1: General requirements, which it supplements or modifies as detailed in the Foreword to EN 61010-2-101. Cross-references The British Standards which implement international or Eu
6、ropean 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 to include
7、 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 any enquirie
8、s 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 title page, pages 2 to 23 and a back cove
9、r. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments EUROPEAN STANDARDEN 61010-2-101 NORME EUROPENNE EUROPISCHE NORMNovember 2002 CENELEC European Committee for Electrotechnical Standardization Com
10、it Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B - 1050 Brussels 2002 CENELEC -All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 61010-2-101:2002 E ICS 11
11、.040.55; 19.080 English version Safety requirements for electrical equipment for measurement, control, and laboratory use Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment (IEC 61010-2-101:2002, modified) Rgles de scurit pour appareils lectriques de mesurage, de rgu
12、lation et de laboratoire Partie 2-101: Prescriptions particulires pour les appareils mdicaux de diagnostic in vitro (DIV) (CEI 61010-2-101:2002, modifie) Sicherheitsbestimmungen fr elektrische Mess-, Steuer-, Regel- und Laborgerte Teil 2-101: Besondere Anforderungen an In-Vitro-Diagnostik-(IVD)-Medi
13、zingerte (IEC 61010-2-101:2002, modifiziert) This European Standard was approved by CENELEC on 2002-09-01. 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 alte
14、ration. 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 t
15、ranslation 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, Czech Republic, Denmark, Finland, France, Germany, Gre
16、ece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United Kingdom. Foreword The text of document 66/261/FDIS, future edition 1 of IEC 61010-2-101, prepared by IEC TC 66, Safety of measuring, control, and laboratory equipm
17、ent, together with common modifications prepared by CLC/SR 66 following deliberations in CLC/BTTF 88-1, was submitted to the Unique Acceptance Procedure and was approved by CENELEC as EN 61010-2-101 on 2002-09-01. The following dates were fixed: latest date by which the EN has to be implemented at n
18、ational level by publication of an identical national standard or by endorsement(dop) 2003-09-01 latest date by which the national standards conflicting with the EN have to be withdrawn(dow) 2005-09-01 This Part 2-101 is to be used in conjunction with EN 61010-1:2001, Safety requirements for electri
19、cal equipment for measurement, control and laboratory use - Part 1: General requirements. Consideration may be given to future editions of, or amendments to, EN 61010-1. This Part 2-101 supplements or modifies the corresponding clauses of EN 61010-1 so as to convert it into the European Standard: Sa
20、fety requirements for in vitro diagnostic (IVD) medical equipment. Where a particular clause or subclause of Part 1 is not mentioned in this Part 2-101, that clause or subclause applies as far as is reasonable. Where this Part 2-101 states “addition“, “modification“ or “replacement“, the relevant te
21、xt of Part 1 is to be adapted accordingly. In this standard: 1)the following print types are used: - requirements: in roman type; -NOTES: in smaller roman type; - conformity and test: in italic type; - terms used throughout this standard which have been defined in clause 3: SMALL ROMAN CAPITALS. 2)s
22、ubclauses or figures which are additional to those in Part 1 are numbered starting from 101, the additional annexes are lettered AA, BB, etc. Annexes designated “normative“ are part of the body of the standard. Annexes designated “informative“ are given for information only. In this standard, annexe
23、s AA and ZA are normative and annex BB is informative. Annex ZA has been added by CENELEC. Endorsement notice The text of the International Standard IEC 61010-2-101:2002 was approved by CENELEC as a European Standard with agreed common modifications. _ Page 2 EN 610102101:2002 160-01-2101 ? IEC:0202
24、 3 CONTENTS 1Scope and object4 2Normative references .5 3Terms and definitions .5 4Tests6 5MARKING and documentation.7 6Protection against electric shock 11 7Protection against mechanical HAZARDS11 8Mechanical resistance to shock and impact 11 9Protection against the spread of fire .12 10Equipment t
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