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INTERNATIONAL STANDARD Safety requirements for electrical equipment for measure

INTERNATIONAL STANDARD Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment INTERNATIONAL ELECTROTECHNICAL COMMISSION ICS 11.040.55; 19.080 ISBN 978-2-8322-6114-9 GROUP SAFETY PUBLICATION ® Registered trademark of the International Electrotechnical Commission ® Warning! Make sure that you obtained this publication from an authorized distributor. IEC 61010-2-101 Edition 3.0 2018-10 REDLINE VERSION colour inside This is a preview - click here to buy the full publication – 2 – IEC 61010-2-101:2018 RLV © IEC 2018 CONTENTS FOREWORD ......................................................................................................................... 3 1 Scope and object ........................................................................................................... 6 2 Normative references..................................................................................................... 7 3 Terms and definitions .................................................................................................... 7 4 Tests ............................................................................................................................. 8 5 Marking and documentation ........................................................................................... 8 6 Protection against electric shock .................................................................................. 12 7 Protection against mechanical HAZARDS ........................................................................ 13 8 Resistance to mechanical stresses ............................................................................... 14 9 Protection against the spread of fire ............................................................................. 15 10 Equipment temperature limits and resistance to heat .................................................... 15 11 Protection against HAZARDS from fluids and solid foreign objects ................................... 15 12 Protection against radiation, including laser sources, and against sonic and ultrasonic pressure ...................................................................................................... 15 13 Protection against liberated gases and substances, explosion and implosion ................ 15 14 Components and subassemblies .................................................................................. 15 15 Protection by interlocks ................................................................................................ 16 16 HAZARDS resulting from application............................................................................... 16 17 RISK assessment ......................................................................................................... 16 Annexes ............................................................................................................................. 16 Annex L (informative) Index of defined terms ...................................................................... 17 Bibliography ....................................................................................................................... 18 Table 1 – Symbols ................................................................................................................ 9 This is a preview - click here to buy the full publication IEC 61010-2-101:2018 RLV © IEC 2018 – 3 – INTERNATIONAL ELECTROTECHNICAL COMMISSION ____________ SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non- governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international consensus of opinion on the relevant subjects since each technical committee has representation from all interested IEC National Committees. 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any misinterpretation by any end user. 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any services carried out by independent certification bodies. 6) All users should ensure that they have the latest edition of this publication. 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and members of its technical committees and IEC National Committees for any personal injury, property damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC Publications. 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is indispensable for the correct application of this publication. 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights. This redline version of the official IEC Standard allows the user to identify the changes made to the previous edition. A vertical bar appears in the margin wherever a change has been made. Additions are in green text, deletions are in strikethrough red text. This is a preview - click here to buy the full publication – 4 – IEC 61010-2-101:2018 RLV © IEC 2018 International Standard IEC 61010-2-101 has been prepared by IEC technical committee 66: Safety of measuring, control and laboratory equipment. It has the status of a group safety publication, as specified in IEC Guide 104. This document has been prepared in close collaboration with Working Group CENELEC BTTF 88.1. This third edition cancels and replaces the second edition published in 2015. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) adaptation of changes introduced by Amendment 1 of IEC 61010-1; b) added tolerance for stability of AC voltage test equipment to Clause 6. The text of this International Standard is based on the following documents: CDV Report on voting 66/644/CDV 66/669/RVC Full information on the voting for the approval of this International Standard can be found in the report on voting indicated in the above table. This document has been drafted in accordance with the ISO/IEC Directives, Part 2. A list of all parts of the IEC 61010 series, under the general title: Safety requirements for electrical equipment for measurement, control, and laboratory use, may be found on the IEC website. This Part 2-101 is intended to be used in conjunction with IEC 61010-1. It was established on the basis of the third edition (2010) and its Amendment 1 (2016). This Part 2-101 supplements or modifies the corresponding clauses in IEC 61010-1 so as to convert that publication into the IEC standard: Particular requirements for in vitro diagnostic (IVD) medical equipment. Where a particular subclause of Part 1 is not mentioned in this Part 2, that subclause applies as far as is reasonable. Where this part states “addition”, “modification”, “replacement”, or “deletion” the relevant requirement, test specification or note in Part 1 should 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) subclauses, figures, tables and notes which are additional to those in part 1 are numbered starting from 101. Additional annexes are lettered starting from AA and additional list items are lettered from aa). This is a preview - click here to buy the full publication IEC 61010-2-101:2018 RLV © IEC 2018 – 5 – The committee has decided that the contents of this document will remain unchanged until the stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to the specific document. At this date, the document will be • reconfirmed, • withdrawn, • replaced by a revised edition, or • amended. IMPORTANT – The “colour inside” logo on the cover page of this publication indicates that it contains colours which are considered to be useful for the correct understanding of its contents. Users should therefore print this publication using a colour printer. This is a preview - click here to buy the full publication – 6 – IEC 61010-2-101:2018 RLV © IEC 2018 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment 1 Scope and object This clause of Part 1 is applicable except as follows: 1.1.1 Equipment included in scope Replacement: Replace the text, except the first paragraph, with the following new text: This part of IEC 61010 applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes. IVD medical equipment, whether used alone or in combination, is intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning one or more of the following: • a physiological or pathological state; or • a congenital abnormality; • the determination of safety and compatibility with potential recipients; • the monitoring of therapeutic measures. Self-test IVD medical equipment is intended by the manufacturer for use by lay persons in a home environment. NOTE If all or part of the uploads/s1/info-iec61010-2-101-ed3-0-rlv-en.pdf