1、UL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION OR DISTRIBUTION WITHOUT PERMISSION FROM UL UL 61010-2-101 (IEC 61010-2-101:2015) Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 2-101: Particular Requirements for In Vitro Diagnostic (IVD)
2、Medical EquipmentUL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION OR DISTRIBUTION WITHOUT PERMISSION FROM ULUL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION OR DISTRIBUTION WITHOUT PERMISSION FROM UL UL Standard for Safety for Safety Requirements for Electrical Equipmen
3、t for Measurement, Control and Laboratory Use Part 2-101: Particular Requirements for In Vitro Diagnostic (IVD) Medical Equipment, UL 61010-2-101 (IEC 61010-2-101:2015) Second Edition, Dated August 14, 2015 Summary of Topics Adoption of IEC 61010-2-101, Safety Requirements for Electrical Equipment f
4、or Measurement, Control and Laboratory Use Part 2-101: Particular Requirements for In Vitro Diagnostic (IVD) Medical Equipment (second edition issued January 2015) as a new IEC-based UL standard, UL 61010-2-101 (IEC 61010-2-101:2015), with no National Differences. Although this is the rst-time publi
5、cation of this Standard by UL, it is being published as the Second edition in order to align ULs edition number with that of the IEC Standard. As a result, one or more UL edition numbers have been skipped to match that of the IEC edition number. The new requirements are substantially in accordance w
6、ith Proposal(s) on this subject dated June 12, 2015. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form by any means, electronic, mechanical photocopying, recording, or otherwise without prior permission of UL. UL provides thi
7、s Standard as is without warranty of any kind, either expressed or implied, including but not limited to, the implied warranties of merchantability or tness for any purpose. In no event will UL be liable for any special, incidental, consequential, indirect or similar damages, including loss of prots
8、, lost savings, loss of data, or any other damages arising out of the use of or the inability to use this Standard, even if UL or an authorized UL representative has been advised of the possibility of such damage. In no event shall ULs liability for any damage ever exceed the price paid for this Sta
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10、ion introduced while purchaser is storing an electronic Standard on the purchasers computer system. The requirements in this Standard are now in effect, except for those paragraphs, sections, tables, gures, and/or other elements of the Standard having future effective dates as indicated in the prefa
11、ce. The prior text for requirements that have been revised and that have a future effective date are located after the Standard, and are preceded by a SUPERSEDED REQUIREMENTS notice. AUGUST 14, 2015 UL 61010-2-101 (IEC 61010-2-101:2015) tr1UL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCT
12、ION OR DISTRIBUTION WITHOUT PERMISSION FROM UL AUGUST 14, 2015 UL 61010-2-101 (IEC 61010-2-101:2015) tr2 No Text on This PageUL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION OR DISTRIBUTION WITHOUT PERMISSION FROM UL AUGUST 14, 2015 1 UL 61010-2-101 (IEC 61010-2-101:2015) Safety Requi
13、rements for Electrical Equipment for Measurement, Control and Laboratory Use Part 2-101: Particular Requirements for In Vitro Diagnostic (IVD) Medical Equipment Second Edition August 14, 2015 This ANSI/UL Standard for Safety consists of the Second Edition dated August 14, 2015. The most recent desig
14、nation of ANSI/UL 61010-2-101 (IEC 61010-2-101:2015) as an American National Standard (ANSI) occurred on August 14, 2015. ANSI approval for a standard does not include the Cover Page, Transmittal Pages, Title Page, Preface, or effective date information. The IEC Foreword is also excluded from the AN
15、SI approval of IEC-based standards. Comments or proposals for revisions on any part of the Standard may be submitted to UL at any time. Proposals should be submitted via a Proposal Request in ULs On-Line Collaborative Standards Development System (CSDS) at http:/. ULs Standards for Safety are copyri
16、ghted by UL. Neither a printed nor electronic copy of a Standard should be altered in any way. All of ULs Standards and all copyrights, ownerships, and rights regarding those Standards shall remain the sole and exclusive property of UL. COPYRIGHT 2015 UNDERWRITERS LABORATORIES INC. ANSI/UL 61010-2-1
17、01-2015UL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION OR DISTRIBUTION WITHOUT PERMISSION FROM UL AUGUST 14, 2015 UL 61010-2-101 (IEC 61010-2-101:2015) 2 No Text on This PageUL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION OR DISTRIBUTION WITHOUT PERMISSION FROM UL CON
18、TENTS Preface (UL) 4 FOREWORD 5 1 Scope and object .8 1.2 Object .9 2 Normative references 9 3 Terms and denitions 9 3.1 Equipment and states of equipment 9 4 Tests .10 5 Marking and documentation .10 5.2 Warning markings .12 5.3 Durability of markings 13 6 Protection against electric shock .16 7 Pr
19、otection against mechanical HAZARDS 17 8 Resistance to mechanical stresses .18 8.1 General 19 9 Protection against the spread of re 19 10 Equipment temperature limits and resistance to heat 19 11 Protection against HAZARDS from uids .19 12 Protection against radiation, including laser sources, and a
20、gainst sonic and ultrasonic pressure .19 13 Protection against liberated gases and substances, explosion and implosion .19 13.101 Biohazardous substances .20 14 Components and subassemblies .20 14.3 Overtemperature protection devices 20 15 Protection by interlocks 20 15.1 General .20 16 HAZARDS resu
21、lting from application .20 16.2 Ergonomic aspects .20 17 RISK Assessment 21 Annexes Annex L (informative) Index of dened terms Bibliography AUGUST 14, 2015 UL 61010-2-101 (IEC 61010-2-101:2015) 3UL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION OR DISTRIBUTION WITHOUT PERMISSION FROM U
22、L Preface (UL) This UL Standard is based on IEC Publication 61010-2-101: second edition Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 2-101: Particular Requirements for In Vitro Diagnostic (IVD) Medical Equipment. IEC publication 61010-2-101 is copyrig
23、hted by the IEC. Efforts have been made to synchronize the UL edition number with that of the corresponding IEC standard with which this standard is harmonized. As a result, one or more UL edition numbers have been skipped to match that of the IEC edition number. This UL Standard 61010-2-101 Standar
24、d for Safety for Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 2-101: Particular Requirements for In Vitro Diagnostic (IVD) Medical Equipment, is to be used in conjunction with the third edition of UL 61010-1. The requirements for laboratory equipment
25、for the heating of materials are contained in this Part 2 Standard and UL 61010-2-101. Requirements of this Part 2 Standard, where stated, amend the requirements of UL 61010-1. Where a particular subclause of UL 61010-1 is not mentioned in UL 61010-2-101, the UL 61010-1 subclause applies. The text,
26、gures and tables of IEC Publication 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, copyright January, 2015 are used in this Standard with the consent of the
27、 IEC and the American National Standards Institute (ANSI). The IEC copyrighted material has been reproduced with permission from ANSI. ANSI should be contacted regarding the reproduction of any portion of the IEC material. The IEC Foreword and Introduction are not a part of the requirements of this
28、Standard but are included for information purposes only. Copies of IEC Publication 61010-2-101 may be purchased from ANSI, 11 West 42nd Street, New York, New York, 10036, (212) 642-4900. Note Although the intended primary application of this Standard is stated in its Scope, it is important to note t
29、hat it remains the responsibility of the users of the Standard to judge its suitability for their particular purpose. UL Effective Date The effective date for UL 61010-2-101 (IEC 61010-2-101:2015), Second edition is August 14, 2015. A UL effective date is one established by Underwriters Laboratories
30、 Inc. and is not part of the ANSI approved standard. AUGUST 14, 2015 UL 61010-2-101 (IEC 61010-2-101:2015) 4UL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION OR DISTRIBUTION WITHOUT PERMISSION FROM UL INTERNATIONAL ELECTROTECHNICAL COMMISSION SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMEN
31、T 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 N
32、ational Committees). The object of IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic elds. To this end and in addition to other activities, IEC publishes International Standards, Technical Specications, Technical Reports, Public
33、ly Available Specications (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 nongovernmenta
34、l 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 tech
35、nical 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 I
36、EC 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 unifo
37、rmity, 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)
38、IEC itself does not provide any attestation of conformity. Independent certication 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 certication bodies. 6) All users should ensure th
39、at 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 na
40、ture 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 referenc
41、ed 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. Internati
42、onal 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 in accordance with IEC Guide 104. AUGUST 14, 2015 UL 61010-2-101 (IEC 61010-2-101:2015) 5UL COPYRIGHTED MATERIAL NOT A
43、UTHORIZED FOR FURTHER REPRODUCTION OR DISTRIBUTION WITHOUT PERMISSION FROM UL This standard has been prepared in close collaboration with Working Group CENELEC BTTF 88.1. This second edition cancels and replaces the rst edition published in 2002. It constitutes a technical revision and includes the
44、following signicant changes from the rst edition, as well as numerous other changes: excluded IEC 61010-2-081 (general laboratory equipment) from the scope. This separates IEC 61010-2-081 and IEC 61010-2-101 equipment; updated Biohazard and Lot symbols in Table 1 in Clause 5; added requirement for w
45、ithin expiration consumables and authorized representative details in Instructions for Use to Clause 5; added requirement for gas or liquid markings and ratings to Clause 5; added requirement to include OPERATOR instructions to deal with consumable or sample spills, jams or breakage inside equipment
46、, disposal of hazardous waste, personal protection, RISK reduction procedures relating to ammable liquids, burns from surfaces, and loading and unloading of sample and reagents in Instructions for Use to Clause 5; added requirement for manufacturer to provide instructions on equipment transport, sto
47、rage and removal from use to Clause 5; added normative reference ISO 18113-5 for instructions for use of self-test IVD medical equipment in Clause 5; added requirement for OPERATOR maintenance instructions to Clause 7; added requirements for sample zones and loading zones to Clause 7; excluded equip
48、ment whose size and weight make unintentional movement unlikely from drop test in Clause 8; added requirement for biohazard marking to Clause 13; added requirement for interlock systems containing electric/electronic or programmable components to Clause 15; added informative reference to Usability s
49、tandard IEC 62366 to Clause 16; replaced Clause 17with requirements of ISO 14971 for RISK assessment. Annex BB Instructions for use for self-testing IVD Medical Equipment deleted and a reference given to ISO 18113-5 in Clause 5; The text of this standard is based on the following documents: FDIS Report on voting 66/545/FDIS 66/560/RVD AUGUST 14, 2015 UL 61010-2-101 (IEC 61010-2-101:2015) 6UL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION OR DISTRIBUTION WITHOUT
