prEN IEC 61010-2-101:2017

Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment

NEW!IEC 61010-2-101:2018 is available as IEC 61010-2-101:2018 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 61010-2-101:2018 applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes. 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: - adaptation of changes introduced by Amendment 1 of IEC 61010-1; - added tolerance for stability of AC voltage test equipment to Clause 6. 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).

Sicherheitsbestimmungen für elektrische Mess-, Steuer-, Regel- und Laborgeräte – Teil 2-101: Besondere Anforderungen an In-vitro-Diagnostik (IVD) Medizingeräte

Varnostne zahteve za električno opremo za meritve, nadzor in laboratorijsko uporabo - 2-101. del: Posebne zahteve za diagnostično in vitro (IVD) medicinsko opremo (IEC 61010-2-101:201X (EQV)

General Information

• Status: Not Published
• ICS: 11.040.55 - Diagnostic equipment
• ICS: 19.080 - Electrical and electronic testing
• Technical Committee: CLC/TC 66X - Safety of measuring, control, and laboratory equipment
• Drafting Committee: IEC/TC 66 - IEC_TC_66
• Current Stage: 4020 - Enquiry circulated
• Due Date: 01-Dec-2017
• Completion Date: 01-Dec-2017
• Directive: 2017/746 - Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
• Mandate: M/252 - Standardization Mandate to CEN/CENELEC concerning the development of European standards relating to in vitro diagnostic medical devices
• Ref Project: oSIST prEN 61010-2-101:2018 - Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment IEC 61010-2-101:201X (EQV)

RELATIONS

• Revised: EN 61010-2-101:2017 - Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
• Effective Date: 10-Oct-2017
• Amended By: prEN IEC 61010-2-101:2017/prA11 - Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment
• Effective Date: 27-Apr-2021

Standards Content (sample)

SLOVENSKI STANDARD
oSIST prEN 61010-2-101:2018
01-februar-2018
9DUQRVWQH]DKWHYH]DHOHNWULþQRRSUHPR]DPHULWYHQDG]RULQODERUDWRULMVNR
XSRUDERGHO3RVHEQH]DKWHYH]DGLDJQRVWLþQRLQYLWUR,9'PHGLFLQVNR
RSUHPR,(&;(49

Safety requirements for electrical equipment for measurement, control, and laboratory

use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment IEC

61010-2-101:201X (EQV)
Ta slovenski standard je istoveten z: prEN 61010-2-101:2017
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
19.080 (OHNWULþQRLQHOHNWURQVNR Electrical and electronic
SUHVNXãDQMH testing
oSIST prEN 61010-2-101:2018 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN 61010-2-101:2018
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oSIST prEN 61010-2-101:2018
66/644/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 61010-2-101 ED3
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2017-12-01 2018-02-23
SUPERSEDES DOCUMENTS:
66/630A/RR
IEC TC 66 : SAFETY OF MEASURING, CONTROL AND LABORATORY EQUIPMENT
SECRETARIAT: SECRETARY:
United Kingdom Mr David Hyde
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:
Other TC/SCs are requested to indicate their interest, if
any, in this CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY

SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING

Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft
for Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.

This document is still under study and subject to change. It should not be used for reference purposes.

Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of

which they are aware and to provide supporting documentation.
TITLE:

Safety requirements for electrical equipment for measurement, control, and laboratory use – Part

2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment
NOTE FROM TC/SC OFFICERS:

This CDV is intended only to align IEC 61010-2-101:2015 with IEC 61010-1:2010 and its amendment

1:2016. A revision this soon is justified by the large number of significant changes introduced by this

amendment 1. With this revision IEC 61010-2-101 will be in line with the latest requirements of IEC

61010-1 + A1.

Copyright © 2017 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to

download this electronic file, to make a copy and to print out the content for the sole purpose of preparing National

Committee positions. You may not copy or "mirror" the file or printed version of the document, or any part of it, for

any other purpose without permission in writing from IEC.
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This document contains no technical changes to already accepted base documents (IEC 61010-1:2010

and its amendment 1:2016 and IEC 61010-2-101:2015) but one; Clause 6.8.3.1 is modified because

otherwise it would need a specific European deviation in order to be harmonised to the LVD

2014/35/EU (ref. NAC assessment of IEC 61010-1/A1). Further technical development is reserved for a

new amendment or edition to be initiated separately as necessary.

This alignment is realised as a new 3rd edition of IEC 61010-2-101 simply because of document

control; the previous edition 2.0 is based on the third edition of IEC 61010-1:2010 (without the

Amendment 1:2016) and amending it to incorporate the contents of IEC 61010-1 Amendment 1 would

need an unnecessary repeating of the requirements in that amendment 1 that are not particular for the

equipment in the scope of IEC 61010-2-101. Furthermore, technically, one would need to follow 4

documents in parallel to get the full text of this part 2 (61010-1:2010, 61010-1 A1:2016, 61010-2-

101:2015, and 61010-2-101 A1).With this approach, and when the consolidated version of IEC 61010-

1:2010/A1:2016 conveniently is published, only two documents are needed.
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oSIST prEN 61010-2-101:2018
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1 CONTENTS

2 FOREWORD ......................................................................................................................... 3

3 1 Scope and object ........................................................................................................... 5

4 2 Normative references..................................................................................................... 6

5 3 Terms and definitions .................................................................................................... 6

6 4 Tests ............................................................................................................................. 7

7 5 Marking and documentation ........................................................................................... 7

8 6 Protection against electric shock .................................................................................. 11

9 7 Protection against mechanical HAZARDS ........................................................................ 12

10 8 Resistance to mechanical stresses ............................................................................... 13

11 9 Protection against the spread of fire ............................................................................. 14

12 10 Equipment temperature limits and resistance to heat .................................................... 14

13 11 Protection against HAZARDS from fluids ......................................................................... 14

14 12 Protection against radiation, including laser sources, and against sonic and

15 ultrasonic pressure ...................................................................................................... 14

16 13 Protection against liberated gases and substances, explosion and implosion ................ 14

17 14 Components and subassemblies .................................................................................. 14

18 15 Protection by interlocks ................................................................................................ 15

19 16 HAZARDS resulting from application............................................................................... 15

20 17 RISK assessment ......................................................................................................... 15

21 Annexes ............................................................................................................................. 15

22 Annex L (informative) Index of defined terms ...................................................................... 16

23 Bibliography ....................................................................................................................... 17

25 Table 1 – Symbols ................................................................................................................ 7

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28 INTERNATIONAL ELECTROTECHNICAL COMMISSION
29 ____________
31 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT
32 FOR MEASUREMENT, CONTROL AND LABORATORY USE –
34 Part 2-101: Particular requirements for
35 in vitro diagnostic (IVD) medical equipment
37 FOREWORD

38 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising

39 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote

40 international co-operation on all questions concerning standardization in the electrical and electronic fields. To

41 this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,

42 Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC

43 Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested

44 in the subject dealt with may participate in this preparatory work. International, governmental and non-

45 governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely

46 with the International Organization for Standardization (ISO) in accordance with conditions determined by

47 agreement between the two organizations.

48 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international

49 consensus of opinion on the relevant subjects since each technical committee has representation from all

50 interested IEC National Committees.

51 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National

52 Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC

53 Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any

54 misinterpretation by any end user.

55 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications

56 transparently to the maximum extent possible in their national and regional publications. Any divergence

57 between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in

58 the latter.

59 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity

60 assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any

61 services carried out by independent certification bodies.

62 6) All users should ensure that they have the latest edition of this publication.

63 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and

64 members of its technical committees and IEC National Committees for any personal injury, property damage or

65 other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and

66 expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC

67 Publications.

68 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is

69 indispensable for the correct application of this publication.

70 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of

71 patent rights. IEC shall not be held responsible for identifying any or all such patent rights.

72 International Standard IEC 61010-2-101 has been prepared by IEC technical committee 66:

73 Safety of measuring, control and laboratory equipment.

74 It has the status of a group safety publication, as specified in IEC Guide 104.

75 This standard has been prepared in close collaboration with Working Group CENELEC

76 BTTF 88.1.

77 This second third edition cancels and replaces the first second edition published in 201502. It

78 constitutes a technical revision and includes the following significant changes from the first

79 second edition, as well as numerous othera few editorial changes:
80 • adaptation of changes introduced by Amendment 1 of IEC 61010-1;
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81 • added tolerance for stability of a.c. voltage test equipment to Clause 6.
82 • .
83 The text of this standard is based on the following documents:
FDIS Report on voting
66/xxx/FDIS 66/xxx/RVD

85 Full information on the voting for the approval of this standard can be found in the report on

86 voting indicated in the above table.

87 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

88 A list of all parts of the IEC 61010 series, under the general title: Safety requirements for

89 electrical equipment for measurement, control, and laboratory use, may be found on the IEC

90 website.

91 This Part 2-101 is intended to be used in conjunction with IEC 61010-1. It was established on

92 the basis of the third edition (2010) and its Amendment 1 (2016). This Part 2-101 supplements

93 or modifies the corresponding clauses in IEC 61010-1 so as to convert that publication into

94 the IEC standard: Safety requirements for in vitro diagnostic (IVD) medical equipment.

95 Where a particular subclause of Part 1 is not mentioned in this Part 2, that subclause applies

96 as far as is reasonable. Where this part states “addition”, “modification”, “replacement”, or

97 “deletion” the relevant requirement, test specification or note in Part 1 should be adapted

98 accordingly.
99 In this standard:
100 1) the following print types are used:
101 – requirements: in roman type;
102 – NOTES: in smaller roman type;
103 – conformity and test: in italic type;

104 – terms used throughout this standard which have been defined in clause 3: SMALL

105 ROMAN CAPITALS;

106 2) subclauses, figures, tables and notes which are additional to those in part 1 are numbered

107 starting from 101. Additional annexes are lettered starting from AA.

108 The committee has decided that the contents of this publication will remain unchanged until

109 the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data

110 related to the specific publication. At this date, the publication will be
111 • reconfirmed,
112 • withdrawn,
113 • replaced by a revised edition, or
114 • amended.
115
116
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117 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT
118 FOR MEASUREMENT, CONTROL AND LABORATORY USE –
119
120 Part 2-101: Particular requirements for
121 in vitro diagnostic (IVD) medical equipment
122
123
124
125 1 Scope and object
126 This clause of Part 1 is applicable except as follows:
127 1.1.1 Equipment included in scope
128 Replacement:
129 Replace the text by the following:

130 This part of IEC 61010 applies to equipment intended for in vitro diagnostic (IVD) medical

131 purposes, including self-test IVD medical purposes.

132 IVD medical equipment, whether used alone or in combination, is intended by the

133 manufacturer to be used in vitro for the examination of specimens, including blood and tissue

134 samples, derived from the human body, solely or principally for the purpose of providing

135 information concerning one or more of the following:
136 • a physiological or pathological state; or
137 • a congenital abnormality;
138 • the determination of safety and compatibility with potential recipients;
139 • the monitoring of therapeutic measures.

140 Self-test IVD medical equipment is intended by the manufacturer for use by lay persons in a

141 home environment.

142 NOTE If all or part of the equipment falls within the scope of one or more other part 2 standards of IEC 61010 as

143 well as within the scope of this standard, considerations have to be given to those other part 2 standards.

144 1.1.2 Equipment excluded from scope
145 Addition:
146 Add the following item:

147 aa) Equipment in the scope of IEC 61010-2-081 unless they are specifically intended by

148 their manufacturer to be used for in vitro diagnostic examination.
149 1.2 Object
150 1.2.1 Aspects included in scope
151 Addition:
152 Add two items:
153 aa) biohazards;
154 bb) hazardous chemical substances.
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155 1.2.2 Aspects excluded from scope
156 Addition:
157 Add the following item and note:

158 aa) the handling or manipulation outside the equipment of material under analysis.

159 NOTE Requirements covering these subjects are the responsibility of committees preparing relevant standards.

160 2 Normative references
161 This clause of Part 1 is applicable except as follows:
162 Addition:
163 Add the following references:

164 IEC 62061, Safety of machinery – Functional safety of safety-related electrical, electronic and

165 programmable electronic control systems

166 ISO 14971, Medical devices – Application of risk management to medical devices

167 ISO 18113-5, In vitro diagnostic medical devices – Information supplied by the manufacturer

168 (labelling) – In vitro diagnostic instruments for selftesting

169 ISO 13849 (all parts), Safety of machinery – Safety-related parts of control systems

170 ISO 13857, Safety of machinery – Safety distances to prevent hazard zones being reached by

171 upper and lower limbs
172 3 Terms and definitions
173 This clause of Part 1 is applicable except as follows:
174 3.1 Equipment and states of equipment
175 Addition:
176 Add the following terms and definitions:
177 3.1.101
178 SAMPLE ZONE

179 area where OPERATOR access is typically unintended; the inside of this zone presents

180 mechanical HAZARDS and a more likely probability of biohazardous human skin puncture

181 3.1.102
182 LOADING ZONE

183 area of automated equipment where an OPERATOR handles sample or reagent material.

184 3.5.12 RESPONSIBLE BODY
185 Addition:
186 Add the following note:
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187 NOTE 1 This is not the European Community responsible authority.
188 4 Tests
189 This clause of Part 1 is applicable.:
190 5 Marking and documentation
191 This clause of Part 1 is applicable except as follows:
192 5.1.1 General
193 Replacement:
194 Replace the third paragraph by the following:

195 Letter symbols for quantities and units shall be in accordance with IEC 60027. Internationally

196 recognized symbols, including those of Table 1, shall be used as far as possible. If other

197 additional symbols are required, it shall not be possible to confuse them with the

198 internationally recognized symbols. There are no colour requirements for symbols. Graphic

199 symbols shall be explained in the documentation.
200 Table 1 – Symbols
201 Addition:
202 Add the following symbols to Table 1:
Number Symbol Publication Description
Background colour
– optional;
Symbol colour
101 ISO 7000- 0659 (2004-01) Biological RISKS
– optional;
Outline / outline colour
– optional;
102 ISO 7000- 2492 (2004-01) Batch code
203
204 5.1.2 Identification
205 Replacement:
206 Replace the text by the following:
207 Equipment shall, as a minimum, be marked with the following information:

208 a) manufacturer’s name or trade mark, and the address. The address shall include at least

209 the city and country;

210 NOTE 1 National regulation may require more details on the address than required in a).

211 b) model number, name, or other means of identifying the equipment;
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212 The following additional information shall be marked on the equipment or packaging or in the

213 instructions for use:
214 1) the serial number, for example SN XXXX or alternatively th
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