Medical electrical equipment - Part 2-85: Particular requirements for basic safety and essential performance of cerebral tissue oximeter equipment (ISO/FDIS 80601-2-85:2020)

This particular standard applies to basic safety and essential performance of cerebral tissue oximeter equipment (t-NIRS), which is a unique application of NIRS in that it employs multiple wavelengths of light energy and time-resolved (frequency or time domain) and/or spatially resolved methods to derive a quantitative measure of tissue oxygen saturation of haemoglobin within the field of the NIRS sensor. This particular standard applies to ME EQUIPMENT used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. Additional standards may apply to ME EQUIPMENT for those environments of use.
Not included within the scope of this particular standard are:
a) Invasive tissue or vascular oximeters
b) Device measuring dissolved oxygen
c) Functional NIRS device covered by IEC 80601-2-71, where not intended for obtaining cerebral tissue oximeter signals for monitoring purposes
d) Pulse oximeter covered by ISO 80601-2-61, where not intended for obtaining cerebral tissue oximeter signals for monitoring purposes; however, manufacturers should consider using relevant clauses of this standard as appropriate for their intended use.
NOTE: a manufacturer may claim monitoring of tissue other than cerebral, which is not covered
by this standard.

Medizinische elektrische Geräte - Teil 2-85: Besondere Anforderungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Geräten für die zerebrale Oxymetrie (ISO/DIS 80601-2-85:2020)

Dieses Dokument gilt für die Basissicherheit und wesentlichen Leistungsmerkmale von zerebralen Gewebeoximetriegeräten, die Licht verschiedener Wellenlänge zur quantitativen Messung der Sauerstoffsättigung des Hämoglobins innerhalb des unter dem am Kopf befestigten Sensor befindlichen Gewebevolumens nutzen. Die Technologie des zerebralen Gewebeoximetriegeräts kann auf Dauerlicht, dem Frequenzbereich oder dem Zeitbereich basieren. Dieses Dokument gilt für in einer Klinikumgebung verwendete ME Geräte, sowie wenn diese außerhalb der Klinikumgebung z. B. in Rettungsdienstfahrzeugen oder beim Lufttransport verwendet werden. Weitere Normen für diese Einsatzbedingungen können auf ME Geräte anwendbar sein.
ANMERKUNG 1 Zerebrale Gewebeoximetriegeräte werden in der medizinischen Literatur manchmal auch als Nahinfrarotspektroskopiegeräte bezeichnet.
Nicht im Anwendungsbereich dieses Dokuments enthalten sind:
- invasive Gewebe  oder Gefäßoximeter;
- Oximeter, die eine Blutprobe des Patienten erfordern;
- Geräte zur Messung von Gelöstsauerstoff;
- ME Geräte, oder Teile davon, die pfadlängenabhängige Hämoglobinänderungen messen. Die Anforderungen an funktionelle Nahinfrarotspektroskopiegeräte sind in ISO 80601 2 71 [2] zu finden;
- ME Geräte, oder Teile davon, die die arterielle Sättigung anhand pulsatiler Änderungen der optischen Eigenschaften des Gewebes (SpO2) messen. Die Anforderungen an Pulsoximetriegeräte sind in ISO 80601 2 61 [2] zu finden;
- ME Geräte, oder Teile davon, die zur Überwachung von Gewebe in anderen Körperteilen als dem Kopf bestimmt sind.
Diese Anforderungen gelten auch für zerebrale Gewebeoximetriegeräte, einschließlich zerebrale Gewebeoximetriemonitore, zerebrale Gewebeoximetriesensoren und Sensorverlängerungskabel, die wiederaufbereitet wurden.
Wenn ein Abschnitt oder Unterabschnitt speziell nur auf ME Geräte oder ME Systeme angewendet werden soll, wird dies aus der Überschrift und dem Inhalt des jeweiligen Abschnitts oder Unterabschnitts deutlich. In den übrigen Fällen gilt der Abschnitt oder Unterabschnitt je nach Zutreffen für sowohl ME Geräte als auch ME Systeme.
Gefährdungen, die sich aus der vorgesehenen physiologischen Funktion von ME Geräten oder ME Systemen im Anwendungsbereich dieses Dokuments ergeben, sind nicht durch besondere Anforderungen in diesem Dokument erfasst, ausgenommen in201.11 und in 201.7.2.13 und 201.8.4.1 der allgemeinen Norm.
ANMERKUNG 2 Siehe auch 4.2 der allgemeinen Norm. Die „allgemeine Norm“ ist IEC 60601 1:2005+AMD1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
Dieses Dokument kann auch auf ME Geräte und deren Zubehör angewendet werden, die für die Kompensation oder Linderung bei Krankheiten, Verletzungen oder Behinderungen verwendet werden.
Dieses Dokument gilt nicht für entfernt aufgestellte oder gekoppelte (sekundäre) Geräte, die StO2 Werte anzeigen und die sich außerhalb der Patientenumgebung befinden.
ANMERKUNG 3 Von ME Geräten, bei denen die Auswahl zwischen einer Diagnose  und einer Überwachungsfunktion möglich ist, wird erwartet, dass sie die Anforderungen des entsprechenden Dokuments erfüllen, wenn sie für die jeweilige Funktion konfiguriert sind.
Dieses Dokument ist eine besondere Norm aus den Normenreihen IEC 60601 1 und ISO/IEC 80601.

Appareils électromédicaux - Partie 2-85: Exigences particulières pour la sécurité de base et les performances essentielles des oxymètres pour tissu cérébral (ISO/DIS 80601-2-85:2020)

Medicinska električna oprema - 2-85. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za cerebralno oksimetrijo (ISO/FDIS 80601-2-85:2020)

General Information

Status
Not Published
Public Enquiry End Date
19-May-2020
Technical Committee
Current Stage
5020 - Formal vote (FV) (Adopted Project)
Start Date
19-Nov-2020
Due Date
07-Jan-2021
Completion Date
22-Jan-2021

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SLOVENSKI STANDARD
oSIST prEN ISO 80601-2-85:2020
01-maj-2020
Medicinska električna oprema - 2-85. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme za cerebralno oksimetrijo (ISO/DIS 80601-2-85:2020)

Medical electrical equipment - Part 2-85: Particular requirements for basic safety and

essential performance of cerebral tissue oximeter equipment (ISO/DIS 80601-2-85:2020)

Medizinische elektrische Geräte - Teil 2-85: Besondere Anforderungen für die Sicherheit

einschließlich der wesentlichen Leistungsmerkmale von Geräten für die zerebrale
Oxymetrie (ISO/DIS 80601-2-85:2020)

Appareils électromédicaux - Partie 2-85: Exigences particulières pour la sécurité de base

et les performances essentielles des oxymètres pour tissu cérébral (ISO/DIS 80601-2-

85:2020)
Ta slovenski standard je istoveten z: prEN ISO 80601-2-85
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 80601-2-85:2020 en

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

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oSIST prEN ISO 80601-2-85:2020
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oSIST prEN ISO 80601-2-85:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 80601-2-85
ISO/TC 121/SC 3 Secretariat: ANSI
Voting begins on: Voting terminates on:
2020-03-09 2020-06-01
Medical electrical equipment —
Part 2-85:
Particular requirements for basic safety and essential
performance of cerebral tissue oximeter equipment
ICS: 11.040.10
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
This draft is submitted to a parallel vote in ISO and in IEC.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 80601-2-85:2020(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. ISO 2020
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oSIST prEN ISO 80601-2-85:2020
ISO/DIS 80601-2-85:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
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Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
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36 CONTENTS

37 201.1 Scope, object and related standards ....................................................................................... 1

38 201.2 Normative references .................................................................................................................. 3

39 201.3 Terms and definitions .................................................................................................................. 5

40 201.4 General requirements .............................................................................................................. 10

41 201.5 General requirements for testing of ME equipment ....................................................... 12

42 201.6 Classification of ME equipment and ME systems .............................................................. 12

43 201.7 ME equipment identification, marking and documents ................................................ 12

44 201.8 Protection against electrical hazards from ME equipment .......................................... 16

45 201.9 Protection against mechanical hazards of ME equipment and ME systems ........... 17

46 201.10 Protection against unwanted and excessive radiation hazards ................................ 17

47 201.11 Protection against excessive temperatures and other hazards ................................ 17

48 201.12 Accuracy of controls and instruments and protection against hazardous outputs

49 ........................................................................................................................................................... 21

50 201.13 Hazardous situations and fault conditions for ME equipment .................................... 25

51 201.14 Programmable electrical medical systems (PEMS) ......................................................... 26

52 201.15 Construction of ME equipment ............................................................................................... 26

53 201.16 ME systems .................................................................................................................................... 28

54 201.17 Electromagnetic compatibility of ME equipment and ME systems ............................ 28

55 201.101 Cerebral tissue oximeter probes and probe cable extenders ........................................ 28

56 201.102 Functional connection................................................................................................................ 29

57 202 Electromagnetic disturbances – Requirements and tests ........................................... 29

58 206 Usability ......................................................................................................................................... 31

59 208 General requirements, tests and guidance for alarm systems in medical

60 electrical equipment and medical electrical systems ................................................... 31

61 211 Requirements for medical electrical equipment and medical

62 electrical systems used in the home healthcare environment .................................. 32

63 212 Requirements for medical electrical equipment and medical

64 electrical systems used in the emergency medical services environment ............ 32

65 Annex C (informative) Guide to marking and labelling requirements for

66 ME equipment and ME systems ............................................................................................... 33

67 Annex D (informative) Symbols on marking ......................................................................................... 37

68 Annex AA (informative) Particular guidance and rationale ............................................................ 39

69 Annex BB (informative) Skin temperature at the cerebral tissue oximeter probe ................... 50

70 Annex CC (informative) Determination of accuracy ........................................................................... 52

71 Annex DD (informative) Characteristics of a tissue haemoglobin phantom for the

72 verification of the accuracy of cerebral tissue oximeter equipment .......................... 58

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73 Annex EE (informative) Guideline for evaluating and documenting StO accuracy

74 in human subjects .......................................................................................................................68

75 Annex FF (informative) Functional testers for cerebral tissue oximeter equipment ................74

76 Annex GG (informative) Concepts of ME equipment response time ...............................................78

77 Annex HH (normative) Data interface requirements..........................................................................83

78 Annex II (informative) Comparison of methods of performance evaluation .............................87

79 Annex JJ (informative) Reference to the essential principles ...........................................................92

80 Annex KK (informative) Terminology — alphabetized index of defined terms ........................96

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83 Foreword

84 ISO (the International Organization for Standardization) is a worldwide federation of national standards

85 bodies (ISO member bodies). The work of preparing International Standards is normally carried out

86 through ISO technical committees. Each member body interested in a subject for which a technical

87 committee has been established has the right to be represented on that committee. International

88 organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO

89 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

90 electrotechnical standardization.

91 The procedures used to develop this document and those intended for its further maintenance are

92 described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the

93 different types of ISO documents should be noted. This document was drafted in accordance with the

94 editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

95 Attention is drawn to the possibility that some of the elements of this document may be the subject of

96 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any

97 patent rights identified during the development of the document will be in the Introduction and/or on

98 the ISO list of patent declarations received (see www.iso.org/patents).

99 Any trade name used in this document is information given for the convenience of users and does not

100 constitute an endorsement.

101 For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and

102 expressions related to conformity assessment, as well as information about ISO's adherence to the World

103 Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL:

104 www.iso.org/iso/foreword.html.

105 This document was prepared jointly by Technical Committee ISO/TC 121, Anaesthetic and respiratory

106 equipment, Subcommittee SC 3, Respiratory devices and related equipment used for patient care, and

107 Technical Committee IEC/TC 62, Electrical equipment in medical practice, Subcommittee SC 62D,

108 Electromedical equipment. The draft was circulated for voting to the national bodies of both ISO and IEC.

109 This first edition of ISO 80601-2-85 includes an alignment with Amendment 1 of both the third edition of

110 IEC 60601-1 and the second edition of IEC 60601-1-8, as well as the fourth edition of IEC 60601-1-2, the

111 third edition of IEC 60601-1-6, the second edition of IEC 60601-1-11 and IEC 60601-1-12.

112 A list of all the parts of the ISO/IEC 80601 series is available on the ISO website.

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113 Introduction

114 The approximation of cerebral tissue oximetry is increasingly used in many areas of medicine. This

115 document covers basic safety and essential performance requirements achievable within the limits of

116 existing technology.

117 Annex AA contains a rationale for some of the requirements. It is included to provide additional insight

118 into the reasoning of the committees that led to a requirement and identifying the hazards that the

119 requirement addresses.

120 Annex BB is a literature survey relevant to the determination of the maximum safe temperature of the

121 interface between a cerebral tissue oximeter probe and a patient's tissue.

122 Annex CC discusses both the formulae used to evaluate the StO accuracy of cerebral tissue oximeter

123 equipment measurements, and the names that are assigned to those formulae.

124 Annex DD presents guidance on using in-vitro methods for assessing the performance of cerebral tissue

125 oximeter equipment.

126 Annex EE presents a guideline for a controlled desaturation study for the verification of cerebral tissue

127 oximeter equipment.

128 Annex FF is a description of functional testers for use with cerebral tissue oximeter equipment.

129 Annex GG describes concepts of cerebral tissue oximeter equipment response time.

130 Annex HH describes data interface requirements.

131 Annex II is a comparison between human desaturations (in-vivo) and tissue haemoglobin phantom

132 desaturations (in-vitro) for assessing StO accuracy.
133 Annex JJ contains Reference to the essential principles.

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

135 In this document, the following print types are used:
136 – requirements and definitions: roman type;

137 – Instructions, test specifications and terms defined in Clause 3 of the general standard, in this document

138 or as noted: italic type;

139 – informative material appearing outside of tables, such as notes, examples and references: in smaller

140 type; normative text of tables is also in a smaller type;
141 In referring to the structure of this document, the term

142 – “clause” means one of the numbered divisions within the table of contents, inclusive of all

143 subdivisions (e.g. Clause 201.7 includes subclauses 201.7.1, 201.7.2) and

144 – “subclause” means a numbered subdivision of a clause (e.g. 201.7.1, 7.2 and 201.7.2.1 are all

145 subclauses of Clause 201.7).
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146 References to clauses within this document are preceded by the term “Clause” followed by the clause

147 number. References to subclauses within this document are by number only.

148 In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination

149 of the conditions is true.

150 The verbal forms used in this document conform to usage described in Annex H of the ISO/IEC Directives,

151 Part 2. For the purposes of this document, the auxiliary verb:

152 – “shall” means that compliance with a requirement or a test is mandatory for compliance with this

153 document;

154 – “should” means that compliance with a requirement or a test is recommended but is not mandatory

155 for compliance with this document; and

156 – “may” is used to describe permission (e.g. a permissible way to achieve compliance with a

157 requirement or test);
158 – "can" is used to describe a possibility or capability; and
159 – "must" is used to express an external constraint.

160 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates

161 that there is guidance or rationale related to that item in AA.
162
163
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164 Medical electrical equipment — Part 2-85: Particular
165 requirements for basic safety and essential performance of
166 cerebral tissue oximeter equipment
167 201.1 Scope, object and related standards
168 Clause 1 of the general standard applies, except as follows:
169 201.1.1 * Scope
170 Replacement:

171 This document applies to basic safety and essential performance of cerebral tissue oximeter equipment,

172 that employs light at multiple wavelengths to derive a quantitative measure of oxygen saturation of

173 haemoglobin within the volume of tissue sampled under the probe attached to the head. The cerebral

174 tissue oximeter equipment can be based on continuous light, frequency domain or time domain

175 technologies. This document applies to ME equipment used in a hospital environment as well as when

176 used outside the hospital environment, such as in ambulances and air transport. Additional standards

177 may apply to ME equipment for those environments of use.

178 NOTE 1 Cerebral tissue oximeters are sometimes referred to as near infrared spectroscopy equipment in medical

179 literature.
180 Not included within the scope of this document are:
181 ⎯ invasive tissue or vascular oximeters;
182 ⎯ oximeters that require a blood sample from the patient;
183 ⎯ equipment measuring dissolved oxygen;

184 ⎯ ME equipment, or part thereof, that measures path-length-dependent haemoglobin change. The

[2]

185 requirements for functional near-infrared spectroscopy equipment are found in ISO 80601-2-71 ;

186 ⎯ ME equipment, or part thereof, that measures arterial saturation based on pulsatile changes in tissue

187 optical properties (SpO ). The requirements for pulse oximeter equipment are found in

[2]
188 ISO 80601-2-61 ;

189 ⎯ ME equipment, or part thereof, that claims to monitor tissue in other parts of the body other than the

190 head.

191 These requirements also apply to cerebral tissue oximeter equipment, including cerebral tissue oximeter

192 monitors, cerebral tissue oximeter probes and probe cable extenders, which have been remanufactured.

193 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems

194 only, the title and content of that clause or subclause will say so. If that is not the case, the clause or

195 subclause applies both to ME equipment and to ME systems, as relevant.
The general standard is IEC 60601-1:2005+AMD1:2012.
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196 Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope

197 of this document are not covered by specific requirements in this document except in 201.11 and in

198 201.7.2.13 and 201.8.4.1 of the general standard.

199 NOTE 2 See also 4.2 of the general standard. “The general standard” is IEC 60601-1:2005+AMD1:2012, Medical

200 electrical equipment – Part 1: General requirements for basic safety and essential performance.

201 This document can also be applied to ME equipment and their accessories used for compensation or

202 alleviation of disease, injury or disability.

203 This document is not applicable to remote or slave (secondary) equipment that displays StO values that

204 are located outside of the patient environment.

205 NOTE 3 ME equipment that provides selection between diagnostic and monitoring functions is expected to meet

206 the requirements of the appropriate document when configured for that function.

207 This document is a particular standard in the IEC 60601-1 and ISO/IEC 80601 series of standards.

208 201.1.2 Object
209 Replacement:

210 The object of this document is to establish particular basic safety and essential performance requirements

211 for cerebral tissue oximeter equipment [as defined in 201.3.202] and its accessories.

212 NOTE Accessories are included because the combination of the cerebral tissue oximeter monitor and the

213 accessories needs to be adequately safe. Accessories can have a significant impact on the basic safety or essential

214 performance of cerebral tissue oximeter equipment.
215 201.1.3 Collateral standards
216 Amendment (add after existing text):

217 This document refers to those applicable collateral standards that are listed in Clause 2 of the general

218 standard and Clause 201.2 of this document.

219 IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-11 and IEC 60601-1-12 apply as modified in

[4]

220 Clauses 202, 206, 208, 211 and 212 respectively. IEC 60601-1-3 does not apply. All other published

221 collateral standards in the IEC 60601-1 series apply as published.
222 201.1.4 Particular standards
223 Replacement:

224 In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in

225 the general standard, including the collateral standards, as appropriate for the particular ME equipment

226 under consideration, and may add other basic safety or essential performance requirements.

227 A requirement of a particular standard takes priority over the general standard or the collateral

228 standards.

229 For brevity, IEC 60601-1:2005+AMD1:2012 is referred to in this document as the general standard.

230 Collateral standards are referred to by their document number.

231 The numbering of clauses and subclauses of this document corresponds to those of the general standard

232 with the prefix “201” (e.g. 201.1 in this document addresses the content of Clause 1 of the general

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233 standard) or applicable collateral standard with the prefix “2xx” where xx is the final digits of the

234 collateral standard document number (e.g. 202.4 in this document addresses the content of Clause 4 of

235 the IEC 60601-1-2 collateral standard, 208.4 in this document addresses the content of Clause 4 of the

236 IEC 60601-1-8 collateral standard, etc.). The changes to the text of the general standard are specified by

237 the use of the following words:

238 "Replacement" means that the clause or subclause of the general standard or applicable collateral

239 standard is replaced completely by the text of this document.

240 "Addition" means that the text of this document is additional to the requirements of the general standard

241 or applicable collateral standard.

242 "Amendment" means that the clause or subclause of the general standard or applicable collateral

243 standard is amended as indicated by the text of this document.

244 Subclauses or figures that are additional to those of the general standard are numbered starting from

245 201.101, additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.

246 Subclauses or figures that are additional to those of a collateral standard are numbered starting from 2xx,

247 where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-1-2, 203 for IEC 60601-1-3, etc.

248 The term "this document" is used to make reference to the general standard, any applicable collateral

249 standards and this particular document taken together.

250 Where there is no corresponding clause or subclause in this document, the section, clause or subclause

251 of the general standard or applicable collateral standard, although possibly not relevant, applies without

252 modification; where it is intended that any part of the general standard or applicable collateral standard,

253 although possibly relevant, is not to be applied, a statement to that effect is given in this particular

254 document.
255 201.2 Normative references

256 The following documents are referred to in the text in such a way that some or all of their content

257 constitutes requirements of this document. For dated references, only the edition cited applies. For

258 undated references, the latest edition of the referenced document (including any amendments) applies.

259 NOTE 1 The way in which these referenced documents are cited in normative requirements determines the extent

260 (in whole or in part) to which they apply.
261 NOTE 2 Informative references are listed in the Bibliography.
262 Clause 2 of the general standard applies, except as follows:
263 Replacement:
264 ISO 7000:2019, Graphical symbols for use on equipment — Registered symbols

265 ISO 7010:2019, Graphical symbols — Safety colours and safety signs — Registered safety signs

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266 ISO 15223-1:— , Medical devices — Symbols to be used with medical device labels, labelling and

267 information to be supplied — Part 1: General requirements
268 IEC 60529:2013, Degrees of protection provided by enclosures (IP code)

269 IEC 60601-1-2:2014, Medical electrical equipment — Part 1-2: General requirements for basic safety and

270 essential performance — Collateral Standard: Electromagnetic disturbances — Requirements and tests

271 IEC 60601-1-6:2010+AMD1:2013, Medical electrical equipment — Part 1-6: General requirements for

272 basic safety and essential performance —Collateral standard: Usability

273 IEC 60601-1-8:2006+AMD1:2012, Medical electrical equipment — Part 1-8: General requirements for

274 basic safety and essential performance — Collateral Standard: General requirements, tests and guidance for

275 alarm systems in medical electrical equipment and medical electrical systems

276 IEC 60825-1:2014, Safety of laser products - Part 1: Equipment classification and requirements

277 Addition:

278 ISO 14155:2011, Clinical investigation of medical devices for human subjects — Good clinical practice

279 ISO 14937:2009, Sterilization of health care products — General requirements for characterization of a

280 sterilizing agent and the development, validation and routine control of a sterilization process for medical

281 devices

282 ISO 16142-1:2016, Medical devices — Recognized essential principles of safety and performance of medical

283 devices — Part 1: General essential principles and additional specific essential principles for all non-IVD

284 medical devices and guidance on the selection of standards

285 ISO 17664:2017, Processing of health care products — Information to be provided by the medical device

286 manufacturer for the processing of medical devices

287 IEC 60068-2-27:2008+AMD1:2013, Environmental testing — Part 2-27: Tests — Test Ea and guidance:

288 Shock

289 IEC 60068-2-31:2008, Environmental testing — Part 2-31: Tests — Test Ec: Rough handling shocks,

290 primarily for equipment-type specimens

291 IEC 60068-2-64:2008, Environmental testing — Part 2-64: Tests — Test Fh: Vibration, broadband random

292 and guidance

293 IEC 60601-1-11:2015, Medical electrical equipment — Part 1-11: General requirements for basic safety and

294 essential performance — Collateral Standard: Requirements for medical electrical equipment and medical

295 electrical systems used in the home healthcare environment

296 IEC 60601-1-12:2014, Medical electrical equipment — Part 1-12: General requirements for basic safety and

297 essential performance — Collateral Standard: Requirements for medical electrical equipment and medical

298 electrical systems used in the emergency medical services environment
Under preparation. Stage at the time of publication: ISO DIS 15223-1:2020.
© ISO 2020 – All rights reserved 4
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oSIST prEN ISO 80601-2-85:2020
ISO/DIS 80601-2-85:2020(E)

299 IEC 62366-1:2015, Medical devices — Part 1: Application of usability engineering to medical devices

300 IEC 60601-2-2:2009, Medical electrical equipment - Part 2-2: Particular requirements for the basic safety

301 and essential performance of high frequency surgical equipment and high frequency surgical accessories

302 IEC 62471:2006, Photobiological safety of lamps and lamp systems

303 AAMI 2700-1:2019 (formerly ASTM F2761-09), Medical devices and medical systems — Essential safety

304 requirements for equipment comprising the patient-centric integrated clinical environment (ICE) — Part 1:

305 General requirements and conceptual model
306 201.3 Terms and definitions

307 For the purposes of this document, the terms and definitions given in ISO 16142-1:2016, ISO 17664:2017,

308 IEC 60601-1:2005+AMD 1:2012, IEC 60601-1-2:2014, IEC 60601-1-6:2010+AMD 1:2013,

309 IEC 60601-1-8:2006+AMD 1:2012, IEC 60601-1-11:2015, IEC 60601-1-12:2014, IEC 62366-1:2015,

310 IEC 60601-2-2:2009, AAMI 2700-1:2019 and the following apply.

311 ISO and IEC maintain terminological databases for use in standardization at the following addresses:

312 – IEC Electropedia: available at http://www.electropedia.org/
313 – ISO Online browsing platform: available at http://www.iso.org/obp
314 NOTE An alphabetized index of defined terms is found in Annex KK.
315 201.3.201
316 accuracy
317 A
rms
318 closeness of agreement between a test result and the true value

319 Note 1 to entry: 201.12.1.101.2 contains methods for estimating the StO2 accuracy of cerebral tissue oximeter

320 equipment.

321 Note 2 to entry: Additional information is found in Annexes CC, DD, EE and II.

322 Note 3 to entry: In this document, accuracy (A ) is stated in terms of the root mean square difference. See

rms
323 201.12.1.101.3.
[5]
324 [SOURCE: ISO 3534-2:2006 3.3.1, modified, with Notes to entry replaced]
325 201.3.202
326 cerebral tissue oximeter
327 cerebral tissue oximeter equipment

328 ME equipment for the noninvasive estimation of functional oxygen saturation of haemoglobin in cerebral

329 tissue below the probe (StO or rSO ), based on light interacting with tissue
2 2
330 N
...

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