oSIST prEN ISO 80601-2-70:2019

SLOVENSKI STANDARD oSIST prEN ISO 80601-2-70:2019 01-december-2019 Medicinska električna oprema - 2-70. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za zdravljenje prenehanja dihanja v spanju (ISO/DIS 80601-2-70:2019)

Medical electrical equipment - Part 2-70: Particular requirements for basic safety and

essential performance of sleep apnoea breathing therapy equipment (ISO/DIS 80601-2-

Medizinische elektrische Geräte - Teil 2-70: Besondere Festlegungen für die Sicherheit

Appareils électromédicaux - Partie 2-70: Exigences particulières pour la sécurité de base

et les performances essentielles du matériel de traitement respiratoire de l'apnée du

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

Partie 2-70: Exigences particulières pour la sécurité de base et les performances essentielles du matériel de

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2 CONTENTS ............................................................................................................................................................................ 3

3 FOREWORD .......................................................................................................................................................................... 5

4 INTRODUCTION .................................................................................................................................................................. 7

5 201.1 Scope, object and related standards ..................................................................................................... 9

6 201.2 Normative references .............................................................................................................................. 11

7 201.3 Terms and definitions ............................................................................................................................. 14

8 201.4 General requirements ............................................................................................................................. 16

9 201.5 General requirements for testing of ME equipment ................................................................... 17

10 201.6 Classification of ME equipment and ME systems ........................................................................... 17

11 201.7 ME equipment identification, marking and documents ............................................................. 17

12 201.8 Protection against electrical hazards from ME equipment ....................................................... 22

13 201.9 Protection against mechanical hazards of ME equipment and ME systems ........................ 23

14 201.10 Protection against unwanted and excessive radiation hazards ............................................. 24

15 201.11 Protection against excessive temperatures and other hazards ............................................. 25

17 outputs ........................................................................................................................................................... 27

18 201.13 Hazardous situations and fault conditions ...................................................................................... 34

19 201.14 Programmable electrical medical systems (pems) ........................................................................ 34

20 201.15 Construction of ME equipment ............................................................................................................. 34

21 201.16 ME systems.................................................................................................................................................... 34

22 201.17 Electromagnetic compatibility of ME equipment and ME systems ........................................ 34

23 201.101 Breathing gas pathway connectors .................................................................................................... 35

24 201.102 Requirements for the breathing gas pathway and accessories ............................................... 36

25 201.103 Functional connection .............................................................................................................................. 37

26 201.104 Training ......................................................................................................................................................... 37

27 202 Electromagnetic disturbances – Requirements and tests ........................................................ 37

28 206 Usability ........................................................................................................................................................ 38

29 211 Requirements for medical electrical equipment and medical electrical systems

30 used in the home healthcare environment ..................................................................................... 39

31 Annex C (informative) Guide to marking and labelling requirements for ME equipment

32 and ME systems ........................................................................................................................................... 40

33 Annex D (informative) Symbols on marking ...................................................................................................... 44

34 Annex AA (informative) Particular guidance and rationale ......................................................................... 45

35 Annex BB (informative) Data interface requirements ................................................................................... 51

36 Annex CC (informative) Reference to the essential principles ..................................................................... 55

37 Annex DD (informative) Reference to the general safety and performance requirements ............ 58

38 Annex EE (informative) Terminology — alphabetized index of defined terms .................................. 62

40 Figure 201.101 – Standard resistance .................................................................................................................... 24

41 Figure 201.102 – Test set-up for static airway pressure accuracy in normal use ................................. 28

42 Figure 201.103 – Test set-up for dynamic airway pressure accuracy in normal use ........................... 30

43 Figure AA.1 – Relationship of the components of sleep apnoea breathing therapy

44 equipment and masks and application accessories and the related standards ...................................... 45

47 relative humidity .............................................................................................................................................................. 25

48 Table BB.101 – Parameters and units of measurement ................................................................................ 52

49 Table BB.102 – Equipment identification ............................................................................................................ 52

50 Table BB.103 – Session compliance monitoring ............................................................................................ 53

51 Table BB.104 – Session efficacy monitoring ...................................................................................................... 53

52 Table BB.105 – Equipment therapy settings ...................................................................................................... 54

53 Table BB.106 – Service monitoring ........................................................................................................................ 54

54 Table CC.1 — Correspondence between this document and the essential principles ......................... 55

56 performance requirements ......................................................................................................................................... 58

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

69 standards bodies (ISO member bodies). The work of preparing International Standards is

70 normally carried out through ISO technical committees. Each member body interested in a subject

71 for which a technical committee has been established has the right to be represented on that

72 committee. International organizations, governmental and non-governmental, in liaison with ISO,

73 also take part in the work. ISO collaborates closely with the International Electrotechnical

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

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

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

78 with the editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives

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

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

81 Details of any patent rights identified during the development of the document will be in the

82 Introduction and/or on the ISO list of patent declarations received. www.iso.org/patents

83 y trade name used in this document is information given for the convenience of users and does

85 ISO 80601-2-70 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory

86 equipment, Subcommittee SC 3, Lung ventilators and related equipment, and Technical Committee

87 IEC/TC 62, Electrical equipment in medical practice, Subcommittee SC D, Electrical equipment. The

89 This second edition of ISO 80601-2-70 cancels and replaces the first edition of

90 ISO 80601-2-70:2015. This edition of ISO 80601-2-70 constitutes a technical revision of

91 ISO 80601-2-70:2015 and includes an alignment with the third edition of IEC 60601-1-6,

92 including its Amendment 2, the second edition of IEC 60601-1-8, including its Amendment 2, and

100 Sleep apnoea is a chronic medical condition where the patient repeatedly stops breathing during

101 sleep. These episodes typically last 10 s or more and cause the oxygen levels in the blood to drop.

102 It can be caused by obstruction of the upper airway (obstructive sleep apnoea or OSA) or by a

104 NOTE Sleep apnoea breathing therapy equipment is intended for the treatment of obstructive sleep

106 Sleep apnoea, if untreated, can cause and worsen other medical conditions, including

108 Hypopnoea refers to a transient reduction of airflow, often while the patient is asleep, that lasts

109 for at least 10 s, shallow breathing, or an abnormally low respiratory rate. Hypopnoea is less

110 severe than apnoea. It also results in decreased air movement into the lungs and can cause oxygen

111 levels in the blood to drop. It is commonly due to partial obstruction of the upper airway .

112 Awareness of the risks associated with sleep apnoea has grown significantly. As a result, the use

113 of sleep apnoea breathing therapy equipment to treat both sleep apnoea and hypopnoea has

115 This document covers basic safety and essential performance requirements needed to protect

117 ISO 80601-2-70 covers sleep apnoea breathing therapy equipment for patient use. ISO 17510

118 applies to masks and accessories used to connect sleep apnoea breathing therapy equipment to the

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

123 – Test specifications and terms defined in clause 3 of the general standard, in this document or as

125 – Informative material appearing outside of tables, such as notes, examples and references: in smaller type.

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

130 – “subclause” means a numbered subdivision of a clause (e.g. 201.101, 201.102 and 201.102.1

132 References to clauses within this document are preceded by the term “Clause” followed by the

133 clause number. References to subclauses within this document are by number only.

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

136 The verbal forms used in this document conform to usage described in ISO/IEC Directives, Part 2.

138 – “shall” means that conformance with a requirement or a test is mandatory for conformance

140 – “should” means that conformance with a requirement or a test is recommended but is not

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

146 Annex C contains a guide to the marking and labelling requirements in this document.

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

149 indicates that there is guidance or rationale related to that item in Annex AA.

150 The ISO and IEC 80601 family of standards are also parts of the IEC 60601 family of standards.

160 This document is applicable to the basic safety and essential performance of sleep apnoea breathing

161 therapy equipment, hereafter referred to as ME equipment, intended to alleviate the symptoms of

162 patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure

163 to the respiratory tract of the patient. Sleep apnoea breathing therapy equipment is intended for

164 use in the home healthcare environment by lay operators as well as in professional healthcare

166 * Sleep apnoea breathing therapy equipment is not considered to utilize physiologic closed-loop-

167 control system unless it uses a physiological patient variable to adjust the therapy settings.

168 This document excludes sleep apnoea breathing therapy equipment intended for use with

170 This document is applicable to ME equipment or an ME system intended for those patients who are

172 This document is not applicable to ME equipment or an ME system intended for those patients who

173 are dependent on mechanical ventilation such as patients with central sleep apnoea.

174 This document is also applicable to those accessories intended by their manufacturer to be

175 connected to sleep apnoea breathing therapy equipment, where the characteristics of those

176 accessories can affect the basic safety or essential performance of the sleep apnoea breathing

178 Masks and application accessories intended for use during sleep apnoea breathing therapy are

179 additionally addressed by ISO 17510. Refer to Figure AA.1 for items covered further under this

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

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

183 the clause or subclause applies both to ME equipment and to ME systems, as relevant.

The general standard is IEC 60601-1:2005 +AMD1:2012, Medical electrical equipment – Part 1: General requirements for basic

184 Hazards inherent in the intended physiological function of ME equipment or ME systems within the

185 scope of this document are not covered by specific requirements in this document except in 7.2.13

188 This document is not applicable to high-frequency jet ventilators (HFJVs) or high-frequency

190 This document does not specify the requirements for ventilators or accessories intended for

191 critical care ventilators for ventilator-dependent patients, which are given in ISO 80601-2-12. [4]

192 This document does not specify the requirements for ventilators or accessories intended for

194 This document does not specify the requirements for ventilators or accessories intended for home

195 care ventilators for ventilator-dependent patients, which are given in ISO 80601-2-72. [6]

196 This document does not specify the requirements for ventilators or accessories intended for

198 This document does not specify the requirements for ventilators or accessories intended for home-

199 care ventilatory support, which are given in ISO 80601-2-79 [8] and ISO 80601-2-80.

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

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

204 requirements for sleep apnoea breathing therapy equipment [as defined in 201.3.222].

205 NOTE 1 This document has been prepared to address the relevant essential principles of safety and performance

207 NOTE 2 This document has been prepared to address the relevant general safety and performance

211 IEC 60601-1-2:2014 and IEC 60601-1-6:2010+AMD1:2013+AMD2:— apply as modified in

212 Clauses 202 and 206 respectively. IEC 60601-1-3:2008+AMD 1:2013 does not apply. All other

216 In the IEC 60601 series, particular standards may modify, replace or delete requirements

217 contained in the general standard and collateral standards as appropriate for the particular

In the future, this standard is expected to be harmonized with the IEC 60601-1:2005 at which time it will be replaced by ISO 80601-

218 ME equipment under consideration, and may add other basic safety and essential performance

220 A requirement of a particular standard takes priority over the general standard.

221 For brevity, IEC 60601-1 is referred to in this document as the general standard. Collateral

223 The numbering of clauses and subclauses of this document corresponds to that of the general

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

225 the general standard) or applicable collateral standard with the prefix “20x”, where x is the final

226 digit(s) of the collateral standard document number (e.g. 202.4 in this document addresses the

227 content of Clause 4 of the IEC 60601-1-2 collateral standard, 203.4 in this document addresses the

228 content of Clause 4 of the IEC 60601-1-3 collateral standard, etc.). The changes to the text of the

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

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

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

236 Subclauses, figures or tables which are additional to those of the general standard are numbered

237 starting from 201.101. However, due to the fact that definitions in the general standard are

238 numbered 3.1 through 3.139, additional definitions in this document are numbered beginning

239 from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.

240 Subclauses, figures or tables which are additional to those of a collateral standard are numbered

241 starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-1-2,

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

245 Where there is no corresponding clause or subclause in this document, the clause or subclause of

246 the general standard or applicable collateral standard, although possibly not relevant, applies

247 without modification; where it is intended that any part of the general standard or applicable

248 collateral standard, although possibly relevant, is not to be applied, a statement to that effect is

251 The following referenced documents, in whole or in part, are normatively referenced in this

252 document and are indispensable for the application of this document. For dated references, only

253 the edition cited applies. For undated references, the latest edition of the referenced document

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

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

261 safety and essential performance — Collateral standard: Electromagnetic disturbances —

263 IEC 60601-1-6:2010, Medical electrical equipment – Part 1-6: General requirements for basic

267 IEC 60601-1-8:2006, Medical electrical equipment - Part 1-8: General requirements for basic

268 safety and essential performance - Collateral Standard: General requirements, tests and guidance

269 for alarm systems in medical electrical equipment and medical electrical systems

272 IEC 60601-1-10:2007, Medical electrical equipment -- Part 1-10: General requirements for basic

273 safety and essential performance -- Collateral standard: Requirements for the development of

275 IEC 60601-1-11:2015, Medical electrical equipment – Part 1-11: General requirements for basic

276 safety and essential performance – Collateral Standard: Requirements for medical electrical

277 equipment and medical electrical systems used in the home healthcare environment

278 IEC 61672-1:2013, Electroacoustics — Sound level meters — Part 1: Specifications

279 ISO 7010:2011, Graphical symbols -- Safety colours and safety signs -- Registered safety signs