oSIST prEN ISO 80601-2-70:2013

SLOVENSKI STANDARD
01-junij-2013
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLRSUHPH]D]GUDYOMHQMHSUHQHKDQMDGLKDQMDYVSDQMX,62',6

Medical Electrical Equipment - Part 2-70: Particular requirements for basic safety and
essential performance of sleep apneoa breathing therapy equipment (ISO/DIS 80601-2-
70:2013)
Medizinische elektrische Geräte - Teil 2-70: Besondere Festlegungen für die Sicherheit
und die wesentlichen Leistungsmerkmale von Schlafapnoe-Atemtherapiegeräten
(ISO/DIS 80601-2-70:2013)
Appareils électromédicaux - Partie 2-70: Exigences particulières pour la sécurité de base
et les performances essentielles de l'équipement de thérapie respiratoire pour l'apnée du
sommeil (ISO/DIS 80601-2-70:2013)
Ta slovenski standard je istoveten z: prEN ISO 80601-2-70
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
DRAFT
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2013
ICS 11.040.10 Will supersede EN ISO 17510-1:2009
English Version
Medical Electrical Equipment - Part 2-70: Particular
requirements for basic safety and essential performance of
sleep apneoa breathing therapy equipment (ISO/DIS 80601-2-
70:2013)
Appareils électromédicaux - Partie 2-70: Exigences Medizinische elektrische Geräte - Teil 2-70: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit und die wesentlichen
essentielles de l'équipement de thérapie respiratoire pour Leistungsmerkmale von Schlafapnoe-Atemtherapiegeräten
l'apnée du sommeil (ISO/DIS 80601-2-70:2013) (ISO/DIS 80601-2-70:2013)
This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/TC 215.
If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations which
stipulate the conditions for giving this European Standard the status of a national standard without any alteration.

This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other language
made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
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.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 80601-2-70:2013: E
worldwide for CEN national Members.

Contents
Page
Foreword .3

Foreword
This document (prEN ISO 80601-2-70:2013) has been prepared by Technical Committee ISO/TC 121
“Anaesthetic and respiratory equipment” in collaboration with Technical Committee CEN/TC 215 “Respiratory
and anaesthetic equipment” the secretariat of which is held by BSI.
This document is currently submitted to the parallel Enquiry.
This document will supersede EN ISO 17510-1:2009.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
Endorsement notice
The text of ISO/DIS 80601-2-70:2013 has been approved by CEN as prEN ISO 80601-2-70:2013 without any
modification.
DRAFT INTERNATIONAL STANDARD IEC/DIS 80601-2-70
ISO/TC 121/SC 3 Secretariat: ANSI

Voting begins on Voting terminates on
2013-03-28 2013-08-28
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
INTERNATIONAL ELECTROTECHNICAL COMMISSION  • МЕЖДУНАРОДНАЯ ЭЛЕКТРОТЕХНИЧЕСКАЯ КОММИСИЯ  • COMMISSION ÉLECTROTECHNIQUE INTERNATIONALE

Medical electrical equipment —
Part 2-70:
Particular requirements for basic safety and essential performance
of sleep apneoa breathing therapy equipment
Appareils électromédicaux —
Partie 2-70: Exigences particulières pour la sécurité de base et les performances essentielles de l'équipement de
thérapie respiratoire pour l'apnée du sommeil

[Revision of second edition (ISO 17510-1:2007)]
ICS 11.040.10
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for Standardization (ISO), and
processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
five-month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments received, will be
submitted to a parallel two-month approval vote in ISO and formal vote in CEN.

This draft is submitted to a parallel enquiry in ISO and a CDV vote in the IEC.

THIS DOCUMENT IS A DRAFT CIRCULATED 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 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 NATIONAL REGULATIONS.
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.
©  International Electrotechnical Commission, 2013

IEC/DIS 80601-2-70
©  International Electrotechnical Commission, 2013
ii
ISO/IEC DIS 80601-2-70
1 Contents Page
2 Foreword . vi
3 Introduction . viii
4 201.1 Scope, object and related standards. 1
5 201.1.1 Scope . 1
6 201.1.2 Object . 2
7 201.1.3 Collateral standards . 2
8 201.1.4 Particular standards . 2
9 201.2 Normative references . 3
10 201.3 Terms and definitions . 5
11 201.4 General requirements . 6
12 201.4.3 ESSENTIAL PERFORMANCE . 7
13 201.4.3.101 Additional requirements for ESSENTIAL PERFORMANCE . 7
14 201.4.6 ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT . 7
15 201.5 General requirements for testing of ME EQUIPMENT. 7
16 201.5.101 Additional requirements for general requirements for testing of ME EQUIPMENT. 7
17 201.5.101.1 Gas flowrate and pressure specifications . 7
18 201.5.101.2 SLEEP APNOEA BREATHING THERAPY EQUIPMENT testing errors . 7
19 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 7
20 201.7 ME EQUIPMENT identification, marking and documents . 8
21 201.7.1.2 Legibility of markings . 8
22 201.7.2.4.101 Additional requirements for ACCESSORIES . 8
23 201.7.2.13.101 Additional requirements for physiological effects . 8
24 201.7.2.17.101 Additional requirements for protective packaging . 8
25 201.7.2.101 Additional requirements for marking on the outside of ME EQUIPMENT or
26 ME EQUIPMENT parts . 9
27 201.7.4.3 Units of measurement . 9
28 201.7.9.1 Additional general requirements . 9
29 201.7.9.2.1.101 Additional general requirements . 10
30 201.7.9.2.2.101 Additional requirements for warnings and safety notices . 10
31 201.7.9.2.9.101 Additional requirements for operating instructions . 11
32 201.7.9.2.14.101 Additional requirements for ACCESSORIES, supplementary equipment, used
33 material . 11
34 201.7.9.3.1.101 Additional general requirements . 11
35 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 12
36 201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS. 12
37 201.9.6.2.1.101 Additional requirements for audible acoustic energy . 12
38 201.10 Protection against unwanted and excessive radiation HAZARDS . 13
39 201.11 Protection against excessive temperatures and other HAZARDS . 14
40 201.11.1.2.2 APPLIED PARTS not intended to supply heat to a PATIENT . 14
41 201.11.6.4 Leakage . 14
42 201.11.8 Additional requirements for interruption of the power supply/SUPPLY MAINS to
43 ME EQUIPMENT . 15
44 201.12 Accuracy of controls and instruments and protection against hazardous outputs . 15
45 201.12.1 Accuracy of controls and instruments . 15
© ISO/IEC 2013 – All rights reserved iii

ISO/IEC DIS 80601-2-70
201.12.1.101 Stability of static
46 AIRWAY PRESSURE ACCURACY (long-term accuracy) . 15
47 201.12.1.102 Stability of dynamic AIRWAY PRESSURE ACCURACY (short-term accuracy). 16
48 201.12.1.102.1 CPAP mode . 16
49 201.12.1.102.2 BI-LEVEL POSITIVE AIRWAY PRESSURE mode . 18
50 201.12.1.103 Maximum flowrate . 20
51 201.12.4 Protection against hazardous output . 21
52 201.12.4.101 Measurement of AIRWAY PRESSURE . 21
53 201.12.4.102 MAXIMUM LIMITED PRESSURE PROTECTION DEVICE . 21
54 201.12.4.103 CO rebreathing. 21
55 201.13 HAZARDOUS SITUATIONS and fault conditions . 22
56 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 22
57 201.15 Construction of ME EQUIPMENT . 22
58 201.15.101 Mode of operation. 22
59 201.16 ME SYSTEMS . 22
60 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 22
61 201.17.101 Additional requirements for electromagnetic compatibility of ME EQUIPMENT and
62 ME SYSTEMS . 22
63  . 22
64 201.101 BREATHING GAS PATHWAY connectors . 22
65 201.101.1 General . 22
66 201.101.2 Other named ports . 23
67 201.101.2.1 PATIENT-CONNECTION PORT . 23
68 201.101.2.2 GAS OUTPUT PORT . 23
69 201.101.2.3 FLOW-DIRECTION-SENSITIVE COMPONENTS . 23
70 201.101.2.4 Ancillary port . 23
71 201.101.2.5 Monitoring probe port . 23
72 201.102 Requirements for the BREATHING GAS PATHWAY and ACCESSORIES . 23
73 201.102. General . 23
74 201.102.2 Labelling . 24
75 201.102.3 Humidification . 24
76 201.102.4 BREATHING SYSTEM FILTER . 24
77 201.103 FUNCTIONAL CONNECTION . 24
78 201.103.1 General . 24
79 201.103.2 FUNCTIONAL CONNECTION to support remote supervision . 24
80 201.104 Training . 25
81 202 Medical electrical equipment – Part 1-2: General requirements for basic safety and
82 essential performance – Collateral standard: Electromagnetic compatibility –
83 Requirements and tests . 25
84 202.6.2.1.10 Compliance criteria . 25
85 206 Medical electrical equipment – Part 1-6: General requirements for basic safety and
86 essential performance – Collateral Standard: Usability . 25
87 208 Medical electrical equipment – Part 1-8: General requirements for basic safety and
88 essential performance – Collateral Standard: General requirements, tests and
89 guidance for alarm systems in medical electrical equipment and medical electrical
90 systems. 26
91 211 Medical electrical equipment – Part 1-11: General requirements for basic safety and
92 essential performance – Collateral Standard: Requirements for medical electrical
93 equipment and medical electrical systems used in the home healthcare
94 environment . 26
iv © ISO/IEC 2013 – All rights reserved

ISO/IEC DIS 80601-2-70
A
95 NNEX C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and
96 ME SYSTEMS. 27
97 Annex D (informative) Symbols on marking . 31
98 Annex AA (informative) Particular guidance and rationale . 32
99 Annex BB (informative) Data interface requirements . 36
100 Annex CC (informative) Reference to the Essential Principles . 40
101 Bibliography . 42
102 Alphabetized index of defined terms used in this particular standard . 43
103 Annex ZA (informative) Relationship between this Document and the Essential Requirements of
104 EU Directive 93/42/EEC . 45
© ISO/IEC 2013 – All rights reserved v

ISO/IEC DIS 80601-2-70
106 Foreword
107 ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
108 (ISO member bodies). The work of preparing International Standards is normally carried out through ISO
109 technical committees. Each member body interested in a subject for which a technical committee has been
110 established has the right to be represented on that committee. International organizations, governmental and
111 non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
112 International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
113 International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
114 The main task of technical committees is to prepare International Standards. Draft International Standards
115 adopted by the technical committees are circulated to the member bodies for voting. Publication as an
116 International Standard requires approval by at least 75 % of the member bodies casting a vote.
117 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
118 rights. ISO shall not be held responsible for identifying any or all such patent rights.
119 ISO/IEC 80601-2-70 was prepared by a joint working group of Technical Committee ISO/TC 121, Anaesthetic
120 and respiratory equipment, Subcommittee SC 3, Lung ventilators and related equipment and Technical
121 Committee IEC/TC 62, Electrical equipment in medical practice, Subcommittee SC D, Electrical equipment.
122 This first edition of ISO 80601-2-70 cancels and replaces the second edition of ISO 17510-1:2007. This
123 edition of ISO 80601-2-70 constitutes a technical revision of ISO 17510-1:2007 and includes an alignment
124 with third edition of IEC 60601-1 and IEC 60601-1-11.
125 The most significant changes are the following modifications:
126  identification of ESSENTIAL PERFORMANCE for SLEEP APNOEA BREATHING THERAPY EQUIPMENT and its
127 ACCESSORIES;
128 and the following additions:
129  tests for therapy performance; and
130  new symbols.
131 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
132 In this standard, the following print types are used:
133  Requirements and definitions: roman type.
134  Test specifications: italic type.
135  Informative material appearing outside of tables, such as notes, examples and references: smaller type. Normative
136 text of tables is also in a smaller type.
137  TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL
138 CAPITALS TYPE.
139 In referring to the structure of this standard, the term
vi © ISO/IEC 2013 – All rights reserved

ISO/IEC DIS 80601-2-70
140  "clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all
141 subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
142  “subclause” means a numbered subdivision of a clause (e.g. 201.7.1, 201.7.2 and 201.7.2.1 are all
143 subclauses of Clause 201.7).
144 References to clauses within this standard are preceded by the term “Clause” followed by the clause number.
145 References to subclauses within this particular standard are by number only.
146 In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of
147 the conditions is true.
148 The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part
149 2. For the purposes of this standard, the auxiliary verb:
150  “shall” means that compliance with a requirement or a test is mandatory for compliance with this
151 standard;
152  “should” means that compliance with a requirement or a test is recommended but is not mandatory for
153 compliance with this standard;
154  “may” is used to describe a permissible way to achieve compliance with a requirement or test.
155 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that
156 there is guidance or rationale related to that item in Annex AA.
157 The attention of Member Bodies and National Committees is drawn to the fact that equipment manufacturers
158 and testing organizations may need a transitional period following publication of a new, amended or revised
159 ISO or IEC publication in which to make products in accordance with the new requirements and to equip
160 themselves for conducting new or revised tests. It is the recommendation of the committee that the content of
161 this publication not be adopted for mandatory implementation nationally earlier than 3 years from the date of
162 publication for equipment newly designed and not earlier than 5 years from the date of publication for
163 equipment already in production.
© ISO/IEC 2013 – All rights reserved vii

ISO/IEC DIS 80601-2-70
164 Introduction
165 Sleep apnoea is the clinically significant intermittent absences of normal respiration occurring during sleep.
166 The awareness of the RISKS associated with sleep apnoea has grown significantly in recent years. As a result,
167 the use of SLEEP APNOEA BREATHING THERAPY EQUIPMENT has become common. This document covers BASIC
168 SAFETY and ESSENTIAL PERFORMANCE requirements needed to protect PATIENTS in the use of this ME EQUIPMENT.
169 SLEEP APNOEA BREATHING THERAPY EQUIPMENT is commonly used to treat both sleep apnoea and hypopnoea.
170 Sleep apnoea is a chronic medical condition where the affected person repeatedly stops breathing during
171 sleep. These episodes last 10 seconds or more and cause oxygen levels in the blood to drop. It can be
172 caused by obstruction of the upper airway, resulting in obstructive sleep apnoea (OSA), or by a failure of the
173 brain to initiate a breath, called central sleep apnoea and is typically associated with heart failure PATIENTS.
174 Often, co-morbidities are present in PATIENTS with OSA which can contribute to their earlier onset including
175 hypertension, heart failure, and diabetes if left untreated. It can cause and worsen other medical conditions,
176 including hypertension, heart failure, and diabetes.
177 NOTE SLEEP APNOEA BREATHING THERAPY EQUIPMENT is intended for the treatment of obstructive sleep apnoea and not
178 central sleep apnoea.
179 Hypopnoea refers to a transient reduction of airflow (often while asleep) that lasts for at least 10 seconds,
180 shallow breathing, or an abnormally low respiratory rate. Hypopnoea is less severe than apnoea (which is a
181 more complete loss of airflow). It can likewise result in a decreased amount of air movement into the lungs
182 and can cause oxygen levels in the blood to drop. It is more commonly due to partial obstruction of the upper
183 airway.
184 ISO 80601-2-70 covers SLEEP APNOEA BREATHING THERAPY EQUIPMENT for PATIENT use. ISO 17510 applies to
185 MASKS and ACCESSORIES used to connect SLEEP APNOEA BREATHING THERAPY EQUIPMENT to the PATIENT. Figure
186 AA.1 shows this diagrammatically.
source: http://sleepdisorders.about.com/od/glossary/g/Sleep_Apnea.htm
source: http://sleepdisorders.about.com/od/glossary/g/Hypopnea.htm

viii © ISO/IEC 2013 – All rights reserved

DRAFT INTERNATIONAL STANDARD ISO/IEC DIS 80601-2-70

188 Medical Electrical Equipment — Part 2-70: Particular
189 requirements for basic safety and essential performance of
190 sleep apnoea breathing therapy equipment
191 201.1 Scope, object and related standards
192 IEC 60601-1:2005+A1:2012, Clause 1 applies, except as follows:
193 201.1.1 * Scope
194 IEC 60601-1:2005+A1:2012, 1.1 is replaced by:
195 This particular standard is applicable to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SLEEP APNOEA
196 BREATHING THERAPY EQUIPMENT, hereafter referred to as ME EQUIPMENT, intended to alleviate the symptoms of
197 PATIENTS who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the
198 PATIENT. SLEEP APNOEA BREATHING THERAPY EQUIPMENT is intended for use in the HOME HEALTHCARE
199 ENVIRONMENT by LAY OPERATORS as well as in professional healthcare institutions.
200 This particular standard excludes SLEEP APNOEA BREATHING THERAPY EQUIPMENT intended for use with
201 neonates.
202 This particular standard is applicable to ME EQUIPMENT or an ME SYSTEM intended for those PATIENTS who are
203 not dependent on mechanical ventilation such as PATIENTS with central sleep apnoea.
204 This particular standard is also applicable to those ACCESSORIES intended by their MANUFACTURER to be
205 connected to SLEEP APNOEA BREATHING THERAPY EQUIPMENT, where the characteristics of those ACCESSORIES
206 can affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the SLEEP APNOEA BREATHING THERAPY EQUIPMENT.
207 MASKS and application ACCESSORIES intended for use during sleep apnoea breathing therapy also are
3)
208 addressed by ISO 17510. Refer to Figure AA.1 for items covered under this standard.
209 If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only,
210 the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause
211 applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
212 HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of
213 this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the
214 general standard.
215 NOTE 4 See also 4.2 of the General Standard.
216 This particular standard is not applicable to HOME HEALTHCARE ENVIRONMENT ventilators, ventilatory support
217 ME EQUIPMENT, emergency and transport ventilators, anaesthetic ventilators, high-frequency jet ventilators
[15]
218 (HFJVs), critical care ventilators or high-frequency oscillatory ventilators (HFOVs). This particular standard

3) To be published.
© ISO/IEC 2013 – All rights reserved 1

ISO/IEC DIS 80601-2-70
does not specify the requirements for
219 ME EQUIPMENT that is intended solely to augment the ventilation of
220 spontaneously breathing PATIENTS.
221 This particular standard does not specify the requirements for ventilators or ACCESSORIES intended for critical
222 care ventilators for ventilator-dependent PATIENTS which are given in ISO 80601-2-12.
223 This particular standard does not specify the requirements for ventilators or ACCESSORIES intended for
224 anaesthetic applications which are given in IEC 80601-2-13.
225 This particular standard does not specify the requirements for ventilators or ACCESSORIES intended for home
4)
226 care ventilators for ventilator-dependent PATIENTS which are given in ISO 10651-2 .
227 This particular standard does not specify the requirements for ventilators or ACCESSORIES intended for
5)
228 emergency and transport which are given in ISO 10651-3 .
229 This particular standard does not specify the requirements for ventilators or ACCESSORIES intended for home-
6)
230 care ventilatory support devices which are given in ISO 10651-6 .
231 This particular standard is a particular standard in the 60601-1 series of standards.
232 201.1.2 Object
233 IEC 60601-1:2005, 1.2 is replaced by:
234 The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE
235 requirements for SLEEP APNOEA BREATHING THERAPY EQUIPMENT [as defined in 201.3.212].
236 201.1.3 Collateral standards
237 IEC 60601-1:2005+A1:2012, 1.3 applies with the following addition:
238 This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the
239 general standard and 201.2 of this particular standard.
240 IEC 60601-1-3:2008 does not apply.
241 201.1.4 Particular standards
242 IEC 60601-1:2005+A1:2012, 1.4 is replaced by:
243 In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in the
244 general standard, including the collateral standards, as appropriate for the particular ME EQUIPMENT under
245 consideration, and may add other BASIC SAFETY or ESSENTIAL PERFORMANCE requirements.
246 A requirement of a particular standard takes priority over the general standard or the collateral standards.

4) In the future, this standard is expected to be harmonized with the IEC 60601-1:2005 and IEC 60601-1-11:2010 at
which time it will be replaced by ISO 80601-2-xx.
5) 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 80601-2-xx.
6) In the future, this standard is expected to be harmonized with the IEC 60601-1:2005 and IEC 60601-1-11:2010 at
which time it will be replaced by ISO 80601-2-xx.
2 © ISO/IEC 2013 – All rights reserved

ISO/IEC DIS 80601-2-70
For brevity, IEC 60601-1:2005+A 1:2012 is referred to in this particular standard as the general standard.
248 Collateral standards are referred to by their document number.
249 The numbering of clauses and subclauses of this particular standard corresponds to those of the general
250 standard with the prefix “201” (e.g. 201.1 in this standard addresses the content of Clause 1 of the general
251 standard) or applicable collateral standard with the prefix “2xx” where xx is the final digits of the collateral
252 standard document number (e.g. 202.4 in this particular standard addresses the content of Clause 4 of the
253 IEC 60601-1-2 collateral standard, 208.4 in this particular standard addresses the content of Clause 4 of the
254 IEC 60601-1-8 collateral standard, etc.). The changes to the text of the general standard are specified by the
255 use of the following words:
256 "Replacement" means that the clause or subclause of the general standard or applicable collateral standard is
257 replaced completely by the text of this particular standard.
258 "Addition" means that the text of this particular standard is additional to the requirements of the general
259 standard or applicable collateral standard.
260 "Amendment" means that the clause or subclause of the general standard or applicable collateral standard is
261 amended as indicated by the text of this particular standard.
262 Subclauses or figures that are additional to those of the general standard are numbered starting from 201.101,
263 additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
264 Subclauses or figures that are additional to those of a collateral standard are numbered starting from 20x,
265 where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-1-2, 211 for IEC 60601-1-11, etc.
266 The term "this standard" is used to make reference to the general standard, any applicable collateral
267 standards and this particular standard taken together.
268 Where there is no corresponding clause or subclause in this particular standard, the section, clause or
269 subclause of the general standard or applicable collateral standard, although possibly not relevant, applies
270 without modification; where it is intended that any part of the general standard or applicable collateral standard,
271 although possibly relevant, is not to be applied, a statement to that effect is given in this particular standard.
272 201.2 Normative references
273 The following referenced documents are indispensable for the application of this document. The way in which
274 these referenced documents are cited in normative requirements determines the extent (in whole or in part) to
275 which they apply. For dated references, only the edition cited applies. For undated references, the latest
276 edition of the referenced document (including any amendments) applies.
277 NOTE Informative references are listed in the Bibliography beginning on page 42.
278 IEC 60601-1:2005+A1:2012, Clause 2 applies, except as follows:
279 Replacement:
280 IEC 60601-1-2:2007, Medical electrical equipment – Part 1-2: General requirements for basic safety and
281 essential performance – Collateral Standard: Electromagnetic compatibility – Requirements and tests
282 +Amendment 1:2012
283 IEC 60601-1-3:2008, Medical electrical equipment – Part 1-3: General requirements for basic safety and
284 essential performance – Collateral Standard: Radiation protection in diagnostic X-ray equipment
© ISO/IEC 2013 – All rights reserved 3

ISO/IEC DIS 80601-2-70
IEC 60601-1-6:2010, Medical electrical equipment – Part 1-6: General requirements for basic safety and
286 essential performance – Collateral standard: Usability
7)
287 +Amendment 1:
288 IEC 60601-1-8:2006, Medical electrical equipment - Part 1-8: General requirements for basic safety and
289 essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in
290 medical electrical equipment and medical electrical systems
291 +Amendment 1:2011
292 IEC 60601-1-11:2010, Medical electrical equipment – Part 1-11: General requirements for basic safety and
293 essential performance – Collateral Standard: Requirements for medical electrical equipment and medical
294 electrical systems used in the home healthcare environment
8)
295 +Amendment 1:
297 IEC 61672-1:2002, Electroacoustics - Sound level meters - Part 1: Specifications
298 Addition:
299 ISO 3744:2010, Acoustics -- Determination of sound power levels and sound energy levels of noise sources
300 using sound pressure -- Engineering methods for an essentially free field over a reflecting plane
301 ISO 4871:1996, Acoustics -- Declaration and verification of noise emission values of machinery and
302 equipment
303 ISO 5356-1:2004, Anaesthetic and respiratory equipment. Conical connectors. Cones and sockets
304 ISO 7000:2012, Graphical symbols for use on equipment -- Registered symbols
9)
305 ISO 8185:2007 , Humidifiers for medical use -- General requirements for humidification systems
306 ISO 15223-1:2012, Medical devices — Symbols to be used with medical device labels, labelling and
307 information to be supplied — Part 1: General requirements
308 EN 15986:2011, Symbol for use in the labelling of medical devices — Requirements for labelling of medical
309 devices containing phthalates
10)
310 ISO 17510:
, Sleep apnoea breathing therapy masks and application accessories
311 ISO 23328-1:2003, Breathing system filters for anaesthetic and respiratory use: – Part 1: Salt test method to
312 assess filtration performance
313 ISO 23328-2:2002, Breathing system filters for anaesthetic and respiratory use: – Part 2: Non-filtration
314 aspects
7)
To be published.
8)
To be published.
9)
In the future, this standard is expected to be harmonized with the IEC 60601-1:2005+A1:2012 and
IEC 60601-1-11:2010 at which time it will be replaced by ISO 80601-2-xx.
10)
To be published.
4 © ISO/IEC 2013 – All rights reserved

ISO/IEC DIS 80601-2-70
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety and essential
316 performance
317 Amendment 1:2012
318 IEC 62304:2006, Medical device software – Software life cycle processes
319 IEC 62366:2007, Medical devices – Application of usability engineering to medical devices
11)
320 +Amendment 1:
321 ISO 80369-1:2010, Small-bore connectors for liquids and gases in healthcare applications -- Part 1: General
322 requirements
12 )
323 ISO 80369-2:
, Small bore connectors for liquids and gases in healthcare applications -- Part 2:
324 Connectors for breathing systems and driving gases applications
325 201.3 Terms and definitions
326 For the purposes of this document, the terms and definitions given in ISO 8185:2007, ISO 23328-2:2002,
327 IEC 60601-1:2005+A1:2012, IEC 60601-1-2:2007, IEC 60601-1-6:2010+A1:, IEC 62366:2007+A1:,
328 ISO 4135:2001 and the following apply.
329 NOTE An index of defined terms is found beginning on page 43.
330 Addition:
331 201.3.201
332 AIRWAY PRESSURE
333 P
aw
334 pressure at the PATIENT-CONNECTION PORT
335 201.3.202
336 AIRWAY PRESSURE ACCURACY
337 difference between the pressure set on the SLEEP APNOEA BREATHING THERAPY EQUIPMENT and the measured
338 AIRWAY PRESSURE
339 201.3.203
340 BPAP
341 BI-LEVEL POSITIVE AIRWAY PRESSURE
342 two therapeutic positive pressure levels at the PATIENT-CONNECTION PORT during the respiratory cycle
343 201.3.204
344 BREATHING GAS PATHWAY
345 pathway through which gas flows at respiratory pressures between the gas INTAKE PORT and the PATIENT-
346 CONNECTION PORT
11)
To be published.
12)
To be published.
© ISO/IEC 2013 – All rights reserved 5

ISO/IEC DIS 80601-2-70
347 201.3.205
348 CPAP
349 CONTINUOUS POSITIVE AIRWAY PRESSURE
350 therapeutic CONTINUOUS POSITIVE AIRWAY PRESSURE during the respiratory cycle
351 201.3.206
352 FLOW-DIRECTION-SENSITIVE COMPONENT
353 component or ACCESSORY through which gas flow has to be in one direction only for proper functioning or
354 PATIENT safety
355 [ISO 4135:2001, definitions 3.1.7 modified–Added ‘or ACCESSORY’ and replaced ‘must’ with ‘has to’.]
356 201.3.207
357 INTAKE PORT
358 port through which gas is drawn by SLEEP APNOEA BREATHING THERAPY EQUIPMENT
359 [ISO 4135:2001, definitions 3.2.11, modified–Replaced a ventilator or by a PATIENT with SLEEP APNOEA
360 BREATHING THERAPY EQUIPMENT.]
361 201.3.208
362 MAXIMUM LIMITED PRESSURE
363 P
LIM max
364 highest AIRWAY PRESSURE during NORMAL USE or under SINGLE FAULT CONDITION
365 201.3.209
366 MONITORING EQUIPMENT
367 ME EQUIPMENT or part that continuously or continually measures and indicates the value of a variable to the
368 OPERATOR
369 201.3.210
370 PROTECTION DEVICE
371 part or function of ME EQUIPMENT that, without intervention by the OPERATOR, protects the PATIENT from
372 hazardous output due to incorrect delivery of energy or substances
373 201.3.211
374 SELF-ADJUSTING
375 automatically adjusti
...