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oSIST prEN ISO 80601-2-70:2013
01-junij-2013
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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
oSIST prEN ISO 80601-2-70:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 80601-2-70:2013
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oSIST prEN ISO 80601-2-70:2013
EUROPEAN STANDARD
DRAFT
prEN ISO 80601-2-70
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.
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oSIST prEN ISO 80601-2-70:2013
prEN ISO 80601-2-70:2013 (E)
Contents
Page
Foreword .3
2
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oSIST prEN ISO 80601-2-70:2013
prEN ISO 80601-2-70:2013 (E)
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.
3
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oSIST prEN ISO 80601-2-70:2013
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oSIST prEN ISO 80601-2-70:2013
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
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oSIST prEN ISO 80601-2-70:2013
IEC/DIS 80601-2-70
© International Electrotechnical Commission, 2013
ii
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oSIST prEN ISO 80601-2-70:2013
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
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oSIST prEN ISO 80601-2-70:2013
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
2
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
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oSIST prEN ISO 80601-2-70:2013
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
105
© ISO/IEC 2013 – All rights reserved v
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oSIST prEN ISO 80601-2-70:2013
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
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oSIST prEN ISO 80601-2-70:2013
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
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oSIST prEN ISO 80601-2-70:2013
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,
1
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
2
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.
187
1
source: http://sleepdisorders.about.com/od/glossary/g/Sleep_Apnea.htm
2
source: http://sleepdisorders.about.com/od/glossary/g/Hypopnea.htm
viii © ISO/IEC 2013 – All rights reserved
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oSIST prEN ISO 80601-2-70:2013
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 particula
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