prEN ISO 80601-2-67

SLOVENSKI STANDARD
01-marec-2012
Elektromedicinska oprema - 2-67. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme za shranjevanje kisika (ISO/DIS 80601-2-67:2012)
Medical electrical equipment - Part 2-67: Particular requirements for basic safety and
essential performance of oxygen-conserving equipment (ISO/DIS 80601-2-67:2012)
Medizinische elektrische Geräte - Teil 2-67: Besondere Festlegungen für die
Basissicherheit einschließlich der wesentlichen Leistungsmerkmale von Sauerstoff-
Dosiersystemen (ISO/DIS 80601-2-67:2012)
Appareils électromédicaux - Partie 2-67: Exigences particulières pour la sécurité de base
et performances essentielles de l'équipement de conservation de l'oxygène (ISO/DIS
80601-2-67:2012)
Ta slovenski standard je istoveten z: prEN ISO 80601-2-67
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
January 2012
ICS 11.040.10 Will supersede EN ISO 18779:2005
English Version
Medical electrical equipment - Part 2-67: Particular requirements
for basic safety and essential performance of oxygen-conserving
equipment (ISO/DIS 80601-2-67:2012)
Appareils électromédicaux - Partie 2-67: Exigences Medizinische elektrische Geräte - Teil 2-67: Besondere
particulières pour la sécurité de base et performances Festlegungen für die Basissicherheit einschließlich der
essentielles de l'équipement de conservation de l'oxygène wesentlichen Leistungsmerkmale von Sauerstoff-
(ISO/DIS 80601-2-67:2012) Dosiersystemen (ISO/DIS 80601-2-67:2012)
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, 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
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 80601-2-67:2012: E
worldwide for CEN national Members.

Contents Page
Foreword .3

Foreword
This document (prEN ISO 80601-2-67:2012) 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 18779:2005.
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 80601-2-67:2012 has been approved by CEN as a prEN ISO 80601-2-67:2012 without
any modification.
DRAFT INTERNATIONAL STANDARD ISO/DIS 80601-2-67
ISO/TC 121/SC 3 Secretariat: ANSI

Voting begins on Voting terminates on
2012-01-26 2012-06-26
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 2-67:
Particular requirements for basic safety and essential performance
of oxygen-conserving equipment
Appareils électromédicaux —
Partie 2-67: Exigences particulières pour la sécurité de base et performances essentielles de l'équipement de
conservation de l'oxygène
(Revision of ISO 18779:2005)
ICS 11.040.10
This draft is submitted to a parallel enquiry in ISO and a CDV vote in the IEC.

To expedite distribution, this document is circulated as received from the committee
secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at
publication stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.

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 Organization for Standardization, 2012

ISO/DIS 80601-2-67
Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as permitted
under the applicable laws of the user’s country, neither this ISO draft nor any extract from it may be reproduced,
stored in a retrieval system or transmitted in any form or by any means, electronic, photocopying, recording or
otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to either ISO at the address below or ISO’s member
body in the country of the requester.
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Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
ii © ISO 2012 – All rights reserved

ISO/IEC DIS 80601-2-67
1 Contents Page
2 201.1 Scope, object and related standards .1
3 201.1.1 Scope .1
4 201.1.2 Object .1
5 201.1.3 Collateral standards .2
6 201.1.4 Particular standards .2
7 201.2 Normative references .3
8 201.3 Terms and definitions .4
9 201.4 General requirements .5
10 201.4.3 ESSENTIAL PERFORMANCE .5
11 201.4.3.101 Additional requirements for ESSENTIAL PERFORMANCE .5
12 201.4.6 ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT .5
13 201.4.11.101 Additional requirements for pressurized gas input .6
14 201.4.11.101.1 Overpressure requirement .6
15 201.4.11.101.2 Compatibility requirement .6
16 201.5 General requirements for testing of ME EQUIPMENT .7
17 201.5.101 Additional requirements for general requirements for testing of
18 ME EQUIPMENT . . . . . . . . . . . . . . . . . . .7
19 201.5.101.1 CONSERVING EQUIPMENT test conditions .7
20 201.5.101.2 Gas flowrate and leakage specifications .7
21 201.5.101.3 CONSERVING EQUIPMENT testing errors .7
22 201.6 Classification of ME EQUIPMENT and ME SYSTEMS .7
23 201.7 ME EQUIPMENT identification, marking and documents .7
24 201.7.1.2 * Legibility of markings .7
25 201.7.2.3 * Consult ACCOMPANYING DOCUMENTS .7
26 201.7.2.101 Additional requirements for marking on the outside of ME EQUIPMENT or
27 ME EQUIPMENT parts .8
28 201.7.2.4.101 Additional requirements for ACCESSORIES .8
29 201.7.2.13.101 Additional requirements for physiological effects .8
30 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 13
31 201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS . . . . 1 3
32 201.10 Protection against unwanted and excessive radiation HAZARDS . . . . . . . 1 3
33 201.11 Protection against excessive temperatures and other HAZARDS . . . . . . . 1 3
34 201.11.6.4 Leakage . 13
35 201.11.6.6 Cleaning and disinfection of ME EQUIPMENT or ME SYSTEM . . . . . . 1 4
36 201.11.6.7 Sterilization of ME EQUIPMENT or ME SYSTEM . . . . . . . . . . 1 4
37 201.12 Accuracy of controls and instruments and protection against hazardous outputs . . 1 4
38 201.12.1 Accuracy of controls and instruments . 14
39 201.12. .101 Oxygen delivery performance . 15
40 201.12.4 Protection against hazardous output . 17
41 201.12.4.101 Switch-over to continuous flow . 17
42 201.12.4.102 Absence of a detected PATIENT breath ALARM CONDITION . 17
43 201.12.4.103 Gas supply failure ALARM CONDITION . 17
44 201.12.101 Protection against accidental adjustments . 17
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45 201.13 HAZARDOUS SITUATIONS and fault conditions . 17
46 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 17
47 201.15 Construction of ME EQUIPMENT . 17
48 201.15.101 Mode of operation . 17
49 201.16 ME SYSTEMS . 18
50 201.16.1.101 Additional general requirements for ME SYSTEMS . 18
51 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 18
52 201.17.101 Additional requirements for electromagnetic compatibility of ME EQUIPMENT
53 and ME SYSTEMS . 18
54 201.101 Gas connections . 18
55 201.101.1 Oxygen inlet connector . 18
56 201.101.2 Connection to the MEDICAL GAS PIPELINE SYSTEM . 18
57 201.101.3 Oxygen outlet connector . 18
58 201.102 Requirements for parts and ACCESSORIES . . . . . . . . . . . . . 19
59 201.102.1 General . 19
60 201.102.2 Labelling . 19
61 202.6.2.1.10 Compliance criteria . 19
62 208.6.8.3.101 . Additional requirements for global indefinite ALARM SIGNAL inactivation states
63 . 20
64 208.6.8.4.101 . Additional requirements for termination of ALARM SIGNAL inactivation
65 . 20
66 211.8.4 Additional requirements for interruption of the power supply/SUPPLY MAINS to
67 ME EQUIPMENT and ME SYSTEMS . . . . . . . . . . . . . . . . 20
68 ANNEX C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and
69 ME SYSTEMS . 22
70 Annex D (informative) Symbols on marking . 26
71 Annex ZA (informative) Relationship between this Document and the Essential Requirements
72 of EU Directive 93/42/EEC . 42
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74 Foreword
75 ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
76 (ISO member bodies). The work of preparing International Standards is normally carried out through ISO
77 technical committees. Each member body interested in a subject for which a technical committee has been
78 established has the right to be represented on that committee. International organizations, governmental and
79 non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
80 International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
81 International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
82 The main task of technical committees is to prepare International Standards. Draft International Standards
83 adopted by the technical committees are circulated to the member bodies for voting. Publication as an
84 International Standard requires approval by at least 75 % of the member bodies casting a vote.
85 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
86 rights. ISO shall not be held responsible for identifying any or all such patent rights.
87 ISO/IEC 80601-2-67 was prepared by a joint working group of Technical Committee ISO/TC 121, Anaesthetic
88 and respiratory equipment, Subcommittee SC 3, Lung ventilators and related equipment and Technical
89 Committee IEC/TC 62, Electrical equipment in medical practice, Subcommittee SC D, Electrical equipment.
90 This first edition of ISO 80601-2-67 cancels and replaces the first edition of ISO 18779:2005. This edition of
91 ISO 80601-2-67 constitutes a major technical revision of ISO 18779:2005 and includes an alignment with third
92 edition of IEC 60601-1 and IEC 60601-1-11.
93 The most significant changes are the following modifications:
94 – extending the scope to include not only the CONSERVING EQUIPMENT but also its ACCESSORIES,
95 where the characteristics of those ACCESSORIES can affect the BASIC SAFETY and ESSENTIAL
96 PERFORMANCE of the CONSERVING EQUIPMENT;
97 – identification of ESSENTIAL PERFORMANCE for a CONSERVING EQUIPMENT and its ACCESSORIES;
98 And the following additions:
99 – tests for oxygen delivery performance;
100 – new symbols;
101 – tests for cleaning and disinfection procedures; and
102 – consideration of contamination of the breathing gas delivered to the PATIENT from the gas
103 pathways.
104 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
105 In this standard, the following print types are used:
106 – Requirements and definitions: roman type.
107 – Test specifications: italic type.
108 – Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
109 Normative text of tables is also in a smaller type.
110 – TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED:
111 SMALL CAPITALS TYPE.
112 In referring to the structure of this standard, the term
113 – "clause” means one of the seventeen numbered divisions within the table of contents, inclusive of
114 all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
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115 – “subclause” means a numbered subdivision of a clause (e.g. 201.7.1, 201.7.2 and 201.7.2.1 are
116 all subclauses of Clause 201.7).
117 References to clauses within this standard are preceded by the term “Clause” followed by the clause number.
118 References to subclauses within this particular standard are by number only.
119 In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of
120 the conditions is true.
121 The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part
122 2. For the purposes of this standard, the auxiliary verb:
123 – “shall” means that compliance with a requirement or a test is mandatory for compliance with this
124 standard;
125 – “should” means that compliance with a requirement or a test is recommended but is not
126 mandatory for compliance with this standard;
127 – “may” is used to describe a permissible way to achieve compliance with a requirement or test.
128 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that
129 there is guidance or rationale related to that item in Annex AA.
130 The attention of Member Bodies and National Committees is drawn to the fact that equipment manufacturers
131 and testing organizations may need a transitional period following publication of a new, amended or revised
132 ISO or IEC publication in which to make products in accordance with the new requirements and to equip
133 themselves for conducting new or revised tests. It is the recommendation of the committee that the content of
134 this publication not be adopted for mandatory implementation nationally earlier than 3 years from the date of
135 publication for equipment newly designed and not earlier than 5 years from the date of publication for
136 equipment already in production.
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ISO/IEC DIS 80601-2-67
137 Introduction
138 Long term oxygen treatment prolongs survival in PATIENTS with hypoxic chronic respiratory disease, but is
139 expensive. A equipment that delivers oxygen as a bolus, especially during the first part of inspiration when it
140 is most likely to reach the alveoli, should conserve oxygen while allowing a satisfactory PATIENT arterial
141 oxygen saturation (SaO ) to be achieved.
142 This International Standard specifies requirements for oxygen and oxygen mixture saving devices (called
143 CONSERVING EQUIPMENT in this standard) that are used to supply respiratory gas during oxygen therapy. The
144 aim of oxygen therapy is to obtain the desired SaO . CONSERVING EQUIPMENT is intended to achieve the
145 desired SaO while minimizing usage of oxygen by controlling the delivery of oxygen to the PATIENT,
146 particularly during the expiratory phase of the respiratory cycle.
147 CONSERVING EQUIPMENT delivers oxygen gas in a manner different than from continuous flow oxygen (CFO).
148 Currently, most clinicians prescribe oxygen therapy in continuous oxygen flow (i.e. l/min). By nature
149 CONSERVING EQUIPMENT are not "equivalent" to CFO over all breathing rates and anatomies. CONSERVING
150 EQUIPMENT MANUFACTURERS have adopted many different methods for dosing, yet all equipment on the market
151 at the time of the writing of this standard imply similarity to continuous flow by labelling with integer numbers
152 that appear the same as CFO nomenclature of l/min (e.g. 1, 2, 3, 4, etc.). Different CONSERVING EQUIPMENT set
153 to the same numerical setting can differ by 100 % or more in the actual dose delivered to the PATIENT.
154 The American Association for Respiratory Care along with several published studies [9][10][12][13]
155 recommend individual PATIENT titration at rest and activity when prescribing oxygen using CONSERVING
156 EQUIPMENT. The previous standard, ISO 18779:2005, requires a statement to this effect to be included in the
157 instructions for use. Nonetheless, several studies have been published [14][16] that conclude that CONSERVING
158 EQUIPMENT did not perform well when compared to CFO with the CONSERVING EQUIPMENT at equivalent
159 numerical settings, not titrated settings. This standard is intended to reduce this ambiguity between
160 CONSERVING EQUIPMENT models by requiring both standardized performance testing and labelling.
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162 Medical Electrical Equipment — Part 2-67: Particular requirements for basic
163 safety and essential performance of oxygen conserving equipment
164 201.1 Scope, object and related standards
165 IEC 60601-1:2005, Clause 1 applies, except as follows:
166 201.1.1 * Scope
167 IEC 60601-1:2005, 1.1 is replaced by:
168 This International Standard is applicable to the BASIC SAFETY and ESSENTIAL PERFORMANCE of oxygen
169 CONSERVING EQUIPMENT, hereafter referred to as ME EQUIPMENT, in combination with its ACCESSORIES
170 intended to conserve oxygen by delivering supplemental oxygen intermittently and synchronized to the
171 PATIENT'S inspiratory flow, when used in the HOME HEALTHCARE ENVIRONMENT. Oxygen CONSERVING
172 EQUIPMENT is typically used by a LAY OPERATOR.
173 NOTE 1 CONSERVING EQUIPMENT can also be used in professional health care facilities.
174 NOTE 2 CONSERVING EQUIPMENT can be used with an oxygen-enriched air supply produced from an oxygen
175 concentrator.
176 This International Standard is also applicable to those ACCESSORIES intended by their MANUFACTURER
177 to be connected to CONSERVING EQUIPMENT, where the characteristics of those ACCESSORIES can affect
178 the BASIC SAFETY or ESSENTIAL PERFORMANCE of the CONSERVING EQUIPMENT.
179 This International Standard is only applicable to active devices (e.g., pneumatically or electrically
180 powered) and is not applicable to non-active devices (e.g., reservoir cannulas).
181 NOTE 4 CONSERVING EQUIPMENT can be incorporated with other devices.
182 EXAMPLES CONSERVING EQUIPMENT combined with pressure regulators [2], oxygen concentrators [1] or
183 liquid oxygen equipment [6], each of which has its own applicable standard.
184 If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
185 ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case,
186 the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
187 HAZARDS inherent in the intended function of ME EQUIPMENT or ME SYSTEMS within the scope of this
188 standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the
189 general standard.
190 NOTE 5 See also 4.2 of the General Standard.
191 This International Standard is a particular standard in the IEC 60601 series of standards.
192 201.1.2 Object
193 IEC 60601-1:2005, 1.2 is replaced by:
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194 The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
195 PERFORMANCE requirements for a CONSERVING EQUIPMENT [as defined in 201.3.201] and its
196 ACCESSORIES.
197 NOTE ACCESSORIES are included because ACCESSORIES can have a significant impact on the BASIC SAFETY or
198 ESSENTIAL PERFORMANCE of CONSERVING EQUIPMENT.
199 201.1.3 Collateral standards
200 IEC 60601-1:2005, 1.3 applies with the following addition:
201 This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the
202 general standard and 201.2 of this particular standard.
203 IEC 60601-1-3:2008 does not apply.
204 201.1.4 Particular standards
205 IEC 60601-1:2005, 1.4 is replaced by:
206 In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in
207 the general standard, including the collateral standards, as appropriate for the particular ME EQUIPMENT
208 under consideration, and may add other BASIC SAFETY or ESSENTIAL PERFORMANCE requirements.
209 A requirement of a particular standard takes priority over the general standard or the collateral
210 standards.
211 For brevity, IEC 60601-1:2005 + Amendment 1:2012 is referred to in this particular standard as the
212 general standard. Collateral standards are referred to by their document number.
213 The numbering of clauses and subclauses of this particular standard corresponds to those of the
214 general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content of Clause 1 of
215 the general standard) or applicable collateral standard with the prefix “2xx” where xx is the final digits
216 of the collateral standard document number (e.g. 202.4 in this particular standard addresses the
217 content of Clause 4 of the IEC 60601-1-2 collateral standard, 208.4 in this particular standard
218 addresses the content of Clause 4 of the IEC 60601-1-8 collateral standard, etc.). The changes to the
219 text of the general standard are specified by the use of the following words:
220 "Replacement" means that the clause or subclause of the general standard or applicable collateral
221 standard is replaced completely by the text of this particular standard.
222 "Addition" means that the text of this particular standard is additional to the requirements of the
223 general standard or applicable collateral standard.
224 "Amendment" means that the clause or subclause of the general standard or applicable collateral
225 standard is amended as indicated by the text of this particular standard.
226 Subclauses or figures that are additional to those of the general standard are numbered starting from
227 201.101, additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
228 Subclauses or figures that are additional to those of a collateral standard are numbered starting from
229 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-1-2, 203 for IEC 60601-
230 1-3, etc.
231 The term "this standard" is used to make reference to the general standard, any applicable collateral
232 standards and this particular standard taken together.
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233 Where there is no corresponding clause or subclause in this particular standard, clause or subclause
234 of the general standard or applicable collateral standard, although possibly not relevant, applies
235 without modification; where it is intended that any part of the general standard or applicable collateral
236 standard, although possibly relevant, is not to be applied, a statement to that effect is given in this
237 particular standard.
238 201.2 Normative references
239 The following referenced documents are indispensable for the application of this document. The way
240 in which these referenced documents are cited in normative requirements determines the extent (in
241 whole or in part) to which they apply. For dated references, only the edition cited applies. For undated
242 references, the latest edition of the referenced document (including any amendments) applies.
243 NOTE Informative references are listed in the bibliography beginning on page 38.
244 Clause 2 of the general standard applies, except as follows:
245 Replacement:
246 IEC 60601-1-2:2007, Medical electrical equipment – Part 1-2: General requirements for basic safety
247 and essential performance – Collateral Standard: Electromagnetic compatibility – Requirements and
248 tests
249 IEC 60601-1-6:2010, Medical electrical equipment – Part 1-6: General requirements for basic safety
250 and essential performance – Collateral standard: Usability
251 IEC 60601-1-8:2006, Medical electrical equipment - Part 1-8: General requirements for basic safety
252 and essential performance - Collateral Standard: General requirements, tests and guidance for alarm
253 systems in medical electrical equipment and medical electrical systems
1)
254 +Amendment 1:2012
255 IEC 60601-1-9:2007, Medical electrical equipment – Part 1-9: General requirements for basic safety
256 and essential performance – Collateral Standard: Requirements for environmentally conscious design
257 IEC 60601-1-10:2007, Medical electrical equipment – Part 1-10: General requirements for basic safety
258 and essential performance – Collateral Standard: Process requirements for the development of
259 therapeutic closed-loop controllers
260 IEC 60601-1-11:2010, Medical electrical equipment – Part 1-11: General requirements for basic safety
261 and essential performance – Collateral Standard: Requirements for medical electrical equipment and
262 medical electrical systems used in the home healthcare environment
263 Addition:
264 ISO 32:1977, Gas cylinders for medical use -- Marking for identification of content
265 ISO 4135:2001, Anaesthetic and respiratory equipment – Vocabulary
266 ISO 5359:2008, Low-pressure hose assemblies for use with medical gases
267 ISO 7000:2004, Graphical symbols for use on equipment -- Index and synopsis
—————————
1)
To be published.
© ISO/IEC 2011 – All rights reserved
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268 ISO 7010:2003, Graphical symbols -- Safety colours and safety signs -- Safety signs used in
269 workplaces and public areas
270 +Amendment 1:2006
271 +Amendment 2:2007
272 +Amendment 3:2007
273 +Amendment 4:2009
274 ISO 7396-1:2007, Medical gas pipeline systems -- Part 1: Pipeline systems for compressed medical
275 gases and vacuum
276 +Amendment 1:2010
277 ISO 14937:2009, Sterilization of health care products -- General requirements for characterization of a
278 sterilizing agent and the development, validation and routine control of a sterilization process for
279 medical devices
280 ISO 10524-1:2006, Pressure regulators for use with medical gases — Part 1: Pressure
281 regulators and pressure regulators with flow-metering devices
282 ISO 15223-1:2007, Medical devices — Symbols to be used with medical device labels, labelling and
283 information to be supplied — Part 1: General requirements
284 +Amendment 1:2008
285 ISO 17664:2004, Sterilization of medical devices -- Information to be provided by the manufacturer for
286 the processing of resterilizable medical devices
287 ISO 80369-1:2010, Small-bore connectors for liquids and gases in healthcare applications — Part 1:
288 General requirements
289 IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety and
290 essential performance
2)
291 +Amendment 1:2012
292 IEC 62366:2007, Medical devices – Application of usability engineering to medical devices
293 EN 15986:2011, Symbol for use in the labelling of medical devices - Requirements for labelling of
294 medical devices containing phthalates
295 201.3 Terms and definitions
296 For the purposes of this document, the terms and definitions given in ISO 7396-1:2007, IEC 60601-
297 1:2005, IEC 60601-1-2:2007, IEC 60601-1-6:2010, IEC 60601-1-8:2006, IEC 60601-1-11:2010,
298 IEC 60601-2-2:2007, IEC 62366:2007, ISO 4135:2001 and the following apply.
299 NOTE An index of defined terms is found beginning on page 40.
300 Addition:
301 201.3.201
302 CONSERVING EQUIPMENT
303 ME EQUIPMENT intended to improve the utilization of the oxygen source while providing oxygen therapy
304 intended to maintain the required PATIENT SaO
305 NOTE CONSERVING EQUIPMENT can be electrically or pneumatically powered.
—————————
2)
To be published.
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306 201.3.202
307 CONSERVING EQUIPMENT WITH MONITORING FUNCTION
308 CONSERVING EQUIPMENT intended for use with PATIENTS where monitoring of oxygen delivery via the
309 CONSERVING EQUIPMENT is indicated by clinical circumstances
310 201.3.203
311 FLOW-DIRECTION-SENSITIVE COMPONENT
312 component or ACCESSORY through which gas flow has to be in one direction only for proper functioning
313 or PATIENT safety
314 [ISO 4135:2001, definition 3.1.7, modified]
315 201.4 General requirements
316 IEC 60601-1:2005, Clause 4 applies, except as follows:
317 201.4.3 ESSENTIAL PERFORMANCE
318 IEC 60601-1:2005, 4.3 applies, except as follows:
319 Additional subclause:
320 201.4.3.101 * Additional requirements for ESSENTIAL PERFORMANCE
321 Additional ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in Table 201.101.
322 Table 201.101 — Distributed ESSENTIAL PERFORMANCE requirements
Requirement Subclause
a
For [CONSERVING EQUIPMENT WITH MONITORING FUNCTION], the DELIVERED
201.12.1.101
OXYGEN DOSE, in both NORMAL CONDITION and SINGLE FAULT CONDITION, within
the accuracy as indicated in the instructions for use

or generation of an ALARM CONDITION
triggering signal absence ALARM CONDITION 201.12.4.101
gas supply failure ALARM CONDITION 201.12.4.102

a
For other than [CONSERVING EQUIPMENT WITH MONITORING FUNCTION], the
201.12.1.101
DELIVERED OXYGEN DOSE, in NORMAL CONDITION, within the ACCURACY
indicated in the instructions for use

or an indication of abnormal operation

a
Subclause 202.6.2.1.10 indicates methods of evaluating delivered oxygen as
acceptance criteria following specific tests required by this standard.
324 201.4.6 * ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT
325 Amendment (add at end of subclause):
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326 The gas pathways of CONSERVING EQUIPMENT or its parts or ACCESSORIES shall be subject to the
327 requirements for APPLIED PARTS according to this subclause. CONSERVING EQUIPMENT or its parts or
328 ACCESSORIES that can come into contact with the PATIENT shall be subject to the requirements for
329 APPLIED PARTS according to this subclause.
330 201.4.11.101 * Additional requirements for pressurized gas input
331 201.4.11.101.1 Overpressure requirement
332 CONSERVING EQUIPMENT with an OPERATOR-accessible oxygen inlet connector as specified in
333 201.101.1, shall operate and meet the requirements of this particular standard throughout its RATED
334 range of input pressure and shall not cause an unacceptable RISK under the SINGLE FAULT CONDITION of
335 1000 kPa.
336 CONSERVING EQUIPMENT with an OPERATOR-accessible oxygen inlet connector that complies with 5.8 of
337 ISO 80369-1:2010 shall not cause an unacceptable RISK under the SINGLE FAULT CONDITION of twice
338 the maximum RATED input pressure.
339 NOTE 1 Internal pressure regulators can be required to accommodate the SINGLE FAULT CONDITION of maximum
340 input pressure as well as the RATED range of input pressure.
341 NOTE 2 Under the SINGLE FAULT CONDITION of overpressure, it is desirable for gas to continue to flow to the
342 PATIENT. Under this condition, the flowrate from the CONSERVING EQUIPMENT is likely to be outside of its
343 specification.
344 Check compliance by functional testing in NORMAL USE and under NORMAL CONDITION with the most
345 adverse operating settings, by functional testing in SINGLE FAULT CONDITION and inspection of the RISK
346 MANAGEMENT FILE.
347 201.4.11.101.2 Compatibility requirement
348 If CONSERVING EQUIPMENT is intended to be connected to a MEDICAL GAS PIPELINE SYSTEM complying
349 with ISO 7396-1:2007 then:
350 – the RATED range of input pressure shall cover the range specified in ISO 7396-1:2007; and
351 – under NORMAL CONDITION,
352 1) the 10 s average input flow required by the CONSERVING EQUIPMENT for each gas shall
353 not exceed 60 l/min at a pressure of 280 kPa, measured at the gas input port; and
354 2) the transient input flow shall not exceed 200 l/min averaged for 3 s.
355  or:
356 3) the ACCOMPANYING DOCUMENTS shall disclose:
357 i) the 10 s average input flow required by the CONSERVING EQUIPMENT for each gas at
358 a pressure of 280 kPa, measured at the gas input port;
359 ii) the maximum transient input flow averaged for 3 s required by the CONSERVING
360 EQUIPMENT for each gas at a pressure of 280 kPa, measured at the gas input port;
361 and
362 iii) a warning to the effect that “Warning: This CONSERVING EQUIPMENT is a high flow
363 device and should only be connected to a pipeline installation designed using a
364 diversity factor that allows for the indicated high flow at a specified number of
365 terminal outlets, in order to avoid exceeding the pipeline design flow, thereby
366 minimising the RISK that the CONSERVING EQUIPMENT interferes with the operation of
367 adjacent equipment.”
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368 Check compliance by functional testing in NORMAL USE and under NORMAL CONDITION with the most
369 adverse operating settings and by inspection of the ACCOMPANYING DOCUMENTS.
370 EXAMPLE Highest driving gas consumption, highest gas delivery and, if provided, the highest RATED gas
371 consumption at any gas power supply output.
372 201.5 General requirements for testing of ME EQUIPMENT
373 IEC 60601-1:2005, Clause 5 applies, except as follows:
374 Addition:
375 201.5.101 Additional requirements for general requirements for testing of ME EQUIPMENT
376 201.5.101.1 CONSERVING EQUIPMENT test conditions
377 For testing, CONSERVING EQUIPMENT shall be connected to gas supplies as specified for NORMAL USE,
378 except that industrial grade oxygen may be substituted for the equivalent medical gas, as appropriate,
379 unless otherwise stated. When using a substitute gas, care should be taken to ensure that the test gas
380 has the minimum oxygen concentration, maximum water content and the maximum oil content
381 specified for NORMAL USE.
382 201.5.101.2 * Gas flowrate specifications
383 In this standard, requirements for flowrate and volume for the gas supplied to the CONSERVING
384 EQUIPMENT and for gas delivered to the PATIENT are expressed as if tested under STPD (standard
385 temperature and pressure dry) conditions.
386 NOTE 1 For the purposes of this standard, STPD is 101,3 kPa at an operating temperature of 20 °C, dry.
387 Correct all test measurements to STPD, as appropriate.
388 201.5.101.3 * CONSERVING EQUIPMENT testing errors
389 For the purposes of this standard, declared tolerances shall include the measurement uncertainty of
390 the measurement used to determine the specification.
391 201.6 Classification of ME EQUIPMENT and ME SYSTEMS
392 IEC 60601-1:2005, Clause 6 applies.
393 201.7 * ME EQUIPMENT identification, marking and documents
394 IEC 60601-1:2005, Clause 7 applies, except as follows:
395 201.7.1.2 * Legibility of markings
396 IEC 60601-1:2005, 7.1.2 applies, except as follows:
397 Replacement (at the end of the first sentence of the second paragraph of the test method):
398 Replace ‘1 m’ with ‘1 m and for BODY-WORN ME EQUIPMENT 0,5 m’
399 Additional subclauses:
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400 201.7.2.4.101 Additional requirements for ACCESSORIES
401 ACCESSORIES supplied separately shall fulfil the requirements of 201.7.2.101 and shall be marked with
402 an indication of any limitations or adverse effects of the ACCESSORY on the BASIC SAFETY or ESSENTIAL
403 PERFORMANCE of the CONSERVING EQUIPMENT, if applicable. If marking the ACCESSORY is not
404 practicable, this information may be placed in the instructions for use.
405 Check compliance by inspection and inspection of the RISK MANAGEMENT FILE for any limitations or
406 adverse effects of the ACCESSORY.
407 201.7.2.13.
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