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oSIST prEN ISO 80601-2-67:2012
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
oSIST prEN ISO 80601-2-67:2012 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 80601-2-67:2012
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oSIST prEN ISO 80601-2-67:2012
EUROPEAN STANDARD
DRAFT
prEN ISO 80601-2-67
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.
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oSIST prEN ISO 80601-2-67:2012
prEN ISO 80601-2-67:2012 (E)
Contents Page
Foreword .3
2
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oSIST prEN ISO 80601-2-67:2012
prEN ISO 80601-2-67:2012 (E)
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.
3
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oSIST prEN ISO 80601-2-67:2012
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oSIST prEN ISO 80601-2-67:2012
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
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oSIST prEN ISO 80601-2-67:2012
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.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [email protected]
Web www.iso.org
Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
ii © ISO 2012 – All rights reserved
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oSIST prEN ISO 80601-2-67:2012
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
73
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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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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.
2
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
2
145 desired SaO while minimizing usage of oxygen by controlling the delivery of oxygen to the PATIENT,
2
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.
161
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oSIST prEN ISO 80601-2-67:2012
IEC ISO/DIS 80601-2-67 © ISO:2011 – 1 – ISO TC121/SC3-62D JWG12
62D/xxx/CDV
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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62D/xxx/CDV
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 c
...