prEN IEC 80601-2-23:2024
(Main)Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment
Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment
2019-05-29 IP: Link to legislation (MDD) removed following CLC/TC 62 decision 02/2019 decision (May 2019 plenary)
Medizinische elektrische Geräte - Teil 2-23: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Geräten für die transkutane Partialdrucküberwachung
Appareils électromédicaux - Partie 2-23: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de surveillance de la pression partielle transcutanée
Medicinska električna oprema - 2-23. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za skozikožno (transkutano) nadzorovanje delnega (parcialnega) krvnega tlaka
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2024
Medicinska električna oprema - 2-23. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme za skozikožno (transkutano) nadzorovanje delnega
(parcialnega) krvnega tlaka
Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and
essential performance of transcutaneous partial pressure monitoring equipment
Medizinische elektrische Geräte - Teil 2-23: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Geräten für die transkutane
Partialdrucküberwachung
Appareils électromédicaux - Partie 2-23: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils de surveillance de la pression partielle
transcutanée
Ta slovenski standard je istoveten z: prEN IEC 80601-2-23:2024
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
62D/2133/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 80601-2-23 ED1
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2024-06-07 2024-08-30
SUPERSEDES DOCUMENTS:
62D/2037A/RR
IEC SC 62D : PARTICULAR MEDICAL EQUIPMENT, SOFTWARE, AND SYSTEMS
SECRETARIAT: SECRETARY:
United States of America Ms Ladan Bulookbashi
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:
Other TC/SCs are requested to indicate their interest, if any,
in this CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
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CENELEC, is drawn to the fact that this Committee Draft for
Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
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Recipients of this document are invited to submit, with their comments, notification of any relevant “In Some Countries” clau ses
to be included should this proposal proceed. Recipients are reminded that the CDV stage is the final stage for submitting ISC
clauses. (SEE AC/22/2007 OR NEW GUIDANCE DOC).
TITLE:
Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential
performance of transcutaneous partial pressure monitoring equipment
PROPOSED STABILITY DATE: 2030
NOTE FROM TC/SC OFFICERS:
electronic file, to make a copy and to print out the content for the sole purpose of preparing National Committee positions. You
may not copy or "mirror" the file or printed version of the document, or any part of it, for any other purpose without permis sion
in writing from IEC.
62D/2133/CDV – 2 – IEC CDV 80601-2-23 © IEC:2024
1 CONTENTS
2 FOREWORD . 5
3 INTRODUCTION . 9
4 201.1 Scope, object and related standards. 10
5 201.1.1 * Scope . 10
6 201.1.2 Object . 10
7 201.1.3 Collateral standards . 11
8 201.1.4 Particular standards . 11
9 201.2 Normative references . 12
10 201.3 Terms and definitions . 12
11 201.4 General requirements . 13
12 201.4.7 SINGLE FAULT CONDITION for ME EQUIPMENT . 13
13 201.4.101 Additional ESSENTIAL PERFORMANCE requirements . 13
14 201.5 General requirements for testing of ME EQUIPMENT . 14
15 201.5.4 Other conditions . 14
16 201.5.8 * Sequence of tests . 14
17 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 14
18 201.6.2 * Protection against electric shock . 14
19 201.6.6 Mode of operation. 14
20 201.7 ME EQUIPMENT identification, marking and documents . 15
21 201.7.9.2 Instructions for use . 15
22 201.7.9.2.2 Warning and safety notices . 15
23 201.7.9.2.101 Additional instructions for use . 15
24 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 16
25 201.8.101 * TRANSDUCERS and cables . 16
26 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 17
27 201.10 Protection against unwanted and excessive radiation HAZARDS . 17
28 201.11 Protection against excessive temperatures and other HAZARDS . 17
29 201.11.1.2 Temperature of APPLIED PARTS . 17
30 201.11.1.2.2 * APPLIED PARTS not intended to supply heat to a PATIENT . 17
31 201.11.1.2.2.101 Heater in the APPLIED PART . 17
32 201.11.1.2.2.102 Indication of SET TEMPERATURE . 17
33 201.11.1.2.2.103 SET TEMPERATURE . 17
34 201.11.1.2.2.104 Temperature overshoot . 17
35 201.11.1.2.2.105 TEMPERATURE LIMITER . 18
36 201.11.1.2.2.106 * Indication of temperature deviation in SINGLE
37 FAULT CONDITION 19
38 201.11.1.2.2.107 Timer indicating an elapsed time . 19
39 201.11.6.5 * Ingress of water or particulate matter into ME EQUIPMENT
40 and ME SYSTEMS . 19
41 201.11.8 * Interruption of the power supply / SUPPLY MAINS to
42 ME EQUIPMENT . 19
43 201.11.8.101 * Protection against depletion of battery . 20
44 201.12 Accuracy of controls and instruments and protection against hazardous
45 outputs . 21
46 201.12.1 Accuracy of controls and instruments . 21
47 201.12.1.101 * Non-linearity and hysteresis . 21
IEC 80601-2-23 © IEC:2024 – 3 – 62D/2133/CDV
48 201.12.1.102 * Drift . 26
49 201.12.1.103 Response time . 26
50 201.12.3 Alarm systems . 26
51 201.13 HAZARDOUS SITUATIONS and fault conditions . 26
52 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 26
53 201.15 Construction of ME EQUIPMENT . 26
54 201.15.3.4.1 * HAND-HELD ME EQUIPMENT . 26
55 201.15.4.2 Temperature and overload control devices . 27
56 201.15.4.4 Indicators . 27
57 201.15.4.4.101 Indicator of battery operation and battery status . 27
58 201.16 ME SYSTEMS. 27
59 201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 27
60 202 Electromagnetic disturbances – Requirements and tests . 27
61 202.4.3.1 Configurations . 27
62 202.8.1 * General . 29
63 206 Usability . 30
64 206.101 Primary operating functions . 30
65 208 General requirements, tests and guidance for alarm systems in medical electrical
66 equipment and medical electrical systems . 30
67 208.6 ALARM SYSTEMS . 31
68 208.6.1 Alarm condition. 31
69 208.6.1.2 * Determination of ALARM CONDITIONS and assignment of priority . 31
70 208.6.4.1 ALARM SYSTEM delays . 31
71 208.6.4.1.101 Additional requirements for ALARM SYSTEM delays . 31
72 208.6.4.1.102 * Time to alarm for TECHNICAL ALARM CONDITIONS . 32
73 208.6.5 ALARM PRESETS . 32
74 208.6.5.2 Manufacturer-configured ALARM PRESETS . 32
75 208.6.6 ALARM LIMIT . 32
76 208.6.6.1 General requirements . 32
77 208.6.6.1.101 * Adjustment range of pO and pCO ALARM LIMITS . 32
2 2
78 208.6.6.1.102 Resolution of ALARM LIMIT settings . 33
79 208.6.8 ALARM SIGNAL inactivation states . 33
80 208.6.8.1 * General . 33
81 208.6.10 * NON-LATCHING and LATCHING ALARM SIGNALS . 33
82 208.6.12 ALARM SYSTEM logging . 34
83 208.6.12.1 General . 34
84 208.6.12.2 OPERATOR ALARM SYSTEM logging . 34
85 208.6.12.3 RESPONSIBLE ORGANIZATION ALARM SYSTEM logging . 34
86 Annexes . 34
87 Annex AA (informative) Particular guidance and rationale . 35
88 Guidance and rationale for particular clauses . 35
89 Index of defined terms used in this particular standard . 41
91 Figure 201.101 – TRANSDUCER cable strain relief test . 16
92 Figure 201.102 – Foam block test (see 201.11.1.2.2.104 and 201.11.1.2.2.105) . 18
93 Figure 201.103 – Linearity and hysteresis test set-up – Gas mix chamber, assembled . 23
94 Figure 202.101 – Set-up for radiated and conducted EMISSIONS testing . 28
62D/2133/CDV – 4 – IEC CDV 80601-2-23 © IEC:2024
95 Figure 202.102 – Set-up for conducted and radiated immunity test . 29
97 Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements . 13
98 Table 201.102 – Required readings and tolerances . 21
99 Table 201.103 – Calibration test gases . 22
IEC 80601-2-23 © IEC:2024 – 5 – 62D/2133/CDV
102 INTERNATIONAL ELECTROTECHNICAL COMMISSION
103 ____________
105 MEDICAL ELECTRICAL EQUIPMENT –
107 Part 2-23: Particular requirements for the basic safety and
108 essential performance of transcutaneous partial
109 pressure monitoring equipment
112 FOREWORD
113 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
114 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
115 international co-operation on all questions concerning standardization in the electrical and electronic fields. To
116 this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
117 Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
118 Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
119 in the subject dealt with may participate in this preparatory work. International, governmental and non -
120 governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
121 with the International Organization for Standardization (ISO) in accordance with conditions determined by
122 agreement between the two organizations.
123 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
124 consensus of opinion on the relevant subjects since each technical committee has representation from all
125 interested IEC National Committees.
126 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
127 Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
128 Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
129 misinterpretation by any end user.
130 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
131 transparently to the maximum extent possible in their national and regional publications. Any divergence
132 between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
133 the latter.
134 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
135 assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
136 services carried out by independent certification bodies.
137 6) All users should ensure that they have the latest edition of this publication.
138 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
139 members of its technical committees and IEC National Committees for any personal injury, property damage or
140 other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
141 expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
142 Publications.
143 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
144 indispensable for the correct application of this publication.
145 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
146 patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
147 International standard IEC 60601-2-23 has been prepared by a Joint Working Group of IEC
148 subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical
149 equipment in medical practice and ISO subcommittee SC3: Lung ventilators and related
150 equipment, of ISO technical committee 121: Anaesthetic and respiratory equipment .
151 This fourth edition cancels and replaces the third edition published in 2011. This edition
152 constitutes a technical revision to align with Amendment 1:2012 and Amendment 2:2020 of
153 IEC 60601-1:2005, new versions of collateral standards and amendments thereto.
154 Further it includes the following technical changes:
155 – Expansion of the scope to the EMERGENCY MEDICAL SERVICE ENVIRONMENT and
156 HOME HEALTHCARE ENVIRONMENT
157 – Changed ESSENTIAL PERFORMANCE in Table 201.101
158 – Changed requirement for ingress protection
62D/2133/CDV – 6 – IEC CDV 80601-2-23 © IEC:2024
159 – Added PRIMARY OPERATING FUNCTIONS
160 – Added requirements for ALARM SYSTEM logging
IEC 80601-2-23 © IEC:2024 – 7 – 62D/2133/CDV
162 The text of this particular standard is based on the following documents:
FDIS Report on voting
62DXX/FDIS 62D/XX/RVD
164 Full information on the voting for the approval of this particular standard can be found in the
165 report on voting indicated in the above table.
166 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
167 In this standard, the following print types are used:
168 – Requirements and definitions: roman type.
169 – Test specifications: italic type.
170 – Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
171 Normative text of tables is also in a smaller type.
172 – TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
173 NOTED: SMALL CAPITALS.
174 In referring to the structure of this standard, the term
175 – “clause” means one of the twenty numbered divisions within the table of contents,
176 inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
177 – “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
178 subclauses of Clause 7).
179 References to clauses within this standard are preceded by the term “Clause” followed by the
180 clause number. References to subclauses within this particular standard are by number only.
181 In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
182 combination of the conditions is true.
183 The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
184 Directives, Part 2. For the purposes of this standard, the auxiliary verb:
185 – “shall” means that compliance with a requirement or a test is mandatory for compliance
186 with this standard;
187 – “should” means that compliance with a requirement or a test is recommended but is not
188 mandatory for compliance with this standard;
189 – “may” is used to describe a permissible way to achieve compliance with a requirement or
190 test.
191 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
192 indicates that there is guidance or rationale related to that item in Annex AA
193 A list of all parts of the IEC 60601 series, published under the general title Medical electrical
194 equipment, can be found on the IEC website.
62D/2133/CDV – 8 – IEC CDV 80601-2-23 © IEC:2024
196 The committee has decided that the contents of this publication will remain unchanged until
197 the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data
198 related to the specific publication. At this date, the publication will be
199 • reconfirmed,
200 • withdrawn,
201 • replaced by a revised edition, or
202 • amended.
203 NOTE The attention of National Committees and Member Bodies is drawn to the fact that equipment
204 manufacturers and testing organizations may need a transitional period following publication of a new, amended or
205 revised IEC publication in which to make products in accordance with the new requirements and to equip
206 themselves for conducting new or revised tests. It is the recommendation of the committees that the content of this
207 publication be adopted for implementation nationally not earlier than 3 years from the date of publication.
208 The National Committees are requested to note that for this document the stability date
209 is 20xx.
210 This text is included for the information of the national committees and will be deleted at the
211 publication stage.
IEC 80601-2-23 © IEC:2024 – 9 – 62D/2133/CDV
214 INTRODUCTION
215 This particular standard concerns the BASIC SAFETY and ESSENTIAL PERFORMANCE of
216 TRANSCUTANEOUS PARTIAL PRESSURE MONITORS. It amends and supplements
217 IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020:
218 Medical electrical equipment – Part 1: General requirements for basic safety and essential
219 performance, hereinafter referred to as the general standard.
220 The aim of this fourth edition is to bring this particular standard up to date with reference to
221 the edition 3.2 of the general standard and new versions of collateral standards and
222 amendments thereto through technical changes.
223 The requirements of this particular standard take priority over those of the general standard
224 and collateral standards.
225 A “General guidance and rationale” for the more important requirements of this particular
226 standard is included in Annex AA. It is considered that knowledge of the reasons for these
227 requirements will not only facilitate the proper application of the standard but will, in due
228 course, expedite any revision necessitated by changes in clinical practice or as a result of
229 developments in technology. However, Annex AA does not form part of the requirements of
230 this document.
62D/2133/CDV – 10 – IEC CDV 80601-2-23 © IEC:2024
232 MEDICAL ELECTRICAL EQUIPMENT –
234 Part 2-23: Particular requirements for the basic safety and
235 essential performance of transcutaneous partial
236 pressure monitoring equipment
240 201.1 Scope, object and related standards
241 Clause 1 of the general standard applies, except as follows:
242 201.1.1 * Scope
243 Replacement:
244 This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
245 TRANSCUTANEOUS PARTIAL PRESSURE MONITORS as defined in 201.3.203 hereinafter also
246 referred to as ME EQUIPMENT or ME SYSTEM.
247 This document applies to TRANSCUTANEOUS PARTIAL PRESSURE MONITORS intended for use in
248 professional healthcare facilities in the EMERGENCY MEDICAL SERVICE ENVIRONMENT or the
249 HOME HEALTHCARE ENVIRONMENT.
250 This standard applies to TRANSCUTANEOUS PARTIAL PRESSURE MONITORS used with adults,
251 children and neonates, and it includes the use of these devices in foetal monitoring during
252 birth.
253 This standard does not apply to haemoglobin saturation oximeters or to devices applied to
254 surfaces of the body other than the skin (for example conjunctiva, mucosa).
255 If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
256 ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
257 case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as follows:
258 The clause or subclause applies to ME EQUIPMENT, as default. For ME EQUIPMENT with the
259 corresponding safety measure or function not completely integrated into the ME EQUIPMENT but
260 instead implemented in an ME SYSTEM, the ME EQUIPMENT MANUFACTURER shall specify in the
261 ACCOMPANYING DOCUMENTS which functionality and safety requirements shall be provided by
262 the ME SYSTEM to comply with this standard. The ME SYSTEM has to be verified accordingly.
263 HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within
264 the scope of this document are not covered by specific requirements in this document.
265 NOTE See also 4.2 of the General Standard.
266 201.1.2 Object
267 Replacement:
268 The object of this particular standard is to establish BASIC SAFETY and
269 ESSENTIAL PERFORMANCE requirements for TRANSCUTANEOUS PARTIAL PRESSURE MONITORS as
270 defined in 201.3.203.
—————————
The general standard is IEC 60601-1:2005 , IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
IEC 80601-2-23 © IEC:2024 – 11 – 62D/2133/CDV
271 201.1.3 Collateral standards
272 Addition:
273 This particular standard refers to those applicable collateral standards that are listed in
274 Clause 2 of the general standard and Clause 201.2 of this particular standard.
275 IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-6:2010, IEC 60601-1-
276 6:2010/AMD1:2013 and IEC 60601-1-6:2010/AMD2:2020, as well as IEC 60601-1-8:2006,
277 IEC 60601-1-8:2006/AMD1:2012 and IEC 60601-1-8:2006/AMD2:2020 apply as modified in
278 Clauses 202, 206 and 208, respectively. IEC 60601-1-3, IEC 60601-1-9 and IEC 60601-1-10
279 do not apply. All other published collateral standards in the IEC 60601-1 series apply as
280 published.
281 201.1.4 Particular standards
282 Replacement:
283 In the IEC 60601 series, particular standards may modify, replace or delete requirements
284 contained in the general standard and collateral standards as appropriate for the particular ME
285 EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE
286 requirements.
287 A requirement of a particular standard takes priority over the general standard and collateral
288 standards.
289 For brevity, IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-
290 1:2005/AMD1:2020 is referred to in this particular standard as the general standard. Collateral
291 standards are referred to by their document number.
292 The numbering of clauses and subclauses of this particular standard corresponds to that of
293 the general standard with the prefix “201” (e.g. 201.1 in this document addresses the content
294 of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”
295 where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
296 particular standard addresses the content of Clause 4 of the 60601-1-2 collateral standard,
297 208.4 in this particular standard addresses the content of Clause 4 of the 60601-1-8 collateral
298 standard, etc.). The changes to the text of the general standard are specified by the use of
299 the following words:
300 "Replacement" means that the clause or subclause of the general standard or applicable
301 collateral standard is replaced completely by the text of this particular standard.
302 "Addition" means that the text of this particular standard is additional to the requirements of
303 the general standard or applicable collateral standard.
304 "Amendment" means that the clause or subclause of the general standard or applicable
305 collateral standard is amended as indicated by the text of this particular standard.
306 Subclauses, figures or tables which are additional to those of the general standard are
307 numbered starting from 201.101. However, due to the fact that definitions in the general
308 standard are numbered 3.1 through 3.139, additional definitions in this document are
309 numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
310 additional items aa), bb), etc.
311 Subclauses, figures or tables which are additional to those of a collateral standard are
312 numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
313 IEC 60601-1-2, 208 for IEC 60601-1-8, etc.
62D/2133/CDV – 12 – IEC CDV 80601-2-23 © IEC:2024
314 The term "this document" is used to make reference to the general standard, any applicable
315 collateral standards and this particular standard taken together.
316 Where there is no corresponding clause or subclause in this particular standard, the clause or
317 subclause of the general standard or applicable collateral standard, although possibly not
318 relevant, applies without modification; where it is intended that any part of the general
319 standard or applicable collateral standard, although possibly relevant, is not to be applied, a
320 statement to that effect is given in this particular standard.
321 201.2 Normative references
322 Clause 2 of the general standard applies, except as follows:
323 Amendment:
324 IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
325 safety and essential performance – Collateral standard: Electromagnetic disturbances –
326 Requirements and tests
327 IEC 60601-1-2:2014/AMD1:2020
328 IEC 60601-1-6:2010, Medical electrical equipment – Part 1-6: General requirements for basic
329 safety and essential performance – Collateral standard: Usability
330 IEC 60601-1-6:2010/AMD1:2013
331 IEC 60601-1-6:2010/AMD2:2020
332 IEC 60601-1-8:2006, Medical electrical equipment – Part 1-8: General requirements for basic
333 safety and essential performance – Collateral standard: General requirements, tests and
334 guidance for alarm systems in medical electrical equipment and medical electrical systems
335 IEC 60601-1-8:2006/AMD1:2012
336 IEC 60601-1-8:2006/AMD2:2020
337 IEC 60529:1989, Degrees of protection provided by enclosures (IP Code)
338 IEC 60529:1989/AMD1:1999
339 IEC 60529:1989/AMD2:2013
340 Addition:
341 IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
342 safety and essential performance
343 IEC 60601-1:2005/AMD1:2012
344 IEC 60601-1:2005/AMD2:2020
345 IEC 60601-1-11:2015, Medical electrical equipment – Part 1-11: General requirements for
346 basic safety and essential performance – Collateral standard: Requirements for medical
347 electrical equipment and medical electrical systems used in the home healthcare environment
348 IEC 60601-1-11:2015/AMD1:2020
349 IEC 60601-1-12:2014, Medical electrical equipment – Part 1-12: General requirements for
350 basic safety and essential performance – Collateral standard: Requirements for medical
351 electrical equipment and medical electrical systems intended for use in the emergency
352 medical services environment
353 IEC 60601-1-12:2014/AMD1:2020
354 201.3 Terms and definitions
355 NOTE An index of defined terms is found beginning on page 39.
IEC 80601-2-23 © IEC:2024 – 13 – 62D/2133/CDV
356 For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
357 IEC 606011:2005/AMD1:2012, and IEC 60601-1:2005/AMD1:2020, IEC 60601-1-2:2014 and
358 IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-6:2010, IEC 60601-1-6:2010/AMD1:2013 and
359 IEC 60601-1-6:2010/AMD2:2020, IEC 60601-1-8:2006, IEC 60601-1-8:2006/AMD1:2012 and
360 IEC 60601-1-8:2006/AMD2:2020, IEC 60601-1-11:2015 and IEC 60601-1-
361 11:2015/AMD1:2020, IEC 60601-1-12:2014 and IEC 60601-1-12:2014/AMD1:2020 apply,
362 except as follows:
363 ISO and IEC maintain terminological databases for use in standardization at the following
364 addresses:
365 • IEC Electropedia: available at http://www.electropedia.org/
366 • ISO Online browsing platform: available at http://www.iso.org/obp
367 NOTE An index of defined terms is found beginning on page 41.
368 Addition:
369 201.3.201
370 SET TEMPERATURE
371 desired APPLIED PART temperature
372 201.3.202
373 TEMPERATURE LIMITER
374 means of limiting the temperature of the APPLIED PART
375 201.3.203
376 TRANSCUTANEOUS PARTIAL PRESSURE MONITOR
377 ME EQUIPMENT or ME SYSTEM and associated TRANSDUCERS for the monitoring of partial
378 pressures of oxygen or carbon dioxide at the skin surface
379 201.3.204
380 TRANSDUCER
381 device for converting the partial pressure of a gas into a signal for monitoring or recording
382 201.4 General requirements
383 Clause 4 of the general standard applies, except as follows:
384 201.4.7 SINGLE FAULT CONDITION for ME EQUIPMENT
385 Addition:
386 SINGLE FAULT CONDITION includes any single failure in the
387 TRANSCUTANEOUS PARTIAL PRESSURE MONITOR resulting in a transfer of energy to the
388 APPLIED PART which is greater than that necessary to maintain the SET TEMPERATURE value.
389 Additional subclause:
390 201.4.101 Additional ESSENTIAL PERFORMANCE requirements
391 Additional ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in
392 Table 201.101.
393 Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements
Requirement Subclause
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Non-linearity and hysteresis 201.12.1.101
or generation of a TECHNICAL ALARM CONDITION 208.6.1.2,
208.6.4.1.102
Determination of ALARM CONDITIONS and assignment of priority 208.6.1.2
Time to alarm for pO and pCO ALARM CONDITIONS 208.6.4.1.101
2 2
Time to alarm for TECHNICAL ALARM CONDITIONS 208.6.4.1.102
394 201.5 General requirements for testing of ME EQUIPMENT
395 Clause 5 of the general standard applies, except as follows:
396 201.5.4 Other conditions
397 Addition:
398 If necessary for the purpose of conducting the test, the INTERNAL ELECTRICAL POWER SOURCE
399 may be replaced by an external battery or d.c. power supply to provide the necessary test
400 voltage.
401 The values used in test circuits, unless otherwise specified, shall have at least an accuracy as
402 given below:
403 – resistors: 1 %;
404 – capacitors: 10 %;
405 – inductors: 10 %;
406 – test voltages: 1 %
407 201.5.8 * Sequence of tests
408 Amendment:
409 If applicable, the tests specified in 8.5.5 of the general standard shall be carried out prior to
410 the LEAKAGE CURRENT and dielectric strength tests described in subclauses 8.7 and 8.8 of the
411 general standard.
412 201.6 Classification of ME EQUIPMENT and ME SYSTEMS
413 Clause 6 of the general standard applies, except as follows:
414 201.6.2 * Protection against electric shock
415 Replacement of the last paragraph:
416 APPLIED PARTS shall be classified as TYPE BF APPLIED PARTS or TYPE CF APPLIED PARTS
417 (see 7.2.10 and 8.3 b) of the general standard). APPLIED PARTS may be classified as
418 DEFIBRILLATION-PROOF APPLIED PARTS (see 8.5.5 of the general standard).
419 201.6.6 Mode of operation
420 Replacement:
421 TRANSCUTANEOUS PARTIAL PRESSURE MONITORS shall be classified for CONTINUOUS OPERATION.
IEC 80601-2-23 © IEC:2024 – 15 – 62D/2133/CDV
422 201.7 ME EQUIPMENT identification, marking and documents
423 Clause 7 of the general standard applies, except as follows:
424 201.7.9.2 Instructions for use
425 201.7.9.2.2 Warning and safety notices
426 Addition:
427 If protection against the effects of defibrillation is provided, the instructions for use shall
428 include a warning that defibrillator protection requires the use of MANUFACTURER specified
429 ACCESSORIES including TRANSDUCERS.
430 Additional subclause:
431 201.7.9.2.101 Additional instructions for use
432 The operating instructions shall include the following:
433 a) the INTENDED USE including the environment of use;
434 b) procedures affecting safe of operation, in particular the temperature selection and
435 duration of monitoring time, on that particular site at that temperature, based upon
436 clinical evaluation of the PATIENT, for example age, weight and physiological condition;
437 c) the choice and application of the specified TRANSDUCERS and ACCESSORIES;
438 d) * use of the TRANSCUTANEOUS PARTIAL PRESSURE MONITOR with HF SURGICAL EQUIPMENT,
439 to avoid burns to the PATIENT and damage to the TRANSDUCER; a statement, if applicable,
440 that the TRANSDUCER is to be removed from the PATIENT during the high frequency
441 surgical procedures;
442 e) precautions to take when using a defibrillator on a PATIENT; a description how the
443 discharge of a defibrillator affects the TRANSCUTANEOUS PARTIAL PRESSURE MONITOR and
444 the TRANSDUCER;
445 f) a statement to the effect: "This equipment is not a blood gas device";
446 g) * for TRANSDUCERS and cables, particularly disposable TRANSDUCERS, its MANUFACTURER
447 shall state the EXPECTED SERVICE LIFE;
448 h) * proper handling of TRANSDUCERS and their ACCESSORIES to avoid damage to these
449 delicate components, thereby extending their useful life. In addition, these instructions
450 shall refer, in particular, to the TRANSDUCER to cable connection and provide information
451 on the measures that the clinical OPERATOR should adopt to prevent damage to this
452 connection;
453 i) information on the warm-up time for the TRANSDUCER and
454 TRANSCUTANEOUS PARTIAL PRESSURE MONITOR;
455 j) the drift per hour for pO and pCO and recommendations for recalibration (see
2 2
456 201.12.1.102);
457 k) any interfering gases or vapours that are known to cause deviation outside the range
458 specified;
459 l) the maximum time required for the TRANSCUTANEOUS PARTIAL PRESSURE MONITORS to
460 display a 10 % to 90 % response to a step change between test gases 1 and 2 in either
461 direction (see 201.12.1.103);
462 m) advice regarding testing of the TRANSCUTANEOUS PARTIAL PRESSURE MONITOR and
463 ACCESSORIES on a daily basis (by the clinical OPERATOR) and on a scheduled basis (as a
464 service activity). Emphasis should be placed on how the clinician may test visual and
465 auditory ALARM SIGNALS;
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466 n) simple fault finding methods for troubleshooting problems by which the clinical OPERATOR
467 can locate problems if the TRANSCUTANEOUS PARTIAL PRESSURE MONITOR appears to be
468 functioning incorrectly;
469 NOTE This relates to simple operator difficulties, not to technical malfunctions;
470 o) the subsequent operation of the TRANSCUTANEOUS PARTIAL PRESSURE MONITOR after
471 interruption of SUPPLY MAINS exceeding 30 s (see 201.11.8);
472 p) * description of how to disable ALARM SIGNALS for TECHNICAL ALARM CONDITIONS if the
473 TRANSDUCER or module is intentionally disconnected by the clinical OPERATOR;
474 q) the configuration procedure that allows the ALARM SIGNAL inactivation states
475 (ALARM PAUSED, AUDIO PAUSED, ALARM OFF or AUDIO OFF) or the functions ALARM RESET
476 and ALARM ACKNOWLEDGED to be controlled remotely (see 208.6.11.101), if provided;
477 r) advice on the preferred ALARM SETTINGS and configurations of the ALARM SYSTEM when
478 its INTENDED USE includes the monitoring of PATIENTS that are not continuously attended
479 by a clinical OPERATOR;
480 201.8 Protection against electrical HAZARDS from ME EQUIPMENT
481 Clause 8 of the general standard applies, except as follows:
482 Additional subclause:
483 201.8.101 * TRANSDUCERS and cables
484 Re-usable TRANSDUCERS and cables shall be provided with strain relief at the
485 cable/TRANSDUCER junction capable of withstanding the tensile forces occurring during
486 NORMAL USE.
487 After the test, neither the insulation of the cable nor the strain relief shall show any
488 degradation and the TRANSDUCER shall function normally.
489 Compliance is checked by the following test:
490 Suddenly apply a load of 5 N to the cable in any direction within the conic sectional space
491 having an apex angle of 90°, with said apex coinciding with the point of exit of the cable from
492 the TRANSDUCER and limited by a flat plane coinciding with the intended plane of application of
493 the TRANSDUCER to the PATIENT.
494 Repeat this test five times at different angles of the cable from the TRANSDUCER; choose these
495 angles being at random within the conic section (see Figure 201.101).
90°
IEC 376/11
497 Figure 201.101 – TRANSDUCER cable strain relief test
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498 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS
499 Clause 9 of the general standard applies.
500 201.10 Protection against unwanted and excessive radiation HAZARDS
501 Clause 10 of the general standard applies.
502 201.11 Protection against excessive temperatures and other HAZARDS
503 Clause 11 of the general standard applies, except as follows:
504 201.11.1.2 Temperature of APPLIED PARTS
505 201.11.1.2.2 * APPLIED PARTS not intended to supply heat to a PATIENT
506 Replacement:
507 In NORMAL CONDITION the maximum temperature of the APPLIED PART of the TRANSDUCER shall
508 not exceed 45 ºC. The maximum temperature shall not exceed 45,6 ºC for more than a total of
509 20 s in any period of 30 min.
510 NOTE 45,6 °C is the maximum temperature of the APPLIED PART (45°C) plus an allowed overshoot of 0,6 °C.
511 Additional subclauses:
512 201.11.1.2.2.101 Heater in the APPLIED PART
513 TRANSCUTANEOUS PARTIAL PRESSURE MONITORS having a heater in the APPLIED PART shall be
514 provided with means for controlling the temperature of the APPLIED PART.
515 Compliance is checked by inspection.
516 201.11.1.2.2.102 Indication of SET TEMPERATURE
517 Means shall be provided for indicating numerically the SET TEMPERATURE during temperature
518 setting and on request of the clinical OPERATOR.
519 Compliance is checked by inspection.
520 201.11.1.2.2.103 SET TEMPERATURE
521 The SET TEMPERATURE shall not exceed 45 °C.
522 Compliance is checked by inspection.
523 201.11.1.2.2.104 Temperature overshoot
524 In NORMAL CONDITION the temperat
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