oSIST prEN IEC 60601-2-34:2023
(Main)Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
Medizinische elektrische Geräte - Teil 2-34: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von invasiven Blutdruck-Überwachungsgeräten
Amendement 1 - Appareils électromédicaux - Partie 2-34: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de surveillance de la pression sanguine prélevée directement
Medicinska električna oprema - 2-34. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za invazivno nadzorovanje krvnega tlaka
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN IEC 60601-2-34:2023
01-januar-2023
Medicinska električna oprema - 2-34. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme za invazivno nadzorovanje krvnega tlaka
Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and
essential performance of invasive blood pressure monitoring equipment
Medizinische elektrische Geräte - Teil 2-34: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von invasiven Blutdruck-
Überwachungsgeräten
Amendement 1 - Appareils électromédicaux - Partie 2-34: Exigences particulières pour la
sécurité de base et les performances essentielles des appareils de surveillance de la
pression sanguine prélevée directement
Ta slovenski standard je istoveten z: prEN IEC 60601-2-34:2022
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
oSIST prEN IEC 60601-2-34:2023 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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62D/1990/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-34 ED4
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2022-11-11 2023-02-03
SUPERSEDES DOCUMENTS:
62D/1885/CD, 62D/1916A/CC
IEC SC 62D : ELECTROMEDICAL EQUIPMENT
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
Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
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
CENELEC online voting system.
This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of which
they are aware and to provide supporting documentation.
TITLE:
Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential
performance of invasive blood pressure monitoring equipment
PROPOSED STABILITY DATE: 2028
NOTE FROM TC/SC OFFICERS:
Copyright © 2022 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to download this
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
permission in writing from IEC.
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1 CONTENTS
2 CONTENTS . 2
3 FOREWORD . 4
4 INTRODUCTION . 7
5 201.1 Scope, object and related standards . 8
6 201.2 Normative references . 10
7 201.3 Terms and definitions . 10
8 201.4 General requirements . 11
9 201.5 General requirements for testing of ME EQUIPMENT . 12
10 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
11 201.7 ME EQUIPMENT identification, marking and documents . 13
12 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 14
13 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 22
14 201.10 Protection against unwanted and excessive radiation HAZARDS . 23
15 201.11 Protection against excessive temperatures and other HAZARDS . 23
16 201.12 Accuracy of controls and instruments and protection against hazardous outputs . 25
17 201.13 HAZARDOUS SITUATIONS and fault conditions . 31
18 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 31
19 201.15 Construction of ME EQUIPMENT . 31
20 201.16 ME SYSTEMS . 32
21 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 32
22 202 Electromagnetic disturbances – Requirements and tests . 32
23 208 General requirements, tests and guidance for alarm systems in MEDICAL
24 ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS . 38
25 Annexes. 44
26 Annex AA (informative) Particular guidance and rationale . 45
27 Bibliography . 56
28 Index of defined terms used in this particular standard. 57
29
30 Figure 201.101 – Dynamic test for limitation of energy from different parts – Recovery
31 test . 17
32 Figure 201.102 – Diaphragm leak test . 18
33 Figure 201.103 – Measuring circuit for PATIENT LEAKAGE CURRENT via the PATIENT
34 CONNECTION(S) of an F-TYPE APPLIED PART to earth caused by an external voltage on the
35 PATIENT CONNECTION(S) . 19
36 Figure 201.104 – Measuring circuit for the PATIENT LEAKAGE CURRENT from the APPLIED
37 PART to earth of CLASS I ME EQUIPMENT caused by an external voltage on a metal
38 ACCESSIBLE PART that is not PROTECTIVELY EARTHED. . 20
39 Figure 201.105 – Measuring circuit for the PATIENT LEAKAGE CURRENT from the APPLIED
40 PART to earth of INTERNALLY POWERED ME EQUIPMENT caused by an external voltage on
41 a metal ACCESSIBLE PART that is not PROTECTIVELY EARTHED . 21
42 Figure 201.106– Clarification of leakage current tests . 22
43 Figure 201.107 – Over-pressure test . 23
44 Figure 201.108 – Test for accuracy of pressure measurements . 27
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45 Figure 201.109 – Test sequence for sensitivity, repeatability, non-linearity, drift and
46 hysteresis . 28
47 Figure 201.110 – Pressure measurement system for accuracy of systolic and diastolic
48 pressure . 29
49 Figure 201.111 – Frequency response of ME EQUIPMENT and PRESSURE TRANSDUCER . 30
50 Figure 202.101 – Test layout for conducted and radiated EMISSION and radiated
51 immunity test . 33
52 Figure 202.102 – Test circuit for high-frequency surgery interference measurement,
53 when the isolation of the APPLIED PART is in the monitor . 36
54 Figure 202.103 – Test circuit for high-frequency surgery protection, when the isolation
55 of the APPLIED PART is in the PRESSURE TRANSDUCER . 36
56 Figure 202.104 – Test set-up for high-frequency surgery protection . 37
57 Figure 208.101 – Test for delay times of ALARM SIGNALS indicating PHYSIOLOGICAL
58 ALARM CONDITIONS . 41
59 Figure 208.102 – Test for delay times of ALARM SIGNALS indicating PHYSIOLOGICAL
60 ALARM CONDITIONS . 42
61 Figure AA.1 – PRESSURE TRANSDUCER error band . 52
62
63 Table 201.101 – ESSENTIAL PERFORMANCE requirements . 11
64
65
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66 INTERNATIONAL ELECTROTECHNICAL COMMISSION
67 ____________
68
69 MEDICAL ELECTRICAL EQUIPMENT –
70
71 Part 2-34: Particular requirements for the basic safety and essential
72 performance of invasive blood pressure monitoring equipment
73
74
75 FOREWORD
76 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
77 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
78 international co-operation on all questions concerning standardization in the electrical and electronic fields. To
79 this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
80 Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
81 Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
82 in the subject dealt with may participate in this preparatory work. International, governmental and non -
83 governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
84 with the International Organization for Standardization (ISO) in accordance with conditions determined by
85 agreement between the two organizations.
86 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
87 consensus of opinion on the relevant subjects since each technical committee has representation from all
88 interested IEC National Committees.
89 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
90 Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
91 Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
92 misinterpretation by any end user.
93 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
94 transparently to the maximum extent possible in their national and regional publications. Any diverg ence
95 between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
96 the latter.
97 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
98 assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
99 services carried out by independent certification bodies.
100 6) All users should ensure that they have the latest edition of this publication.
101 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
102 members of its technical committees and IEC National Committees for any personal injury, property damage or
103 other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
104 expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
105 Publications.
106 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
107 indispensable for the correct application of this publication.
108 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
109 patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
110 International standard IEC 60601-2-34 has been prepared by a Joint Working Group of IEC
111 subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical
112 equipment in medical practice and ISO subcommittee SC3: Lung ventilators and related
113 equipment, of ISO technical committee 121: Anaesthetic and respiratory equipment.
114 This fourth edition cancels and replaces the third edition of IEC 60601-2-34 published in 2011
115 and constitutes a technical revision. This edition was revised to align with Amendment 1:2012
116 and Amendment 2:2020 of IEC 60601-1:2005 as well as new versions of collateral standards
117 and amendments thereto.
118 Further it includes the following technical changes:
119 – Expansion of the scope to the EMERGENCY MEDICAL SERVICE ENVIRONMENT
120 – Changed ESSENTIAL PERFORMANCE in Table 201.101
121 – Changed requirement for ingress protection
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122 – Added PRIMARY OPERATING FUNCTIONS
123 – Added requirements for ALARM SYSTEM logging
124 – Deleted Annex BB (Alarm diagrams 208/IEC 60601-1-8:2006)
125 The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/XXX/FDIS 62D/XXX/RVD
126
127 Full information on the voting for the approval of this particular standard can be found in the
128 report on voting indicated in the above table.
129 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
130 In this standard, the following print types are used:
131 – Requirements and definitions: roman type.
132 – Test specifications: italic type.
133 – Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
134 Normative text of tables is also in a smaller type.
135 – TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
136 NOTED: SMALL CAPITALS.
137 In referring to the structure of this standard, the term
138 – “clause” means one of the seventeen numbered divisions within the table of contents,
139 inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
140 – “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
141 subclauses of Clause 7).
142 References to clauses within this standard are preceded by the term “Clause” followed by the
143 clause number. References to subclauses within this particular standard are by number only.
144 In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is tru e if any
145 combination of the conditions is true.
146 The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
147 Directives, Part 2. For the purposes of this standard, the auxiliary verb:
148 – “shall” means that compliance with a requirement or a test is mandatory for compliance
149 with this standard;
150 – “should” means that compliance with a requirement or a test is recommended but is not
151 mandatory for compliance with this standard;
152 – “may” is used to describe a permissible way to achieve compliance with a requirement or
153 test.
154 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
155 indicates that there is guidance or rationale related to that item in Annex AA.
156 A list of all parts of the IEC 60601 series, published under the general title Medical electrical
157 equipment, can be found on the IEC website.
158 The committee has decided that the contents of this publication will remain unchanged until
159 the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data
160 related to the specific publication. At this date, the publication will be
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161 • reconfirmed,
162 • withdrawn,
163 • replaced by a revised edition, or
164 • amended.
165 NOTE The attention of National Committees and Member Bodies is drawn to the fact that equipment
166 manufacturers and testing organizations may need a transitional period following publication of a new, amended or
167 revised IEC publication in which to make products in accordance with the new requirements and to equip
168 themselves for conducting new or revised tests. It is the recommendation of the committees that the content of this
169 publication be adopted for implementation nationally not earlier than 3 years from the date of publication.
170
171
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172 INTRODUCTION
173 This particular standard concerns the BASIC SAFETY and ESSENTIAL PERFORMANCE of INVASIVE
174 BLOOD PRESSURE MONITORING EQUIPMENT. It amends and supplements IEC 60601-1:2005,
175 IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020: Medical electrical
176 equipment – Part 1: General requirements for basic safety and essential performance,
177 hereinafter referred to as the general standard.
178 The aim of this fourth edition is to bring this particular standard up to date with reference to
179 Amendment 1:2012 and Amendment 2:2020 of the general standard and new versions of
180 collateral standards and amendments thereto through technical changes.
181 The requirements of this particular standard take priority over those of the general standard
182 and collateral standards.
183 A “General guidance and rationale” for the more important requirements of this particular
184 standard is included in Annex AA. It is considered that knowledge of the reasons for these
185 requirements will not only facilitate the proper application of the standard but will, in due
186 course, expedite any revision necessitated by changes in clinical practice or as a result of
187 developments in technology. However, Annex AA does not form part of the requirements of
188 this standard.
189
190
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191 MEDICAL ELECTRICAL EQUIPMENT –
192
193 Part 2-34: Particular requirements for the basic safety and essential
194 performance of invasive blood pressure monitoring equipment
195
196
197
198 201.1 Scope, object and related standards
1
199 Clause 1 of the general standard applies, except as follows:
200 201.1.1 *Scope
201 Replacement:
202 This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of INVASIVE
203 BLOOD PRESSURE MONITORING EQUIPMENT as defined in 201.3.63, hereinafter also referred to as
204 ME EQUIPMENT.
205 This document applies to INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT intended for use
206 in professional healthcare facilities and in the EMERGENCY MEDICAL SERVICE ENVIRONMENT.
207 This particular standard does not apply to catheter tubing, catheter needles, Luer locks, taps
208 and tap tables that connect to the DOME.
209 This particular standard does not apply to non-invasive blood pressure monitoring equipment.
210 If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
211 ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
212 case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as follows:
213 The clause or subclause applies to ME EQUIPMENT, as default. For ME EQUIPMENT with the
214 corresponding safety measure or function not completely integrated into the ME EQUIPMENT but
215 instead implemented in an ME SYSTEM, the ME EQUIPMENT MANUFACTURER shall specify in the
216 ACCOMPANYING DOCUMENTS which functionality and safety requirements shall be provided by
217 the ME SYSTEM to comply with this standard. The ME SYSTEM has to be verified accordingly.
218 201.1.2 Object
219 Replacement:
220 The object of this particular standard is to establish BASIC SAFETY and ESSENTIAL PERFORMANCE
221 requirements for INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT, as defined in 201.3.63.
222 201.1.3 Collateral standards
223 Addition:
224 This particular standard refers to those applicable collateral standards that are listed in
225 Clause 2 of the general standard and Clause 201.2 of this particular sta ndard.
—————————
1
The general standard is IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-2:2005/AMD2:2020
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
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226 IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-6:2010, IEC 60601-1-
227 6:2010/AMD1:2013 and IEC 60601-1-6:2010/AMD2:2020, IEC 60601-1-8:2006, IEC 60601-1-
228 8:2006/AMD1:2012 and IEC 60601-1-8:2006/AMD1:2020 apply as modified in Clauses 202,
229 206 and 208 respectively. IEC 60601-1-3, IEC 60601-1-9 and IEC 60601-1-10 do not apply.
230 All other published collateral standards in the IEC 60601-1 series apply as published.
231 201.1.4 Particular standards
232 Replacement:
233 In the IEC 60601 series, particular standards may modify, replace or delete requirements
234 contained in the general standard and collateral standards as appropriate for the particular
235 ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
236 PERFORMANCE requirements.
237 A requirement of a particular standard takes priority over the general standard and collateral
238 standards.
239 For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
240 Collateral standards are referred to by their document number.
241 The numbering of clauses and subclauses of this particular standard corresponds to that of
242 the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content
243 of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”
244 where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
245 particular standard addresses the content of Clause 4 of the 60601-1-2 collateral standard,
246 208.4 in this particular standard addresses the content of Clause 4 of the 60601-1-8 collateral
247 standard, etc.). The changes to the text of the general standard are specified by the use of
248 the following words:
249 "Replacement" means that the clause or subclause of the general standard or applicable
250 collateral standard is replaced completely by the text of this particular standard.
251 "Addition" means that the text of this particular standard is additional to the requirements of
252 the general standard or applicable collateral standard.
253 "Amendment" means that the clause or subclause of the general standard or applicable
254 collateral standard is amended as indicated by the text of this particular standard.
255 Subclauses, figures or tables which are additional to those of the general standard are
256 numbered starting from 201.101. However due to the fact that definitions in the general
257 standard are numbered 3.1 through 3.154, additional definitions in this standard are
258 numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
259 additional items aa), bb), etc.
260 Subclauses, figures or tables which are additional to those of a collateral standard are
261 numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
262 IEC 60601-1-2, 208 for IEC 60601-1-8, etc.
263 The term "this standard" is used to make reference to the general standard, any applicable
264 collateral standards and this particular standard taken together.
265 Where there is no corresponding clause or subclause in this particular standard, the clause or
266 subclause of the general standard or applicable collateral standard, although possibly not
267 relevant, applies without modification; where it is intended that any part of the general
268 standard or applicable collateral standard, although possibly relevant, is not to be applied, a
269 statement to that effect is given in this particular standard.
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270 201.2 Normative references
271 Clause 2 of the general standard applies, except as follows:
272 Replacement:
273 IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
274 safety and essential performance – Collateral standard: Electromagnetic disturbances –
275 Requirements and tests
276 IEC 60601-1-2:2014/AMD1:2020
277 IEC 60601-1-6:2010, Medical electrical equipment – Part 1-6: General requirements for basic
278 safety and essential performance – Collateral standard: Usability
279 IEC 60601-1-6:2010/AMD1:2013
280 IEC 60601-1-6:2010/AMD2:2020
281 IEC 60601-1-8:2006, Medical electrical equipment – Part 1-8: General requirements for basic
282 safety and essential performance – Collateral standard: General requirements, tests and
283 guidance for alarm systems in medical electrical equipment and medical electrical systems
284 IEC 60601-1-8:2006/AMD1:2012
285 IEC 60601-1-8:2006/AMD2:2020
286 ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by
287 the manufacturer – Part 1: General requirements
288 Addition:
289 IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
290 safety and essential performance
291 Amendment 1:2012
292 Amendment 2:2020
293
294 IEC 60601-2-2, Medical electrical equipment – Part 2-2: Particular requirements for the basic
295 safety and essential performance of high frequency surgical equipment and high frequency
296 surgical accessories
297 NOTE Informative references are listed in the bibliography.
298 201.3 Terms and definitions
299 NOTE An index of defined terms is found at the end of this document.
300 For the purposes of this document, the terms and definitions given in IEC 60601-1:2005, IEC
301 60601-1:2005/AMD1:2012 and IEC 60601-2:2005/AMD2:2020, IEC 60601-1-2:2014 and
302 IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-6:2010, IEC 60601-1-6:2010/AMD1:2013 and
303 IEC 60601-1-6:2010/AMD2:2020, IEC 60601-1-8:2006, IEC 60601-1-8:2006/AMD1:2012 and
304 IEC 60601-1-8:2006/AMD2:2020, IEC 60601-1-12:2014 and IEC 60601-1-12:2015/AMD1:2020
305 apply, except as follows:
306 ISO and IEC maintain terminological databases for use in standardization at the following
307 addresses:
308 • IEC Electropedia: available at http://www.electropedia.org/
309 • ISO Online browsing platform: available at http://www.iso.org/obp
310 Replacement:
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311 201.3.63
312 MEDICAL ELECTRICAL EQUIPMENT
313 ME EQUIPMENT
314 INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT (ME EQUIPMENT)
315 device including associated PRESSURE TRANSDUCERS, that is used for internal measurement or
316 monitoring of circulatory system pressures
317 Replacement:
318 201.3.8
319 APPLIED PART
320 PRESSURE TRANSDUCER, including its associated catheter and any fluid-filled system
321 Additional definitions:
322 201.3.201
323 CATHETER
324 tubular device, single or multi-lumen, designed to be partially or totally inserted into the
325 cardiovascular system for diagnostic purposes
326 201.3.202
327 CATHETER TIP PRESSURE TRANSDUCER
328 PRESSURE TRANSDUCER mounted at, or close to, the tip of a CATHETER
329 201.3.203
330 DOME
331 means for hydraulically coupling the PATIENT'S blood pressure
...
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