prEN IEC 60601-2-34:2022
(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
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
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Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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
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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
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:
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.
62D/1990/CDV – 2 – IEC CD 60601-2-34 © IEC:2022
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
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
IEC CD 60601-2-34 © IEC:202X – 3 – 62D/xxxx/CDV
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
63 Table 201.101 – ESSENTIAL PERFORMANCE requirements . 11
62D/1990/CDV – 4 – IEC CD 60601-2-34 © IEC:2022
66 INTERNATIONAL ELECTROTECHNICAL COMMISSION
67 ____________
69 MEDICAL ELECTRICAL EQUIPMENT –
71 Part 2-34: Particular requirements for the basic safety and essential
72 performance of invasive blood pressure monitoring equipment
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
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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
IEC CD 60601-2-34 © IEC:202X – 5
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