prEN IEC 80601-2-30:2025
(Main)Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
Medizinische elektrische Geräte - Teil 2-30: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von automatisierten nicht-invasiven Blutdruckmessgeräten
Appareils électromédicaux - Partie 2-30: Exigences particulières pour la sécurité de base et les performances essentielles des sphygmomanomètres non invasifs automatiques
Medicinska električna oprema - 2-30. del: Posebne zahteve za osnovno varnost in bistvene lastnosti avtomatiziranih neinvazivnih sfigmomanometrov
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-april-2025
Medicinska električna oprema - 2-30. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti avtomatiziranih neinvazivnih sfigmomanometrov
Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and
essential performance of automated non-invasive sphygmomanometers
Medizinische elektrische Geräte - Teil 2-30: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von automatisierten nicht-invasiven
Blutdruckmessgeräten
Appareils électromédicaux - Partie 2-30: Exigences particulières pour la sécurité de base
et les performances essentielles des sphygmomanomètres non invasifs automatiques
Ta slovenski standard je istoveten z: prEN IEC 80601-2-30:2025
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
62D/2201/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 80601-2-30 ED3
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2025-02-07 2025-05-02
SUPERSEDES DOCUMENTS:
62D/1946/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: HORIZONTAL FUNCTION(S):
ASPECTS CONCERNED:
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.
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 2-30: Particular requirements for the basic safety and essential
performance of automated non-invasive sphygmomanometers
PROPOSED STABILITY DATE: 2030
NOTE FROM TC/SC OFFICERS:
This edition includes the following significant technical changes with respect to the previous edition:
a) a clarified definition of neonate and infant and associated modes;
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.
b) relabeling of some primary operating functions;
c) additional requirements for monitoring equipment to avoid the misuse of misleading or “stale” data;
d) updated normative references to the current versions where applicable.
IEC 80601-2-30 ED3 © IEC 2024 1 62D/2201/CDV
1 CONTENTS
2 FOREWORD . 3
3 INTRODUCTION . 7
4 201.1 Scope, object and related standards . 8
5 201.2 Normative references . 10
6 201.3 Terms and definitions. 11
7 201.4 General requirements . 13
8 201.5 General requirements for testing ME EQUIPMENT . 14
9 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 14
10 201.7 ME EQUIPMENT identification, marking and documents . 14
11 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 18
12 201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS . 18
13 201.10 Protection against unwanted and excessive radiation HAZARDS . 18
14 201.11 Protection against excessive temperatures and other HAZARDS . 18
15 201.12 Accuracy of controls and instruments and protection against hazardous
16 outputs . 19
17 201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 24
18 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 24
19 201.15 Construction of ME EQUIPMENT . 24
20 201.16 ME SYSTEMS . 25
21 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 25
22 201.101 Requirements for CUFFS . 25
23 201.102 * Connection tubing and CUFF connectors . 26
24 201.103 Unauthorized access. 26
25 201.104 * Maximum inflating time . 26
26 201.105 * Automatic cycling modes . 27
27 201.106 * Clinical accuracy . 31
28 202 Electromagnetic disturbances – Requirements and tests . 31
29 206 Usability . 34
30 210 Requirements for the development of physiologic closed-loop controllers . 36
31 211 Requirements for medical electrical equipment and medical electrical
32 systems used in the home healthcare environment . 36
33 212 Requirements for medical electrical equipment and medical electrical
34 systems intended for use in the emergency medical services environment . 36
35 Annexes . 38
36 Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
37 and ME SYSTEMS . 39
38 Annex AA (informative) Particular guidance and rationale . 42
39 Annex BB (informative) Environmental aspects . 52
40 Annex CC (informative) Reference to the ESSENTIAL PRINCIPLES . 53
41 Bibliography . 56
42 Index of defined terms . 59
62D/2201/CDV 2 IEC 80601-2-30 ED3 © IEC 2024
44 Figure 201.101 – CUFF pressure PROTECTION DEVICE, triggered by overpressure in SINGLE
45 FAULT CONDITION . 21
46 Figure 201.102 – CUFF pressure PROTECTION DEVICE, triggered by prolonged overpressure
47 in SINGLE FAULT CONDITION . 22
48 Figure 201.103 – CUFF pressure and maximum inflation time, NORMAL CONDITION and
49 SINGLE FAULT CONDITION . 27
50 Figure 201.104 – LONG-TERM AUTOMATIC MODE CUFF pressure in NORMAL CONDITION . 28
51 Figure 201.105 – LONG-TERM AUTOMATIC MODE CUFF pressure in SINGLE FAULT CONDITION . 28
52 Figure 201.106 – SHORT-TERM AUTOMATIC MODE CUFF pressure . 29
53 Figure 201.107 – SELF-MEASUREMENT AUTOMATIC MODE CUFF pressure . 30
54 Figure 202.101 – HF SURGICAL EQUIPMENT test layout . 33
55 Figure 202.102 – Simulated PATIENT test set-up for HF SURGICAL EQUIPMENT . 34
57 Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements . 13
58 Table 201.102 – CUFF deflation pressure . 18
59 Table 201.103 – CUFF inflation pressure . 26
60 Table 201.C.101 – Marking on the outside of AUTOMATED SPHYGMOMANOMETERS or
61 their parts . 39
62 Table 201.C.102 – Marking of controls and instruments of AUTOMATED
63 SPHYGMOMANOMETERS or their parts . 39
64 Table 201.C.103 – ACCOMPANYING DOCUMENTS, general information for AUTOMATED
65 SPHYGMOMANOMETERS . 40
66 Table 201.C.104 – ACCOMPANYING DOCUMENTS, instructions for use of AUTOMATED
67 SPHYGMOMANOMETERS . 40
68 Table 201.C.105 – ACCOMPANYING DOCUMENTS, technical description of AUTOMATED
69 SPHYGMOMANOMETERS . 41
70 Table AA.1 – Summary of requirements by mode . 49
71 Table BB.1 – Environmental aspects addressed by clauses of this document . 52
72 Table CC.1 – Correspondence between this particular standard and the ESSENTIAL
73 PRINCIPLES . 53
IEC 80601-2-30 ED3 © IEC 2024 3 62D/2201/CDV
76 INTERNATIONAL ELECTROTECHNICAL COMMISSION
77 ____________
79 MEDICAL ELECTRICAL EQUIPMENT –
81 Part 2-30: Particular requirements for the basic safety
82 and essential performance of automated non-invasive
83 sphygmomanometers
85 FOREWORD
86 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
87 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
88 international co-operation on all questions concerning standardization in the electrical and electronic fields. To
89 this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
90 Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as "IEC
91 Publication(s)"). Their preparation is entrusted to technical committees; any IEC National Committee interested
92 in the subject dealt with may participate in this preparatory work. International, governmental and non -
93 governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
94 with the International Organization for Standardization (ISO) in accordance with conditions determined by
95 agreement between the two organizations.
96 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
97 consensus of opinion on the relevant subjects since each technical committee has representation from all
98 interested IEC National Committees.
99 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
100 Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
101 Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
102 misinterpretation by any end user.
103 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
104 transparently to the maximum extent possible in their national and regional publications. Any divergence
105 between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
106 the latter.
107 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
108 assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
109 services carried out by independent certification bodies.
110 6) All users should ensure that they have the latest edition of this publication.
111 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
112 members of its technical committees and IEC National Committees for any persona
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.