IEC 80601-2-30:2018

IEC 80601-2-30
Edition 2.0 2018-03
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –
Part 2-30: Particular requirements for the basic safety and essential performance
of automated non-invasive sphygmomanometers

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IEC 80601-2-30
Edition 2.0 2018-03
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –

Part 2-30: Particular requirements for the basic safety and essential performance

of automated non-invasive sphygmomanometers

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.01 ISBN 978-2-8322-5515-5

– 2 – IEC 80601-2-30:2018 RLV © IEC 2018
CONTENTS
FOREWORD . 4
INTRODUCTION . 2
201.1 Scope, object and related standards . 8
201.2 Normative references . 10
201.3 Terms and definitions. 11
201.4 General requirements . 14
201.5 General requirements for testing ME EQUIPMENT . 14
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 14
201.7 ME EQUIPMENT identification, marking and documents . 14
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 18
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS . 19
201.10 Protection against unwanted and excessive radiation HAZARDS . 19
201.11 Protection against excessive temperatures and other HAZARDS . 19
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 20
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 25
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 25
201.15 Construction of ME EQUIPMENT . 25
201.16 ME SYSTEMS . 27
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 27
201.101 Requirements for CUFFS . 27
201.102 * Connection tubing and CUFF connectors . 28
201.103 Unauthorized access. 28
201.104 * Maximum inflating time . 28
201.105 * Automatic cycling modes . 29
201.106 * Clinical accuracy . 33
202 Electromagnetic compatibility disturbances – Requirements and tests . 33
206 Usability . 37
210 Requirements for the development of physiologic closed-loop controllers . 38
211 Requirements for medical electrical equipment and medical electrical
systems used in the home healthcare environment . 38
212 Requirements for medical electrical equipment and medical electrical
systems intended for use in the emergency medical services environment . 38
Annexes . 39
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 40
Annex AA (informative) Particular guidance and rationale . 43
Annex BB (informative) Environmental aspects . 53
Annex CC (informative) Reference to the ESSENTIAL PRINCIPLES . 54
Bibliography . 54
Index of defined terms . 61

Figure 201.101 – CUFF pressure PROTECTION DEVICE, triggered by overpressure
in SINGLE FAULT CONDITION . 22
Figure 201.102 – CUFF pressure PROTECTION DEVICE, triggered by prolonged
overpressure in SINGLE FAULT CONDITION . 23
Figure 201.103 – CUFF pressure and maximum inflation time, NORMAL CONDITION
and SINGLE FAULT CONDITION . 29
Figure 201.104 – LONG-TERM AUTOMATIC MODE CUFF pressure in NORMAL CONDITION . 30
Figure 201.105 – LONG-TERM AUTOMATIC MODE CUFF pressure in SINGLE FAULT CONDITION . 31
Figure 201.106 – SHORT-TERM AUTOMATIC MODE CUFF pressure . 31
Figure 201.107 – SELF-MEASUREMENT AUTOMATIC MODE CUFF pressure . 32
Figure 202.101 – HF SURGICAL EQUIPMENT test layout . 36
Figure 202.102 – Simulated PATIENT test set-up for HF SURGICAL EQUIPMENT . 37

Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements . 14
Table 201.102 – CUFF deflation pressure . 19
Table 201.103 – CUFF inflation pressure . 28
Table 201.C.101 – Marking on the outside of AUTOMATED SPHYGMOMANOMETERS
or their parts . 40
Table 201.C.102 – Marking of controls and instruments of AUTOMATED
SPHYGMOMANOMETERS or their parts . 41
Table 201.C.103 – ACCOMPANYING DOCUMENTS, general information for AUTOMATED
SPHYGMOMANOMETERS . 41
Table 201.C.104 – ACCOMPANYING DOCUMENTS, instructions for use of AUTOMATED
SPHYGMOMANOMETERS . 41
Table 201.C.105 – ACCOMPANYING DOCUMENTS, technical description of AUTOMATED
SPHYGMOMANOMETERS . 42
Table AA.1 – Summary of requirements by mode . 50
Table BB.1 – Environmental aspects addressed by clauses of this document . 53
Table CC.1 – Correspondence between this particular standard
and the ESSENTIAL PRINCIPLES . 54

– 4 – IEC 80601-2-30:2018 RLV © IEC 2018
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-30: Particular requirements for the basic safety
and essential performance of automated non-invasive
sphygmomanometers
FOREWORD
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