IEC 80601-2-30:2009

IEC 80601-2-30
Edition 1.0 2009-01
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-30: Particular requirements for the basic safety and essential performance
of automated non-invasive sphygmomanometers

Appareils électromédicaux –
Partie 2-30: Exigences particulières pour la sécurité de base et les performances
essentielles des sphygmomanomètres non invasifs automatiques

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IEC 80601-2-30
Edition 1.0 2009-01
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-30: Particular requirements for the basic safety and essential performance
of automated non-invasive sphygmomanometers

Appareils électromédicaux –
Partie 2-30: Exigences particulières pour la sécurité de base et les performances
essentielles des sphygmomanomètres non invasifs automatiques

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
XA
CODE PRIX
ICS 11.040 ISBN 978-2-88910-781-0

– 2 – 80601-2-30 © IEC:2009
CONTENTS
FOREWORD.4

INTRODUCTION.7

201.1 Scope, object and related standards .8

201.2 Normative references.10

201.3 Terms and definitions.10

201.4 General requirements .13

201.5 General requirements for testing ME EQUIPMENT .13

201.6 Classification of ME EQUIPMENT and ME SYSTEMS.13
201.7 ME EQUIPMENT identification, marking and documents .13
201.8 Protection against electrical HAZARDS from ME EQUIPMENT .17
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS .18
201.10 Protection against unwanted and excessive radiation HAZARDS .18
201.11 Protection against excessive temperatures and other HAZARDS .18
201.12 Accuracy of controls and instruments and protection against hazardous
outputs .19
201.13 HAZARDOUS SITUATIONS and fault conditions .23
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS).23
201.15 Construction of ME EQUIPMENT .23
201.16 ME SYSTEMS .25
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .25
201.101 Requirements for CUFFS .25
201.102 Connection tubing and CUFF connectors.26
201.103 Unauthorized access .26
201.104 * Maximum inflating time .26
201.105 * Automatic cycling modes .27
201.106 * Clinical accuracy.31
202 Electromagnetic compatibility – Requirements and tests .31
Annexes .34
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS.35

Annex AA (informative) Particular guidance and rationale.38
Annex BB (informative) Environmental aspects .46
Annex CC (informative) Reference to the essential principles .47
Bibliography.49
Index of defined terms .51

Figure 201.101 – CUFF pressure PROTECTION DEVICE, triggered by overpressure in
SINGLE FAULT CONDITION.21
Figure 201.102 – CUFF pressure PROTECTION DEVICE, triggered by prolonged
overpressure in SINGLE FAULT CONDITION.22
Figure 201.103 – CUFF pressure and maximum inflation time, NORMAL CONDITION and
SINGLE FAULT CONDITION.27
Figure 201.104 – LONG-TERM AUTOMATIC MODE CUFF pressure in NORMAL CONDITION .28

80601-2-30 © IEC:2009 – 3 –
Figure 201.105 – LONG-TERM AUTOMATIC MODE CUFF pressure in SINGLE FAULT CONDITION .28

Figure 201.106 – SHORT-TERM AUTOMATIC MODE CUFF pressure .29

Figure 201.107 – SELF-MEASUREMENT AUTOMATIC MODE CUFF pressure.30

Figure 202.101 – HF SURGICAL EQUIPMENT test layout .33

Figure 202.102 – Simulated PATIENT test set-up for HF SURGICAL EQUIPMENT .34

Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements .13

Table 201.102 – CUFF deflation pressure .18

Table 201.103 – CUFF inflation pressure .26
Table 201.C.101 – Marking on the outside of AUTOMATED SPHYGMOMANOMETERS or their
parts .35
Table 201.C.102 – Marking of controls and instruments of AUTOMATED
SPHYGMOMANOMETERS or their parts .36
Table 201.C.103 – ACCOMPANYING DOCUMENTS, general information for AUTOMATED
SPHYGMOMANOMETERS .36
Table 201.C.104 – ACCOMPANYING DOCUMENTS, instructions for use of AUTOMATED
SPHYGMOMANOMETERS .36
Table 201.C.105 – ACCOMPANYING DOCUMENTS, technical description of AUTOMATED
SPHYGMOMANOMETERS .37
Table AA.1 – Summary of requirements by mode.43
Table BB.1 – Environmental aspects addressed by clauses of this standard .46
Table CC.1 – Correspondence between this particular standard and the essential
principles .47

– 4 – 80601-2-30 © IEC:2009
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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