IEC 60601-2-23:2011

IEC 60601-2-23 ®
Edition 3.0 2011-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-23: Particular requirements for the basic safety and essential performance
of transcutaneous partial pressure monitoring equipment

Appareils électromédicaux –
Partie 2-23: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de surveillance de la pression partielle transcutanée

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IEC 60601-2-23 ®
Edition 3.0 2011-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-23: Particular requirements for the basic safety and essential performance
of transcutaneous partial pressure monitoring equipment

Appareils électromédicaux –
Partie 2-23: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de surveillance de la pression partielle transcutanée

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX X
ICS 11.040.55 ISBN 978-2-88912-370-4

– 2 – 60601-2-23 © IEC:2011
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 . 11
201.5 General requirements for testing of ME EQUIPMENT . 11
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
201.7 ME EQUIPMENT identification, marking and documents . 12
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 13
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 14
201.10 Protection against unwanted and excessive radiation HAZARDS . 14
201.11 Protection against excessive temperatures and other HAZARDS . 14
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 18
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 . 23
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 24
202 Electromagnetic compatibility – Requirements and tests . 24
208 General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems . 28
Annexes . 34
Annex AA (informative) Particular guidance and rationale . 35
Annex BB (informative) Alarm diagrams of Clause 208/IEC 60601-1-8:2006 . 43
Index of defined terms used in this particular standard. 46

Figure 201.101 – TRANSDUCER cable strain relief test . 14
Figure 201.102 – Foam block test (see 201.11.1.2.2.104 and 201.11.1.2.2.105) . 15
Figure 201.103 – Linearity and hysteresis test set-up – Gas mix chamber, assembled . 20
Figure 201.104 – Linearity and hysteresis test set-up – Gas mix chamber,
manufacturing dimensions . 21
Figure 201.105 – Linearity and hysteresis test set-up – Gas mix chamber, dimensions
of hose connector . 22
Figure 202.101 – Set-up for radiated and conducted EMISSIONS testing according to
202.6.1.1.2 a) . 25
Figure 202.102 – Set-up for radiated immunity test according to 202.6.2.3.2 . 27
Figure BB.1 – NON-LATCHING ALARM SIGNALS without ALARM RESET . 43
Figure BB.2 – NON-LATCHING ALARM SIGNALS with ALARM RESET . 43
Figure BB.3 – LATCHING ALARM SIGNALS with ALARM RESET . 44
Figure BB.4 – Two ALARM CONDITIONS with ALARM RESET . 44

60601-2-23 © IEC:2011 – 3 –
Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements . 11
Table 201.102 – Required readings and tolerances . 19
Table 201.103 – Calibration test gases . 19
Table 208.101 – ALARM CONDITION priorities . 29
Table 208.102 – Characteristics of the burst of auditory ALARM SIGNALS . 30

– 4 – 60601-2-23 © IEC:2011
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-23: Particular requirements for the basic safety and
essential performance of transcutaneous partial
pressure monitoring equipment
FOREWORD
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International standard IEC 60601-2-23 has been prepared by IEC subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This third edition cancels and replaces the second edition published in 1999 and constitutes a
technical revision. This edition of IEC 60601-2-23 was revised to align structurall
...