IEC TR 60601-4-4:2017

IEC TR 60601-4-4 ®
Edition 1.0 2017-08
TECHNICAL
REPORT
Medical electrical equipment –
Part 4-4: Guidance and interpretation – Guidance for writers of particular
standards when creating alarm system-related requirements
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IEC TR 60601-4-4 ®
Edition 1.0 2017-08
TECHNICAL
REPORT
Medical electrical equipment –

Part 4-4: Guidance and interpretation – Guidance for writers of particular

standards when creating alarm system-related requirements

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.01 ISBN 978-2-8322-4685-6

– 2 – IEC TR 60601-4-4:2017 © IEC 2017
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope and object . 7
1.1 Scope . 7
1.2 Object . 7
2 Normative references . 7
3 Terms and definitions . 8
4 Overview . 8
5 Recommendations . 9
5.1 Prohibiting the use of the untimed ACKNOWLEDGED ALARM SIGNAL inactivation
state . 9
5.1.1 General . 9
5.1.2 Recommended text to prohibit the use of the untimed ACKNOWLEDGED
ALARM SIGNAL inactivation state . 9
5.2 Requiring an ALARM CONDITION and its priority . 10
5.2.1 General . 10
5.2.2 Recommended text to require an ALARM CONDITION and its priority . 10
5.2.3 Example 1 for ELECTROCARDIOGRAPHIC (ECG) MONITORING EQUIPMENT . 10
5.2.4 Example 2 for ELECTROCARDIOGRAPHIC (ECG) MONITORING EQUIPMENT . 10
5.2.5 Example for PULSE OXIMETER EQUIPMENT . 11
5.3 Requiring a maximum pause duration, option 1 . 11
5.3.1 General . 11
5.3.2 Recommended text to require a maximum pause duration, option 1 . 11
5.3.3 Example . 11
5.4 Requiring a maximum pause duration, option 2 . 11
5.4.1 General . 11
5.4.2 Recommended text to require a maximum pause duration, option 2 . 12
5.4.3 Example for a critical care VENTILATOR . 12
5.5 Requiring a restriction for the adjustment range of an ALARM LIMIT . 13
5.5.1 General . 13
5.5.2 Recommended text to restrict the adjustment range of an ALARM LIMIT,
option 1, limit the range . 13
5.5.3 Example for a RESPIRATORY GAS MONITOR (RGM) . 13
5.5.4 Recommended text to restrict the adjustment range of an ALARM LIMIT,
option 2, ensure that the range is wide enough . 14
5.5.5 Example for ELECTROCARDIOGRAPHIC (ECG) MONITORING EQUIPMENT . 14
5.6 Requiring disclosure of a means for testing ALARM SIGNALS . 14
5.6.1 General . 14
5.6.2 Recommended text to require disclosure of a means of testing ALARM
SIGNALS . 14
5.6.3 Example for ELECTROCARDIOGRAPHIC (ECG) MONITORING EQUIPMENT . 15
5.7 Requiring disclosure of a means for testing the ALARM SYSTEM . 15
5.7.1 General . 15
5.7.2 Recommended text to require disclosure of a means of testing the
ALARM SYSTEM . 15
5.7.3 Example for a critical care VENTILATOR . 15
5.8 Requiring REMINDER SIGNALS during ALARM SIGNAL inactivation, option 1 . 16
5.8.1 General . 16

5.8.2 Recommended text to require the generation of REMINDER SIGNALS
during ALARM SIGNAL inactivation . 16
5.8.3 Example for INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT . 16
5.9 Requiring REMINDER SIGNALS during ALARM SIGNAL inactivation, option 2 . 16
5.9.1 Recommended text to require the generation of REMINDER SIGNALS
during ALARM SIGNAL inactivation . 16
5.9.2 Example . 17
5.10 Requiring the capability for a connection to a DISTRIBUTED ALARM SYSTEM . 17
5.10.1 General . 17
5.10.2 Recommended text to require the capability for a connection to a
DISTRIBUTED ALARM SYSTEM . 17
5.10.3 Example for a VENTILATOR FOR A VENTILATOR-DEPENDENT PATIENT. 17
5.11 Requiring a maximum ALARM SIGNAL GENERATION DELAY . 18
5.11.1 General . 18
5.11.2 Recommended text to require a maximum ALARM SIGNAL GENERATION
DELAY . 18
5.11.3 Example for ELECTROCARDIOGRAPHIC (ECG) MONITORING EQUIPMENT . 18
5.12 Requiring ALARM SYSTEM logging . 18
5.12.1 General . 18
5.12.2 Recommended text to require ALARM SYSTEM logging . 18
5.12.3 Example for a life-supporting homecare VENTILATOR . 19
5.13 Requiring the use of the ACKNOWLEDGED ALARM SIGNAL inactivation state . 20
5.13.1 General . 20
5.13.2 Recommended text to require the use of the ACKNOWLEDGED ALARM
SIGNAL inactivation state . 20
Bibliography . 21
Index of defined terms used in this document . 22

Table 1 – Recommendations for particular standard references to the collateral
standard IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD:2012 . 9

– 4 – IEC TR 60601-4-4:2017 © IEC 2017
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 4-4: Guidance and interpretation – Guidance for
writers of particular standards when creating
alarm system-related requirements

FOREWORD
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