IEC TR 60601-4-4:2017

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

IEC TR 60601-4-4:2017(E) is intended to assist writers when drafting alarm system-related requirements for particular standards in the IEC 60601 and IEC 80601 or ISO 80601 series of standards.
The object of this document is to encourage consistent references to alarm system-related requirements when introducing those requirements to particular standards. This is accomplished by providing suggested model language, with examples, for common alarm system-related requirements. Each of the recommendations is based upon text that has been used in existing particular standards. The expectation is that this model language will be used when alarm system-related requirements are needed in particular standards.
The collateral standard for alarm systems, IEC 60601-1-8, contains the horizontal alarm system-related requirements for me equipment and me systems. The recommendations in this document are intended to aid the writers of particular standards when referencing IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012.

General Information

• Status: Published
• Publication Date: 16-Aug-2017
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: SC 62A - Common aspects of medical equipment, software, and systems
• Current Stage: PPUB - Publication issued
• Start Date: 05-Sep-2017
• Completion Date: 17-Aug-2017

Standards Content (Sample)

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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