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PD IEC/TR 60601-4-4:2017 Medical electrical equipment - Guidance and interpretation. Guidance for writers of particular standards when creating alarm system-related requirements, 2017
- National foreword
- CONTENTS
- FOREWORD
- INTRODUCTION
- 1 Scope and object [Go to Page]
- 1.1 Scope
- 1.2 Object
- 2 Normative references
- 3 Terms and definitions
- 4 Overview
- 5 Recommendations [Go to Page]
- 5.1 Prohibiting the use of the untimed acknowledged alarm signal inactivation state [Go to Page]
- 5.1.1 General
- 5.1.2 Recommended text to prohibit the use of the untimed acknowledged alarm signal inactivation state
- Table 1 – Recommendations for particular standard references to the collateralstandard IEC 60601-1-8:2006 and IEC 606011-8:2006/AMD:2012 [Go to Page]
- 5.2 Requiring an alarm condition and its priority [Go to Page]
- 5.2.1 General
- 5.2.2 Recommended text to require an alarm condition and its priority
- 5.2.3 Example 1 for electrocardiographic (ecg) monitoring equipment
- 5.2.4 Example 2 for electrocardiographic (ecg) monitoring equipment
- 5.2.5 Example for pulse oximeter equipment
- 5.3 Requiring a maximum pause duration, option 1 [Go to Page]
- 5.3.1 General
- 5.3.2 Recommended text to require a maximum pause duration, option 1
- 5.3.3 Example
- 5.4 Requiring a maximum pause duration, option 2 [Go to Page]
- 5.4.1 General
- 5.4.2 Recommended text to require a maximum pause duration, option 2
- 5.4.3 Example for a critical care ventilator
- 5.5 Requiring a restriction for the adjustment range of an alarm limit [Go to Page]
- 5.5.1 General
- 5.5.2 Recommended text to restrict the adjustment range of an alarm limit, option 1, limit the range
- 5.5.3 Example for a respiratory gas monitor (rgm)
- 5.5.4 Recommended text to restrict the adjustment range of an alarm limit, option 2, ensure that the range is wide enough
- 5.5.5 Example for electrocardiographic (ecg) monitoring equipment
- 5.6 Requiring disclosure of a means for testing alarm signals [Go to Page]
- 5.6.1 General
- 5.6.2 Recommended text to require disclosure of a means of testing alarm signals
- 5.6.3 Example for electrocardiographic (ecg) monitoring equipment
- 5.7 Requiring disclosure of a means for testing the alarm system [Go to Page]
- 5.7.1 General
- 5.7.2 Recommended text to require disclosure of a means of testing the alarm system
- 5.7.3 Example for a critical care ventilator
- 5.8 Requiring reminder signals during alarm signal inactivation, option 1 [Go to Page]
- 5.8.1 General
- 5.8.2 Recommended text to require the generation of reminder signals during alarm signal inactivation
- 5.8.3 Example for invasive blood pressure monitoring equipment
- 5.9 Requiring reminder signals during alarm signal inactivation, option 2 [Go to Page]
- 5.9.1 Recommended text to require the generation of reminder signals during alarm signal inactivation
- 5.9.2 Example
- 5.10 Requiring the capability for a connection to a distributed alarm system [Go to Page]
- 5.10.1 General
- 5.10.2 Recommended text to require the capability for a connection to a distributed alarm system
- 5.10.3 Example for a ventilator for a ventilator-dependent patient
- 5.11 Requiring a maximum alarm signal generation delay [Go to Page]
- 5.11.1 General
- 5.11.2 Recommended text to require a maximum alarm signal generation delay
- 5.11.3 Example for electrocardiographic (ecg) monitoring equipment
- 5.12 Requiring alarm system logging [Go to Page]
- 5.12.1 General
- 5.12.2 Recommended text to require alarm system logging
- 5.12.3 Example for a life-supporting homecare ventilator
- 5.13 Requiring the use of the acknowledged alarm signal inactivation state [Go to Page]
- 5.13.1 General
- 5.13.2 Recommended text to require the use of the acknowledged alarm signal inactivation state
- Bibliography
- Index of defined terms used in this document [Go to Page]