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AS 3864.2-2012
[Pending Revision]Medical refrigeration equipment - For the storage of blood and blood products, Part 2: User-related requirements for care, maintenance, performance verification and calibration
Specifies user-related requirements for the care, maintenance, performance verification and calibration of medical refrigeration equipment used for the storage of blood and blood products in the temperature range 2 degrees Celsius to 6 degrees Celsius and frozen plasma and plasma products at a temperature of minus 25 degrees Celsius or lower.
Published: 23/11/2012
Pages: 15
Table of contents
Cited references
Content history
Table of contents
Header
About this publication
Preface
1 Scope and general
1.1 Scope
1.2 Referenced documents
1.3 Definitions
2 Requirements for care, maintenance, performance, verification and calibration
2.1 Scope of section
2.2 General requirements
2.3 Staff training
2.4 Maintenance, performance verification and calibration
2.4.1 General
2.4.2 Temperature monitoring system
2.4.2.1 Temperature recording and alarm systems
2.4.2.2 Nonconforming equipment
2.4.2.3 Performance verification and calibration testing
2.5 Documentation and record keeping
3 Procedures for care, maintenance, performance verification and calibration
3.1 Scope of section
3.2 Summary of outcomes
3.3 Daily tasks
3.4 Weekly tasks
3.5 Monthly tasks
3.5.1 Alarm back-up battery check
3.5.2 Cleaning
3.6 Six-monthly tasks
3.6.1 Temperature monitoring and alarm system accuracy
3.6.2 High and low temperature alarm testing/alarm function
3.6.2.1 General
3.6.2.2 Alarm set points
3.6.2.3 Automated testing
3.6.2.4 Manual testing
3.6.2.5 External alarms
3.6.2.6 Alarm failures
3.6.3 Power failure alarm testing
3.6.4 Mechanical inspection
3.7 Annual tasks
3.7.1 General
3.7.2 Temperature monitoring and alarm system calibration
3.7.3 Alarm reactivation test
3.7.4 General cleaning
3.8 Miscellaneous tasks (Performed as necessary)
3.8.1 General
3.8.2 Download of electronic monitoring system data
3.8.3 Spatial temperature distribution check
3.8.4 Spills
3.8.5 Defrosting
3.9 Checklist
Cited references in this standard
[Pending Revision]
Medical refrigeration equipment - For the storage of blood and blood products, Part 1: Manufacturing requirements
[Current]
General requirements for the competence of testing and calibration laboratories
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