AAMI SP10 : 2002

Glossary of equivalent standards
Committee representation
In memoriam
Acknowledgements
Foreword
1 Scope
  1.1 General
  1.2 Inclusions
  1.3 Exclusions
2 Normative references
3 Definitions
4 Requirements
  4.1 Labeling requirements
      4.1.1 General
      4.1.2 Device and outer container labeling
      4.1.3 Information manual
      4.1.4 Component labeling
  4.2 Environmental performance and stability
      4.2.1 Storage conditions
      4.2.2 Operating conditions
      4.2.3 Vibration and shock
      4.2.4 Stability
      4.2.5 Electromagnetic compatibility
  4.3 Safety requirements
      4.3.1 Devices incorporating automatic inflation systems
      4.3.2 Electrical safety
      4.3.3 Conductive components
  4.4 Performance requirements
      4.4.1 Aneroid manometers
      4.4.2 Mercury manometers
      4.4.3 Electronic manometers
      4.4.4 Pressure transducer accuracy
      4.4.5 Overall system efficacy - Automated systems
  4.5 Requirements for inflation source and pressure control
      valves
      4.5.1 Inflation source
      4.5.2 Manually adjustable valve
      4.5.3 Self-bleeding pressure control valve
      4.5.4 Automated Valves
  4.6 Requirements for the inflatable bladder and cuff
      4.6.1 Inflatable bladder
      4.6.2 Cuff
      4.6.3 Cuff with integral
5 Tests
  5.1 Labeling
  5.2 Environmental performance and stability
      5.2.1 Storage conditions
      5.2.2 Operating conditions
      5.2.3 Vibration and shock
      5.2.4 Stability
  5.3 Safety requirements
      5.3.1 Cuff deflation
      5.3.2 Electrical safety
      5.3.3 Conductive components
  5.4 Performance
      5.4.1 Aneroid manometers
      5.4.2 Mercury manometers
      5.4.3 Electronic manometers
      5.4.4 Pressure indicator accuracy
      5.4.5 Overall system efficacy
      5.4.6 Battery-powered devices
  5.5 Requirements for inflation source and pressure control
      valves
      5.5.1 Inflation source
      5.5.2 Manually adjustable valve
      5.5.3 Self-bleeding pressure control valve
  5.6 Requirements for the inflatable bladder and cuff
      5.6.1 Inflatable bladder
      5.6.2 Cuff
      5.6.3 Cuff with integral bladder
Section A: Manual sphygmomanometers
Section B: Automated sphygmomanometers
Annexes
A - Rationale for the development and provisions of this
    standard
B - Verification of overall system efficacy by comparison with
    manual auscultatory measurements
C - Verification of overall system efficacy by comparison with
    intra-arterial measurements
D - Data analysis and reporting
E - Special considerations for the assessment of ambulatory blood
    pressure monitoring systems
F - Statistical considerations
G - Bibliography

Describes safety and performance requirements for all sphygmomanometers, whether nonautomated, automated, or electronic, that are used with an occluding cuff for the indirect determination of arterial blood pressure.