EN 1060-4:2004

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
  4.1 General information on the non-invasive reference methods
  4.2 General information on the invasive reference methods
  4.3 Selection of clinical test method
  4.4 Application of test method
      4.4.1 Non-invasive reference measurement
      4.4.2 Invasive reference measurement
  4.5 Test equipment
      4.5.1 Non-invasive reference measurement
      4.5.2 Invasive blood pressure measurement
  4.6 Subjects
      4.6.1 General
      4.6.2 Non-invasive reference measurement
      4.6.3 Invasive reference measurement
  4.7 Cuff size
  4.8 Procedure
  4.9 Evaluation of results
      4.9.1 General
      4.9.2 Non-invasive reference measurement
      4.9.3 Documentation
5 Non-invasive test methods
  5.1 Test method N1 - simultaneous blood pressure
      measurement on the same upper arm
      5.1.1 Procedure
      5.1.2 Evaluation
  5.2 Test method N2 - blood pressure measurement on
      the opposite arms
      5.2.1 Procedure
      5.2.2 Evaluation
      5.2.3 Documentation
  5.3 Test method N3 - sequential blood pressure measurement
      on the same arm
      5.3.1 Procedure
      5.3.2 Evaluation
  5.4 Test method N4 - simultaneous blood pressure measurement
      on the same upper arm at restand under physical load
      5.4.1 Procedure
      5.4.2 Evaluation
      5.4.3 Documentation
  5.5 Test method N5 - ambulatory blood pressure measurement
      on the same upper arm
      5.5.1 Procedure of measurement
      5.5.2 Evaluation
      5.5.3 Documentation
  5.6 Test method N6 - ambulatory blood pressure measurement
      on the opposite arms
      5.6.1 Procedure
      5.6.2 Evaluation
      5.6.3 Documentation
6 Invasive test methods
  6.1 Test method I 1 - invasive blood pressure measurement
      on adults
      6.1.1 Procedure
      6.1.2 Evaluation
      6.1.3 Documentation
  6.2 Test method I 2 - invasive blood pressure measurement
      on neonates and infants
      6.2.1 Procedure
      6.2.2 Evaluation
      6.2.3 Documentation
Annex A (informative) Chronological order of the test
        method N3 Sequential blood pressure measurement
        on the same arm
Annex B (informative) Example of a record of a clinical
        investigation according to method N1 or N3
Annex C (informative) Summary of the WHO recommendations
        for auscultatory blood pressure measurement
Annex D (informative) Observer training and assessment etc.
Annex E (informative) A-deviations
Annex ZA (informative) Relationship between this European
        Standard and the Essential Requirements of
        EU Directive 93/42/EC Medical Devices
Bibliography

This document describes test procedures for investigations to determine the overall system accuracy of automated non-invasive sphygmomanometers, designed for the indirect measurement of blood pressure.