NEN EN 1060-4 : 2004
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
NON-INVASIVE SPHYGMOMANOMETERS - PART 4: TEST PROCEDURES TO DETERMINE THE OVERALL SYSTEM ACCURACY OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS
07-05-2014
12-01-2013
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 N 3 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
Describes test procedures for investigations to determine the overall system accuracy of automated non-invasive sphygmomanometers, designed for the indirect measurement of blood pressure.
DocumentType |
Standard
|
PublisherName |
Netherlands Standards
|
Status |
Superseded
|
Standards | Relationship |
BS EN 1060-4:2004 | Identical |
EN 1060-4:2004 | Identical |
UNE-EN 1060-4:2005 | Identical |
DIN EN 1060-4:2004-12 | Identical |
I.S. EN 1060-4:2004 | Identical |
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