UNI EN ISO 81060-2 : 2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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NON-INVASIVE SPHYGMOMANOMETERS - PART 2: CLINICAL INVESTIGATION OF AUTOMATED MEASUREMENT TYPE
13-09-2022
01-01-2014
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for CLINICAL INVESTIGATIONS
5 CLINICAL INVESTIGATION with an auscultatory
REFERENCE SPHYGMOMANOMETER
6 CLINICAL INVESTIGATION with REFERENCE INVASIVE
BLOOD PRESSURE MONITORING EQUIPMENT
7 Pregnant (including pre-eclamptic) PATIENT
populations
Annex A (informative) - Rationale and guidance
Annex B (normative) - Target heart rates for
exercise stress testing
Annex C (informative) - Reference to the essential
principles
Bibliography
Terminology - Alphabetized index of defined terms
Annex ZA (informative) - Relationship between
this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
on medical devices
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