I.S. EN ISO 81060-2:2019
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 2: Clinical investigation of intermittent automated measurement type (ISO 81060- 2:2018)
Hardcopy , PDF
10-27-2020
English
12-16-2019
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Foreword
Introduction
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 monitoringequipment
7 * Pregnant patient populations
Annex A (informative) Rationale and guidance
Annex B (informative) Reference to the essential principles
Annex C (informative) Terminology — alphabetized index of defined terms
Bibliography
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