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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type (ISO 81060- 2:2018)
Hardcopy , PDF
27-10-2020
English
16-12-2019
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Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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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
This document specifies the requirements and methods for the clinical investigation of me equipment used for the intermittent non-invasive automated estimation of the arterial blood pressure by utilizing a cuff.
| Committee |
TC 121
|
| DocumentType |
Standard
|
| Pages |
0
|
| ProductNote |
THIS STANDARD ALSO REFERS TO ANSI/AAMI SP10:2002,ANSI/AAMI SP10: 1987. The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| EN ISO 81060-2:2019 | Identical |
| ISO 81060-2:2018 | Identical |
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