I.S. EN ISO 81060-2:2019/A1:2020
Current
The latest, up-to-date edition.
Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type - Amendment 1 (ISO 81060-2:2018/Amd 1:2020)
Hardcopy , PDF
English
05-10-2020
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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 ambulatory monitoring
6 Clinical investigation with reference invasive blood pressure monitoring equipment
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 |
68
|
| ProductNote |
This standard is also refer as 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 |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 81060-2:2018/Amd 1:2020 | Identical |
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