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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Defines the requirements and methods for the clinical investigation of non-invasive sphygmomanometers used for the intermittent non-invasive automated estimation of the arterial blood pressure by utilizing a cuff.
| Committee |
U42.01
|
| DevelopmentNote |
Supersedes UNI EN 1060-4. (08/2014)
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 81060-2:2013 | Identical |
| EN ISO 81060-2:2014 | Identical |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| ISO 81060-1:2007 | Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-automated measurement type |
| AAMI SP10 : 2002 | MANUAL, ELECTRONIC, OR AUTOMATED SPHYGMOMANOMETERS |
| EN 1060-4:2004 | Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers |
| IEC 60601-2-34:2011 | Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment |
| ISO/TR 16142:2006 | Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices |
| IEC 80601-2-30:2009+AMD1:2013 CSV | Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers |
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects Good clinical practice |
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