BS ISO 81060-2 : 2013
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 AUTOMATED MEASUREMENT TYPE
Hardcopy , PDF
English
01-01-2013
30-06-2014
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
Describes 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 |
CH/121/5
|
| DevelopmentNote |
Supersedes 08/30174059 DC. (03/2010) Renumbered and superseded by BS EN ISO 81060-2. (06/2014)
|
| DocumentType |
Standard
|
| Pages |
52
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| 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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