CSA ISO 81060-2 : 2014
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
NON-INVASIVE SPHYGMOMANOMETERS - PART 2: CLINICAL INVESTIGATION OF AUTOMATED MEASUREMENT TYPE
Hardcopy , PDF
24-07-2019
English, French
01-01-2014
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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
Defines 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.
| DocumentType |
Standard
|
| Pages |
58
|
| PublisherName |
Canadian Standards Association
|
| Status |
Withdrawn
|
| SupersededBy |
| Standards | Relationship |
| ISO 81060-2:2013 | 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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