BS 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 Clinical investigation of automated measurement type
Hardcopy , PDF
18-09-2020
English
30-06-2014
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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
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/205
|
| DevelopmentNote |
Renumbers and supersedes BS ISO 81060-2. 2014 Version incorporates corrigendum to BS ISO 81060-2. Supersedes 08/30174059 DC & BS EN 1060-4. (06/2014)
|
| DocumentType |
Standard
|
| Pages |
52
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
ISO 81060-2:2013 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. ISO 81060-2:2013 is applicable to all sphygmomanometers that sense or display pulsations, flow or sounds for the estimation, display or recording of blood pressure. These sphygmomanometers need not have automatic cuff inflation. ISO 81060-2:2013 covers sphygmomanometers intended for use in all patient populations and all conditions of use. ISO 81060-2:2013 specifies additional disclosure requirements for the accompanying documents of sphygmomanometers that have undergone clinical investigation according to ISO 81060-2:2013.
| Standards | Relationship |
| EN ISO 81060-2:2014 | Identical |
| 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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