17/30357644 DC : 0
NA
Status of Standard is Unknown
BS EN ISO 81060-2 - NON-INVASIVE SPHYGMOMANOMETERS - PART 2: CLINICAL INVESTIGATION OF INTERMITTENT AUTOMATED MEASUREMENT TYPE
Hardcopy , PDF
English
Foreword
European 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
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 (informative) - Reference to the
ESSENTIAL PRINCIPLES
Annex C (informative) - Terminology - alphabetized
index of defined terms
Annex ZA (informative) - Relationship between this
European Standard and the essential
requirements of Directive 93/42/EEC
[OJ L 169] aimed to be covered
Bibliography
BS EN ISO 81060-2.
| Committee |
CH/121/9
|
| DocumentType |
Draft
|
| Pages |
51
|
| PublisherName |
British Standards Institution
|
| Status |
NA
|
| EN 60601-2-34:2014 | Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment |
| EN ISO 81060-1:2012 | Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007) |
| 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 |
| ISO 16142-1:2016 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
| 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 |
| EN 80601-2-30:2010/A1:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS (IEC 80601-2-30:2009/A1:2013) |
| 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 |
| EN 60601-1-11:2015 | Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
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