I.S. EN 1060-3:1997
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
NON-INVASIVE SPHYGMOMANOMETERS - PART 3: SUPPLEMENTARY REQUIREMENTS FOR ELECTRO-MECHANICAL BLOOD PRESSURE MEASURING SYSTEMS
Hardcopy , PDF
17-12-2009
English
23-12-1997
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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Foreword
1 Scope
2 Normative references
3 Definitions
4 Cuff
5 Display
6 Units
7 Requirements
8 Test methods
9 Information supplied by the manufacturer
Annex A (informative) - Bibliography
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements
of EU Directive 93/42/EC on medical devices
Describes performance, efficiency and safety requirements for electro-mechanical blood pressure measuring systems that, by means of an inflatable cuff are used for non-invasive measurements of arterial blood pressure at the upper arm, the wrist and the thigh.
| DevelopmentNote |
1997 Edition Re-Issued in December 2009 & incorporates AMD 2 2009. (12/2009)
|
| DocumentType |
Standard
|
| Pages |
27
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Withdrawn
|
| Standards | Relationship |
| NS EN 1060-3 : 1997 + A2 2009 | Identical |
| NF EN 1060-3 : 1997 + A2 2010 | Identical |
| NBN EN 1060-3 : 1997 + A2 2010 | Identical |
| BS EN 1060-3 : 1997 | Identical |
| SN EN 1060-3 : 1998 + A2 2010 | Identical |
| DIN EN 1060-3:2010-03 | Identical |
| UNI EN 1060-3 : 2010 | Identical |
| NEN EN 1060-3 : 1997 + A2 2009 | Identical |
| UNE-EN 1060-3:1997 | Identical |
| EN 1060-3:1997+A2:2009 | Identical |
| EN 1060-2:1995+A1:2009 | Non-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical sphygmomanometers |
| EN 1060-1:1995+A2:2009 | Non-invasive sphygmomanometers - Part 1: General requirements |
| IEC 60601-2-30:1999 | Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment |
| EN 1060-4:2004 | Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers |
| ISO/IEC Guide 99:2007 | International vocabulary of metrology Basic and general concepts and associated terms (VIM) |
| EN 60601-1-2:2015 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| EN 60601-2-30:2000 | Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment |
| EN 60601-1-8:2007/A11:2017 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS (IEC 60601-1-8:2006/A1:2012) |
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