EN 1060-3:1997+A2:2009
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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
25-04-2018
18-11-2009
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
This Part of EN 1060 specifies 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. It also specifies requirements for their accessories and gives test methods.This Part of EN 1060 applies to electro-mechanical blood pressure measuring systems in which the cuff pressure is measured electronically, but in which the blood pressure can be determined either manually with the aid of a stethoscope or automatically.Additional safety requirements for automatic cycling indirect blood pressure monitoring equipment are specified in EN 60601-2-30:1995.This Part of EN 1060 is to be used in conjunction with EN 1060-1.
| Committee |
CEN/TC 205
|
| DevelopmentNote |
To be read in conjunction with EN 1060-1. (04/2006) 1997 Edition Re-Issued in November 2009 & incorporates AMD 2 2009. (12/2009)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| 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Withdrawn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 |
| DIN EN 1060-3:2010-03 | Identical |
| AS EN 1060.3-2004 | Identical |
| UNI EN 1060-3 : 2010 | Identical |
| PN EN 1060-3 : 2002 + A2 NOV 2010 | Identical |
| NEN EN 1060-3 : 1997 + A2 2009 | Identical |
| SN EN 1060-3 : 1998 + A2 2010 | Identical |
| UNE-EN 1060-3:1997 | Identical |
| I.S. EN 1060-3:1997 | Identical |
| BS EN 1060-3:1997+A2:2009 | Identical |
| UNE-EN 1060-3:1997+A2:2010 | Identical |
| I.S. EN 740:1999 | ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS |
| I.S. EN 1060-4:2004 | NON-INVASIVE SPHYGMOMANOMETERS - PART 4: TEST PROCEDURES TO DETERMINE THE OVERALL SYSTEM ACCURACY OF AUTOMATED NONINVASIVE SPHYGMOMANOMETERS |
| BS 5724-2.204(1999) : 1999 | ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS |
| DIN EN 1060-4:2004-12 | NON-INVASIVE SPHYGMOMANOMETERS - PART 4: TEST PROCEDURES TO DETERMINE THE OVERALL SYSTEM ACCURACY OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS |
| 02/565110 DC : DRAFT DEC 2002 | BS EN 1060-4 - NON-INVASIVE SPHYGMOMANOMETERS - PART 4: TEST PROCEDURES TO DETERMINE THE OVERALL SYSTEM ACCURACY OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS |
| BS EN 740:1999 | Anaesthetic workstations and their modules. Particular requirements |
| BS EN 1060-4:2004 | Non-invasive sphygmomanometers Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers |
| EN 1060-4:2004 | Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers |
| 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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