EN 1060-1:1995+A2:2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Non-invasive sphygmomanometers - Part 1: General requirements
05-01-2012
12-16-2009
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 ZA (informative) Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC on medical devices
This Part of this European Standard specifies general requirements for non-invasive sphygmomanometers and their accessories which, by means of an inflatable cuff, are used for the non-invasive measurement of arterial blood pressure.It specifies performance, efficiency, mechanical and electrical safety requirements for these devices and gives test methods.NOTEThis standard recommends that Luer lock connectors should not be used with these devices.
| Committee |
CEN/TC 205
|
| DevelopmentNote |
1995 Edition Re-issued in December 2009 & incorporates AMD 2 2009. (01/2010)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| PN EN 1060-1 : 2002 + A2 OCT 2010 | Identical |
| UNE-EN 1060-1:1996 | Identical |
| SN EN 1060-1 : 1996 + A2 2010 | Identical |
| I.S. EN 1060-1:1996 | Identical |
| NBN EN 1060-1 : 1996 + A2 2010 | Identical |
| UNI EN 1060-1 : 2010 | Identical |
| AS EN 1060.1-2002 | Identical |
| NF EN 1060-1 : 1996 + A2 2010 | Identical |
| DIN EN 1060-1:2010-03 | Identical |
| NS EN 1060-1 : 1995 + A2 2009 | Identical |
| NEN EN 1060-1 : 1995 + A2 2010 | Identical |
| BS EN 1060-1:1995+A2:2009 | Identical |
| UNE-EN 1060-1:1996+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 |
| 12/30266576 DC : 0 | BS EN 13718-2 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS OF AIR AMBULANCES |
| DIN EN 1060-3:2010-03 | NON-INVASIVE SPHYGMOMANOMETERS - PART 3: SUPPLEMENTARY REQUIREMENTS FOR ELECTRO-MECHANICAL BLOOD PRESSURE MEASURING SYSTEMS |
| EN 1060-3:1997+A2:2009 | Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems |
| BS 5724-2.204(1999) : 1999 | ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS |
| UNE-EN 13976-2:2011 | Rescue systems - Transportation of incubators - Part 2: System requirements |
| I.S. EN 1060-3:1997 | NON-INVASIVE SPHYGMOMANOMETERS - PART 3: SUPPLEMENTARY REQUIREMENTS FOR ELECTRO-MECHANICAL BLOOD PRESSURE MEASURING SYSTEMS |
| DIN EN 1060-4:2004-12 | NON-INVASIVE SPHYGMOMANOMETERS - PART 4: TEST PROCEDURES TO DETERMINE THE OVERALL SYSTEM ACCURACY OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS |
| UNI EN 1060-2 : 2010 | NON-INVASIVE SPHYGMOMANOMETERS - PART 2: SUPPLEMENTARY REQUIREMENTS FOR MECHANICAL SPHYGMOMANOMETERS |
| UNI EN 1060-3 : 2010 | NON-INVASIVE SPHYGMOMANOMETERS - PART 3: SUPPLEMENTARY REQUIREMENTS FOR ELECTRO-MECHANICAL BLOOD PRESSURE MEASURING SYSTEMS |
| PREN 13976-2 : DRAFT 2016 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| 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 |
| I.S. EN 13976-2:2011 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| BS EN 13976-2:2011 | Rescue systems. Transportation of incubators System requirements |
| BS EN 740:1999 | Anaesthetic workstations and their modules. Particular requirements |
| DIN EN 13976-2 E : 2011 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| EN 1060-2:1995+A1:2009 | Non-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical sphygmomanometers |
| EN 740:1998/A1:2004 | ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS |
| 16/30333925 DC : 0 | BS EN 13976-2 - RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| UNI EN 13976-2 : 2011 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| EN 13976-2:2011 | Rescue systems - Transportation of incubators - Part 2: System requirements |
| DIN EN 13976-2:2016-03 (Draft) | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| DIN EN 1060-2:2010-03 | NON-INVASIVE SPHYGMOMANOMETERS - PART 2: SUPPLEMENTARY REQUIREMENTS FOR MECHANICAL SPHYGMOMANOMETERS |
| BS EN 1060-3 : 1997 | NON-INVASIVE SPHYGMOMANOMETERS - PART 3: SUPPLEMENTARY REQUIREMENTS FOR ELECTRO-MECHANICAL BLOOD PRESSURE MEASURING SYSTEMS |
| BS EN 1060-4:2004 | Non-invasive sphygmomanometers Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers |
| DIN EN 13976-2:2011-08 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| EN 1060-4 : 2004 | NON-INVASIVE SPHYGMOMANOMETERS - PART 4: TEST PROCEDURES TO DETERMINE THE OVERALL SYSTEM ACCURACY OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
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