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EN 1060-1:1995+A2:2009

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

Non-invasive sphygmomanometers - Part 1: General requirements

Superseded date

01-05-2012

Superseded by

EN ISO 81060-1:2012

Published date

16-12-2009

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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 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Superseded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

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
EN 1060-2:1995+A1:2009 Non-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical sphygmomanometers
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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