DIN EN ISO 81060-2:2014-10

Withdrawn

NON-INVASIVE SPHYGMOMANOMETERS - PART 2: CLINICAL INVASTIGATION OF AUTOMATED MEASUREMENT TYPE (ISO 81060-2:2013)

Available format(s)

Hardcopy , PDF

Withdrawn date

02-03-2021

Language(s)

German, English

Published date

10-01-2014

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

This part of ISO 81060 specifies the requirements and methods for the CLINICAL INVESTIGATION of ME EQUIPMENT used for the intermittent non-invasive automated estimation of the arterial BLOOD PRESSURE by utilizing a CUFF.

Committee	TC 121
DevelopmentNote	Supersedes DIN EN 1060-4. (10/2014) DRAFT 2017 issued in August 2017. (08/2017)
DocumentType	Standard
Pages	49
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Withdrawn
Supersedes	DIN EN 1060-4:2004-12

Standards	Relationship
EN ISO 81060-2:2014	Identical
ISO 81060-2:2013	Identical

DIN EN 60601-2-34 : 2015	MEDICAL ELECTRICAL EQUIPMENT - PART 2-34: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT (IEC 60601-2-34:2011)
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
VDE 0750-2-30 : 2016	MEDIZINISCHE ELEKTRISCHE GERAETE - TEIL 2-30: BESONDERE FESTLEGUNGEN FUER DIE SICHERHEIT EINSCHLIESSLICH DER WESENTLICHEN LEISTUNGSMERKMALE VON AUTOMATISIERTEN NICHT-INVASIVEN BLUTDRUCKMESSGERAETEN (IEC 80601-2-30:2009 + CORRIGENDUM JAN. 2010 + A1:2013)
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
DIN EN 80601-2-30 : 2016	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 + CORRIGENDUM JAN. 2010 + A1:2013)
ISO/TR 16142:2006	Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
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
VDE 0750-2-34 : 2015	MEDICAL ELECTRICAL EQUIPMENT - PART 2-34: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT (IEC 60601-2-34:2011)
DIN EN ISO 14155:2012-01	CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011 + COR. 1:2011)
ISO 14155:2011	Clinical investigation of medical devices for human subjects Good clinical practice
DIN EN ISO 81060-1:2012-08	Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007)
VDE 0750-1 : 2013	MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005 + COR.:2006 + COR.:2007 + A1:2012)
DIN EN 60601-1-11 : 2016	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 (IEC 60601-1-11:2015)