UNI EN ISO 81060-2 : 2014

Name: UNI EN ISO 81060-2 : 2014
Brand: UNI

Superseded

View Superseded by

NON-INVASIVE SPHYGMOMANOMETERS - PART 2: CLINICAL INVESTIGATION OF AUTOMATED MEASUREMENT TYPE

Superseded date

09-13-2022

Published date

01-01-2014

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for CLINICAL INVESTIGATIONS
5 CLINICAL INVESTIGATION with an auscultatory
  REFERENCE SPHYGMOMANOMETER
6 CLINICAL INVESTIGATION with REFERENCE INVASIVE
  BLOOD PRESSURE MONITORING EQUIPMENT
7 Pregnant (including pre-eclamptic) PATIENT
  populations
Annex A (informative) - Rationale and guidance
Annex B (normative) - Target heart rates for
        exercise stress testing
Annex C (informative) - Reference to the essential
        principles
Bibliography
Terminology - Alphabetized index of defined terms
Annex ZA (informative) - Relationship between
         this European Standard and the Essential
         Requirements of EU Directive 93/42/EEC
         on medical devices

Defines the requirements and methods for the clinical investigation of non-invasive sphygmomanometers used for the intermittent non-invasive automated estimation of the arterial blood pressure by utilizing a cuff.

Committee	U42.01
DevelopmentNote	Supersedes UNI EN 1060-4. (08/2014)
DocumentType	Standard
PublisherName	Ente Nazionale Italiano di Unificazione (UNI)
Status	Superseded
SupersededBy	UNI EN ISO 81060-2:2020
Supersedes	UNI EN 1060-4 : 2005

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

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
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
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
ISO 14155:2011	Clinical investigation of medical devices for human subjects Good clinical practice