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AAMI ISO 81060-2 : 2013

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 2: CLINICAL INVESTIGATION OF AUTOMATED MEASUREMENT TYPE

Available format(s)

Hardcopy , PDF

Superseded date

09-05-2019

Language(s)

English

Published date

01-01-2013

Glossary of equivalent standards
Committee representation
Background of AAMI adoption of IEC 81060-2:2013
Foreword
Introduction
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

Provides 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
WG 07
DevelopmentNote
Supersedes AAMI SP10. (11/2009)
DocumentType
Standard
Pages
55
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
ISO 81060-2:2013 Identical

AAMI TIR44 : 2012 NON-INVASIVE BLOOD PRESSURE MOTION ARTIFACT - TESTING AND EVALUATION OF NIBP DEVICE PERFORMANCE IN THE PRESENCE OF MOTION ARTIFACT

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

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