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CSA ISO 81060-2 : 2014

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

View Superseded by

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

Available format(s)

Hardcopy , PDF

Withdrawn date

24-07-2019

Superseded by

CSA ISO 81060-2:19

Language(s)

English, French

Published date

01-01-2014

€141.78
Excluding VAT

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

Defines 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.

DocumentType
Standard
Pages
58
PublisherName
Canadian Standards Association
Status
Withdrawn
SupersededBy

Standards Relationship
ISO 81060-2:2013 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

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