BS ISO 81060-2 : 2013

Superseded

View Superseded by

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

Available format(s)

Hardcopy , PDF

Superseded date

06-30-2014

Language(s)

English

Published date

01-01-2013

Publisher

British Standards Institution

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

Describes 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	CH/121/5
DevelopmentNote	Supersedes 08/30174059 DC. (03/2010) Renumbered and superseded by BS EN ISO 81060-2. (06/2014)
DocumentType	Standard
Pages	52
PublisherName	British Standards Institution
Status	Superseded
SupersededBy	BS EN ISO 81060-2:2014
Supersedes	08/30174059 DC : DRAFT JUNE 2008 BS ISO 81060-2:2009

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