ISO 81060-2:2013 pdf download.Non-invasive sphygmomanometers-Part 2:Clinical investigation of automated measurement type.
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.
This part of ISO 81060 is applicable to all SPHYGMOMANOMETERS that sense or display pulsations, flow or sounds for the estimation, display or recording of BLOOD PRESSURE. These SPHYGMOMANOMETERS need not have automatic CUFF inflation.
This part of ISO 81060 covers SPHYGMOMANOMETERS intended for use in all PATIENT populations (e.g. all age and weight ranges), and all conditions of use (e.g. ambulatory BLOOD PRESSURE monitoring, stress testing BLOOD PRESSURE monitoring and BLOOD PRESSURE monitors for the HOME HEALTHCARE ENVIRONMENT for self- measurement as well as use in a professional healthcare facility).
EXAMPLE AUTOMATED SPHYGMOMANOMETER as given in IEC 80601-2-30 undergoing CLINICAL INVESTIGATION according to this part of ISO 81060.
This part of ISO 81060 specifies additional disclosure requirements for the ACCOMPANYING DOCUMENTS of SPHYGMOMANOMETERS that have undergone CLINICAL INVESTIGATION according to this part of ISO 81060.
This part of ISO 81060 is not applicable to CLINICAL INVESTIGATIONS of NON-AUTOMATED SPHYGMOMANOMETERS as given in ISO 81060-1 or INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT as given in IEC 60601 -2-34.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 14155:2011, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 81060-1, Non-invasive sphygmomanometers — Part 1: Requirements and test methods for nonautoma ted measurement type
IEC 80601-2-30:2009, Medical electrical equipment — Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers
IEC 60601-1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance
IEC 60601-1-11:2010, 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 home care applications
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
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 14155, IEC 80601-2-30, IEC 60601-1, IEC 60601-1-11, IEC 60601-2-34 and the following apply.
NOTE For convenience, an alphabetized index of defined terms is found beginning on page 40.
3.1
REFERENCE, adj
established accuracy used for the CLINICAL INVESTIGATION of other instruments
3.2
SPHYGMOMANOMETER
ME EQUIPMENT for non-invasive estimation of systemic arterial BLOOD PRESSURE
3.3
SPHYGMOMANOMETER-UNDER-TEST
SPHYGMOMANOMETER undergoing CLINICAL INVESTIGATION
4 General requirements for CLINICAL INVESTIGATIONS
4.1 CLINICAL INVESTIGATION methods
SPHYGMOMANOMETERS other than NON-AUTOMATED SPHYGMOMANOMETERS shall undergo CLINICAL INVESTIGATION either by using a non-invasive (auscultatory) REFERENCE SPHYGMOMANOMETER or by using REFERENCE INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT according to this part of ISO 81060 in each mode of operation.ISO 81060-2 pdf download.