ISO 19614:2017 pdf download.Traditional Chinese medicine — Pulse graph force transducer
1 Scope
This document specifies the technical requirements, classification and test method for a pulse graph force transducer, hereafter referred to as transducer.
It only applies to pulse graph acquisition over the patient’s radial artery based on TCM pulse condition requirements.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
IEC 60068-2-6, Environmental testing — Part 2-6: Test Fc: Vibration (sinusoidal)
IEC 60068-2-14, Environmental testing — Part 2-14: Tests — Test N: Change of temperature
IEC 60068-2-27, Environmental testing — Part 2-27: Tests — Test Ea and guidance: Shock
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at http:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1 pulse graph force transducer
transducer that can detect pulsation of the radial artery and its peripheral tissues as a mechanical
quantity and convert it into an electrical signal output according to a certain pattern for the purpose of TCM pulse condition acquisition
Note 1 to entry: Transducers involved in this document only refer to pressure or force transducers.
3.2 calibration
process of recording input/output data through applied standard mechanical quantities to determine the performance of transducers
Note 1 to entry: The calibration unit of transducers may be the unit of either pressure or force.
6.2 Preparation
According to the different transducer types, the test equipment and the tested transducer are linked as per Figure 3, and the output mechanical quantities are imposed on the effective surface of the transducer by testing the mechanical quantity generator.
a) The rated load F n is imposed on the transducer three times and zero load is returned to after each loading. The rated load is maintained for a period of 10 s each time.
b) Forward stroke: The load on the transducer is imposed in uniform steps from zero load to the rated load (i,e. 0 %, 20 %, 40 %, 60 %, 80 % and 100 % of the rated load). The output voltage value is read after the loading at every point is stabilized.
c) After the rated load is reached, the load is increased to 105 % rated load and maintained for 10 s before being reduced back to the rated load. After the load is stabilized, the output value is read as the output value of the rated load on the backward stroke.
d) Backward stroke: Following the reduction back to rated load, a tapered load is imposed with the same decrement as specified in 6.2 b). The output value is then read after the loading at every point is stabilized.
e) Zero load is returned to and the offset value is read after an interval of 5 s;
f) The procedures in b) to e) are repeated at an interval of not less than 1 min and this is repeated three times.
ISO 19614:2017 pdf download
