CEI 62-236 PDF

This Standard deals with the technical assessment of the measuring performance of the medical PPMD (classified by the Manufacturer to be an active MD with measuring function), and the maintenance of the quality of measuring performance during its lifetime.

The Standard is addressed to:

● Manufacturers, Notified Bodies or Third Parties who are assessing on-the-bench the measurement performance of a PPMD before its certification as a MD in class Im or higher; in this case each sensor response shall be accurately assessed. All applicable parts of this Standard shall be implemented, together with any eventual further assessment required by legislation in force;

● Manufacturers or Third Parties, who are assessing on-the-bench the measurement performance of a PPMD immediately before putting it into service, or at scheduled times during its lifetime, or following extraordinary events, failures, partial replacements, updates, environmental changes and so on; in this case tests shall be performed at least under the recommended number of subareas as described in the Standard;

● Manufacturers, Users, Third Parties or Qualified Persons who are periodically assessing the PPMD on-site.

Specifically, the present document focusses on:

i) the set of parameters to assess;

ii) the essential requirements of testing devices for on-the-bench assessment and for on-site periodical assessment;

iii) the time interval between two successive assessments;

iv) the testing protocols for each type of assessment;

v) the report of the test (Test Report) for on-the-bench assessment;

vi) the report of the test (Test Report) for on-site periodical assessment.

NOTE 1 The above technical assessment partly takes into account the appropriateness of the acquisition software associated with the PPMD, since the measured quantities shall be read through it (i.e. data from the PPMD shall be obtained only by means of interfaces delivered by the Manufacturer and Operating Systems declared by the Manufacturer). The assessment of the eventual further software applications associated with the PPMD is beyond the scope of this Standard.

However, when the PPMD is a MD, all the software applications associated with it and manipulating the PPMD data shall be considered as a MD itself – or accessory of a MD - and shall be compliant with the MD EU Regulations. Especially important, the Manufacturer shall deliver complete documentation dealing with the clear definition of each and every acquired and calculated parameter, and with the clear description of the algorithms applied to process the data.

NOTE 2 Particularly important is to highlight the difference between the PPMD calibration and the on-the-bench assessment of its performance: the latter, in fact, aims at proving the final product performance with respect to the entire active area or to properly selected subareas; the former must rather guarantee for the accurate calibration of each sensor, under static and dynamic conditions along the whole declared pressure range, performed through dedicated procedures and equipment by the Manufacturer who shall also keep all the associated documentation in the device Technical files. Testing equipment and procedures described in the present Standard are not addressed to calibration.

NOTE 3 Since PPMDs may exist in the form of sensor matrices included in rigid frames, or in the form of flexible – sometimes wearable - sensor matrices, the requirements for the testing devices and protocols may change accordingly. Whenever necessary, this will be clearly specified in the present Standard.

NOTE 4 Whilst isolated pressure sensors are not suitable for the quantification of the plantar pressure distribution under the whole sole of the foot, a Manufacturer may however declare a medical intended use for such products and may need to certify them as MD in Class Im or higher. In such a case, and within the scope of this Standard, they shall be tested similarly to flexible sensor matrices. A clear description shall be delivered by the Manufacturer of each and every parameter measured by the device, and of the parts of the present Standard which are applicable accordingly.

At a more general level, a Pressure Measurement Device (PMD), may be used to investigate other aspects of human motion like gripping, sitting, lying in a bed. PMDs specific for all these actions may ask for peculiar requirements of the testing apparatus. Even though the identification of such requirements is beyond the scope of the present Standard, Annex B of the Standard contains examples of testing devices which can be adapted to test PPMDs intended for use in further clinical contexts.