with "measuring
function"
Background
Annex VII, § 5, requires that manufacturers of Class I devices with a measuring
function must also follow one of the procedures referred to in either Annex IV, V or VI
for: "the aspects of manufacture concerned with the conformity of the products with
the metrological requirements". It is therefore necessary to specify criteria for
the existence of a "measuring function" in medical devices.
Criteria for determining devices with measuring function.
The following criteria, if fulfilled together, indicate that a device has a measuring
function:
A) The device is intended by the manufacturer to measure: - quantitatively a
physiological or anatomical parameter, or - a quantity or a qualifiable characteristic of
energy or of substances delivered to or removed from the human body
B) The result of the measurement - is displayed in legal units or other acceptable
units within the meaning of Directive 80/181/EEC or - is compared to at least one point of
reference indicated in legal units or other acceptable units in compliance with the
pre-mentioned Directive
C) The intended purpose implies accuracy, claimed explicitly or implicitly
Note 1: The expression "claimed implicitly" covers cases where the user, on
the basis of the designation of the device or of its accompanying documents, or on the
basis of the common use is entitled to expect accuracy (examples: a device designated with
the use of the suffix "-meter" or a device where the accuracy of the measurement
has an impact on the diagnosis or therapy of the patient).
Note 2: Measuring activities during the manufacturing process including those for
calibration purposes are not covered by this recommendation and do not imply a measuring
function of the manufactured device.
Note 3: For the following examples, it is assumed that the relevant classification
rules permit classification in Class I, provided that relevant criteria are met.
Examples for Class I devices WITH a measuring function: * non-active device for
measuring body temperature, * pacifier which includes a non-active temperature display, *
device for indicating that a body temperature is above or below a specified value, *
non-active non-invasive device for measuring blood pressure, * non-active device for
measuring intra-occular pressure, * device for measuring volume or flow of liquid or gases
delivered to or removed from the human body (including any container with a graduation
scale or with a single point graduation) Examples for Class I devices WITHOUT a measuring
function: * patch for indicating trends in body temperature (where criteria B is not met),
* device for the delivery of liquid to the human body (e.g. medicine spoons, cups,
droppers, without graduation or scale), * device for displaying trends of physiological
parameters (e.g. urine drainage bags without graduation or scale, callipers for obesity),
* eye-test charts
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