Annex I of the Directive requires that the safety and health of patients, users, and any third party must not be endangered by proper use of the product and that any possible product risk –compared with the associated benefit –is acceptableIn addition to these general requirements, there are other requirements that apply above all to the design and manufacture of the IVD products:
1、Chemical and physical characteristics(compatibility with the material to be tested).
2、Protection against infection and microbialcontamination (processing, packaging).
3、Suitability for use under the respectiveenvironmental conditions (risk minimization).
4、Combination with other products disposal.
5、Measurement function.
6、Protection against radiation (intentional ornon-intentional radiation, ionizing radiation).
7、Protection against electrical shocks,electromagnetic compatibility.
8、Protection against mechanical or thermal risks.
9、Use by laypersons: easy to use, low risk of incorrect interpretation of results (products for self-testing only).
10、Provision of information by the manufacturer (labelling, instructions).
