Specifies the minimum requirements for equipment and critical aspects of the test
methods for best practice in laboratories performing basic examination of human semen collected by
ejaculation..
Describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and delayed-type hypersensitivity..
Specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical devices testing in biological systems in accordance with one or more parts of the KS ISO 109..
Provides guidance on general requirements for the design of tests for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use..
Provides guidance on general requirements for the design of tests for identifying and quantifying degradation products from finished metallic medical devices or corresponding material samples finished as ready for clinical use..