Framework for identification and quantification of potential degradation products
€193.00
Clinical investigation of medical devices for human subjects plans
Clinical investigation of medical devices for human subjects General requirements
€316.00
Biological evaluation of medical devices Selection tests for interactions with blood
€355.00
Medical laboratories. Particular requirements for quality and competence
€374.00
In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids Interpretation and reports
€269.00
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes circulating tumour cells (CTCs) venous whole blood Isolated RNA
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes circulating tumour cells (CTCs) venous whole blood Isolated DNA
Molecular in vitro diagnostic examinations Specifications for pre-examination processes circulating tumour cells (CTCs) venous whole blood Preparations analytical CTC staining
Manufacturers’ considerations for in vitro diagnostic medical devices in a public health emergency
BS EN ISO 10993-2 Biological evaluation of medical devices Part 2: Animal welfare requirements
€23.00
Medical laboratories. Concepts and specifications for the design, development, implementation, and use of laboratory-developed tests
Clinical investigation of medical devices for human subjects. Good clinical practice
€404.00
Medical laboratories - Requirements for quality and competence
€28.00
BS EN ISO 10993-23:2021/Amd 1 Biological evaluation of medical devices Part 23: Tests for irritation. AMENDMENT 1: Additional in vitro reconstructed human epidermis models