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Standards Development is a service provided by BSI Group
ISO 18704 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for urine and other body fluids. Isolated cell free DNA
Feedback closing date:
16/12/2024
Biological evaluation of medical devices — Part 23: Tests for irritation - Amendment 1: Biological evaluation of medical devices — Part 23: Tests for irritation — Amendment 1
18/11/2024
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic instruments for professional use
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling). Part 5: In vitro diagnostic instruments for self-testing
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Terms, definitions, and general requirements
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for self-testing
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for professional use
In vitro diagnostic medical devices. Clinical performance studies using specimens from human subjects. Good study practice
In vitro diagnostic Next Generation Sequencing (NGS) workflows. Human RNA examination
In vitro diagnostic Next Generation Sequencing (NGS) workflows. Human DNA examination