In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) Part 1: Terms, definitions, and general requirements
€235.00
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) Part 2: In vitro diagnostic reagents for professional use
€77.00
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) Part 3: In vitro diagnostic instruments for professional use
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) Part 4: In vitro diagnostic reagents for self-testing
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) Part 5: In vitro diagnostic instruments for self-testing
Requirements for the collection and transport of samples for medical laboratory examinations
€208.00
In vitro diagnostic medical devices — Single-use containers for the collection of specimens from humans other than blood
€115.00
In vitro diagnostic test systems — Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
€50.00
Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 2: Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution (ISO 20776-2:2021)
€92.00
Medical laboratories — Requirements for quality and competence
€259.00
Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma (ISO 20186-3:2019)
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
€187.00
Laboratory glassware — Disposable serological pipettes
€51.00
In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids Part 2: Validation and verification