Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables
€115.00
Biological evaluation of medical devices Part 18: Chemical characterization of medical device materials within a risk management process
€259.00
Biological evaluation of medical devices Part 22: Guidance on nanomaterials
€235.00
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue Part 1: Isolated RNA
€155.00
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue Part 1: Isolated RNA
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood Part 1: Isolated cellular RNA
Biological evaluation of medical devices Part 11: Tests for systemic toxicity
€206.00
Biological evaluation of medical devices Part 15: Identification and quantification of degradation products from metals and alloys
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood Part 2: Isolated genomic DNA
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood Part 3: Isolated circulating cell free DNA from plasma
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue Part 2: Isolated proteins
Molecular in vitro diagnostic examinations — Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue Part 2: Isolated proteins
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue Part 3: Isolated DNA
Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices Part 1: Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals Amendment 1: Applicability of allowable limits for neonates and infants
€21.00
