11.100.20 Biological evaluation of medical devices

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)

Biological evaluation of medical devices Guidance on the conduct of biological evaluation within a risk management process

Biological evaluation of medical devices Guidance on the conduct of biological evaluation within a risk management process

Clinical laboratory testing Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing

Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy

Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy

Clinical laboratory testing and in vitro diagnostic test systems Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices

Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices

Clinical laboratory testing and in vitro diagnostic test systems Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices

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

Infekcijas ierosinātāju uzņēmības pārbaude un pretmikrobu jutības pārbaudes ierīču veiktspējas novērtēšana. 1.daļa: References metode vāršķidruma mikroatšķaidīšanai pretmikrobu līdzekļu in vitro aktivitātes testēšanai pret infekcijas slimības izraisošām ātri augošām aerobām baktērijām (ISO 20776-1:2019, ieskaitot koriģēto versiju 2019-12)