Pretražite srpske, evropske i međunarodne standarde. Odredite organizaciju koja je donosilac standarda, izaberite oznaku standarda ili ključnu reč i završite željenu pretragu. Možete dodati i fazu u izradi standarda ili komitet/komisiju koja je izradila standard.
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
90.92 Odluka o izmeni ili reviziji standarda
Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
90.93 Odluka o potvrđivanju standarda
Biological evaluation of medical devices — Part 55: Interlaboratory study on cytotoxicity
60.60 Standard objavljen
Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
90.92 Odluka o izmeni ili reviziji standarda
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
90.92 Odluka o izmeni ili reviziji standarda
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Amendment 1: Applicability of allowable limits for neonates and infants
60.60 Standard objavljen
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Technical Corrigendum 1
60.60 Standard objavljen
Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
90.20 Početak postupka preispitivanja standarda
Biological evaluation of medical devices — Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices
60.60 Standard objavljen
Medical products containing viable human cells — Application of risk management and requirements for processing practices
90.93 Odluka o potvrđivanju standarda
Clinical investigation of medical devices for human subjects — Good clinical practice
90.92 Odluka o izmeni ili reviziji standarda
Clinical laboratory testing — Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
90.60 Završetak postupka preispitivanja standarda
Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
60.60 Standard objavljen
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
90.60 Završetak postupka preispitivanja standarda
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
60.60 Standard objavljen
Pyrogenicity — Principles and methods for pyrogen testing of medical devices
90.92 Odluka o izmeni ili reviziji standarda
Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
90.93 Odluka o potvrđivanju standarda
Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management
60.60 Standard objavljen