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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

ISO/TC 194 Saznaj više

Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity

90.93 Odluka o potvrđivanju standarda

ISO/TC 194 Saznaj više

Biological evaluation of medical devices — Part 55: Interlaboratory study on cytotoxicity

60.60 Standard objavljen

ISO/TC 194 Saznaj više

Biological evaluation of medical devices — Part 6: Tests for local effects after implantation

90.92 Odluka o izmeni ili reviziji standarda

ISO/TC 194 Saznaj više

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals

90.92 Odluka o izmeni ili reviziji standarda

ISO/TC 194 Saznaj više

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

ISO/TC 194 Saznaj više

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Technical Corrigendum 1

60.60 Standard objavljen

ISO/TC 194 Saznaj više

Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products

90.20 Početak postupka preispitivanja standarda

ISO/TC 194 Saznaj više

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

ISO/TC 194 Saznaj više

Medical products containing viable human cells — Application of risk management and requirements for processing practices

90.93 Odluka o potvrđivanju standarda

ISO/TC 194 Saznaj više

Clinical investigation of medical devices for human subjects — Good clinical practice

90.92 Odluka o izmeni ili reviziji standarda

ISO/TC 194 Saznaj više

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

90.60 Završetak postupka preispitivanja standarda

ISO/TC 212 Saznaj više

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

ISO/TC 212 Saznaj više

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

ISO/TC 212 Saznaj više

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

ISO/TC 212 Saznaj više

Pyrogenicity — Principles and methods for pyrogen testing of medical devices

90.92 Odluka o izmeni ili reviziji standarda

ISO/TC 194 Saznaj više

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

ISO/TC 194 Saznaj više

Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management

60.60 Standard objavljen

ISO/TC 194 Saznaj više