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Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
60.60 Standard published
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
60.60 Standard published
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants (ISO 10993-7:2008/Amd 1:2019)
60.60 Standard published
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Technical Corrigendum 1 (ISO 10993-7:2008/Cor 1:2009)
60.60 Standard published
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)
60.60 Standard published
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
60.60 Standard published
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 (ISO 20776-1:2019, including Corrected version 2019-12)
60.60 Standard published
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)
60.60 Standard published
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)
60.60 Standard published
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)
60.60 Standard published
Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007)
60.60 Standard published
Biological evaluation of medical devices — Part 10: Tests for skin sensitization
60.60 Standard published
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
90.92 Standard to be revised
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
90.92 Standard to be revised
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
60.60 Standard published
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials — Amendment 1
40.00 DIS registered
Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
90.20 Standard under periodical review
Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
90.20 Standard under periodical review