Registration number (WIID)Project No.TitleStatus
79539LVS EN ISO 14155:2020/A11:2024Clinical investigation of medical devices for human subjects - Good clinical practiceStandarts spēkā
60724LVS EN ISO 10993-16:2018Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)Standarts spēkā
9493LVS EN ISO 10993-7:2009Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)Standarts spēkā
32000LVS EN ISO 10993-14:2009Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)Standarts spēkā
74131LVS EN ISO 10993-18:2020/A1:2023Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - Amendment 1: Determination of the uncertainty factor (ISO 10993-18:2020/Amd 1:2022)Standarts spēkā
65481EN ISO 22442-2:2020Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO/DIS 22442-2:2018)Standarts spēkā
64034LVS EN ISO 10993-7:2009/A1:2022Biological 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)Standarts spēkā
60721LVS EN ISO 10993-1:2021Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-11)Standarts spēkā
65727LVS EN ISO 10993-4:2018Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)Standarts spēkā
25795EN ISO 22442-3:2007Medical 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)Standarts spēkā
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