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DIN EN ISO 10993-6
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO/DIS 10993-6:2024); German and English version prEN ISO 10993-6:2024
DIN EN ISO 10993-7
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO/DIS 10993-7:2024); German and English version prEN ISO 10993-7:2024
DIN EN ISO 10993-7/A11
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants
DIN EN ISO 10993-11 rev
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
DIN EN ISO 10993-12/A1
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials - AMENDMENT 1 (ISO 10993-12:2021/DAM 1:2024); German and English version EN ISO 10993-12:2021/prA1:2024
DIN EN ISO 10993-16 rev
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
DIN EN ISO 10993-17/A1
Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents - Amendment 1 (ISO 10993-17:2023/DAM 1:2024); German and English version EN ISO 10993-17:2023/prA1:2024
DIN EN ISO 10993-23/A1
Biological evaluation of medical devices - Part 23: Tests for irritation - Amendment 1
DIN EN ISO 14155
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO/DIS 14155:2024); German and English version prEN ISO 14155:2024
DIN EN ISO 14155/A11
Clinical investigation of medical devices for human subjects - Good clinical practice
