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ISO/TC 194  - Biological and clinical evaluation of medical devices

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Standards and projects under the direct responsibility of ISO/TC 194 Secretariat and its SCs

Standard and/or projectStageICSTC
ISO/CD 10993-4
Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood
30.20 11.100.20ISO/TC 194
ISO/CD 10993-5
Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
30.60 11.100.20ISO/TC 194
ISO/DIS 10993-6
Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
40.60 11.100.20ISO/TC 194
ISO/AWI 10993-7
Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals
20.00 11.100.20ISO/TC 194
ISO/NP 10993-11
Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
10.99 11.100.20ISO/TC 194
ISO/NP TR 10993-22
Biological evaluation of medical devices -- Part 22: Guidance on nanomaterials
10.99ISO/TC 194
ISO/DIS 22442-1
Medical devices utilizing animal tissues and their derivatives -- Part 1: Application of risk management
40.99 11.100.20ISO/TC 194/SC 1
ISO/DIS 22442-2
Medical devices utilizing animal tissues and their derivatives -- Part 2: Controls on sourcing, collection and handling
40.99 11.100.20ISO/TC 194/SC 1
ISO/AWI TS 29741
Biological evaluation of medical devices -- Development of tolerable intake values for Di(2-ethylhexyl)phthalate (DEHP)
20.00ISO/TC 194