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

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Subcommittees

Subcommittee Subcommittee Title
ISO/TC 194/SC 1 Tissue product safety

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

Standard and/or projectStageICS
ISO/NP 10993-1
Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
10.99 11.100.20
ISO/CD 10993-4
Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood
30.60 11.100.20
ISO/CD 10993-5
Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
30.60 11.100.20
ISO/DIS 10993-6
Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
40.60 11.100.20
ISO/AWI 10993-7
Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals
20.00 11.100.20
ISO/NP 10993-9
Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products
10.99 11.100.20
ISO/NP 10993-11
Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
10.99 11.100.20
ISO/NP 10993-15
Biological evaluation of medical devices -- Part 15: Identification and quantification of degradation products from metals and alloys
10.99 11.100.20
ISO/NP 10993-16
Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables
10.99 11.100.20
ISO/NP 10993-18
Biological evaluation of medical devices -- Part 18: Chemical characterization of materials
10.99 11.100.20
ISO/NP TS 10993-19
Biological evaluation of medical devices -- Part 19: Physico-chemical, morphological and topographical characterization of materials
10.99 11.100.20
ISO/NP TS 10993-20
Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices
10.99 11.100.20
ISO/NP TR 10993-22
Biological evaluation of medical devices -- Part 22: Guidance on nanomaterials
10.99
ISO/NP TR 15499
Biological evaluation of medical devices -- Guidance on the conduct of biological evaluation within a risk management process
10.99 11.100.20
ISO/AWI TS 29741
Biological evaluation of medical devices -- Development of tolerable intake values for Di(2-ethylhexyl)phthalate (DEHP)
20.00