DPS
Drejtoria e Përgjithshme e Standardizimit
Phone: +355 4 222 62 55
E-mail: info@dps.gov.al
Address: Address: "Reshit Collaku" Str., (nearby ILDKPKI, VI floor), Po.Box 98, Tiranë - Albania
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Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents — Amendment 1

60.60 Standard published

ISO/TC 194 more

Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process

90.93 Standard confirmed

ISO/TC 194 more

Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process — Amendment 1: Determination of the uncertainty factor

60.60 Standard published

ISO/TC 194 more

Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials

90.20 Standard under periodical review

ISO/TC 194 more

Biological evaluation of medical devices — Part 2: Animal welfare requirements

90.92 Standard to be revised

ISO/TC 194 more

Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices

90.60 Close of review

ISO/TC 194 more

Biological evaluation of medical devices — Part 22: Guidance on nanomaterials

60.60 Standard published

ISO/TC 194 more

Biological evaluation of medical devices — Part 23: Tests for irritation

90.93 Standard confirmed

ISO/TC 194 more

Biological evaluation of medical devices — Part 23: Tests for irritation — Amendment 1: Additional in vitro reconstructed human epidermis models

60.60 Standard published

ISO/TC 194 more

Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

90.92 Standard to be revised

ISO/TC 194 more

Biological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3

90.92 Standard to be revised

ISO/TC 194 more

Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood

90.92 Standard to be revised

ISO/TC 194 more

Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood — Amendment 1

60.60 Standard published

ISO/TC 194 more

Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity

90.93 Standard confirmed

ISO/TC 194 more

Biological evaluation of medical devices — Part 55: Interlaboratory study on cytotoxicity

60.60 Standard published

ISO/TC 194 more

Biological evaluation of medical devices — Part 6: Tests for local effects after implantation

60.60 Standard published

ISO/TC 194 more

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals

60.60 Standard published

ISO/TC 194 more

Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products

90.60 Close of review

ISO/TC 194 more