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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Projects

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Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)

60.60 Standard published

DPS/KT 206 more

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)

60.60 Standard published

DPS/KT 206 more

Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)

60.60 Standard published

DPS/KT 206 more

Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 2: Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution (ISO 20776-2:2021)

60.60 Standard published

DPS/KT 140 more

Clinical laboratory testing and in vitro medical devices - Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy

60.60 Standard published

DPS/KT 140 more

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)

60.60 Standard published

DPS/KT 206 more

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)

60.60 Standard published

DPS/KT 206 more

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)

60.60 Standard published

DPS/KT 316 more

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)

60.60 Standard published

DPS/KT 206 more

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)

60.60 Standard published

DPS/KT 316 more

Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)

60.60 Standard published

DPS/KT 206 more

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)

60.60 Standard published

DPS/KT 206 more

Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)

60.60 Standard published

DPS/KT 206 more

Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)

60.60 Standard published

DPS/KT 206 more

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)

60.60 Standard published

DPS/KT 206 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 (ISO 10993-18:2020/Amd 1:2022)

60.60 Standard published

DPS/KT 206 more

Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)

60.60 Standard published

DPS/KT 206 more

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)

60.60 Standard published

DPS/KT 206 more