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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Joint implants - Part 2: Tiered toolkit approach to evaluate the biological impact of wear particles from joint replacements and related devices

60.60 Standard published

DPS/KT 140 more

Medical devices utilizing animal tissues and their derivatives — Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes

60.60 Standard published

DPS/KT 316 more

Clinical laboratory testing — Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing

60.60 Standard published

DPS/KT 140 more

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

40.60 Close of voting

DPS/KT 206 more

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

40.60 Close of voting

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)

40.60 Close of voting

DPS/KT 206 more

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

40.60 Close of voting

DPS/KT 206 more

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

40.60 Close of voting

DPS/KT 206 more

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

40.60 Close of voting

DPS/KT 206 more

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants (ISO 10993-7:2008/Amd 1:2019)

40.60 Close of voting

DPS/KT 206 more

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)

40.60 Close of voting

DPS/KT 206 more

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

40.60 Close of voting

DPS/KT 206 more

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)

40.60 Close of voting

DPS/KT 206 more

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)

40.60 Close of voting

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 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 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)

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