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

Use the form below to find the searched projects. Enter your criteria for searching (single or in combination) in the fields below and press the button “Search”.

Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) - Amendment 1: Climate action changes (ISO 15378:2017/Amd 1:2024)

60.60 Standard published

DPS/KT 261 more

Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates

60.60 Standard published

DPS/KT 316 more

Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards

60.60 Standard published

DPS/KT 316 more

Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards

60.60 Standard published

DPS/KT 316 more

Medical devices — Hierarchical coding structure for adverse events — Part 1: Event-type codes

60.60 Standard published

DPS/KT 316 more

Medical devices — Hierarchical coding structure for adverse events — Part 1: Event-type codes — Amendment 1

60.60 Standard published

DPS/KT 316 more

Medical devices — Hierarchical coding structure for adverse events — Part 2: Evaluation codes

60.60 Standard published

DPS/KT 316 more

Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020)

60.60 Standard published

DPS/KT 316 more

Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12)

60.60 Standard published

DPS/KT 6 more

Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)

60.60 Standard published

DPS/KT 316 more

Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

60.60 Standard published

DPS/KT 6 more

Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

60.60 Standard published

DPS/KT 6 more

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

60.60 Standard published

DPS/KT 6 more

Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

60.60 Standard published

DPS/KT 4 more

Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers

60.60 Standard published

DPS/KT 6 more

Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment

60.60 Standard published

DPS/KT 6 more

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

60.60 Standard published

DPS/KT 6 more

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

60.60 Standard published

DPS/KT 6 more