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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Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems

60.60 Standard published

DPS/KT 6 more

Guide to the development and inclusion of aspects of safety in International Standards for medical devices

60.60 Standard published

DPS/KT 1 more

Medical devices - Guidance on the application of ISO 14971

60.60 Standard published

DPS/KT 316 more

Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)

60.60 Standard published

DPS/KT 316 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

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

60.60 Standard published

DPS/KT 205 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 6 more

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

60.60 Standard published

DPS/KT 316 more

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

60.60 Standard published

DPS/KT 316 more

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

60.60 Standard published

DPS/KT 316 more

Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances

60.60 Standard published

DPS/KT 206 more

Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances

60.60 Standard published

DPS/KT 206 more

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

60.60 Standard published

DPS/KT 316 more

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

60.60 Standard published

DPS/KT 316 more

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)

60.60 Standard published

DPS/KT 316 more

Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)

60.60 Standard published

DPS/KT 1 more

Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)

60.60 Standard published

DPS/KT 205 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