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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Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)

40.60 Close of voting

DPS/KT 206 more

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)

40.60 Close of voting

DPS/KT 206 more

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)

40.60 Close of voting

DPS/KT 206 more

Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)

40.60 Close of voting

DPS/KT 206 more

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)

60.60 Standard published

DPS/KT 316 more

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)

60.60 Standard published

DPS/KT 316 more

Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1 (ISO 11737-1:2018/Amd 1:2021)

60.60 Standard published

DPS/KT 316 more

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)

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 - 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

In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)

60.60 Standard published

DPS/KT 140 more

In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples

60.60 Standard published

DPS/KT 140 more