FDA:s ASCA-program

I september 2020 lanserade USA:s Food & Drug Administration (FDA) ett nytt frivilligt program i syfte att snabba på processen för marknadstillträde för medicintekniska produkter.

Under programmet kan tillverkare vända sig till ett ASCA-ackrediterat labb för att få sin produkt testad inför ansökan om marknadsgodkännande (premarket submission). Detta försväntas minska FDA:s behov av att begära in ytterligare information under ansökningsprocessen och därigenom tiden till marknad för tillverkarna. 

Mer om programmet finns att läsa på FDA:s hemsida 

Interteks svenska labb är ett ASCA-Accredited Testing Laboratory. I vårt ackrediterings-scope ingår följande standarder:

ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text): Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 MOD)

IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION: Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

IEC 60601-1-8 Edition 2.1 2012-11: 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

IEC 60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION: 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

ISO 80601-2-12 First edition 2011-04-15 Medical electrical equipment - Part 2-12: Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators [Including: Technical Corrigendum 1 (2011)]

ISO 80601-2-12 Second edition 2020-02 Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators

ISO 80601-2-13 First edition 2011-08-11 Medical electrical equipment -- Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation [Including: Amendment 1 (2015) and Amendment 2 (2018)]

ISO 80601-2-55 Second edition 2018-02 Medical electrical equipment  - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors

IEC 61010-1 Edition 3.1 2017-01: Safety requirements for electrical equipment for measurement control and laboratory use - Part 1: General requirements.

Webinar: FDA:s ASCA-program (på engelska)

ASCA-processen