香港ISO13485認證 EN ISO 13485:2016 已成爲歐盟協調標准 发布时间: 2020-10-02 11:10 点击:
香港ISO13485認證 EN ISO 13485:2016 已成爲歐盟協調標准
Hong Kong ISO13485 certification EN ISO 13485:2016 has become the EU harmonized standard
醫療器械質量管理體系標准ISO 13485:2016已成爲歐盟醫療器械指令:MDD,AIMDD和IVDD的協調標准。歐盟官方公報(EU Official Journal)已公布EN ISO 13485:2016正式取代上壹版EN ISO 13485:2012。EN ISO 13485:2012的 “推定符合的截止日期(cessation of presumption of conformity)”爲2019年3月31日。
Medical device quality management system standard ISO 13485:2016 has become the harmonized standard of European Medical Device Directive: MDD, aimdd and IVDD. The official journal of the European Union (EU official journal) has published EN ISO 13485:2016, officially replacing the previous version of EN ISO 13485:2012. According to EN ISO 13485:2012, "cession of presumption of conformity" is March 31, 2019.
歐盟協調性標准是應歐盟委員會的要求,由認可的歐盟標准組織(CEN / CENELEC / ETSI)開發的標准,標准以“EN”開頭。協調性標准雖爲自願性標准,卻是歐盟最認可的標准(State of the art)。選擇歐盟協調標准,是證實符合歐盟法規最好的途徑和方法。
According to the requirements of the European Commission, EU harmonized standards are developed by the recognized EU standards organization (CEN / CENELEC / ETSI). The standard begins with "en". Although the harmonization standard is voluntary, it is the most recognized standard in the EU (state of the art). The best way to confirm compliance with EU regulations is to select EU harmonized standards.
EN ISO 13485:2016協調標准的發布,進壹步推進了標准與MDR法規 和IVDR法規間的融合,使得制造商能夠將符合標准,作爲滿足相關法規要求的證據。MDR和IVDR的轉版期分別爲3年和5年。
The release of EN ISO 13485:2016 harmonizes the standards, further promotes the integration of standards with MDR regulations and ivdr regulations, enabling manufacturers to take compliance as evidence to meet the requirements of relevant regulations. The transfer period of MDR and ivdr was 3 years and 5 years respectively.
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