domain
醫療器材
(5 項標準)行業: 醫療器材
CE MarkingActive
CE Marking
Conformité Européenne — European Conformity
歐盟歐洲經濟區
ISO 13485:2016Active
ISO 13485:2016
Medical devices — Quality management systems — Requirements for regulatory purposes
全球
ISO 14971:2019Active
ISO 14971:2019
Medical devices — Application of risk management to medical devices
全球
IEC 60601-1 Ed.3.2 (2020)Active
IEC 60601-1 Ed.3.2 (2020)
Medical electrical equipment — Part 1: General requirements for basic safety and essential performance
全球
IEC 62366-1:2015+AMD1:2020Active
IEC 62366-1:2015+AMD1:2020
Medical devices — Part 1: Application of usability engineering to medical devices
全球