domain
医疗器械
(5 项标准)行业: 医疗器械
CE MarkingActive
CE Marking
Conformité Européenne — European Conformity
欧盟欧洲经济区
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