Medical Devices
(13 standards)Industries: Medical Devices
CE Marking
Conformité Européenne — European Conformity
ISO 13485:2016
Medical devices — Quality management systems — Requirements for regulatory purposes
ISO 14971:2019
Medical devices — Application of risk management to medical devices
IEC 60601-1 Ed.3.2 (2020)
Medical electrical equipment — Part 1: General requirements for basic safety and essential performance
IEC 62366-1:2015+AMD1:2020
Medical devices — Part 1: Application of usability engineering to medical devices
RoHS 3 (2011/65/EU)
Restriction of Hazardous Substances in Electrical and Electronic Equipment
UKCA Marking
UK Conformity Assessed — United Kingdom Product Compliance
EU MDR 2017/745
European Medical Devices Regulation — Regulation (EU) 2017/745
FDA 510(k)
Premarket Notification — US Medical Device Clearance Program
GMP (cGMP)
Good Manufacturing Practice — WHO Guidelines & FDA 21 CFR 210/211
IEC 62304:2006+A1:2015
Medical device software — Software life cycle processes
ISO 15189:2022
Medical laboratories — Requirements for quality and competence
EU PFAS Restriction Proposal
REACH Annex XVII restriction proposal for per- and polyfluoroalkyl substances