医疗器械
(17 项标准)行业: 医疗器械
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 — General requirements for basic safety and essential performance
IEC 62366-1:2015+AMD1:2020
Medical devices — 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
ISO 35001:2019
Biorisk management for laboratories and other related organisations
ISO 7101:2023
Healthcare organization management — Management systems for quality in healthcare organizations — Requirements
EU PFAS Restriction Proposal
REACH Annex XVII restriction proposal for per- and polyfluoroalkyl substances
EU RED
Radio Equipment Directive — Directive 2014/53/EU
ANSI/ESD S20.20
Requirements for the Development, Implementation and Maintenance of an ESD Control Program