User's Manual

14
Product safety standards
MDD
Council Directive 93/42/EEC as amended by Directive 2007/47/EC concerning
medical devices
ISO 13485[2016]
Medical Device Quality management systems – Requirements for regulatory
purpose
MEDDEV 2.12-1 Rev.8 Guidelines on a medical device vigilance system
CGMP 21 CFR PART 820- Quality System Regulation
EN ISO 14971 [2012]
Medical devices - Application of risk management to medical device
(ISO 14971:2007, Corrected version 2007-10-01)
ISO 14644-1 [2015]
Cleanrooms and associated controlled environments Part 1 : Classification of air
cleanliness by Particle concentration
ISO 14644-2 [2015]
Cleanrooms and associated controlled environments Part 2 : Monitoring to
provide evidence of cleanroom performance related to air cleanliness by particle
concentration
EN60601-
1:2006+A1:2013+A12:2014
Medical electrical equipment – Part 1 : General requirements for basic safety and
essential performance
EN 60601-1-2:2015
Medical electrical equipment - Part 1-2 : General requirements for basic safety
and essential performance – Collateral standard : Electromagnetic compatibility –
Requirements and tests
EN 62304:2006+A1:2015
Medical device software – Software life – cycle processes
EN ISO 15223-1:2016
Medical devices - Symbols to be used with medical device labels, labelling and
information to be supplied - Part 1: General requirements
ISO 2248 [1985]
Packaging-Complete, filled transport Packages - Vertical impact test by dropping
MEDDEV 2.7.1 Rev.4
CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES
UNDER DIRECTIVES 93/42/EEC and 90/385/EEC
IEC 62366:2007/AMD
1:2014
Medical devices — Application of usability engineering to medical devices —
Amendment 1
EN 1041:2008+A1:2013
Information supplied by the manufacturer of medical devices