User's Manual

Edition：AO
No
Standard Name
Reference No.
1
Standard Name
Reference No.
2
Medical Device Quality System for the regulation
requirement
EN ISO13485: 2012
3
Medical device risk management to medical devices
application
EN ISO14971: 2012
4
Symbol for the label of medical devices
EN 980: 2008
5
Term, symbol and information of medical device—
information of medical device manufacturer offering
EN 1041: 2008
6
Medical electrical equipment – Part 1: General
requirements for safety
EN60601-1: 2005/AC:2012
7
Medical electrical equipment – Part 1-2: General
requirements for safety – Collateral standard:
Electromagnetic compatibility – Requirements and
tests
EN 60601-1-2: 2007
8
Clinical investigation of medical devices for human
subjects. General requirements
EN ISO 14155-1:2009
9
Clinical investigation of medical devices for human
subjects. Clinical investigation plans
EN ISO 14155-2:2009
10
Medical device software – Software life-cycle
processes
EN 62304: 2006/AC: 2008
11
Medical electrical equipment – Part 1-6: General
requirements for basic safety and essential
performance – Collateral standard: Usability
EN 60601-1-6: 2010
12
Medical electrical equipment. Part 1-11:General
requirements for basic safety and essential
performance. Collateral standard:Requirements for
medical electrical equipment and medical electrical
systems used in the home healthcare environment
EN 60601-1-11：2010
13
Medical devices – Application of usability engineering
to medical devices
EN62366: 2008
14
Council Directive 93/42/EECof 14 June 1993
concerning medical devices
OJ L 169 of 12 July 1993 (including Directive
2007/47/EC )
MDD 93/42/EEC
15
Non-invasive sphygmomanometers —Part 1:
General requirements
EN 1060-1
16
Non-invasive sphygmomanometers.Part
3:Supplementary requirements for
electro-mechanical blood pressure measuring
systems
EN 1060-3
17
Secondary cells and batteries containing alkaline
IEC62133:2012