Complied European Standards List - inventum BDA432 Instruction Manual

External dimensions
Attachment
Mode of operation
Degree of protection
Protection against ingress of water
Software version
Device classification
14

complied European standards list

Risk management
Labelling
User manual
General requirements for safety
Approx. 110 mm x 110 mm x 41 mm (exclude the cuff)
4 x AAA batteries, user manual and storage box
Continuous operation
Type BF applied part
IP21
A01
Internally Powered ME Equipment
EN ISO 14971: 2012 Medical devices - Application of risk management to medical devices
(ISO14971: 2007, Corrected version 2007-10-01)
EN ISO 15223-1: 2016 Symbols for use in the labelling of medical devices
EN 1041: 2008 Information supplied by the manufacturer of medical devices
EN 60601-1: 2006+A1: 2013 Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance
EN 60601-1-11: 2015/IEC 6060-1-11:2015 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
IEC 80601-2-30:2009 + A1:2013 Medical electrical equipment - Part 2-30: Particular
requirements for the basic safety and essential performance of automated non-invasive
sphygmomanometers
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