Welch Allyn Home - Complied Standards List

50 Welch Allyn Home Blood Pressure Monitor
Complied standards list
Item Standard
Risk
management
ISO/EN 14971 Medical
devices — Application of
risk management to
medical devices
Labeling ISO/EN 15223-1 Medical
devices. Symbols to be
used with medical device
labels, labeling and
information to be
supplied. General
requirements
User manual EN 1041 Medical
equipment manufacturers
to provide information
General
Requirements
for Safety
IEC 60601-1+A1 Medical
electrical equipment -
Part 1: General
requirements for basic
safety and essential
performance
IEC 60601-1-11 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