User's Manual

30
Safety and Regulatory
Compliance
Safety standards
The HomeSafe Help Buttons and Home Communicator comply with the following
safety standards for medical devices and home healthcare equipment:
Safety Standards
UL1637 Home Healthcare Signaling Equipment
CSA C22.2 NO 205-M1983 Signal Equipment
IEC60601-1:2005
(3rd Edition)
Medical Electrical Equipment
General Requirements for Basic Safety and
Essential Performance (CA/EN/US National
Differences)
IEC60601-1-2 Electromagnetic Compatibility
IEC62133 Safety requirements for portable sealed
secondary cells, and for batteries made from
them, for use in portable applications
RSS-GEN General Requirements and Information for the
Certication of Radio Apparatus
RSS-210 Licence-exempt Radio Apparatus (All Frequency
Bands): Category I Equipment
ISO10993-1 Biological evaluation of medical devices