46
Regulatory Compliance
FCC Regulations
US/CANADA
Telephone
ACTA FCC Part 68 and Part 47
Batteries
UL 1725 = CTI Battery Certification program
Carrier by location
AT&T
EMC
EN60601-1, Safety
EN60601-1-2 (EMC for Medical, includes emissions)
IEC 60601, 3rd Edition Safety
PTCRB testing
Radiated spurious emissions, OTA (antenna performance),
electrical SIM tests and MMI protocol tests if a MMI
is supported. In case that Wi-Fi is supported as well
converged device testing will become applicable.
Radio: SRD/ISM
FCC 47CFR 15C / AIRB - RSS 210
FCC Parts 22 and 24
*
IC: RSS132 and RSS133 –
RSS-GEN includes RSS-210-
Social alarms
N/A
Safety
UL 1725 - UL1637 and UL 1635, IEC 60601, 3rd Edition -
CAN/CSAC22.2 (#60950-1)
Design/MFG
ISO9001:2008 or ISO13485
Submission
Class II, 510k Exempted
Labeling
21 CFR 801, IEC 60878: 1998
Biocompatibility
ISO 10993-1:2009
* Applies to GoSafe Mobile Button only
DRAFT
For Internal Use