Safety And Regulatory Standards - Digi Connect WS Manual De Referencia De Hardware

Specification
Dimensions

Safety and regulatory standards

Category
Medical electrical equipment — General requirements for basic
safety and essential performance
Medical electrical equipment — Part 1-2: General requirements
for basic safety and essential performance Collateral standard:
Electromagnetic compatibility — requirements and tests
Medical electrical equipment — Part 1-6: General requirements
for basic safety and essential performance Collateral standard:
Usability
Medical device software life cycle processes
Medical device usability
EMC/EMI
Radio
OET65
Wi-Fi
Note
The safety and regulatory information in this section is provided for information purposes only, and is
believed to be accurate at the time of publication of this manual. Please refer to the Declaration of
Conformity for current safety and regulatory information. The above categories reference the common
names of standards and do not necessarily reflect intended uses. The Connect WS does not change or
manipulate transmitted data or its display in any way. It does not incorporate a therapeutic or diagnostic
function, and is not intended to be used with active patient monitoring. The Connect WS is intended for use
as an ITE device for data transmission only.
Connect WS Hardware Reference Manual
Connect WS 1
Connect WS 4/8
Safety and regulatory standards
Value
135 mm x 115 mm x 30 mm
200 mm x 157 mm x 36 mm
Standard
EN 60601-1: 2005 + corr.1 (2006) + corr.2
(2007) + A1 :2013
IEC 60601-1-2 Ed3 : 2007
IEC 60601-1-6: 2006 + A1:2013
EN 62304:2006
EN 62366: 2008
FCC 47 CFR Part 15 part B and C
ICES-003
EN 301 489-1 v1.9.2
EN 301 489-17 v2.1.1
EN 300 328 v2.1.1
EN 301 893 v1.8.1
EN 62311: 2008
RSS-210
ANSI/IEEE C95.1-1992
Wi-Fi Alliance Certified
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