Table of Contents - Covidien

Specifications
C.4 Compliance and approvals
IEC 601-1
classification
The 700
Series
Ventilator
System
complies
with these
International
and
European
standards:
The 700
Series
Ventilator
System has
been
certified by
these test
agencies:
Table C-4: Compliance and approvals
The 700 Series Ventilator System complies with the
requirements of Directive 93/42/EEC concerning
medical devices. It therefore bears the CE marking.
Protection class I, Type B, internally powered, dripproof
equipment, continuous operation.
IEC 601-1/EN 60601-1
IEC 601-1-2/EN 60601-1-2
EN 794-1
In addition, the 700 Series Ventilator System has
been approved to the type test requirements
of Annex III of the Medical Device Directive, by
the notified body, TUV Rheinland.
TUV Rheinland: EC Type Test Certificate to the
requirements of Annex III of the Medical Device
Directive
CSA: CSA C22.2 No. 601-1, CSA C22.2
No. 601-2-12, NRTL certification
C-6 10066984 Rev. D 700 Series Ventilator Operator’s Manual