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Technical Specifications
iSleep 20 clinician’s manual
Doc. 003923 En-Us V-2
11.3 Compliance of Standards
S
TANDARD
S
PECIFICATIONS
IEC 60601-1 (1988)
A1 (1991)
A2 (1995)
Medical electrical equipment - Part 1: General
requirements for safety.
IEC 60601-1-1 (2000)
Medical electrical equipment - Part 1-1: Gen-
eral requirements for safety - Collateral stand-
ard: Safety requirements for medical electrical
systems.
IEC 60601-1-2 (2001)
Medical electrical equipment - Part 1-2: Gen-
eral requirements for safety - Collateral stand-
ard: Electromagnetic compatibility -
Requirements and tests.
IEC 60601-1-4 (2000)
Medical electrical equipment - Part 1-4: Gen-
eral requirements for safety - Collateral Stand-
ard: Programmable electrical medical systems.
ISO 17510-1 (2001)
Sleep apnea breathing therapy - Part 1: Sleep
apnea breathing therapy devices.
ISO 8185 (1997)
C1(2001)
Humidifiers for medical use - General require-
ments for humidification systems.
C
LASSIFICATIONS
S
PECIFICATIONS
Class IIa
Classification according to the European
Medical Device Directive 93/42/EEC.
Class II
FDA classification
Class II (IEC 60601-1) Class
II, Type BF
Electrical equipment with dual isolation and
body floating (isolated) applied part according
to IEC 60601-1.
IPX1
Degree of protection provided by enclosure.
The iSleep 20 and its packaging do not contain any natural rubber latex.
