ASTOPAD
®
Instructions for Use
15 Conformity with international standards
60
15 Conformity with international standards
Standard
Title
IEC/EN 60601-1
ANSI/AAMI ES
60601-1
CAN/CSA C22.2
No. 60601-1
Medical electrical equipment
– Part 1: General require-
ments for basic safety, including essential performance
IEC/EN 60601-1-2
Medical electrical equipment
– Part 1-2: General re-
quirements for basic safety and essential performance -
collateral standard: Electromagnetic compatibility
– Re-
quirements and tests
IEC/EN 60601-1-8
Medical electrical equipment
– Part 1-8: General re-
quirements for basic safety and essential performance -
collateral standard: Alarm systems
– General require-
ments, tests, and guidance for alarm systems in medi-
cal electrical equipment and medical electrical systems
IEC/EN 80601-2-35
Medical electrical equipment Part 2-35: Particular re-
quirements for basic safety and essential performance
of heating devices using blankets, pads, or mattresses
and intended for heating in medical use.
IEC/EN 60601-1-6
(IEC/EN 62366-1)
Medical electrical equipment
– Part 1-6: General re-
quirements for basic safety and essential performance -
collateral standard: Usability.
Definitions according to IEC/EN 80601-2-35:
Term
Definition
ASTOPAD
applied parts
Over-blanket
Blanket for use on top of patient.
COV070, COV105,
COV150, COV155,
COV180
Under-blanket
Blanket for use underneath patient.
COV070, COV105,
COV150, COV180
Pad
Applied part of a heating element
that may be bent, but not folded.
SOF4, SOF5, SOF7
Mattress
Applied part of a heating element
that supports the patient’s entire
body resiliently.
SOF2, ROE4, ROE8
