Safety Standards
Medical Devices Directive 93/42/EEC
IEC 60601-1:2005+A1:2012/EN 60601-1:2006 Medical electrical
equipment - Part 1: General requirements for basic safety and
essential performance.
IEC 60601-1-2:2007/EN 60601-1-2:2007 Medical electrical equipment
- Part 1-2: General requirements for safety - Collateral standard:
Electromagnetic compatibility - Requirements and tests.
IEC 60601-2-10:2012/EN 60601-2-10:2000+A1:2001 Medical electrical
equipment - Part 2-10: Particular requirements for the safety of nerve
and muscle stimulators.
IEC 60601-1-11:2010 Medical electrical equipment -- Part 1-11: General
requirements for basic safety and essential performance -- Collateral
standard: Requirements for medical electrical equipment and
medical electrical systems used in the home healthcare
environment.
EN 980 Symbols for use in the labeling of medical devices.
EN 1041 Information supplied by the manufacturer with medical
devices
IEC/60601-1-6/ EN 60601-1-6 Medical electrical equipment – Part1-6:
General requirements for basic safety and essential performance –
Collateral standard: Usability.
IEC 60601-1-11/ EN 60601-1-11 Medical electrical equipment – Part
1-11: General requirements for basic safety and essential
IEC 60601-1-11/ EN 60601-1-11 Medical electrical equipment – Part
1-11: General requirements for basic safety and essential
performance – Collateral standard: Requirements for medical
electrical equipment and medical electrical systems used in home
The subject device has been tested and found to comply with the
limits for a Class B digital device, pursuant to part 15 of the FCC
rules. These limits are designed to provide reasonable protection
against harmful interference in a residential installation.
The product generates, uses, and can radiate radio frequency
energy and, if not installed and used accordance with the
instructions, may cause harmful interference to radio
communications.
However, there is no guarantee that the interference will not occur
in a particular installation. If the product does cause harmful
interference to radio or television reception, which can be
determined by turning the product on or off, the user is encouraged
to try to correct the interference by one or more of the following
measures:
a.)
Reorient or relocate the recieving antenna;
b.)
Increase the separation between the product and the receiver;
c.)
Consult the dealer or an experienced radio/TV technician for
help.
d.)
Connect the equipment into an outlet on a circuit different from
that to which the receiver is connected.
Changes or modifications to this product not expressly approved by
the party responsible for compliance could void the user’s authority
to operate the equipment.
healthcare environment.
IEC 62304/ EN 62304 Medical device so
ſt
ware - So
ſt
ware life-cycle
processes.
IEC 62366/ EN 62366 Medical devices – Application of usability
engineering to medical devices.
ISO 10993-1 Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management process.
FCC COMPLIANCE STATEMENT:
9
10
