Download MSDS - MagQu

Clause
Description
Appli-ca Standard/Sub-clause(s)
ble
or not?
12.7.
Protection against mechanical and thermal risks
Yes
12.7.1 Devices must be designed and manufactured in such a way as to
protect the patient and user against mechanical risk connected with,
for example, resistance, stability, and moving parts.
Directive 98/79/EC
ENISO13485:2012
ENISO14971:2012
EN 61010-1:2010
EN 61010-2-101:2002
Report/Document
Comments
ISO 13485 Quality
System Cert. No
TW14/10079
_Risk Management
Report No. RM07-02
Product user Manual
(XacPro-S, ver.201411)
12.7.2 Devices must be designed and manufactured in such a way as to
Yes
reduce to the lowest possible level the risks arising from vibration
generated by the devices, taking account of technical progress and of
the means available for limiting vibrations, particularly at source,
unless the vibrations are part of the specified performance.
Directive 98/79/EC
ENISO13485:2012
ENISO14971:2012
EN 61010-1:2010
EN 61010-2-101:2002
ISO 13485 Quality
System Cert. No
TW14/10079
_Design Verification and
Validation report
No.RD07
_Risk Management
Report No. RM07-02
Product user Manual
(XacPro-S, ver.201411)
12.7.3 Devices must be designed and manufactured in such a way as to
No
reduce to the lowest possible level the risks arising from the noise
emitted, taking account of technical progress and of the means
available to reduce noise, particularly at source, unless the noise
emitted is part of the specified performance.
31
The device can not
work in the
surroundings full of
the noise.