UL offers a complete range of testing services for wearable technology products, and has a comprehensive knowledge of the regulatory approval process in key target markets. In addition, UL can provide specialized testing services, including energy efficiency testing and certification, product performance testing and product reliability testing. UL can also support quality and safety initiatives across global supply chains through product inspections and factory audits. For additional information about UL’s services for wearable technology products, contact wearables@ul.com, ul.com/wearables

1. UL
Service
Portfolio
for
Wearable
Electronics
Maxi
Tsai
蔡昌益
Business
Development
Manager
UL
AG
,
Taiwan
Branch
Maxi.Tsai@ul.com
Wearables@ul.com
ul.com/Wearables
© 2014 UL LLC

2. ul.com/Wearables

3. Challenges
of
developing
Wearables

4. UL
Service
Portfolio
for
Wearables
Concept
&
RFQ
_Component
&
Material
Database;
_Advisory
&
Knowledge
solutions;
_Hazard-­‐Based-­‐
Safety-­‐Engineering.
_Human
Factor
Engineering.
Development
&
Launch
_Product
Safety;
_EMC,/RF
Certifications;
_SAR
evaluation;
_Wireless
Interoperability;
_Energy
Efficiency;
_Global
Market
Access.
Production
&
Improvement
_Inspection
&
Audit;
_Customer
Complaints
Management;
_Chemical
Analysis.
End
of
Life
_Environmental;
_Sustainability;

5. 3
Keys
…………...
make
your
product
differentiation

6. Regulatory
&
Market
Entry
Quality
&
Performance
User
eXperience

7. Regulatory
&
Market
Entry
• Wearables
typically
include
some
or
all
of
the
following
component
technologies:
§ Microprocessors
§ Radios
§ Batteries
§ Battery
Chargers
§ Sensors
§ Displays
§ Chemicals
(plastics,
fabrics,
etc.)
§ …

8. UL
can
be
of
your
assistance…
• How
to
get
there?
• Identify
existing
standards
for
various
considerations
- Work
within
existing
regulations
and
standards
now
• Identify
where
additional
standards
or
International
standards
would
be
helpful
- Develop
new
standards
as
appropriate
to
facilitate
market
access
and
acceptance
• UL
is
involved
in
domestic
and
international
standards
development
in
many
areas
–
we
are
a
‘Standards
Development
Organization’
and
participate
with
others
in
the
development
of
their
standards
as
well
–
we
can
help
with
this
process.

9. According
to
UL
2013
Product
Mindset…
http://productmindset.ul.com/

10. Quality
&
Performance
• UL
Mark
is
a
tool
to
build
your
brand
and
stand
out
of
competition.
• Functionality
and
usability
test
• Durability
and
life
cycle
test
• Temperature
rise
test
• Critical
parts
review
• Physical
constructions
review
• Label
and
mark
review
• Benchmark
and
Comparison
Testing
• Packaging
testing
• …

11. Proper
Material
Selection
&
Design
“…the
result
of
galvanic
corrosion
caused
when
sweat
mixes
with
a
running
electrical
current
between
two
metals….”
“…skin
sensitivity
to
the
device's
stainless
steel,
which
contains
nickel…
”…reactions
to
bacteria
that
can
accumulate
in
wristbands,
or
a
sensitivity
to
the
material
of
the
band
elastomer…”

12. www.ul-­‐mdt.com
Non-­‐Clinical
Testing
for
Wearables
• Biocompatibility
testing
• ISO
10993,
USP,
MHLW
• Materials
Characterization
• Microbiological
testing
• Virological
testing
• Cleaning,
Reprocessing,
Sterilization
• Physico-­‐Chemical
analysis
• Shelf
Life
of
devices
and
packages
• Transport
safety
• Testing
of
Ophthalmic
devices

13. Webinar:: Skin Irritation and Wearable Material
http://www.ides.com/webinars/2014/skin-­‐
irritation-­‐wearables.asp

14. User
eXperience
–
Usability
Evaluation
&
Testing
“Ultimately,
manufacturers
must
validate
that
the
product’s
users
can
employ
the
device
safely
and
effectively
in
the
intended
use
environments”
“If
you
can’t
get
to
a
tool
within
two
seconds,
your
use
of
it
goes
down
exponentially.”
~
Robert
B.
Miller,
Georgia
Tech.
Professor,
IBM
psychologist,
1968.
~
Safety
and
Human
Factors
Engineering
in
Medical
Device
Design,
UL,
2014.

15. Human
Factors
Engineering
(HFE)
UL
supports
your
product
development
efforts:
• Perform
required
HFE
studies
leading
to
devices
that
are
safe
to
use
and
deliver
a
better
user
experience.
• Lead
or
assist
in
the
design
of
user
interfaces,
including
hardware,
software,
labeling,
warnings,
packaging,
and
user
documentation.
UL
assesses
your
product’s
interactive
quality:
• Conduct
a
validation
usability
tests
according
to
best
practice.
• Assess
overall
conformance
with
FDA’s
HFE
guidance
and
the
requirements
set
forth
in
IEC
62366:2007
(usability).
http://www.wiklundrd.com/services.html

16. Thank you