There are 3 additional requirements as compared with existing one.
The technical documentation shall include an adequate analysis and assessment
of the risk(s). What is objective and scope for these? Do these analysis and
assessment refer to 3rd party verification of compliance with applicable
Scott
There is a recently published draft guidance document on this Directive that
may address some of your questions:
http://ec.europa.eu/DocsRoom/documents/13141/attachments/1/translations/en/renditions/pdf
regards
Charlie
-Original Message-
From: Scott Xe [mailto:scott...@gmail.com
Scott,
The New LVD as with the latest Machinery Directive requires a Risk Assessment
of the Essential Health and Safety Requirements called out in the Directive.
Most likely the new ISO EN 12100 Risk Assessment standard will be harmonized to
the LVD and you can use this on your DoCs to show com
Does anybody know of a standard which describes cable retention force other
than safety standards such as 60601-1 (Medical General Safety) or 60950 (ITE
general safety) and if so can you give me the numbers. The product is about 2
pounds. ITE would say that the value is about 6 pounds.
-
--
A color photograph has been a requirement of the Toy Directive for a long time.
However, toys are different than most other products. If customs receives a
shipment of toy cars of model X from company Y, it can be difficult to
determine if what is in the box is what is declared on the DoC. The p
W.r.t. to what Brian and Ted said below, I've come across a number of cases at
work where routine production safety testing has identified assembly safety
defects - and one actually here at home when my wife bought an exercise machine
which, during final assembly, I noted to have the conductor f
UL 508A refers us to UL 310 for bushings; UL 486A-486B Table 27 has values
for #30 up to 2000 kCM, but that is only based on cable size, not the weight of
equipment. My non-indexed search didn't come up with anything else through a
dozen or so IEC standards while searching for "retention" or
Dear members.
Does anybody can point me out the mandatory of request for Power Frequency
Magnetic Field testing for medical equipment even if none magnetic sensitive
elements are in the EUT ?
If this test is a must regardless of existence or not these elements.
Thanks,Eugene
-
--
Eugene,
The EMC Directive requires the manufacturer performs a “Conformity Assessment”,
sometimes referred to as an “EMC Compatibility Assessment”. Within this
assessment, the manufacturer can explain the reasons for and against which EMC
tests and test levels they tested their products to to
I have received EMC directive test reports (non-medical equipment) from our
NRTLs in the past stating this as well, that magnetic field testing was not
done as there were no magnetic sensitive elements.
-Dave
From: Kunde, Brian [mailto:brian_ku...@lecotc.com]
Sent: Monday, November 30, 2015 4:
IEC60601-1-2 points to the IEC61000-4-X and -6 stuff for immunity, and
IEC60601-1-11 extends EMC stuff for home healthcare equipment. The latest
edition of -1-2 has some interesting stuff about test levels in annex E, and
all medical EMC is based on intended end-use environment with no allowance
Team,
Do you know if there are special rules/certifications required in the USA to
install Electronic Products in cars (bus)?
And if so, what will be the standard?
Sam Yoga
Crestron Electronics
This e-mail message and all attachments transmitted with it may contain legally
privileged and co
'Cars' and 'busses' are two different regulatory subjects. Requirements
standards can range from nothing to ISO 26262 (nee IEC61508); and from nothing
to CISPR25/VCA for EMC.
And happen to know that Crestron has, or did have, more than one compliance
engineer. Your local compliance engineer sho
Hi Charlie,
It is a good reference guidance! Thanks!
Regards,
Scott
On 30 November 2015 at 23:08, Charlie Blackham wrote:
> Scott
>
> There is a recently published draft guidance document on this Directive
> that may address some of your questions:
>
> http://ec.europa.eu/DocsRoom/documents/
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