ISO 14971, IEC 60601 Satisfy 98/37/EC, 2006/95/EC, 2004/108/EC Directives?

M

MDDRegAffairs

#1
Dear All,

I am working for a medical device company looking to manufacture a veterinary device(hence medical device directive not applicable).

I am seeking to conform with - satisfied by:

1. Safety of Machinery - EN 12100
2. Electromagnetic Emission - EN 6100-6-3, EN 5501
3. Electromagnetic Immunity - EN 61000-6-1
4. Safety (Low Voltage) - EN 61010-1

The device is ISO 14971 compliant and UL tested. Will this satisfy the above 4 requirements (e.g., ISO 14971 in place of EN 12100 or UL test in place of EN 6100-6-3)?

Bonus Question:

If the device receives 9V from the power supply and the motor voltage is 9V, does the Low Voltage Directive apply (50 - 1000 V)?

Any comments or guidance would be greatly appreciated,

Regards,

Tom
 
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M

MDDRegAffairs

#2
Dear all,

I have made some progress but am again stuck.

Looking to the following links (cannot put full links due to spam):

Electromagnetic Compatibility: ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/electromagnetic-compatibility/index_en

Machinery: ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/machinery/index_en

General Product Safety: ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/general-product-safety/index_en

Low Voltage: ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/low-voltage/index_en

Neither ISO 13485, ISO 14971, or IEC 60601 are found under harmonized standards.



What would be the best action to demonstrate compliance with the directives for a device that is ISO 13485 and ISO 14971 compliant?


Regards,


Tom


 
#4
Hi All!

That is a "huge bump".

We have the same trouble at my company. Can anyone help us?
We have a veterinary hematology analyzer what should administered/regulated under the LVD, MD EMC and GSDP directives.

Our instruments are "classified" under the IVDD directive using the harmonized standards. ISO 13485 quality system is also provided.

Should we all Machinery Directive's harmonized standard review which are relevant for our device and shall we prove the compliance for all relevant standard or is there any presumption to demonstrate the compliance in Machinery using the IVD related harmonized standards?

Thanks a lot.

Attila
 
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