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Information about certification for medical field

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hot_chmock

hot_chmock

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do-178/278

Hi guy's,

I'm looking for information about certification requested to assemble electronics and electro-mechanics part in the medical field.
Any ebook or link is welcome.

Thanks,

hc
 

Hi,
you wont find such standards online free of cost. u need to pay for it. First its important for which country u want the standards . US, UK etc. etc. all are having different standards.U can check EN60601-1 to 4 , UL and most important FDA standards,
thanks
nikhil

if u have some more information please let me know./
 

You do not necessary need certification.
It depend of country ( FDA for USA ) but also it depend of your product. Before certification, you must ask the help of a pharmacist to know the rules in you country. For example: if electronics is in contact of human body, you nedd 2 or 3 level of isolation.... if you are in contact with sterile stuffs, the rules are also quite complex.... about the cleaning of the objects....
 

Many mechanial and electrical IC tests are based on the military standard : MIL-STD883
 

yes thats right. but most of the IC's are having note that they are not for medical equipment. So designer need to verify the components very well.
 

If any medical equipment has software involved in it, it has to follow RTCA-DO 178, 278, and 254 certification
 

Re: MEDICAL certification

hot_chmock said:
Hi guy's,

I'm looking for information about certification requested to assemble electronics and electro-mechanics part in the medical field.
Any ebook or link is welcome.

Thanks,

hc
Click to expand...
What do you mean with "certification"?
In general, you need to conform to IEC60601-1(UL2601-1 in US), Medical electrical equipment, General requirements for safety. There are also particular standards for some devices(60601-x). If your device contains sortware, you need to conform to IEC60601-1-4.
In US you have to obtain FDA approval, in Europe - CE mark. Rules are similair.
In Europe certification process guided by Medical Device Directive.You can read about at **broken link removed**
If you need further help, don't hesitate to contact me.
Alex
 

CE markings for medical certifications

Hi friend
check the link below
**broken link removed**
8)
 

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