What is required to sell a medical product in the US?

K

Kdavid

#1
I have conflicting answers to this question from different test houses (different quotes of what they think is a requirement).

This is for a medical surgical laser system.

What is the minimum requirement as far as testing goes? Is IEC 60601-1-2 the only requirement?

Some test houses gave me a quote with EN/UL 60601-1; 1-4; 1-6; 2-22 in it.
 
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#2
Some test houses will try to rip you off and get you to do more than is necessary.

Forget 4, 6 & 2-22.

You want 60601-1 test certification and EMC testing.

And BTW a UL mark bears no legal weight.

Edited to add...what's your location? Make sure your test house is an NRTL if you're in the US.
 
Last edited:
K

Kdavid

#3
EMC is 60601-1-2 correct?

Also...in our manual what self declarations can we say. Like 'this product conforms to the following standards:'?

Are the following valid?
IEC 60825-1 <--it is labeled and classified properly
IEC 60601-2-22
IEC 60601-1-6 <--if we run our own usability study can we declare this?
ISO 14971 <--we have a risk management program so we can declare this

Any others?

Thanks for your time.
 
K

Kdavid

#4
Alright according to UL the following standards are necessary for a medical laser in the US (they said EMC is optional in the US)...

IEC 60601-1: General requirements for basic safety and essential performance
IEC 60601-2-22: Particular requirements for the safety of diagnostic and therapeutic laser equipment
IEC 60825-1: Equipment classification and requirements

Optional:
60601-1-2: Collateral standard: Electromagnetic compatibility - Requirements and tests (EMC)
 
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