Information on Heavy Metal testing in Medical Devices

D

dcraig

#1
First thank you for reading this!

First some back ground;
Disposable single use
All PVC but with blank ink printing
Limited Contact Mucosal memebrane per 10993

I am looking into testing for heavy metal as it came up with PMDA on a previous device but the question was never answered to my full satisfaction. I have found EN71 which refers to Heavy Metals in toys and USP661 which talks about it as it realtes to containers for food and cosmetics. I cannot find anywhere that specifically covers medical devices. Is it just assumed that the ISO 10993 Cyto, Irritation and Maximization will detect it? Does anyone have any info to steer me in the right direction as far as a standard or requirements on this? I want to include it in a DID I am doing currently.

Thanks
 
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M

MIREGMGR

#3
I'm not aware of any relevant patient-focused standards or rules within FDA or EU regulatory schemes, other than ISO 10993.

Depending on the constituent materials, the product might become subject to workplace regulation in regard to its users, though.

For distribution within California/USA, the product also might require a Prop 65 warning.
 
A

arios

#4
There are various stds. derived from 10993, one of which is:

CEN EN ISO 10993-15:2000

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)

Have you consider this one? Even the AAMI web site points me to this one
 
D

dcraig

#5
As I said we have been using EN71 which is inteneded for toys. We do not believe there is any in the product we just want to have a nice lab report that says it is so. Our goal is not to determine how much but to show there is none. I believe 10993-15 is more to do with how they effect the materials they come into contact with.

Thanks for the comments
 

harry

Super Moderator
#6
Just a view from the RoHS angle. The medical device industry had lobbied hard and obtained exemption especially in relation to the unavailability of viable substitutes (eg: lead in relation to radiation). In its appeal, it did mentioned that the industry will comply where possible.

In this connection and in view of the fact that you are using PVC, I think you need to comply to RoHS as a minimum.
 
A

arios

#7
Hi DCraig

One last suggestion. Contact AAMI, they may be able to provide you with further assistance and hopefully additional guidance on your particular inquire

Hope you can get something from them. If you do please let me know

Alberto
 
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