Mold Material Standard - Material for making molds supporting medical devices

Ajit Basrur

Leader
Admin
Hi,

Is there any industry standard for use of a particular type of material for making molds supporting medical devices ?

:thanx:
 
E

Ederie - 2007

Not that I have ever encountered,
....could be some specification out there though.
Ed
 

Statistical Steven

Statistician
Leader
Super Moderator
Mr

Qualityalways said:
Hi,

Is there any industry standard for use of a particular type of material for making molds supporting medical devices ?

:thanx:
There are standards for the resin (usually needs to be virgin resin) and releasing solutions. The standards deal with "impurity" levels on the medical device and not the mold used to make it.
 

Ajit Basrur

Leader
Admin
Hi,

Thanks for the info. In the absence of the standard for the material of the mold, can I know from the forum members what type of steel / other material is being used when they build a mold for medical device ?

Any weblinks, presentations on mold materials most welcome

:bigwave:
 
W

wrodnigg

There is no specific requirement for materials for making molds.

There are just requirements for biocompatibility of materials for medical devices (and residues on the surface of devices in contact with the human body).

The mold material is selected as in any other moldmaking process.
 
W

wrodnigg

Qualityalways said:
Is it that Stainless Steel molds are preferred for medical devices ?

I had audits at several (contract) manufacturers of medical devices and all of them used their standard materials (yes some kind of steel).

There was one exception for a special Teflon material, because this material is corrosive to steel at that high temperatures...
 
B

brandwood

There is no specific requirement for materials for making molds.

There are just requirements for biocompatibility of materials for medical devices (and residues on the surface of devices in contact with the human body).

The mold material is selected as in any other moldmaking process.

Just came across the above old post - the point is that the biocompatibility has to be considered for the "as processed" device. Therfore the mold material (and any mold release agents etc.) have to be considered for potential effect on the patient caused by any residues from the mold ending up on the device. So the selection of mold material is important in the context of potential effects on biocompatibility.

Arthur
 
N

nvdisdesi

Theres no requirement in the Mold material to make medical molds. It should be chosen not to the nature of your part but to the production and feasability and delivery time.
We have used aluminum inserts to En31 steel on medical jobs.

The MOLDING procedure is 90% of the time a lot different then the regular molding procedure but not the mold making procedure!

Hopefully this helps

Cheerys
 
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