Stainless Steel Surface Quality for Ophthalmic Surgical Device

[Hendel]

Dear all,
I'm part of a group developing a device for an ophthalmic surgical procedure. The device is composed of stainless steel 420
I'm looking for relevant guiding standards providing requirements for surface quality (and additional attributes) for (such) stainless steel surgical instrumentation.

I'm already familiar with the following:

ASTM F0899-09e_Standard Specification for Wrought Stainless Steels for Surgical Instruments

Appreciate your assistance.
Many thanks,
Eyal

 

[Claes Gefvenberg]

Anyone savvy around?

 

[somashekar]

Dear all,
I'm part of a group developing a device for an ophthalmic surgical procedure. The device is composed of stainless steel 420
I'm looking for relevant guiding standards providing requirements for surface quality (and additional attributes) for (such) stainless steel surgical instrumentation.

I'm already familiar with the following:

ASTM F0899-09e_Standard Specification for Wrought Stainless Steels for Surgical Instruments

Appreciate your assistance.
Many thanks,
Eyal

Electropolish it Eyal ...
See About Electropolishing here

 

[Ronen E]

Dear all,
I'm part of a group developing a device for an ophthalmic surgical procedure. The device is composed of stainless steel 420
I'm looking for relevant guiding standards providing requirements for surface quality (and additional attributes) for (such) stainless steel surgical instrumentation.

I'm already familiar with the following:

ASTM F0899-09e_Standard Specification for Wrought Stainless Steels for Surgical Instruments

Appreciate your assistance.
Many thanks,
Eyal

Hi Eyal,

420 sounds strange. Why not 316 or 304?

Cheers,
Ronen.

 

[Stijloor]

Hi Eyal,

420 sounds strange. Why not 316 or 304?

Cheers,
Ronen.

Going back to my previous life with stainless steel; 420 can be hardened.

 

[Ronen E]

Going back to my previous life with stainless steel; 420 can be hardened.

You may be right, but why would hardening be an issue for an ophthalmic surgical device?

 

[Stijloor]

You may be right, but why would hardening be an issue for an ophthalmic surgical device?

That, I don't know....

 

[Wes Bucey]

You may be right, but why would hardening be an issue for an ophthalmic surgical device?

If it's an edged instrument - hardened material holds an edge better than non-hardened metal.

 

[pkost]

It's a bit difficult to give specific advise without specific details (Even if you provided specific details, its not my specialism so I'm not going to be much help); consequently, a general answer is that the requirements for your device surface qualities are those that you specify as appropriate for the intended use

You may want to consider:
1. roughness
2. carbide formation
3. contamination (physical and microbiological)

 

[Hendel]

Thanks all,
I'm not talking about hardening but about surface quality