Are ASTM F745 & ASTM F75 still valid?

mpfizer

Involved In Discussions
#1
We would like manufacture hip and knee joints to the above standards in SS and Co-Cr , we would like to know the following:

are these standards still valid?

are these standards harmonized?

would NB's be able to certify for Ce marking if we use these standards?

what are the equivalent ISO standards for these.

Any help would be highly appreciated.

Thanks

michelle
 
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dgrainger

Trusted Information Resource
#2
re: Are ASTM F745 & ASTM F75 still valid?

ASTM F745 - 07 Standard Specification for 18 Chromium-12.5 Nickel-2.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications (Withdrawn 2012) is "WITHDRAWN, NO REPLACEMENT"
ASTM F75 - 12 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075) is still an Active Standard.

They are not harmonized to the medical device directives.

You can use any standard as evidence but only the harmonized standards confer a presumption of conformity.

The ISO 5832 series may be what you want.
 

mpfizer

Involved In Discussions
#3
re: Are ASTM F745 & ASTM F75 still valid?

what is the meaning of withdrawn does it mean withdrawn from circulation ? since it has not been superseded.

ISO 5832 does not seem to have any standard for castings to be used in orthopedic devices can anyone help also on my other questions in my first post
Thanks
michelle
 

dgrainger

Trusted Information Resource
#4
ASTM help states:

"What is a Withdrawn Standard?
A withdrawn standard is an ASTM standard that has been discontinued by the ASTM Sponsoring Committee responsible for the standard.

A standard may be withdrawn with or without replacement.

ASTM makes withdrawn standards available for informational purposes."
 
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