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Withdrawal of ASTM F-745 07

E

Exceller

#1
Hi all,

This standard ASTM F-745-07 for cast stainless steel surgical implants has been withdrawn and the reason given is because of lack of use.
What is the implication for companies manufacturing the products as per this standard?
Do we have to stop manufacturing...? Or can we continue to manufacture as per this standard?
Or is there any other alternative...?

Regards
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
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#3
Another quick "Bump". My Thanks in advance to anyone who can help with this one!

Marc
 
R

rsimano

#4
Formerly under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, this specification was withdrawn in September 2012 due to lack of use.
Withdrawn, No Replacement.

You can still manufacture to the ASTM F-745-07 standard uness your customer requests you manufacture to a different standard. This specification has only been withdrawn not canceled, superseded or replaced.

Withdrawn means this will be out of print or ASTM will no longer maintain print for this standard or review it for future updates. The standard will still be available in PDF format. You can get Withdrawn ASTM print standards from a secondary supplier if you need it.

I previously had the same question and contacted ASTM for clairification.
 
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mpfizer

Involved In Discussions
#5
Withdrawn, No Replacement.

You can still manufacture to the ASTM F-745-07 standard uness your customer requests you manufacture to a different standard. This specification has only been withdrawn not canceled, superseded or replaced.

Withdrawn means this will be out of print or ASTM will no longer maintain print for this standard or review it for future updates. The standard will still be available in PDF format. You can get Withdrawn ASTM print standards from a secondary supplier if you need it.

I previously had the same question and contacted ASTM for clairification.
i would like to know if this was a "Harmonised Standard" with regard to CE marking and if yes what is the implication if u have refrenced this standard in Technical file
 
R

rsimano

#6
i would like to know if this was a "Harmonised Standard" with regard to CE marking and if yes what is the implication if u have refrenced this standard in Technical file
I have not worked directly with Harmonised Standards to the European Commission it may be listed with them or they may have a European Steel Standard equivalent. ASTM-F-745 07 is listed as a Recognized Standard in the US and Canada.

I don't see where there would be any implications of it being referenced in a technical file unless the standard is Cancelled, Superseded or Replaced. The standard is still active just not under annual review by any specific committee or active paperback print.
 
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