A
achih100
can anyone send me a sample of TCF file (for CE mark)? Medical directive /MDD）93/42/EEC is best. Thanks!
Jessica
Jessica
Re: CE / TCF (Technical Construction File) File sample??
Have a look at the 'Similar Threads' box below, especially this thread: Technical File for CE declaration - Template or Sample of required contents
Have a look at the 'Similar Threads' box below, especially this thread: Technical File for CE declaration - Template or Sample of required contents
Re: CE / TCF (Technical Construction File) File sample??
Hi Jessica,
Welcome to the Cove. In addition to the suggestions that my friend Harry has give, I am attaching a Guidance Document Technical Files / Design Dossiers Non Active Medical Devices , issued by TUV.
Another not so relevant but appropriate example is CE MARK TECHNICAL FILE / AUSTRALIA EMC CONSTRUCTION FILE of Personal Computer
Hi Jessica,
Welcome to the Cove. In addition to the suggestions that my friend Harry has give, I am attaching a Guidance Document Technical Files / Design Dossiers Non Active Medical Devices , issued by TUV.
Another not so relevant but appropriate example is CE MARK TECHNICAL FILE / AUSTRALIA EMC CONSTRUCTION FILE of Personal Computer
Re: CE / TCF (Technical Construction File) File sample??
Dear Ajit,
Thank you.
Regards,
Valli
Hi Jessica,
Dear Ajit,
Thank you.
Regards,
Valli
Last edited by a moderator:
Re: CE / TCF (Technical Construction File) File sample??
Hi Valli,
Namaskara (Welcome) to the Cove
Hope to have your participation in this great place
Hi Valli,
Namaskara (Welcome) to the Cove
Hope to have your participation in this great place
A
abcauto
Ce certification Technical File as example for Low voltage Directives?
Dear All,
Please post A sample example Technical file for Ce Marking Low Voltage Directives & Electromagnetic Compatibility.
Thanks & Regards
ANAND
Dear All,
Please post A sample example Technical file for Ce Marking Low Voltage Directives & Electromagnetic Compatibility.
Thanks & Regards
ANAND
P
pgopgo
Tx! The guidance is a big help
L
lisakrotha
Regarding the EN ISO and ISO standards
Dear friends,
our medical device is spinal screw system so we have noted [FONT="]ISO 11737-1 for the sterilization process but the CE audit person asked us to submit a one analysis report why you used ISO 11737-1 instead of EN ISO 11737-1 then we didn't find any difference so could you please help me what are the differences among ISO and EN ISO .
Waiting for your replies friends.
[/FONT]
Dear friends,
our medical device is spinal screw system so we have noted [FONT="]ISO 11737-1 for the sterilization process but the CE audit person asked us to submit a one analysis report why you used ISO 11737-1 instead of EN ISO 11737-1 then we didn't find any difference so could you please help me what are the differences among ISO and EN ISO .
Waiting for your replies friends.
[/FONT]
S
Sarah Stec
Re: Regarding the EN ISO and ISO standards
ISO = International Standard
EN ISO = European harmonized standard version of the ISO standard.
There's usually not much difference between this and the ISO version, although there is usually additional annexes/introductions. So when we say "European Harmonized Standard," we mean the "EN ISO" version, unless otherwise specified in the OJEU.
ISO = International Standard
EN ISO = European harmonized standard version of the ISO standard.
There's usually not much difference between this and the ISO version, although there is usually additional annexes/introductions. So when we say "European Harmonized Standard," we mean the "EN ISO" version, unless otherwise specified in the OJEU.
Harmonization in Europe means harmonized with EC directives. Not all EN nor EN ISO nor EN IEC are harmonized, in fact the majority is not.
ISO uses the term "adoption" to national/regional versions, so EN ISO would be and adoption of an ISO standard.
This topic always generates discussion, I and some other are creating a FAQ to try to simplify the discussion.
Similar threads
