New list (01-2013) of Harmonised Standards for The MDD published

D

drewsky1

#11
Does anyone know why "Do Not Resterilize" symbol is required to be on a medical device label if the labeling already has "Single Use" symbol and the sterilization symbol? We are updating our symbols and this question has come up. I understand this is required if one complies to IEC60601-1 for an electrical device as our consultant has instructed us, however I question this.

Thanks

Thanks,
 
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Ronen E

Problem Solver
Staff member
Moderator
#12
Does anyone know why "Do Not Resterilize" symbol is required to be on a medical device label if the labeling already has "Single Use" symbol and the sterilization symbol? We are updating our symbols and this question has come up. I understand this is required if one complies to IEC60601-1 for an electrical device as our consultant has instructed us, however I question this.

Thanks

Thanks,
Hi,

In the past, it was a convention that a single-use device (typically supplied sterile) is discarded after that single use. Today, many "single-use" devices are "reprocessed" and then re-used, out of economic considerations. If these are sterile devices in nature, reprocessing also involves sanitization and re-sterilization. So today, "single use" means that the device must be reprocessed (as prescribed and validated) between uses, unless it's discarded. It's even regulated by the FDA: http://www.fda.gov/MedicalDevices/D...ReprocessingofSingle-UseDevices/ucm121093.htm

A "Do not resterilize" symbol (or text) on a sterile device clarifies that the manufacturer intends that this device is not reporocessed, and of course not reused. If any third party decides to override this instruction, they would bear full regulatory responsibility for the reprocessed device.

Cheers,
Ronen.
 

Ajit Basrur

Staff member
Admin
#13
You are wrong. There is no standard for marking listed at all in the current list of harmonised standards. This has today been confirmed to me personally by the European Commission. Until EN 15223-1:2012 is accepted by the EC we will have to use the EN980.
Yes, you are right.
 

RobertvanBoxtel

Involved In Discussions
#14
Just to share, this is the formal feedback from EUR-lex:

Please find the explanation the Author of this document has sent to us:

EN980:2008 (Symbols for use in the labelling of medical devices) has been deleted from Harmonized Standard and is intended to be superseded by new standard EN ISO 15223-1:2012.

However, due to deficiencies of the new standard, our services had to delete it from the OJ publication and, to this end, in the standards publication database. According to the program of this database, the superseded standard EN 980:2008 was unfortunately deleted as well. This is linked to the fact that CEN-CENELEC loads-up the standards in the standards publication database, and the Commission's role is limited to deleting deficient standards. The Commission cannot re-introduce standards into the database.

Our services are of course not pleased with the deletion of the superseded standard. Accordingly, the standards publication database now needs to be re-programmed to avoid the automatic disappearance of superseded standards in case of deletion of deficient new (superseding) standards. Pending this re-programming, we will try to re-insert EN 980:2008 into the next publication.

Regards
EUR-Lex Helpdesk
 
C

casar83

#15
Hi all,

Then, what about standards that are not listed in this publication and were listed in 2011 publication?

e.g. ISO 8536-4......

Thank you very much
Regards
Juan
 

RobertvanBoxtel

Involved In Discussions
#16
about every half year, the EC publishes in the OJ the latest list of harmonized standards. That list will change as standards have become obsolete / replaced by others. Or if the EC considers the contents not to cover elements of the Medical device Directives.
 

Sue789

Involved In Discussions
#17
What is the current situation of EN 988 and EN ISO 15223-1?

The Harmonized standards list references neither standard and has been nearly a year since this was posted.

Which standard should I be referencing on my Essential Requirements Checklist, my product conforms to both standards?

Thanks in advance,
 
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