YY/T 0682-2026Implants for surgery. Minimum data sets for surgical implants (English PDF)

YY/T 0682-2026 (Implants for surgery. Minimum data sets for surgical implants) is available as an English-translated PDF.

YY/T 0682-2026 is the Chinese standard "Implants for surgery. Minimum data sets for surgical implants". This standard specifies the order to implant registration, tracking and analysis for the purpose of removing surgical implants with a minimum data base, and its role is to facilitate the recording and international exchange of information.

Group minimum data collection requirements to the implant for the purpose of tracking, so that when the device defect unexpected event occurs, the patient can track the defective device and recall.

Group also meets the minimum information for the purpose to remove the analysis and research-extension data base for the purpose of cross-reference between the core data requirements.

This standard applies to implantable medical devices (implants over 30d) manufacturers and distributors, as well as perform implant operations hospitals and other medical institutions.

This standard specifies the specific requirements of data items, these items should be implantable medical device manufacturers and distributors, hospitals and other medical institutions at any time after implantation and when removing documented.

It was issued by State Food and Drug Administration. Issued on 2008-10-17, in force from 2010-01-01. It cites 2 other standards.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 8 pages — is available in the English PDF.

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