Standard Number: YY/T 0682-2008(YY/T0682-2008)
Chinese:外科植入物 外科植入物用最小资料群
English:Surgical Implants Minimum Data Set for Surgical Implants
Effective Date:2010-01-01
ICS:11.040.40
Standard Applicability:This standard defines the minimum group of information for surgical implants for the purpose of implant registration, tracking and removal analysis, and serves to facilitate record keeping and international exchange of information. This standard applies to manufacturers and distributors of implantable medical devices (implanted for more than 30 d), as well as to hospitals and other healthcare facilities performing implant operations. This standard establishes specific requirements for information items that should be recorded by manufacturers and distributors of implantable medical devices, hospitals, and other healthcare facilities at the time of implantation and at any time after removal.
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