YY/T 0682-2008Implants for surgery - Minimum data sets for surgical implants (English PDF)

Foreword

This standard is identical with ISO 16054:2000 "Surgical implants Surgical implants with minimal information group." Appendix A of this standard is an informative annex.

1 Scope

This standard defines an implant registration, tracking and analysis for the purpose of removing the surgical implant with minimal data group, whose role is to facilitate record And recording data on international exchange. The minimum data collection requirements to the group for the purpose of tracking implant, so that when something unexpected equipment defects When members occurs, the patient can track and recall defective devices. Groups also meet the minimum information to take out for the purpose of analysis and research - Mutual core information requirements for reference purposes between extended data base.

This standard applies to implantable medical devices (implants than 30d) manufacturers and distributors, as well as to perform the implantation procedure and its hospitals His medical institutions. This standard specifies the requirements for specific information on the project, these data items by manufacturers and distributors of implantable medical devices Providers, hospitals and other medical institutions to be recorded when the implant removed and after any time.

This standard is intended to define to record all events inserted and removed a minimum data base, while also providing quick inquiry with a specific patient groups The implant associated data in order to track the patient, the particular patient population refers to specific patients receiving implantable device or a group of devices overall.

This standard is not to collect information for the purpose of specific medical practitioners, the medical institutions or the manufacturer, but rather to track patients for the purpose.

Note: Users of this standard should ensure compliance with the data storage process involving national standards or laws and regulations.

2 Normative references

The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.

GB/T 19000-2000 Quality Management System - Fundamentals and vocabulary (idt ISO 9000:2000)

YY/T 0287 medical device quality management system for regulatory requirements (YY/T 0287-2003, ISO 13485:2003, IDT)

3 Terms and Definitions

YY/T 0287 and the following terms and definitions and GB/T 19000-20003.1 established in applicable to this standard.