GB/T 24629-2009Implants for surgery -- Guidance on care and handling of orthopaedic implants (English PDF)

Foreword

This standard is equivalent to using ISO 8828. 1988 "Surgical implants orthopedic implants maintenance and operation." this standard of "discomfort implant manufacturers used" refers to post-implant product is delivered to the purchaser, for the maintenance and operation of the implant means South does not apply to manufacturers. Manufacturers should be the standard requirements, labels, brochures and other maintenance Ogata face implant product after delivery and Operation provides sufficient information.

This standard was proposed by the State Food and Drug Administration.

This standard by the national surgical implants and orthopedic instruments Standardization Technical Committee (SAC/TC110) centralized.

This standard was drafted. Tianjin, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center, China Association for Medical Devices Industry Society Professional Committee of surgical implants, China Pharmaceutical and Biological Products Inspection Center for Medical Devices.

Introduction

This standard gives orthopedic implants delivered to the purchaser after the maintenance and operating instructions are designed to help ensure that the implant implanted in a patient Before the body from contamination or damage. This standard gives the reception, storage, transport, handling, cleaning and sterilization procedures implants; as well as an overview of the issues prior to use of the implant must be taken to prepare for work. The standard for all personnel involved in the operation and receiving the implant.

Such persons should be familiar with the recommended procedures to reduce the risk of damage to the implant and damage occurring.

GB/T 24629-2009/ISO 8828. 1988 Surgical implants orthopedic implants and maintenance Operations Guide

1 Scope

This standard gives for orthopedic implants (such as a metal currently used ceramic or polymer implant, further comprising an acrylic resin and other bone cement) received from the hospital to be implanted or abandoned during the guidance of the program handling.

NOTE. This standard does not apply to the implant manufacturer.

2 Terms and definitions

The following terms and definitions apply to this standard.

Surgical instruments rely wholly or partially implantable device for temporarily or permanently repair of bone and/or related organizations, or temporary or Permanently replace these organizations.

Note 1. This standard, the term "implant" refers to "orthopedic implants."

Note 2. The acrylic resin for fixing some equipment is considered an "implant."

3 General guidelines

Received 3.1