GB/T 24629-2009 English PDF

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GB/T 24629-2009: Implants for surgery -- Guidance on care and handling of orthopaedic implants
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 24629-2009	154	Add to Cart	3 days	Implants for surgery -- Guidance on care and handling of orthopaedic implants	Valid

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Basic data

Standard ID: GB/T 24629-2009 (GB/T24629-2009)
Description (Translated English): Implants for surgery -- Guidance on care and handling of orthopaedic implants
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: C35
Classification of International Standard: 11.040.40
Word Count Estimation: 8,891
Date of Issue: 2009-11-15
Date of Implementation: 2010-05-01
Adopted Standard: ISO 8828-1988, IDT
Regulation (derived from): National Standard Approval Announcement 2009 No.13 (Total No.153)
Issuing agency(ies): General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Summary: This standard provides for orthopedic implants (eg metals currently used, ceramic or polymer implants, also include acrylic resins and other bone cement) during reception from the hospital to be implanted to regulate the operation or retirement guidance program.

GB/T 24629-2009: Implants for surgery -- Guidance on care and handling of orthopaedic implants

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Implants for surgery. Guidance on care and handling of orthopaedic implants ICS 11.040.40 C35 National Standards of People's Republic of China GB/T 24629-2009/ISO 8828. 1988 Surgical implants orthopedic implants and maintenance Operations Guide (ISO 8828. 1988, IDT) Posted 2009-11-15 2010-05-01 implementation Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China Standardization Administration of China released

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. The main drafters of this standard. Yao Zhi repair, Feng Xiaoming, Fan Cheng phase, Xi Tingfei, Sun Huili, Song Duo, Qibao Fen. GB/T 24629-2009/ISO 8828. 1988

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. 2.1 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 3.1.1 Overview The implant delivery status when packaged may be. a) pre-sterilized (see 3.1.2), or b) non-sterile (see 3.1.3). 3.1.2 sterilized implants Pre-sterilized implant packaging before use should be kept intact. Should check whether the packaging is damaged, if found to be damaged, the implant It shall be considered as non-sterile. In this case, the implant should be returned to the supplier reprocessing, or when conditions permit, in the operating area and repackaging Sterilization. 3.1.3 Non-sterile implants Some non-sterile implants may, upon receiving the package can be sterilized in a special package, the package should not be removed. Without this package The non-sterile implants, only to open the package before sterilization process, in order to maintain the shape and surface accuracy is not affected, and should add as little as possible Moving. 3.1.4 implant availability Any fall to the ground or through improper handling of the implant, if the suspect has been compromised, you must not use, should be returned to the supplier. However, should the total Surgeons use implants made implant is available in the final decision. 3.2 Transport Transport the implant should be avoided in the state of the implant and its packaging when received any damage or change. 3.3 inventory records 3.3.1 Overview Inventory records should be easy to inventory, inventory turnover, manufacturers retroactive, in some cases there should be transferred to the patient's medical record. GB/T 24629-2009/ISO 8828. 1988 ......

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