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YY/T 0809.1-2010Implants for surgery-Partial and total hip joint prostheses - Part 1: Classification and designation of dimensions (English PDF)

外科植入物 部分和全髋关节假体 第1部分:分类和尺寸标注

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

December 27, 2010

Implementation date

June 1, 2012

Scope

YY/T 0809.1-2010 is the English-translated version of 外科植入物 部分和全髋关节假体 第1部分:分类和尺寸标注.

YY/T 0809.1-2010 is the Chinese pharmaceutical industry standard that classifies partial and total hip joint prostheses and sets the way their dimensions are designated.

It is an identical adoption of ISO 7206-1:2008 and is the first part of the YY/T 0809 series, whose later parts cover the fatigue and static testing of femoral components; the classification and the sizes it defines are the basis for all those test standards.

It defines the terms used across the series, among them the bipolar femoral component, bone cement and cemented and cementless hip replacement components, and the modular and monobloc femoral stem, and it refers to ISO 21534 and ISO 21535. Issued on 27 December 2010, it has applied since 1 June 2012.

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Document preview — YY/T 0809.1-2010

National Standard of the People's Republic of China

ICS
11.040.40
Classification
C 35

Issued by: National Medical Products Administration of the People's Republic of China

Contents

  • Preface
  • Introduction
  • 1 Scope
  • 2 normative reference document
  • 3 Terms and definitions
  • 4 Category
  • 5 Dimensions

Foreword

YY/T 0809 "Surgical Implants Part and Total Hip Joint" is expected to be divided into the following sections.

- Part 1. Classification and dimensioning;

- Part 2. metal, ceramic and plastic joints;

- Part 4. Determination of fatigue properties of the femoral component;

Part 6. Determination of fatigue properties of the head and neck of the femoral component;

- Part 8. Fatigue properties of the femoral component with torque;

Part 10. Determination of anti - static loading of combined femoral head.

This part is part 1 of YY/T 0809.

This part is drafted in accordance with the rules given in GB/T 1.1-2009.

This part uses the translation method equivalent to ISO 7206-1.:2008 "Surgical Implant Section and Total Hip Joints Part 1. Section Class and dimension ".

Introduction

Partial and total hip prostheses are designed to transfer loads and allow movement under high stress conditions. Currently used worldwide for hip clearance There are many different designs for the prosthesis, and this part of the YY/T 0809 will be passed through a detailed classification system for the most common hip prosthesis To elaborate. The size of the selected type of hip prosthesis will be the basis for all test criteria in YY/T 0809.

1 Scope

This part of YY/T 0809 specifies the classification and standardized dimensioning of partial and total hip prostheses.

2 Normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.

ISO 21534 Passive Surgical Implants Joint Replacement Special Requirements (Non-activesurgicalimplants-Joint replacementimplants-Particularrequirements

ISO 21535 Passive Surgical Implants Joint Replacement Implants Hip Replacement Implants Specific requirements (Non-active surgicalimplants-Jointreplacementimplants-Specificrequirementsforhip-jointreplacementim- plants

3 Terms and definitions

ISO 21534 and ISO 21535 and the following terms and definitions apply to this document.

3.1 Bipolar femoral component

A hip replacement member connected to the femoral head and a convex surface connected to the physiological acetabulum.

3.2 Bone cement

A radiopaque or radiopaque acrylic resin adhesive for immobilizing the implanted part, a sterile powder and a sterile liquid, The number of determinations is provided as a unit, and its form is suitable for implantation when mixed.

3.3 Bone cement hip replacement parts

The hip replacement component is expected to be secured to the bone by bone cement.

3.4 Non - cement - type hip replacement parts

The hip replacement component is intended to be secured to the bone by means of press fit and/or bone ingrowth surface structures.

3.5 Modular femoral stem

A femoral stem consisting of two or more components (without a combined femoral head, femoral neck) is expected to be assembled preoperatively or intraoperative.

3.6 Monolithic monoblocstem

Consists of a femoral stem that consists of a single part of the femoral head, with no components.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 23 pages — is available in the English PDF.

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