YY/T 1634-2018Joint replacement implants—Shoulder prostheses—Standard test methods for dynamic evaluation of glenoid loosening or disassociation (English PDF)
关节置换植入物 肩关节假体 关节盂松动或分离动态评价试验方法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 20, 2018
Implementation date
January 1, 2020
Scope
YY/T 1634-2018 is the English-translated version of 关节置换植入物 肩关节假体 关节盂松动或分离动态评价试验方法.
YY/T 1634-2018 is the Chinese pharmaceutical industry standard that gives the test method for the subluxation, or rocking, of shoulder prosthesis components: the humeral head is displaced cyclically against the edge of the glenoid, up and down or front and back, and the resulting displacement of each bearing edge is measured after the dynamic phase.
It also covers the corresponding measurement for a reverse shoulder, where the glenosphere articulates with its humeral liner. Issued on 20 December 2018, it has applied since 1 January 2020.
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Document preview — YY/T 1634-2018
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
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Test methods and principles
- Appendix A (Normative Appendix) Anatomical shoulder joint licking test method
- Appendix B (informative appendix) Basic principles of anatomical shoulder joint tamping test
- Appendix C (Normative Appendix) Component Separation Test Method
- Appendix D (Normative Appendix) Test method for loosening or separation of inverted shoulder joints
- Appendix E (informative) Basic principles of inverted shoulder joint loosening or separation test Reference
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard is prepared using the redrafting method with reference to ASTM F2028-2014 "Test method for dynamic evaluation of joint stagnation or separation".
1 Scope
This standard specifies the anatomical shoulder component to be periodically displaced (eg, up and down or front and rear) under the humeral head to the opposite shoulder edge, shoulder A test method for the amount of swing or the amount of rotation of a component. After the dynamic oscillation, the motion is quantified by the tensile displacement of each bearing edge. with This standard also specifies the amount of swing of the shoulder blade component when the inverted joint glenoid component is periodically articulated with its associated tibial lining.
The method of measuring the amount of rotation. The motion is quantized by the amount of displacement before and after the loading cycle.
The same device can be used to test the locking mechanism of the combined shoulder component, such as the separation of the anatomical and inverted components.
This standard applies to cemented solid or composite shoulder blades and non-cemented inverted shoulder blades.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 16825.1 Inspection of static single-axis testing machines - Part 1. Examination and testing of tensile and/or pressure testing machines calibration
YY/T 0963 joint replacement implant shoulder prosthesis
3 Terms and definitions
The following terms and definitions apply to this document.
3.1 Anatomical full shoulder joint replacement implant
A shoulder joint implant having a concave shoulder member and a convex tibial component design.
3.1.1 Anatomical shoulder blade
Instead of the concave component of the scapula socket, in the anatomical total shoulder joint replacement, the convex humeral head forms an articular surface, which may contain One or more components made of one or more materials, such as a full polyethylene or a polymeric liner with a metal base.
3.1.2 Humeral head
A convex component that forms an articular surface with a physiological shoulder or an anatomical shoulder prosthesis instead of a proximal humerus or a component of a physiological humeral head.
3.2 Inverted full shoulder joint replacement implant
A shoulder joint component that includes a convex shoulder piece and a concave tibial component design.
3.2.1 Shoulder pedestal glenoidbaseplate
The non-articular portion of the inverted shoulder component that is attached to the shoulder ball and is usually secured to the shoulder blade by screws rather than cement. Nest.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.
Referenced standards
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Related Standards
GB/T 16825.1-2022 — Metallic materials - Calibration and verification of static uniaxial testing machines - Part 1: Tension/compression testing machines - Calibration and verification of the force-measuring system
YY/T 0963-2014 — Joint replacement implants—Shoulder prostheses
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
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