YY/T 1705-2020Implants for surgery—Determination of impact resistance of ceramic femoral heads for hip joint prostheses (English PDF)
外科植入物 髋关节假体陶瓷股骨头抗冲击性能测定方法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
February 21, 2020
Implementation date
January 1, 2021
Scope
YY/T 1705-2020 is the English-translated version of 外科植入物 髋关节假体陶瓷股骨头抗冲击性能测定方法.
YY/T 1705-2020 is the Chinese pharmaceutical industry standard that gives two alternative test methods for determining the impact resistance of the ceramic femoral heads of hip prostheses, the property that governs how a head survives a sudden load such as a fall or an impingement.
It sets out the specimens and their mounting on the taper, the impact energy and how it is applied in each method, and the examination of the head afterwards, so that designs and materials can be compared. It was issued on 21 February 2020 and has applied since 1 January 2021.
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Document preview — YY/T 1705-2020
National Standard of the People's Republic of China
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- Introduction4
- 1 Scope5
- 2 Normative references5
- 3 Terms and definitions5
- 4 Principle6
- 5 Apparatus and equipment7
- 6 Procedure11
- 7 Impact test: Calculation of an impact energy13
- 8 Test report13
- Bibliography15
Foreword
This Standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This Standard uses the redraft law to modify and adopt ISO 11491:2017 "Implants for surgery - Determination of impact resistance of ceramic femoral heads for hip joint prostheses".
The technical differences between this Standard and ISO 11491:2017 are as follows:
- As for the normative references, this Standard has made adjustments with technical differences, to adapt to the technical conditions of China. The adjustments are mainly reflected in Clause 2 "Normative references". The specific adjustments are as follows:
lambda Replace ISO 4288 with GB/T 10610, which is identical to the international standard;
lambda Replace ISO 197-1 with GB/T 11086, which modifies and adopts the international standard;
lambda Replace ISO 7206-10 with YY/T 0809.10, which modifies and adopts the international standard;
- Regarding bibliography, replace ISO 148-2 with GB/T 3808, which modifies and adopts the international standard.
1 Scope
This Standard specifies two alternative test methods for determining the impact resistance of ceramic femoral heads for hip joint prostheses.
This Standard applies to ceramic femoral heads for hip joint prostheses.
2 Normative references
The following documents are indispensable for the application of this document.
For the dated references, only the editions with the dates indicated are applicable to this document. For the undated references, the latest edition (including all the amendments) are applicable to this document.
GB/T 10610 Geometrical product specifications (GPS) - Surface texture:
Profile method - Rules and procedures for the assessment of surface texture (GB/T 10610-2009, ISO 4288:1996, IDT)
GB/T 11086 Copper and copper alloys - Terms and definitions (GB/T 11086- 2013, ISO 197-1:1983, MOD)
YY/T 0809.10 Implants for surgery - Partial and total hip joint prostheses - Part 10: Determination of resistance to static load of modular femoral heads (YY/T 0809.10-2014, ISO 7206-10:2003, MOD)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in YY/T 0809.10 and the following apply.
3.1 Impact energy
Potential mechanical energy of the falling/drop weight used for applying the impact.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 21 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 10610Geometrical product specifications (GPS) -- Surface texture: Profile method -- Rules and procedures for the assessment of surface texture
- GB/T 11086Copper and copper alloys -- Terms and definitions
- YY/T 0809.10Implants for surgery-Partial and total hip-joint prostheses - Part 10: Determination of resistance to static load of modular femoral heads
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Related Standards
GB/T 10610-2009 — Geometrical product specifications (GPS) -- Surface texture: Profile method -- Rules and procedures for the assessment of surface texture
GB/T 11086-2013 — Copper and copper alloys -- Terms and definitions
YY/T 0809.10-2014 — Implants for surgery—Partial and total hip joint prostheses - Part 10: Determination of resistance to static load of modular femoral heads
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YY/T 1705-2020
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