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YY/T 1705-2020 English PDF (YYT1705-2020)

YY/T 1705-2020 English PDF (YYT1705-2020)

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YY/T 1705-2020: Implants for surgery--Determination of impact resistance of ceramic femoral heads for hip joint prostheses

YY/T 1705-2020
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
C 35
Implants for surgery - Determination of impact
resistance of ceramic femoral heads for hip joint
prostheses
外科植入物 髋关节假体陶瓷
(ISO 11491:2017, MOD)
ISSUED ON: FEBRUARY 21, 2020
IMPLEMENTED ON: JANUARY 01, 2021
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
Introduction ... 4
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions ... 5
4 Principle ... 6
5 Apparatus and equipment ... 7
6 Procedure ... 11
7 Impact test: Calculation of an impact energy ... 13
8 Test report ... 13
Bibliography ... 15
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:
 Replace ISO 4288 with GB/T 10610, which is identical to the
international standard;
 Replace ISO 197-1 with GB/T 11086, which modifies and adopts the
international standard;
 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.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing authority of this document shall not be held responsible for identifying any or all such patent rights.
This Standard was proposed by National Medical Products Administration. This Standard shall be under the jurisdiction of Subcommittee 1 on Orthopedic Implants, National Technical Committee 110 on Implants for Surgery and
Orthopedic Devices of Standardization Administration of China (SAC/TC
110/SC 1).
Drafting organizations of this Standard: Tianjin Medical Devices Quality Supervision and Testing Center, Fito Samo Medical Devices (Beijing) Co., Ltd., Beijing Montagne Medical Device Co., Ltd.
Main drafters of this Standard: Wang Tao, Li Wenjiao, Zhao Binghui, Liang Fanghui, Xu Zhiyong, Xing Jianshuo.
Implants for surgery - Determination of impact
resistance of ceramic femoral heads for hip joint
prostheses
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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