YY 0341.1-2020 PDF English
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| YY 0341.1-2020 | English | 245 |
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Non-active surgical implants - Osteosynthesis and spinal implants - Part 1: Particular requirements for osteosynthesis implants
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| YY 0341-2009 | English | 150 |
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General technological requirements for non-active metallic surgical implants for osteosynthesis
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| YY 0341-2002 | English | 519 |
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General technological requirements for non-active metallic surgery implants of osteosynthesis
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YY 0341.1-2020: Non-active surgical implants - Osteosynthesis and spinal implants - Part 1: Particular requirements for osteosynthesis implants
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YY0341.1-2020
YY
PHARMACEUTICALS INDUSTRY STANDARD
ICS 11.040.40
C 35
Replacing YY 0341-2009
Non-active surgical implants - Osteosynthesis and
spinal implants - Part 1.Particular requirements for
osteosynthesis implants
Issued on. SEPTEMBER 27, 2020
Implemented on. JUNE 01, 2022
Issued by. National Medical Products Administration
Table of Contents
Foreword... 3
1 Scope... 5
2 Normative references... 5
3 Terms and definitions... 6
4 Requirements... 6
5 Test method... 8
6 Manufacturing... 10
7 Sterilization... 10
8 Packaging... 10
9 Information provided by the manufacturer... 10
Appendix A (Informative) Relevant standards for clinically acceptable
osteosynthesis implants... 12
Appendix B (Informative) Relevant material standards acceptable for clinical
use... 14
Appendix C (Informative) List of approved method standards for chemical
analysis... 16
Appendix D (Informative) Relevant standards for design evaluation and testing
... 17
Foreword
All technical contents of this standard are mandatory.
The standard of YY 0341 "Non-active surgical implants - Osteosynthesis and
spinal implants" is divided into the following two parts.
- Part 1.Particular requirements for osteosynthesis implants;
- Part 2.Particular requirements for spinal implants.
This part is part 1 of YY 0341.
This part was drafted in accordance with the rules given in GB/T 1.1-2009.
"Non-active surgical implants - Osteosynthesis and spinal implants" replace YY
0341-2009 "General technological requirements for non-active metallic surgical
implants for osteosynthesis". The main technical differences between this part
and YY 0341-2009 are as follows.
- SPLIT the original standard into two parts. "Osteosynthesis implant" and
"spinal implant";
- MODIFY the scope of application to no longer only apply to non-active
surgical implants made of metal materials. In addition, MODIFY the
inapplicable scope in YY 0341.1 to "coating of osteosynthesis implant with
surface coatings" (see Chapter 1; Chapter 1 of the 2009 edition);
- ADD relevant terms and definitions, such as "anodization of titanium and
titanium alloys" (see 3.3);
- MODIFY the "appearance" requirements (see 4.5.3; 4.4.3 of the 2009
edition);
- ADD the "anodized surface treatment" requirements (see 4.5.4);
- ADD the "cooperating performance" requirements (see 4.7);
- ADD the requirement of "residual amount of ethylene oxide" (see 4.8);
- DELETE the original Chapter 6 "Inspection rules". MERGE the
requirements on the number of test samples into Chapter 5 "Test methods".
DELETE the original Chapter 7 "Instructions for use", the original Chapter
10 "Transport and storage", the original Chapter 11 "Requirements for use";
ADD "Manufacturing" and "Information provided by the manufacturer" and
other chapters.
Please note that certain contents of this document may involve patents. The
issuing agency of this document is not responsible for identifying these patents.
This part was proposed by the State Drug Administration.
This part shall be under the jurisdiction of the Orthopedic Implants Sub-
Technical Committee of the National Technical Committee on Surgical Implants
and Orthopedic Devices (SAC/TC 110/SC 1).
Drafting organizations of this part. Tianjin Medical Device Quality Supervision
and Inspection Center, Medical Device Technology Evaluation Center of the
State Drug Administration, Beijing Natong Technology Group Co., Ltd.
The main drafters of this part. Jiang Xi, Zhang Lu, Fu Ruizhi, Song Duo, Liu Bin,
Liu Yinghui, Li Renyao, Zhao Wenwen.
This standard replaces the standard previously issued as follows.
-YY 0341-2002, YY 0341-2009.
Non-active surgical implants - Osteosynthesis and
spinal implants - Part 1.Particular requirements for
osteosynthesis implants
1 Scope
This part of YY 0341 specifies the special requirements for non-active surgical
implants for osteosynthesis (hereinafter referred to as "osteosynthesis
implants"), including the terms and definitions, requirements, test methods,
manufacturing, sterilization, packaging and information provided by the
manufacturer, etc. of osteosynthesis implants.
This part of YY0341 applies to osteosynthesis implants, not to the coating part
of osteosynthesis implants with surface coating.
2 Normative references
The following documents are essential to the application of this document. For
the dated documents, only the versions with the dates indicated are applicable
to this document; for the undated documents, only the latest version (including
all the amendments) is applicable to this standard.
GB/T 4340.1 Metallic materials - Vickers hardness test - Part 1.Test method
GB/T 10610 Geometrical product specifications(GPS) - Surface texture.
Profile method - Rules and procedures for the assessment of surface texture
GB/T 14233.2 Test methods for infusion, transfusion, injection equipment for
medical use - Part 2.Biological test methods
GB/T 16886.7 Biological evaluation of medical devices - Part 7.Ethylene
oxide sterilization residuals
3 Terms and definitions
The terms and definitions as defined in YY/T 0640-2016 as well as the following
terms and definitions apply to this document.
3.1
Non-active surgical implant for osteosynthesis
Non-active surgical implant products used to support bone, cartilage, tendon
or ligament structures.
Note. See Appendix A for common types of osteosynthesis implants that
have been proven acceptable for clinical use.
4 Requirements
4.1 Materials
Manufacturers shall give priority to materials suitable for osteosynthesis
implants specified in international standards, national standards, industry
standards.
4.2 Hardness
The hardness of metal osteosynthesis implants shall meet the requirements of
the corresponding product standards.
4.3 Static and/or dynamic mechanical properties
The manufacturer shall combine the characteristics of the osteosynthesis
implant and its clinical use to specify its static and/or dynamic mechanical
properties.
4.4 Corrosion resistance
The pitting potential (Eb) on the surface of the final product of the stainless steel
osteosynthesis implant shall not be less than 800 mV.
4.5 Surface quality
4.5.1 Surface defects
The surface of the non-coated metal osteosynthesis implant shall not have any
discontinuity defects.
4.5.4 Anodized surface treatment
For osteosynthesis implants made of titanium and titanium alloy materials, if the
surface is anodized, the manufacturer shall specify the relevant properties of
the anodized film.
4.6 Dimensions of important parts
The manufacturer shall specify the dimensions of the important parts of the
osteosynthesis implant.
4.7 Fitting performance
The manufacturer shall specify the fitting performances of the osteosynthesis
implants that need to be used together.
5 Test method
5.1 Materials
The chemical composition and microstructure of metal materials for
osteosynthesis implants, as well as the physical and chemical properties of
polymer materials are tested according to the method specified in the material
standard or refer to the recommended method in Appendix C.
5.2 Hardness
It is performed according to the method of GB/T 4340.1.
5.3 Static and/or dynamic mechanical properties
When using static and/or dynamic load tests to evaluate osteosynthesis
implants, existing inspection standards can be used (see Appendix D for related
information) or a custom test model that considers the characteristics of the
implant can be used;
5.4 Corrosion resistance
It is performed according to the method specified in YY/T 1074.The number of
samples shall be no less than 3.
5.5 Surface quality
5.5.1 Surface defects
It is performed according to the method specified in YY/T 0343; the number of
samples shall be no less than 3.
5.6 Dimensions of important parts
Use general measuring tools or special inspection tools to measure; the number
of samples shall be no less than 3.
5.7 Fitting performance
The action can be imitated or other methods can be used to test the fitting
performance.
5.8 Sterility
6 Manufacturing
It shall meet the requirements of Chapter 8 in YY/T 0640-2016.
7 Sterilization
It shall meet the requirements of Chapter 9 in YY/T 0640-2016.
8 Packaging
It shall meet the requirements of Chapter 10 in YY/T 0640-2016.
9 Information provided by the manufacturer
9.1 General
Chapter 11 of YY/T 0640-2016 and the following specific terms apply.
9.3 Marking
9.3.1 The 11.5, 11.6 in YY/T 0640-2016 or the following clauses apply.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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