YY 0341.1-2020_English: PDF (YY0341.1-2020)
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Non-active surgical implants -- Osteosynthesis and spinal implants -- Part 1: Particular requirements for osteosynthesis implants
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YY 0341.1-2020
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Standards related to: YY 0341.1-2020
| Standard ID | YY 0341.1-2020 (YY0341.1-2020) | | Description (Translated English) | Non-active surgical implants -- Osteosynthesis and spinal implants -- Part 1: Particular requirements for osteosynthesis implants | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 14,168 | | Date of Issue | 2020-09-27 | | Date of Implementation | 2022-06-01 | | Older Standard (superseded by this standard) | YY 0341-2009 | | Drafting Organization | Tianjin Medical Device Quality Supervision and Inspection Center, Medical Device Technical Evaluation Center of the State Drug Administration, Beijing Natong Technology Group Co., Ltd. | | Administrative Organization | Orthopedic Implants Sub-Technical Committee of the National Standardization Technical Committee for Surgical Implants and Orthopedic Devices (SAC/TC 110/SC 1) | | Regulation (derived from) | Announcement No. 108 (2020) of the National Medical Products Administration | | Proposing organization | State Drug Administration | | Issuing agency(ies) | State Drug Administration | YY 0341.1-2020
YY
PHARMACEUTICALS INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
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
无源外科植入物 骨接合与脊柱植入物
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
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
YY/T 0343 Liquid penetrant inspection of metallic surgical implants
YY/T 0640-2016 Non-active surgical implants - General requirements
YY/T 1074 Implants for surgery - Measuring method for pitting corrosion
potential on stainless products
YY/T 1615 Surgical implants - Anodizing oxide layers on titanium and
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. If there are relevant product standards, the mechanical properties
of osteosynthesis implants shall meet the requirements of the corresponding
standards. Due to the different characteristics of osteosynthesis implants, the
test standards may not yet exist or the existing test standards may be modified
as needed.
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.
4.5.2 Surface roughness
The manufacturer shall specify the roughness Rα value of the main surface of
the osteosynthesis implant.
If there are relevant product standards, the roughness Rα value of
osteosynthesis implants shall meet the requirements of the corresponding
standards.
4.5.3 Appearance
The surface of the osteosynthesis implant shall be free of defects that affect the
function of the implant, as well as inlays, final processing deposits or other
contaminants.
Note: Defects affecting function include oxide skin, knife marks, small nicks,
scratches, cracks, depressions, sharp edges (except for cutting edges), burrs
and other 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.
Note 2: Preclinical evaluation shall consider the existing data of similar implants
or design characteristics.
Note 3: Tests can be performed on specific implants under specific loads and/or
specific environmental conditions to evaluate their performance.
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.
Note: If the final product cannot be sampled due to structure (such as locking
screw) or size, the same batch of raw materials and specimens of the same
manufacturing process can also be used.
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.
Note: Other validated methods are also acceptable.
5.5.2 Surface roughness
Use the sample comparison method or the electrical measurement method
specified in GB/T 10610. The electrical measurement method is the arbitration
method, wherein the number of samples shall be no less than 3.
5.5.3 Appearance
Carry out inspection under normal or corrected vision; the number of samples
shall be no less than 3.
5.5.4 Anodized surface treatment
It is performed according to the method specified in YY/T 1615; at least the
qualitative analysis and cytotoxicity of the surface elements of the anodic oxide
film shall be tested.
Note: Other validated methods are also acceptable.
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
Appendix A
(Informative)
Relevant standards for clinically acceptable osteosynthesis implants
A.1 Bone nail
YY 0018 Implants osteosynthesis - Metallic bone screws
ISO 5835 Surgical implants - Asymmetric thread, spherical lower surface,
hexagon socket metal bone screw size
ISO 9268 Surgical implants - Conical lower surface metal bone screw size
A.2 Bone plate
YY 0017 Implants for osteosynthesis - Metallic bone plates
YY/T 0856 Implants for osteosynthesis - Metallic angled fixation device
ISO 5836 Surgical implant - Metal bone plate - Asymmetric thread, the hole
corresponding to the screw on the spherical lower surface
ISO 9269 Surgical implants - Metal bone plates - Holes and grooves
corresponding to the tapered lower surface
A.3 Implants for intramedullary fixation
YY/T 0019.1 Implants for surgery - Intramedullary nailing systems - Part 1:
Intramedullary nails with cloverleaf or V-shaped cross-section
YY/T 0019.2 Implants for surgery - Intramedullary nailing systems - Part 2:
Intramedullary nails
YY/T 0591 Implants for osteosynthesis - Metallic lockable intramedullary nail
YY/T 0727.1 Implants for surgery - Metal intramedullary nailing systems - Part
1: Intramedullary nails
YY/T 0727.2 Implants for surgery - Metal intramedullary nailing systems - Part
2: Locking components
YY/T 0727.3 Implants for surgery - Metal intramedullary nailing systems - Part
3: Connection devices and reamer diameter measurements
A.4 Implants for adult femoral end fixation
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