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GB/T 12417.2-2008 English PDF (GBT12417.2-2008)

GB/T 12417.2-2008 English PDF (GBT12417.2-2008)

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GB/T 12417.2-2008: Non-active surgical implants -- Osteosynthesis and joint replacement implants -- Part 2: Particular requirements for joint replacement implants

GB/T 12417.2-2008
Non-active surgical implants. Osteosynthesis and joint replacement implants. Part 2. Particular requirements for joint replacement implants ICS 11.040.40
C35
National Standards of People's Republic of China
GB/T 12417.2-2008/ISO 21534.2002
Partially replace GB 12417-1990
Passive surgical implant
Bone joint and joint replacement implant
Part 2. Special requirements for joint replacement implants
(ISO 21534.2002, Non-activesurgicalimplants-
Jointreplacementimplants-Particularrequirements, IDT)
2008-12-15 released.2010-02-01 implementation
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China China National Standardization Administration issued
Foreword
GB/T 12417 "Passive Surgical Implants and Joint Replacement Implants" is divided into two parts. --- Part 1. Special requirements for osteosynthesis implants;
--- Part 2. Special requirements for joint replacement implants.
This part is the second part of GB/T 12417.
This section is equivalent to ISO 21534.2002 "Passive surgical implant joint replacement implants - special requirements." This part of GB/T 12417 replaces GB 12417-1990 "General Technical Conditions for Surgical Metal Implants" for joint replacement implants The content of the object, the first part of GB/T 12417 replaces the content of the bone-engaged implant in GB 12417-1990, the two parts are completed together Replacement of paired GB 12417.
The main changes in this section compared with GB 12417-1990 are as follows. --- This section adjusts the technical requirements of GB 12417-1990, increasing the expected performance of joint replacement implants, Information provided by attributes, materials, design evaluation, manufacturing, sterilization, packaging, and manufacturer; --- GB 12417-1990 standard for metal surgical implants, this section applies to joint replacement implants. Appendix A, Appendix B, Appendix C and Appendix D of this part are informative annexes. This part is proposed by the State Food and Drug Administration.
This part is under the jurisdiction of the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices (SAC/TC110). This section drafted by. China Medical Device Industry Association Surgical Implants Professional Committee, State Food and Drug Administration Tianjin Medical Medical Device Quality Supervision and Inspection Center, Pross Surgical Implants (Beijing) Co., Ltd. The main drafters of this section. Yao Zhixiu, Sun Jianwen, Song Yi, Zhang Chen, Zhang Tao, Cheng Buyuan. The previous versions of the standards replaced by this section are.
---GB 12417-1990.
GB/T 12417.2-2008/ISO 21534.2002
introduction
The standards for passive surgical implants are divided into three levels, the highest at one level, which are. --- Level 1. General requirements for passive surgical implants;
--- Level 2. special requirements for all types of passive surgical implants; --- Level 3. Special requirements for various passive surgical implants. This part of GB/T 12417 is a secondary standard that contains requirements for all joint replacement implants in passive surgical implants. The primary standard includes requirements that apply to all passive surgical implants. It also states that some additional requirements are included in the secondary and In the third-level standard.
As a first-class standard ISO 14630.1997 has been released, see YY/T 0640-2008 "General requirements for passive surgical implants Seeking" (ISO 14630.2005, IDT).
The tertiary standard applies to specific implants in certain types of implants, such as the knee and hip joints. If all requirements are involved, it is recommended to start with the current minimum level criteria. Related references can also be found in the appendix to this section.
GB/T 12417.2-2008/ISO 21534.2002
Passive surgical implant
Bone joint and joint replacement implant
Part 2. Special requirements for joint replacement implants
1 range
This part of GB/T 12417 specifies implants, artificial ligaments and bone cement for whole joints and partial joints (hereinafter referred to as implants). Special requirements for entry. In this section, artificial ligaments and related fixation devices are included in the term implant, the following Called an implant.
This section specifies information for expected performance, design properties, materials, design evaluation, manufacturing, sterilization, packaging, and manufacturer. Claim.
Some tests that require confirmation of this part are included in the Level 3 standard or its reference documents. 2 Normative references
The terms of the following documents become the provisions of this part by reference in this part of GB/T 12417. Quotations with dated And all subsequent amendments (not including errata content) or revisions do not apply to this section, however, encouragement is achieved in accordance with this section. The parties to the agreement study whether the latest versions of these documents can be used. For undated references, the latest edition applies to this section.
ISO 14630.1997 General requirements for passive surgical implants
ISO 7206-2 Surgical Implant Part and Total Hip Prosthesis Part 2. Articular surfaces made of metal, ceramic and plastic materials 3 Terms and definitions
The following terms and definitions established in ISO 14630.1997 apply to this part of GB/T 12417. 3.1
An implant for providing a natural joint function similar to a human body and connected to a corresponding bone, including an auxiliary implant component and material. 3.2
An implant used to reinforce or replace a natural ligament of the human body, including its necessary fixation means. Note. Artificial ligaments provide short-term or long-term reinforcement. 4 expected performance
For this part, the expected performance of the implant should comply with the requirements of Chapter 4 of ISO 14630.1997. In addition, the following issues should be considered. a) the expected minimum and maximum relative angular motion between the fixed bones of the joint replacement implant; b) the maximum expected load and its effect (force and moment) delivered to the bony tissue fixed to the joint replacement implant; c) the dynamic response of the human body to the shape/stiffness of the implant; d) expected wear of the articular surface and ligaments;
e) the suitability of the size and shape of the implant relative to the intended population; GB/T 12417.2-2008/ISO 21534.2002
f) Adhesion strength and durability of surface treatment or surface coating. Note 1. The indications and contraindications of using a particular implant are a complex issue. When selecting an implant for a specific patient, the surgeon should Human judgment and experience are analyzed and considered.
Note 2. The life of an implant depends on the interaction of multiple factors. Some are the responsibility of the manufacturer; some are the responsibility of the doctor's surgical operation, such as implant technology; some are related to the patient, such as the patient's birth to the implant Physical and physiological responses, medical conditions of patients, behavioral characteristics of patients, such as weight gain, carrying heavy loads, and large amounts of activity. 5 design properties
5.1 General
In order to achieve the expected performance, the design attributes shall be formulated in accordance with the requirements of Chapter 5 of ISO 14630.1997, and The following aspects.
a) adhesion strength and durability of surface treatment and surface coating; b) wear of the articular surface and other surfaces;
c) the stability of the implant when the minimum and maximum relative motion between the permitted bones is specified; d) avoid cutting or rubbing the tissue while exercising function, except when implanting and removing the implant; e) Creep resistance and fracture characteristics, especially when associated with ligaments. Note 1. Methods for assessing articular surface and other surface wear and their allowable values are described in the three-level standard. Note 2. More specific requirements may be in the third-level standard, such as the hip joint standard. 5.2 Surface processing of metal or ceramic implants connected to UHMWPE activities Note. The ultra high molecular weight polyethylene in this section is abbreviated as UHMWPE. For the surface of a metal or ceramic component connected to UHMWPE with total joint replacement, the surface roughness R犪 shall not be greater than 0.1 μm (measured according to 7.2.1).
5.3 Surface processing of metal or ceramics of some joint implants
For the articular surface of a metal or ceramic component with partial joint replacement, the surface roughness R犪 should be no more than 0.5μm (according to 7.2.1 measuring).
5.4 Convex spherical metal or ceramic surface connected to UHMWPE
The total joint replacement metal or ceramic component connected to the UHMWPE activity, if the joint surface is convex spherical, the surface roughness R犪 should not Above 0.05 μm, the spherical radial deviation is not more than 10 μm (measured according to 7.2.1 and 7.2.2). 5.5 Spherical metal or ceramic implant surface for partial joint replacement For spherical metal or ceramic parts with partial joint replacement, the roughness R犪 of the joint surface should be no more than 0.5μm, and the spherical radial deviation The difference is not more than 100 μm (measured according to 7.2.1 and 7.2.2). 5.6 concave spherical UHMWPE parts surface
For the surface of the concave spherical UHMWPE part with total joint replacement, the roughness R犪 of the joint surface should be no more than 2μm, the spherical diameter The deviation is not more than.200 μm (measured according to 7.2.1 and 7.2.2). 6 materials
6.1 General
The requirements of Chapter 6 of ISO 14630.1997 and the special requirements of 6.2 of this Part apply to this part. Note 1. Appendix A of this section lists materials that are manufactured using approved implants or materials that are used with implants. Note 2. Appendix B of this section lists matching materials that have been approved for use and are not approved for use as implant articular surfaces. Note 3. Chapter 6 of ISO 14630.1997 provides that it can also be selected from materials that have proven to be suitable for clinical use in similar applications. For this part, To demonstrate the availability of materials, an implant record of at least 500 implants is required and there are no less than 5 years of successful clinical use records. 6.2 Different metals or alloys
In some applications, two different metals or alloys, or two metals of different metallographic states, are in contact, but not active GB/T 12417.2-2008/ISO 21534.2002
The type of material used should not produce unacceptable contact electrical effects. Note. Appendix C lists the permitted and disallowed metal combinations for implant non-articular bearing surfaces. 7 Design assessment
7.1 General
Joint replacement implants should be evaluated to demonstrate that they achieve the desired performance. The assessment shall be in accordance with Chapter 7 of ISO 14630.1997, And the special requirements of 7.2, and take the note of 7.3 as a guide. 7.2 Preclinical evaluation
Preclinical evaluation should consider.
a) the mechanical load and associated movement of the implant when it functions as described in ISO 14630.1997; b) fatigue testing of highly stressed components (see Level 3 ISO 7206-4, ISO 7206-8 and ISO 14879-1, etc.); c) wear tests on joint bearing surfaces and artificial ligaments (see Level 3 ISO 14242-1, ISO 14242-2, ISO 14243-1, etc.); d) the suitability of the size and shape of the implant to the intended population (see note); Note. The fit of the implant size and shape to the intended population can be confirmed by. cadaveric implantation; X-ray, CAT scan and magnetic resonance imaging Such as the imaging system; or refer to the corresponding implant that has been clinically validated (see Note 3 of 6.1). e) If there is a coating, the adhesion strength and durability of the coating. 7.2.1 Surface roughness measurement
Surface roughness shall be measured in accordance with the method given in ISO 7206-2. 7.2.2 sphericity measurement
The spherical radial deviation value shall be measured in accordance with the method given in ISO 7206-2.1996. 7.3 Clinical evaluation
Note. The scope and nature of any clinical study should depend on the innovation of the design and the innovation of the materials used to make the implant. 8 Manufacturing and inspection
The requirements of Chapter 8 of ISO 14630.1997, and the special requirements of 8.1, 8.2 and 8.3 apply to this part. 8.1 Metal surface
When visual inspection is performed with normal and corrected visual acuity, the surface of the metal part shall have no defects affecting the function of the implant, and there shall be no inlay or final processing. Sediments and other contaminants, for this purpose, parts should be cleaned, degreased, rinsed and dried, all polishing procedures should be used without Iron polishing agent.
Note. Defects that affect function include oxide scales, tool marks, small notches, scratches, cracks, dents, burrs, and other defects. 8.2 Plastic surface
When visually inspected with normal or corrected vision, the joint surface of the implant made of plastic should be free of particulate matter. The support surface must not be prepared with a non-removable abrasive or polishing agent. Parts should be cleaned, rinsed and dried. 8.3 Ceramic surface
When visually inspected with normal or corrected vision, the articular surface of the ceramic component should have no defects affecting the function of the implant. Note. Defects include particulate contamination, speckled or large areas of chemical discoloration, knife marks, small notches, debris, dents and cracks. 9 sterilization
The requirements of Chapter 9 of ISO 14630.1997 and the following requirements apply to this section. 9.1 Implants containing UHMWPE
If the cumulative radiation dose received exceeds 40kGy, UHMWPE-containing implants sterilized with ionizing radiation should not be used for clinical use. If other sterilization methods are used, the sterilization process must not impair the expected performance of the implant [see Chapter 4, 7.2b), c) and e)]. GB/T 12417.2-2008/ISO 21534.2002
10 packaging
The requirements of Chapter 10 of ISO 14630.1997 apply to this section. 11 Information provided by the manufacturer
Chapter 11 of ISO 14630.1997 and the following requirements apply to this section. 11.1 Only for implant markings on the side of the human body
For implants designed to be used only on one side of the human body, if the implant is for the left only, the mark should be marked with the characters "Left" and/or "L". If the implant is for the right side only, its mark should be marked with the characters "Right" and/or "R". 11.2 Description of implant orientation
If necessary, the instructions or manual should state the orientation of the implant relative to the human body. Can also rely on the relevant mark on the implant or The label indicates the orientation of the implant (see 11.1 and 11.3). 11.3 Implant orientation markers
If necessary, to embody the desired orientation of the implant as expressed in the instructions and/or manual, the implant may be "front" and/or for the forward direction. The "ANT" word mark, for the rearward direction, the implant can be marked with a "post" and/or "POST" word (see 11.2). 11.4 Implanted marked parts
The appropriate site of the implant should be selected for labeling so that it does not affect the intended function of the implant [see 7.2b), c) and e)]. 11.5 Restrictions on use
If an implant is restricted to a specific population, it should be stated in the instruction manual or manual. GB/T 12417.2-2008/ISO 21534.2002
Appendix A
(informative appendix)
List of approved materials for manufacturing implants
The following materials have been validated for use in the manufacture of implants. The inclusion of materials in this appendix does not imply that they are satisfactory for use in any particular application, nor does it exempt manufacturers from Responsibility for design assessment as specified in Chapter 7.
ISO 5832-1 Surgical Implants - Metallic materials - Part 1 . Forged stainless steel (GB 4234 Surgical implants, stainless steel, MOD)
Metallic materials for surgical implants - Part 2. Pure titanium (eqv GB/T 13810-1997 Titanium for surgical implants) And titanium alloy processing materials)
Metallic materials for surgical implants - Part 3. Forged Ti-6Al-4V alloy Metallic materials for surgical implants - Part 4. Casting cobalt-chromium-molybdenum alloys (eqvGB 17100-1997 Cast cobalt-chromium-molybdenum alloy for implants)
Metallic materials for surgical implants - Part 5. Forged cobalt-chromium-tungsten-nickel alloys (YY/T 0605.5, IDT) Metallic materials for surgical implants - Part 6. Forged cobalt-nickel-chromium-molybdenum alloys (YY/T 0605.6, IDT) Metallic materials for surgical implants - Part 7. Refractory and cold worked cobalt-chromium-nickel-molybdenum-iron alloys (YY/T 0605.7, IDT)
Metallic materials for surgical implants - Part 8. Forged cobalt-nickel-chromium-molybdenum-tungsten-iron alloys (YY/T 0605.8, IDT)
Metallic materials for surgical implants - Part 9. Forged high-nitrogen stainless steel (YY0605.9, IDT) Metallic materials for surgical implants - Part 11. Forged titanium 6-aluminum 7-... Metallic materials for surgical implants - Part 12. Forged cobalt-chromium-molybdenum alloys (YY0605.12, IDT) ISO 5833 Surgical Implant Acrylic Bone Cement (YY0459, IDT)
ISO 5834-1 Surgical implants - Ultra high molecular weight polyethylene - Part 1. Powders (GB/T 19701.1, IDT) Note 1. The materials described in ISO 5834-1 Component B are currently more precisely defined in ASTMF 648-96. ISO 5834-2 Surgical Implants - Ultra High Molecular Weight Polyethylene Part 2. Molding Plastics (GB/T 19701.2, IDT) ISO 6474.1994 Surgical implants, high purity alumina ceramic materials
ISO 133561) Surgical implant yttria-stabilized, tetragonal zirconia-based ceramic material (Y-TZP) 1) ISO 13356.2002 has been released.
Note 2. ISO TC150/SC1 is working on the development of standards for hydroxyapatite ceramics. Before the release of the ISO standard for hydroxyapatite, ASTMF1185 The hydroxyapatite specified in -93 is acceptable.
ISO 13782.1996 Surgical implants, metallic materials, surgical implants, pure sputum Note 3. ISO 13782 is omitted from ISO 21534.2002.
GB/T 12417.2-2008/ISO 21534.2002
Appendix B
(informative appendix)
List of approved and unapproved implant articular surfaces
B. 1 Suitable material combination
As long as sufficient attention is paid to the design, surface finishing and surface treatment, for the articular surface of the replacement implant, from Appendix A material The following combinations selected are recognized.
Stainless steel processing materials (ISO 5832-1) and UHMWPE (ISO 5834-1, ISO 5834-2); High nitrogen stainless steel processing material (ISO 5832-9) and UHMWPE (ISO 5834-1, ISO 5834-2); Cast cobalt chromium molybdenum alloy (ISO 5832-4) and UHMWPE (ISO 5834-1, ISO 5834-2); Cobalt-chromium-tungsten-nickel alloy processing material (ISO 5832-5) and UHMWPE (ISO 5834-1, ISO 5834-2); Malleable and cold worked cobalt-nickel-chromium-molybdenum-iron alloy (ISO 5832-7) and UHMWPE (ISO 5834-1, ISO 5834-2); Cobalt nickel chromium molybdenu...

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