GB/T 12417.1-2008 PDF English
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Non-active surgical implants -- Osteosynthesis and joint replacement implants -- Part 1: Particular requirements for osteosynthesis implants
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The gereral technological conditions of surgical metal implant
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GB/T 12417.1-2008: PDF in English (GBT 12417.1-2008) GB/T 12417.1-2008
Non-active surgical implants.Osteosynthesis and joint replacement implants.Part 1. Particular requirements for osteosynthesis implants
ICS 11.040.40
C35
National Standards of People's Republic of China
GB/T 12417.1-2008/ISO 14602.1998
Partially replace GB 12417-1990
Passive surgical implant
Bone joint and joint replacement implant
Part 1. Special requirements for osteosynthesis implants
(ISO 14602.1998, Non-activesurgicalimplants-
Implantsforosteosynthesis-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 first part of GB/T 12417.
This section is equivalent to ISO 14602.1998 "Special requirements for passive surgical implant bone-engaged implants". for
The basic requirements for passive surgical implants covered by ISO 14630.1997 shall apply in conjunction with this section.
This part of GB/T 12417 replaces GB 12417-1990 "General Technical Conditions for Surgical Metal Implants" for bone-engagement implants
The content of the object, the second part of GB/T 12417 replaces the content of the joint replacement implant in GB 12417-1990, the two parts are common
Complete the replacement of 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 and design of bone-engaged implants.
Provisions for information provided by attributes, materials, design evaluation, manufacturing, sterilization, packaging, and manufacturers;
--- GB 12417-1990 standard for metal surgical implants, this section applies to bone-engaged implants.
Appendix A, Appendix B and Appendix C 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. State Food and Drug Administration Tianjin Medical Device Quality Supervision and Inspection Center.
The main drafters of this section. Li Libin, Fan Platinum, Dong Shuangpeng, Wang Wei, Song Wei.
The previous versions of the standards replaced by this section are.
---GB 12417-1990.
GB/T 12417.1-2008/ISO 14602.1998
introduction
Passive surgical bone-engagement implants for wound healing or orthopedic surgery with the goal of stabilizing the fractured bone and its structure to achieve healing of the bone
Or a fusion effect, and/or provide support and correction functions. When the intended function is completed, the implant can be removed or left in the body.
The standards for passive surgical implants and related instruments are divided into three grades. The standard levels related to the implant itself are as follows
(The first level standard is the highest).
--- 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 covers the requirements for use in bone-engaged 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 second and third levels.
In the 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 the search from the current minimum level standard.
Related references can also be found in the appendix to this section.
GB/T 12417.1-2008/ISO 14602.1998
Passive surgical implant
Bone joint and joint replacement implant
Part 1. Special requirements for osteosynthesis implants
1 range
This part of GB/T 12417 specifies the special requirements for passive surgical implants for bone joining (hereinafter referred to as implants).
In addition to the provisions of the ISO 14630 provisions, this section on the expected performance of the implant, design properties, materials, design evaluation, manufacturing, extinction
The information provided by the bacteria, packaging and manufacturer has made special requirements.
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
Note. Normative or informative references in ISO 14630.1997 apply to this section.
3 Terms and definitions
The following terms and definitions established in ISO 14630.1997 apply to this part of GB/T 12417.
3.1
A passive surgical implant for supporting bone, cartilage, tendon or ligament structures.
4 expected performance
The expected performance should meet the requirements of Chapter 4 of ISO 14630.1997, and the following requirements should be considered.
Note. Because of the diversity of anatomy, fracture site and application, bone-joined implants should have certain versatility; the size of the implant should also be anatomically
There are certain limitations; bone, bone structure and other defects may also affect the performance of the implant.
4.1 Functional characteristics
In describing the expected performance of the implant, the following items should be given where applicable.
a) the type of tissue fixed to bone, cartilage, tendon or ligament;
b) the manner of attachment or fixation to the bone;
c) the connection between the implant component and the bone or other tissue structure;
d) the use of the repair process;
e) Can it be taken out;
f) role in bone or adjacent tissue structure, for example.
---stable;
---Limit or control movement;
--- Prevent deformation of fractures and dislocation of bone or other structural tissues;
---Connect the debris;
GB/T 12417.1-2008/ISO 14602.1998
---Control extrusion or transfer;
--- Protection against adjacent tissue structures.
4.2 Typical clinical application
When describing the expected performance of the implant, the range of expected typical applications should be given, for example.
a) fracture treatment;
b) tumor treatment;
c) the stability of the osteotomy;
d) stability of arthrodesis;
e) bone extension, shortening or connection;
f) support for bone replacement (bone graft);
g) attachments for joint replacement;
h) scoliosis treatment;
i) spinal fixation;
j) treatment of degenerative diseases;
k) reconstruction of tendons;
l) Reconstruction of the ligament.
Note. The anatomical location should also be stated as appropriate.
4.3 Conditions of use
Physical or physical differences can affect the expected performance of the implant, and the following should be considered.
a) body shape (height, weight);
b) the age of the patient;
c) pathological condition;
d) bone quality;
e) organizational vitality;
f) the status of the peripheral organization;
g) load conditions;
h) implantation method;
i) interaction and joint action with other fixtures;
j) The patient's activity.
Note. Special circumstances may limit the application of the implant or alert for clinical use; the performance of the implant may also be affected by other relevant conditions of the patient.
5 design properties
ISO 14630.1997 Chapter 5 and the following provisions apply.
5.1 When a bone-engaging implant is used as part of a connection system, the shape, dimensions and tolerances of the implant should be such that its intended use and performance are guaranteed.
Not destroyed.
5.2 When appropriate, the size of the implant should be consistent with the anatomical characteristics of the human body to be implanted.
Note 1. When the implant consists of two or more components, the potential wear, electrolysis and corrosion effects need to be considered in the design [compared to ISO 14630.1997).
5a), c), e), i), j)].
Note 2. The design of the implant needs to consider anatomical structure, type of tissue defect, surgical method, bone rehabilitation, fusion rate and rapid surgical treatment.
The design may be a compromise that satisfies such different needs.
Note 3. Appendix A gives an informative list of common implant designs that have proven to be acceptable.
6 materials
Chapter 6 of ISO 14630.1997 applies.
Note. Appendix B contains an informative list of materials that have been demonstrated to be useful for bone-engaging implants through clinical application.
GB/T 12417.1-2008/ISO 14602.1998
7 Design evaluation
7.1 Summary
For preclinical evaluation, the implant should be evaluated in accordance with Chapter 7 of ISO 14630.1997 and the following terms.
Note. Appendix C (informative) lists the standard catalogues that can be used to assess whether different types of implants meet the above requirements.
7.2 Preclinical evaluation
7.2.1 An in vitro operational test is required to verify the expected mutual interaction between the implant and the instrument used (including between the osseointegrated implants)
effect.
Note. When the implant (removal) cannot be directly compared with the ready-made device for evaluation, it can also be evaluated by the corpse.
7.2.2 Test report
When evaluating implants using static and/or dynamic load testing, a well-established test standard or custom model that takes into account implant characteristics should be used.
Types are assessed, and due to the different implants and their characteristics, off-the-shelf testing standards may not exist or need to be modified.
Note 1. The scope of preclinical evaluation should take into account existing data on similar implants or design characteristics.
Note 2. The test method may be related to different test levels.
a) basic technical tests (eg stretching, bending, torsion) describing the characteristics of the implant or implant component;
b) the expected load condition test of the installed components;
c) biomechanical testing after assembly of the component (the bone may be replaced by a suitable man-made material);
d) Static or dynamic testing (cyclic fatigue).
Note 3. Specific implants can be tested under specific loads and/or specific environmental conditions to evaluate their performance.
8 manufacturing
Chapter 8 of ISO 14630.1997 applies.
9 sterilization
Chapter 9 of ISO 14630.1997 applies.
10 packaging
ISO 14630.1997 Chapter 10 applies.
11 Information provided by the manufacturer
ISO 14630.1997 Chapter 11 and the following specific terms apply.
11.1 Special conditions used
The information provided by the manufacturer shall include the following information under the appropriate conditions.
a) the implant removal information;
b) Processing limitations of the implant after delivery, such as size, shape and surface condition.
11.2 Implant marking
11.3 of ISO 14630.1997 and the following special provisions apply.
The marking of the implant should not affect its intended performance.
GB/T 12417.1-2008/ISO 14602.1998
Appendix A
(informative appendix)
ISO standard. implants and related instruments that have been accepted for clinical use in the field of bone bonding
Note. The informative reference standard, including other parts of the European Standard for this series, is listed in Appendix 14 of ISO 14630.1997.
Summary of different types of osteosynthesis implants and related instruments, relevant international standards are listed in parentheses.
a) Bone cement implants (see A.1).
--- bone nails (see A.1.1);
---Bone plate (see A.1.2);
---Intramedullary fixation device (A.1.3);
--- Implants that fix the ends of the femur (A.1.4);
---Bone nails and wire (A.1.5);
--- Nail (A.1.6);
--- cerclage and other fixed wires (see A.1.7);
---Orthopedic external fixation equipment (see A.1.8);
--- Spinal fixation device (see A.1.9).
b) related equipment (see A.2).
--- Drive connecting devices (see A.2.1);
--- Drilling and knocking instruments (see A.2.2).
A. 1 Type of bone cement implant and related ISO standards
A. 1.1 bone nail
ISO 5835 surgical implant hex drive connecting spherical lower surface, asymmetric threaded metal bone screw size
ISO 9268 surgical implant conical lower surface metal bone screw size
A. 1.2 bone plate
ISO 5836 surgical implant metal plate with asymmetrical threads, corresponding to the spherical lower surface screws
ISO 9269 Surgical Implant Metal Plate with Holes and Grooves Corresponding to Conical Lower Surface Screws
A. 1.3 intramedullary fixation device
ISO 5837-1 Surgical Implants Intramedullary Nail System Part 1. Intramedullary nails with trilobal or V-shaped cross-section
ISO 5837-2 Surgical Implants Intramedullary Nail System Part 2. Bone Marrow Needles
Note. These two standards are being revised (ISO /WD15142).
A. 1.4 Implants that fix the ends of the femur
ISO 8615 surgical implant adult femoral end fixation device
A. 1.5 bone nails and wire
ISO 5838-1 - Surgical implants - Needles and wires - Part 1 . Material and mechanical performance requirements
ISO 5838-2 Surgical implants - Needles and wires - Part 2. Steinmann
ISO 5838-3 Surgical implants - Needles and wires - Part 3. Kirschner
A. 1.6 nail
ISO 8827 U-shaped nails for orthopedic implants
A. 1.7 Circling and other fixed forged wire
ISO 10334 surgical implant sutures and other surgical wires
GB/T 12417.1-2008/ISO 14602.1998
A. 1.8 External fixation equipment
Note. There are proposals, but there are no relevant international standards.
A. 1.9 spinal fixation device
Note. The work of ISO has begun, but it is still in the working draft stage. Several relevant standards will be developed.
A. 2 ISO standards for related devices
A. 2.1 Drive connection equipment.
ISO 8319-1 orthopedic instruments - Screw joints - Part 1
ISO 8319-2 orthopedic instruments - Screw joints - Part 2. Rotary chiss
A. 2.2 Drilling and tapping instruments
ISO 9714-1 orthopedic drills - Part 1. Drills, taps and countersinks
GB/T 12417.1-2008/ISO 14602.1998
Appendix B
(informative appendix)
Clinical application has proven to be acceptable for ISO standard catalogues of materials
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. Forged 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)
Surgical implants - Metallic materials - 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. ISO 5834-1 is the version currently adopted, and the corresponding standard for this content in the ASTM standard is F648-84.
ISO 5834-2 Surgical Implants - Ultra High Molecular Weight Polyethylene Part 2. Molding Plastics (GB/T 19701.2, IDT)
Note. Similar national standards can be applied equally.
GB/T 12417.1-2008/ISO 14602.1998
Appendix C
(informative appendix)
Testing and design evaluation related standards
ISO 6475 - Surgical implants - Asymmetric and spherical
(YY/T 0662, IDT)
ISO 9585 Determination of flexural strength and stiffness of surgical implant plates (YY/T 0342, IDT)
ISO 9584 Non-destructive testing of surgical implants X-ray examination of cast metal surgical implants
ISO 9583 Non-destructive testing of surgical implants - Liquid penetrant testing of metallic surgical implants (YY/T 0343, NEQ)
GB/T 12417.1-2008/ISO 14602.1998
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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