GB/T 12417.1-2024Non-active surgical implants - Osteosynthesis and joint replacement implants - Part 1: Particular requirements for osteosynthesis implants (English PDF)

3.1 Non-Active Surgical Implants for Osteosynthesis

Non-active surgical implants intended to provide support for bone, cartilage, tendon, or ligament structures.

4.1 General

The intended performance shall comply with the requirements of Clause 4 of YY/T 0640-2016, while also taking into account the requirements of 4.2 to 4.4.

NOTE. Due to the diversity of anatomical sites, fracture locations, and applications, osteosynthesis

7.1 General

For preclinical evaluation, the implant shall be evaluated in accordance with Clause 7 of YY/T

0640-2016 and the following particular requirements.

NOTE. Appendix D lists standards that can be used to assess whether different types of implants meet the aforementioned requirements.

7.2 Preclinical Evaluation

The requirements in 7.2 of YY/T 0640-2016 apply, together with the following particular requirements.

a) In vitro simulated-use testing shall be conducted to verify the intended interactions between the implant and surgical instruments, and, where applicable, the intended interactions between interconnected implants. Where applicable, if the removal of the implant cannot be evaluated through direct comparison with existing instruments, cadaveric evaluation should be performed if possible.

b) When evaluating implants using static and/or dynamic load testing, recognized test standards (where applicable) or test models customized to the implant’s characteristics shall be used. Due to the diversity of implants and their characteristics, test standards may not exist or may require modification as needed.

c) Biological, physical, or modeling studies may be used to demonstrate that the implant achieves its intended performance, provided that they are appropriately verified.

NOTE 1.Existing data on similar implants or design characteristics are taken into account during preclinical evaluation.

NOTE 2.Test methods may involve different levels of testing.

a) Basic technical tests characterizing the implant or implant components (e.g., tension, bending, torsion);

b) Tests under expected loading conditions for installed components;

c) Biomechanical performance tests of assembled components (bone may be replaced by suitable artificial materials);

d) Static or dynamic tests (cyclic fatigue).

NOTE 3.Specific implants may be tested under specific loading and/or environmental conditions to evaluate their performance.

7.3 Clinical Evaluation

Section 7.3 of YY/T 0640-2016 applies.

7.4 Post-Market Follow-Up

Section 7.4 of YY/T 0640-2016 applies.

11.1 General

Section 11.1 of YY/T 0640-2016 applies.

11.2 Label

Section 11.2 of YY/T 0640-2016 applies.

11.3 Instructions for Use

The requirements in 11.3 of YY/T 0640-2016 apply, together with the following particular requirements. The information supplied by the manufacturer shall include the following data under the corresponding conditions.

a) Restrictions on any modifications to the implant after delivery, e.g., dimensions, shape, surface condition.

b) Date of issue or latest revision of the instructions for use.

11.4 Restrictions on Combinations

Section 11.4 of YY/T 0640-2016 applies.

11.5 Implant Marking

The requirements in 11.5 of YY/T 0640-2016 apply, together with the following particular requirements.

The application of implant markings shall not impair the intended performance of the implant.

11.6 Special-Purpose Marking

Section 11.6 of YY/T 0640-2016 applies.

Appendix B (Informative)

Standards for Osteosynthesis Implants and Associated Surgical Instruments Proven

Acceptable in Clinical Use

NOTE. Informative reference standards, including other parts of this series of international standards, are listed in the bibliography of YY/T 0640-2016.

B.1 Summary of Different Types of Osteosynthesis Implants and Associated

Surgical Instruments

Relevant standards are listed in parentheses.

a) General requirements for osteosynthesis implants and associated surgical instruments (see B.2).

b) Osteosynthesis implants (see B.3).

--- Bone screws (see B.3.1);

--- Bone plates (see B.3.2);

--- Intramedullary fixation devices (see B.3.3);

--- Implants for fixation of the ends of the femur (see B.3.4);

--- Metallic skeletal pins and wires (see B.3.5);

--- Staples (see B.3.6);

--- Malleable wires for cerclages and other fixation purposes (see B.3.7);

--- Devices for external fixation of bones (see B.3.8);

--- Devices for fixation of the spine (see B.3.9);

--- Absorbable implants for internal osteosynthesis (see B.3.10).

c) ISO standards for associated surgical instruments (see B.4).

--- Drive connection instruments (see B.4.1);

--- Drilling and tapping instruments (see B.4.2).

B.2 General Requirements and Guidance

GB/T 24629 Implants for surgery - Guidance on care and handling of orthopaedic implants

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