What is ISO 14879-1 about ?
ISO 14879 discusses total knee-joint prostheses for surgical implants. ISO 14879-1 outlines a test method for determining the endurance properties, under specified laboratory conditions, of tibial trays used in knee-joint prostheses to support and secure the plastic articulating surface. ISO 14879-1 applies to tibial trays which cover both the medial and lateral plateaux of the tibia.
The test method does not apply to tibial components manufactured solely from plastic materials.
Note 1: ISO 14879-1 does not cover methods of examining and reporting the final condition of the test specimen, these can be the subject of agreement between the test laboratory and the parties submitting the specimen for test.
Note 2: Correlation of test results within vivo performance has not been established
Who is ISO 14879-1 for ?
ISO 14879-1 on knee-joint prostheses for surgical implants is useful for:
- Manufacturers of knee-joint prostheses surgical implants
- Medical laboratories for surgical implants
- Regulatory authorities
Why should you use ISO 14879-1 ?
A prosthesis is a device designed to replace a missing part of the body or to make a part of the body work better. The metal prosthetic device in knee joint replacement surgery replaces cartilage and bone which is damaged from disease or aging.
ISO 14879-1 guideline helps you with principles, sample size, test conditions, testing procedures, test report, and disposal of test specimens for knee-joint prostheses surgical implants. This helps in improving the quality and safety of knee-joint prostheses surgical implants that ensure patient’s health.
What’s changed since the last update ?
BS ISO 14879-1:2020 supersedes ISO 14879-1:2000, which has been withdrawn. BS ISO 14879-1:2020 has some technical changes with respect to ISO 14879-1:2000. These include:
- In Clause 2, dynamic force calibration according to ISO 49651 was excluded and ISO 75001 was included
- In 3.1 and 3.2, the centreline was defined considering stem as a reference
- In 5.3, was included the possibility to glue the spacer
- In 7.7, the test frequency was limited up to 10 Hz but higher test frequencies may be used if evidence (dynamic calibration) is provided.
