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ISO 16428:2005

Current Date published:

Implants for surgery — Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices

ISO 16428:2005 specifies standard environmental conditions for the testing of metallic materials intended for implantation, surgical implants, and medical devices. The testing conditions described simulate physiological conditions in a simplified manner controlling the test solution, the temperature, the gaseous atmosphere and the proportions of sample size and volume of solution.

These environmental testing conditions can be employed where necessary in combination with various static or dynamic tests where the effect of the physiological environment is to be considered. Typical applications are corrosion fatigue tests and selected fretting and wear tests, as well as general electrochemical tests.

Typical articulating joint simulator tests and aspects particular to the dental field are not considered by ISO 16428:2005. Solutions that attempt to replicate the tribological properties of body fluids, such as those used in wear studies, are outside the scope of ISO 16428:2005.

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Related Information

Similar Standards

  • AS/NZS 2817:1997

    Implants for surgery - Care and handling of orthopaedic implants

  • BS 2574-1:1991

    Lower limb orthoses, Guide to the design and manufacture of lower limb orthoses, excluding foot orthoses

  • BS 2574-2:1994

    Lower limb orthoses, Specification for hip, knee and ankle joints for lower limb orthoses

  • BS 3531-11:1991

    Implants for osteosynthesis, Implants for osteosynthesis. Specification for staples with parallel legs

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ISO 16428:2005

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