What is ISO 5834-2- Moulded forms using ultra-high-molecular-weight polyethylene about?
ISO 5834 is an international standard that discusses ultra-high-molecular-weight polyethylene for surgical implants. ISO 5834-2 provides the best industry guidance on moulded forms using ultra-high-molecular-weight polyethylene for surgical plants to produce high-quality surgical implants.
ISO 5834-2 is the second part of a multi-part series that specifies the requirements and corresponding test methods for moulded forms, that is sheets and rods, made from ultra-high-molecular-weight polyethylene (UHMWPE) for use in the manufacture of surgical implants.
Note: ISO 5834-2 does not apply to direct-moulded (near net shape), irradiated or finished products or products manufactured from polyethylene blended with additives or by blending different forms of polyethylene.
Who is ISO 5834-2- Moulded forms using ultra-high-molecular-weight polyethylene for?
ISO 5834-2 on moulded forms using ultra-high-molecular-weight polyethylene is relevant to:
- Ultra-high-molecular-weight polyethylene manufacturers
- Ultra-high-molecular-weight polyethylene suppliers
- Test centres
Why should you use ISO 5834-2- Moulded forms using ultra-high-molecular-weight polyethylene?
Ultra-high-molecular-weight polyethylene has high strength, high hardness, high toughness, and wear properties are combined and extremely low wear rates have been detected in ring-on-disc and HP stimulator tests.
ISO 5834-2 assists you with minimum requirements and test methods for manufacturing and evaluation of moulded forms made from ultra-high-molecular-weight polyethylene for use in surgical plants.
With compliance and obedience to ISO 5834-2, you can enhance the efficacy of surgical implants by manufacturing efficient quality moulded forms from ultra-high-molecular-weight polyethylene.
What’s changed since the last update?
BS ISO 5834-2:2019 supersedes ISO 5834-2:2011, which is withdrawn. BS ISO 5834-2:2019 has made some technical changes compared to ISO 5834-2:2011. These include:
- Requirement and test for maximum ash content is removed
- Limit values and test methods harmonized with respective ASTM standards
- Editorial updates are in line with all other parts of the ISO 5834 series