BS ISO 5834-2:2011 pdf download.Implants for surgery – Ultra-high-molecular-weight polyethylene Part 2: Moulded forms.
This part of ISO 5834 specifies the requirements and corresponding test methods for moulded forms, e.g. sheets and rods, made from ultra-high-molecular-weight polyethylene (UHMWPE) for use in the manufacture of surgical implants.
This part of ISO 5834 is not applicable 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.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 527-1, Plastics — Determination of tensile properties — Part 1: General principles
ISO 11831:_1), Plastics — Methods for determining the density of non-cellular plastics — Part 1: Immersion method, liquid pyknometer method and titration method
ISO 3451-1:2008, Plastics — Determination of ash — Part 1: General methods
ISO 5834-1, Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 1: Powder form
ISO 11542-2:1998, Plastics — Ultra-high-molecular-weight polyethylene (PE-UHMW) moulding and extrusion
materials — Part 2: Preparation of test specimens and determination of properties
3 Classification
The material moulded from Type 1. Type 2 or Type 3 powder as defined in ISO 5834-1 shall be classified as
Type 1, Type 2 or Type 3 respectively.
4 Material
The moulded material shall be made from UHMWPE powder in accordance with the requirements of ISO 5834-1.
5 Manufacturing requirements
The moulded material supplied for each order shall be identified by lot numbers.
NOTE -Lor refers to the material for which testing has been carried out and for which discrete records are kept.
The material shall be subjected to a stress-relief annealing process as agreed by the purchaser and the vendor.
In the moulding process, no liquid or powdery release agents shall be used (such as silicon or talc-based release agent) in order to avoid contamination, migration and moulding defects.
6 Requirements
6.1 Physical properties
When measured using the appropriate test method, as defined in Table 1. the physical properties of the moulded material shall conform to the relevant values given in Table 1 for each type of material.
The physical properties shall be measured on material in the consolidated and annealed state before further processing. Subsequent manufacturing processes can influence the comparison of test results.
6.2 Particulate matter
When visually inspected using normal or corrected vision with no magnification, not more than ten particles shall be visible on the surface of a sample or samples prepared in accordance with 7.8.BS ISO 5834-2 pdf free download.
Tags: Implants for surgery
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