BS ISO 5834-5:2019 pdf download – Implants for surgery — Ultra-high- molecular-weight polyethylene Part 5: Morphology assessment method
This document specifies the test method for assessing the morphology of UHMWPE moulded formswhich are described in ISO 5834‑2.
It is not applicable to UHMWPE powder forms, which are described in ISO 5834‑1.
NOTE Performance requirements for this test method have not been established.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements 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 11542‑1, Plastics — Ultra-high-molecular-weight polyethylene (PE-UHMW) moulding and extrusion materials — Part 1: Designation system and basis for specifications
SO 11542‑2, Plastics — Ultra-high-molecular-weight polyethylene (PE-UHMW) moulding and extrusion materials — Part 2: Preparation of test specimens and determination of properties
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 11542‑1 and ISO 11542‑2 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at http://www.electropedia.org/
Type A non-fused flake
indication visible under the conditions described in 4.2.2 that has an essentially complete circumferential black boundary and a white centre
Note 1 to entry: See Figure 1.
Type? B? non-fused? flake
indication visible under the conditions described in 4.2.2 that has a partially circumferential black boundary that appears to trace out 50 % to 99 % of a flake’s perimeter
Maximum scores of 100 shall be reported for the number of Type A non-fused flakes or Type B non fused flakes in a single sample.
The maximum morphology index of 100 reflects a practical limit to the number of defects an operator is willing to count. The maximum value of 100 for morphology index should not be construed as a performance requirement for the morphology of UHMWPE.
4.3 Test certificate
The certificate shall include the following for each material tested.
a) reference to this document, i.e. ISO 5834‑5:2019;
b) The arithmetic average of the number Type A non-fused flakes observed for the five specimens.
c) The arithmetic average of the number Type B non-fused flakes observed for the five specimens.
d) Total surface area examined in cm 2 .
e) The arithmetic average of the morphology index (3.3) for the five specimens.BS ISO 5834-5 pdf download.