BS ISO 5834-2:2019 pdf download – Implants for surgery — Ultra-high- molecular-weight polyethylene Part 2: Moulded forms
This document 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 document 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 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. Forundated references, the latest edition of the referenced document (including any amendments) applies.
ISO 1183‑1:2012, Plastics — Methods for determining the density of non-cellular plastics — Part 1:Immersion method, liquid pyknometer method and titration method
ISO 5834‑1, Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 1: Powder form ASTM F648, Standard specification for ultra-high-molecular-weight polyethylene powder and fabricated form for surgical implants
3 Terms and definitions
No terms and definitions are listed in this document.
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
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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.
The moulded material shall be made from UHMWPE powder in accordance with the requirements of ISO 5834‑1.
The density shall be measured by means of method A (immersion method) specified in ISO 1183-1, using at least three specimens. The mean of the results on the three test specimens shall be within the limits given in Table 1
8.3 Tensile testing
The tensile test shall be conducted as specified in ASTM F648. At least five test specimens shall be tested.
8.3.2 Tensile stress at yield
The tensile stress at yield, Oy shall be determined in accordance with 8.3.1. The mean of the results on the five test specimens shall not be less than the values given in Table 1.
8.3.3 Tensile stress at break
The tensile stress at break, OR, shall be determined in accordance with 8.3.1. The mean of the results on the five test specimens shall not be less than the values given in Table 1
8.3.4 Elongation at break
The elongation at break, ER, shall be determined in accordance with 8.3.1. The mean of the results on the five test specimens shall not be less than the values given in Table 1.
8.4 Notched impact strength
The double-notched impact strength, acN, shall be determined by the impact test specified in ASTM F648. The number of test specimens is specified in ASTM F648.
8.5 Sample area for particulate matter
A total machined surface area of (0,500土0,005) m2 shall be taken from locations within the fabricated form. The area examined shall include both transverse and longitudinal samples, or it may be produced by repeated sectioning through the thickness of the fabricated form. The sample area shall be visually inspected for particulate matter using normal or corrected vision with no magnification.
9 ldentification marking
Each item supplied shall be identified with at least a lot identification. A marking, which can also be a serial identification, with reference to the lot identification, may be repeated at intervals along the length of the item.
10 Test certificate
Each lot shall be supplied with a test certificate stating the results of the tests conducted and conformance with the requirements of this document. The test certificate shall include the following information:
a) reference to this document, i.e. ISO 5834-2:2019;
b) staterment of material type, i.e. Type 1 or Type 2 or Type 3;
c lot number or serial number with reference to the lot number;BS ISO 5834-2 pdf download.