ISO 5834-4:2019 PDF

Name: ISO 5834-4:2019 — Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 4: Oxidation index measurement method
SKU: ISO 5834-4:2019
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Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 4: Oxidation index measurement method

Название (английский):

ISO 5834-4:2019

Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 4: Oxidation index measurement method

Статус документа:: Отменён
Формат:: Электронный (PDF)
Количество страниц:: 8
Дата публикации:: 12 февраля 2019 г.
Издание:: ISO IS 5834 edition 2 version 1
ICS:: 11.040.40

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Описание (английский):

This document specifies a method for the measurement of the relative extent of oxidation present in ultra-high molecular weight polyethylene (UHMWPE). It is applicable to ultra-high molecular weight polyethylene (UHMWPE) intended for use in surgical implants.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 5834-4:2019 - "Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 4: Oxidation index measurement method" specifies a standardized infrared spectroscopy method to measure the relative extent of oxidation in UHMWPE used in surgical implants. The method quantifies carbonyl (C=O) absorptions and reports an oxidation index useful for comparing UHMWPE batches, evaluating shelf ageing, post‑implant retrievals, and accelerated oxidative challenges.

Key topics and technical requirements

Measurement principle: Transmission infrared spectroscopy (FTIR) measuring carbonyl absorptions (~1720 cm‑1) related to chemically bound oxygen; other oxygen species may not be detected.

Oxidation index (Iox): Ratio of oxidation peak area (1 650–1 850 cm‑1) to normalization peak area (1 330–1 396 cm‑1, typically C–H at ~1 370 cm‑1).

Specimen preparation:

Thin slices (films) 150–250 µm thick, cut perpendicular to the articular surface (microtome).
For retrieved devices exposed to lipids, solvent extraction (e.g., heptane or hexane) is required to remove interfering lipids.

Spectrometer and acquisition:

Transmission range ~1 200–2 000 cm‑1, resolution 4 cm‑1, recommended aperture ~0.2 mm × 0.2 mm.
Recommended increment size 0.2 mm between spectral locations to build oxidation profiles.
FTIR: minimum 32 scans per spectrum (minimum of 8 allowed if justified per ASTM F2102). Purge sample compartment with inert gas (N2, He, Ar) to reduce H2O/CO2 interference.

Outputs and calculations:

Surface oxidation index: mean Iox from surface to 3 mm depth.
Bulk oxidation index: mean Iox over ~0.5 mm near sample center.
Oxidation index profile: Iox vs. depth (depth locator dl, increment size Li).

Test articles: UHMWPE moulded materials classified per ISO 5834‑2 (Type 1/2/3).

Practical applications

Quality control and materials characterization for orthopedic implant manufacturers.

Comparative testing during product development, sterilization validation, and accelerated ageing studies.

Analysis of retrieved implants to assess in vivo oxidative degradation.

Regulatory submissions and batch release testing where documented UHMWPE oxidation status is required.

ISO 5834-4:2019 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Practical applications

Who should use this standard

Related standards and keywords

Технические детали

ISO 5834-2:2006

Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 2: Moulded forms

ISO 11542-1:1994/Amd 1:1996

Plastics — Ultra-high-molecular-weight polyethylene (PE-UHMW) moulding and extrusion materials — Part 1: Desi…

BS EN ISO 11542-2:1998

Plastics. Ultra-high-molecular-weight polyethylene (PE-UHMW) moulding and extrusion materials - Preparation o…