ISO 5834-1:2019
Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 1: Powder form
Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 1: Powder form
- Статус документа:
- Отменён
- Формат:
- Электронный (PDF)
- Количество страниц:
- 4
- Дата публикации:
- 12 февраля 2019 г.
- Издание:
- ISO IS 5834 edition 4 version 1
- ICS:
- 11.040.40
This document specifies the requirements and corresponding test methods for moulding materials in powder form made from ultra-high-molecular-weight polyethylene (UHMWPE) for use in the manufacture of surgical implants. It is not applicable to finished products.
Abstract
Overview
ISO 5834-1:2019 is an international standard developed by the International Organization for Standardization (ISO) that specifies the requirements and test methods for ultra-high-molecular-weight polyethylene (UHMWPE) in powder form. This material is intended specifically for use in the manufacturing of surgical implants. The standard covers the powder molding material stage and does not apply to finished implant products. By setting clear guidelines on composition, contamination limits, and physical properties, ISO 5834-1:2019 ensures the quality and safety of UHMWPE powders used in medical implant production.
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