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ISO 5834-2:2025

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

General information

Valid from 04.07.2025
ICS Groups
11.040.40 Implants for surgery, prosthetics and orthotics
Directives or regulations
None

Standard history

Status
Date
Type
Name
04.07.2025
Main
ISO 5834-2:2025
12.02.2019
Main
ISO 5834-2:2019
This document specifies the requirements and corresponding test methods for moulded forms (e.g. sheets, rods and near net shape bars) made from ultra-high-molecular-weight polyethylene (UHMWPE) powder for use in the manufacture of surgical implants.
This document is not applicable to moulded forms that were intentionally irradiated, that were made from UHMWPE blended with additives or UHMWPE blended with different forms of polyethylene, and the packaged and sterilized finished implant.

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Paper
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Standard monitoring
English (PDF 977 KB)

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English