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ISO 5834-2:2011

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

View Superseded by

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

Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Withdrawn date

02-03-2019

Superseded by

ISO 5834-2:2019

Language(s)

English, Russian

Published date

02-08-2011

€60.00
Excluding VAT

ISO 5834-2:2011 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.

ISO 5834-2:2011 is not applicable to direct-moulded (near net shape), irradiated or finished products or products manufactured from polyethylene blended with additives or from blending of different forms of polyethylene.

DevelopmentNote
DRAFT ISO/DIS 5834-2 is also available for this standard. (10/2017)
DocumentType
Standard
Pages
5
PublisherName
International Organization for Standardization
Status
Withdrawn
SupersededBy
Supersedes

Standards Relationship
BS ISO 5834-2:2011 Identical
GOST R ISO 5834-2 : 2014 Identical
DIN ISO 5834-2:2014-02 Identical
DIN 58836:1979-06 Similar to
NF ISO 5834-2 : 2006 Identical
BS 3531-21:1986 Identical
BS 7253-5:1990 Similar to

ASTM F 2759 : 2011 : REDLINE Standard Guide for Assessment of the Ultra High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices
BS ISO 5834-4:2005 Implants for surgery. Ultra-high molecular weight polyethylene Oxidation index measurement method
17/30360584 DC : 0 BS ISO 5834-3 - IMPLANTS FOR SURGERY - ULTRA-HIGH-MOLECULAR-WEIGHT POLYETHYLENE - PART 3: ACCELERATED AGEING METHODS
BS 7253-5:1990 Non-metallic materials for surgical implants Specification for ultra-high molecular mass polyethylene in moulded form
11/30229855 DC : 0 BS ISO 5834-4 - IMPLANTS FOR SURGERY - ULTRA-HIGH-MOLECULAR-WEIGHT POLYETHYLENE - PART 4: OXIDATION INDEX MEASUREMENT METHOD
BS ISO 5834-3:2005 Implants for surgery. Ultra-high-molecular-weight polyethylene Accelerated ageing methods
BS ISO 5834-5:2005 Implants for surgery. Ultra-high molecular weight polyethylene Morphology assessment method
ISO 5834-5:2005 Implants for surgery Ultra-high-molecular-weight polyethylene Part 5: Morphology assessment method
BS ISO 12891-2:2014 Retrieval and analysis of surgical implants Analysis of retrieved surgical implants
BS EN ISO 10993-6:2016 Biological evaluation of medical devices Tests for local effects after implantation
BS EN 12010:1998 Non-active surgical implants. Joint replacement implants. Particular requirements
I.S. EN ISO 10993-6:2016 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION (ISO 10993-6:2016)
BS 7251-7:1990 Orthopaedic joint prostheses Guide to hip joint simulators
03/317992 DC : DRAFT DEC 2003 BS ISO 5834-4 - IMPLANTS FOR SURGERY - ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE - PART 4: MEASUREMENT OF OXIDATION INDEX
ANSI/AAMI/ISO 10993-6:2016 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION
17/30360587 DC : 0 BS ISO 5834-4 - IMPLANTS FOR SURGERY - ULTRA-HIGH-MOLECULAR-WEIGHT POLYETHYLENE - PART 4: OXIDATION INDEX MEASUREMENT METHOD
04/30031040 DC : 0 ISO 5834-3 - IMPLANTS FOR SURGERY - ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE - PART 3: ACCELERATED AGEING METHODS
14/30261590 DC : 0 BS EN ISO 10993-6 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION
04/30099319 DC : DRAFT APR 2004 ISO 5834-5 - IMPLANTS FOR SURGERY - ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE - PART 5: MORPHOLOGY ASSESSMENT METHOD
BS ISO 14879-1:2000 Implants for surgery. Total knee-joint prostheses Determination of endurance properties of knee tibial trays
13/30242622 DC : 0 BS ISO 12891-2 - RETRIEVAL AND ANALYSIS OF SURGICAL IMPLANTS - PART 2: ANALYSIS OF RETRIEVED SURGICAL IMPLANTS
CSA ISO 10993-6 : 1997(R2009) BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION
ISO 12891-2:2014 Retrieval and analysis of surgical implants Part 2: Analysis of retrieved surgical implants
ISO 5834-3:2005 Implants for surgery Ultra-high-molecular-weight polyethylene Part 3: Accelerated ageing methods
BS EN 30993-6:1995 Biological evaluation of medical devices Tests for local effects after implantation
EN ISO 10993-6:2016 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
17/30360590 DC : 0 BS ISO 5834-5 - IMPLANTS FOR SURGERY - ULTRA-HIGH-MOLECULAR-WEIGHT POLYETHYLENE - PART 5: MORPHOLOGY ASSESSMENT METHOD
ASTM F 2887 : 2017 : REDLINE Standard Specification for Total Elbow Prostheses
ISO 5834-4:2005 Implants for surgery Ultra-high-molecular-weight polyethylene Part 4: Oxidation index measurement method
DIN EN ISO 10993-6:2009-08 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION (ISO 10993-6:2016)
ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local effects after implantation
DIN EN ISO 10993-6:2017-09 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION (ISO 10993-6:2016)

ISO 5834-1:2005 Implants for surgery Ultra-high-molecular-weight polyethylene Part 1: Powder form
ISO 3451-1:2008 Plastics Determination of ash Part 1: General methods
ISO 11542-2:1998 Plastics Ultra-high-molecular-weight polyethylene (PE-UHMW) moulding and extrusion materials Part 2: Preparation of test specimens and determination of properties
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 11542-1:2001 Plastics Ultra-high-molecular-weight polyethylene (PE-UHMW) moulding and extrusion materials Part 1: Designation system and basis for specifications
ASTM F 648 : 2014 : REDLINE Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
ISO 527-1:2012 Plastics Determination of tensile properties Part 1: General principles

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