ISO 5834-2:2011
Withdrawn
View Superseded by
Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 2: Moulded forms
Hardcopy , PDF
English, Russian
08-02-2011
04-09-2025
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.
| Committee |
ISO/TC 150/SC 1
|
| 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Withdrawn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 |
| DS ISO 5834-2 : 2014 | 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 |
| 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 |