ISO 21534:2007
Current
Current
The latest, up-to-date edition.
Non-active surgical implants Joint replacement implants Particular requirements
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Language(s)
English, French, Russian
Published date
09-26-2007
ISO 21534:2007 specifies particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, referred to as implants in the text. For the purposes of this International Standard, artificial ligaments and their associated fixing devices are included in the term "implant".
ISO 21534:2007 specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information to be supplied by the manufacturer.
| DevelopmentNote |
Supersedes ISO/DIS 21534. (10/2007)
|
| DocumentType |
Standard
|
| Pages |
13
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| DIN EN ISO 21534:2009-08 | Identical |
| NF EN ISO 21534 : 2009 | Identical |
| GOST R ISO 21534 : 2013 | Identical |
| NBN EN ISO 21534 : 2009 | Identical |
| NEN EN ISO 21534 : 2009 | Identical |
| NS EN ISO 21534 : 2009 | Identical |
| I.S. EN ISO 21534:2009 | Identical |
| PN EN ISO 21534 : 2009 | Identical |
| SN EN ISO 21534 : 2009 | Identical |
| UNI EN ISO 21534 : 2009 | Identical |
| UNE-EN ISO 21534:2009 | Identical |
| BS EN ISO 21534:2009 | Identical |
| EN ISO 21534:2009 | Identical |
| DIN EN ISO 21534 E : 2009 | Identical |
| DIN EN 12010:1998-05 | Corresponds |
| UNE-EN ISO 21534:2008 | Identical |
| DIN EN ISO 21536 E : 2014 | NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR KNEE JOINT REPLACEMENT IMPLANTS (ISO 21536:2007 + AMD.1:2014) |
| BS ISO 7206-12:2016 | Implants for surgery. Partial and total hip joint prostheses Deformation test method for acetabular shells |
| 15/30296038 DC : 0 | BS ISO 7206-12 - IMPLANTS FOR SURGERY - PARTIAL AND TOTAL HIP JOINT PROSTHESES - PART 12: DEFORMATION TEST FOR ACETABULAR SHELLS |
| UNE-EN ISO 21535:2009 | Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2007) |
| ISO 16142-1:2016 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
| I.S. EN ISO 21536:2009 | NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR KNEE-JOINT REPLACEMENT IMPLANTS (ISO 21536:2007) |
| EN ISO 21535:2009/A1:2016 | NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR HIP-JOINT REPLACEMENT IMPLANTS (ISO 21535:2007/AMD 1:2016) |
| DIN EN ISO 21535:2017-04 | NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR HIP-JOINT REPLACEMENT IMPLANTS (ISO 21535:2007 + AMD 1:2016) |
| 06/30143831 DC : DRAFT JUN 2006 | ISO 21535 - NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR HIP-JOINT REPLACEMENT IMPLANTS |
| ISO 7206-1:2008 | Implants for surgery — Partial and total hip joint prostheses — Part 1: Classification and designation of dimensions |
| BS EN ISO 21535 : 2009 | NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR HIP-JOINT REPLACEMENT IMPLANTS (ISO 21535:2007) |
| BS EN ISO 14630:2012 | Non-active surgical implants. General requirements |
| I.S. EN ISO 14630:2012 | NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 14630:2012) |
| BS ISO 16142-1:2016 | Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
| 04/300654 DC : DRAFT JAN 2004 | BS EN ISO 14630 - NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| BS ISO 7207-1:2007 | Implants for surgery. Components for partial and total knee joint prostheses Classification, definitions and designation of dimensions |
| BS EN ISO 21536 : 2009 | NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR KNEE-JOINT REPLACEMENT IMPLANTS (ISO 21536:2007) |
| ISO 7206-12:2016 | Implants for surgery — Partial and total hip joint prostheses — Part 12: Deformation test method for acetabular shells |
| UNI EN ISO 14630 : 2013 | NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| DIN EN ISO 21535:2009-08 | NICHTAKTIVE CHIRURGISCHE IMPLANTATE - IMPLANTATE ZUM GELENKERSATZ - BESONDERE ANFORDERUNGEN AN IMPLANTATE FUER DEN HUEFTGELENKERSATZ (ISO 21535:2007 + AMD 1:2016) |
| DIN EN ISO 21536:2014-07 | NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR KNEE-JOINT REPLACEMENT IMPLANTS (ISO 21536:2007 + AMD.1:2014) |
| BS ISO 7206-1:2008 | Implants for surgery. Partial and total hip joint prostheses Classification and designation of dimensions |
| 15/30316683 DC : 0 | BS EN ISO 21535:2009/AMD 1 - NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR HIP-JOINT REPLACEMENT IMPLANTS |
| DIN EN ISO 21535 E : 2017 | NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR HIP-JOINT REPLACEMENT IMPLANTS (ISO 21535:2007 + AMD 1:2016) |
| ISO 7207-1:2007 | Implants for surgery Components for partial and total knee joint prostheses Part 1: Classification, definitions and designation of dimensions |
| DIN EN ISO 14630:2013-03 | Non-active surgical implants - General requirements (ISO 14630:2012) |
| UNE-EN ISO 14630:2013 | Non-active surgical implants - General requirements (ISO 14630:2012) |
| ISO 21536:2007 | Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants |
| ISO 21535:2007 | Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants |
| EN ISO 14630:2012 | Non-active surgical implants - General requirements (ISO 14630:2012) |
| 06/30143888 DC : DRAFT JUN 2006 | ISO 21536 - NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR KNEE-JOINT REPLACEMENT IMPLANTS |
| I.S. EN ISO 21535:2009 | NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR HIP-JOINT REPLACEMENT IMPLANTS (ISO 21535:2007) |
| ISO 14630:2012 | Non-active surgical implants General requirements |
| EN ISO 21536:2009/A1:2014 | NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR KNEE-JOINT REPLACEMENT IMPLANTS (ISO 21536:2007/AMD 1:2014) |
| BS 6324-3:1983 | Terms relating to surgical implants Glossary of terms relating to materials |
| BS 6324-2:1983 | Terms relating to surgical implants Glossary of terms relating to mechanics |
| ISO 4287:1997 | Geometrical Product Specifications (GPS) — Surface texture: Profile method — Terms, definitions and surface texture parameters |
| ISO 14242-1:2014 | Implants for surgery Wear of total hip-joint prostheses Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test |
| ISO 7206-8:1995 | Implants for surgery — Partial and total hip joint prostheses — Part 8: Endurance performance of stemmed femoral components with application of torsion |
| ASTM F 1357 : 2014 : REDLINE | Standard Specification for Articulating Total Wrist Implants |
| BS 6324-5:1990 | Terms relating to surgical implants Guidance on the usage of the terms \'valgus\' and \'varus\' in orthopaedic surgery |
| ISO 7206-4:2010 | Implants for surgery Partial and total hip joint prostheses Part 4: Determination of endurance properties and performance of stemmed femoral components |
| ISO 14155-1:2003 | Clinical investigation of medical devices for human subjects Part 1: General requirements |
| ISO 14242-2:2016 | Implants for surgery — Wear of total hip-joint prostheses — Part 2: Methods of measurement |
| ASTM F 370 : 1994 : R1999 | Standard Specification for Proximal Femoral Endoprosthesis (Withdrawn 2005) |
| ISO 7206-6:2013 | Implants for surgery — Partial and total hip joint prostheses — Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components |
| ISO/TR 9326:1989 | Implants for surgery Partial and total hip joint prostheses Guidance for laboratory evaluation of change of form of bearing surfaces |
| ISO/TR 9325:1989 | Implants for surgery Partial and total hip joint prostheses Recommendations for simulators for evaluation of hip joint prostheses |
| ISO 14630:2012 | Non-active surgical implants General requirements |
| ISO 9584:1993 | Implants for surgery — Non-destructive testing — Radiographic examination of cast metallic surgical implants |
| ISO 7207-2:2011 | Implants for surgery — Components for partial and total knee joint prostheses — Part 2: Articulating surfaces made of metal, ceramic and plastics materials |
| BS 6324-1:1983 | Terms relating to surgical implants Glossary of general medical terms |
| ISO 9583:1993 | Implants for surgery — Non-destructive testing — Liquid penetrant inspection of metallic surgical implants |
| ASTM F 1223 : 2014 : REDLINE | Standard Test Method for Determination of Total Knee Replacement Constraint |
| ISO 14879-1:2000 | Implants for surgery Total knee-joint prostheses Part 1: Determination of endurance properties of knee tibial trays |
| ISO 7206-2:2011 | Implants for surgery — Partial and total hip joint prostheses — Part 2: Articulating surfaces made of metallic, ceramic and plastics materials |
| ISO 8828:2014 | Implants for surgery Guidance on care and handling of orthopaedic implants |
| ISO 7207-1:2007 | Implants for surgery Components for partial and total knee joint prostheses Part 1: Classification, definitions and designation of dimensions |
| ISO 14243-3:2014 | Implants for surgery Wear of total knee-joint prostheses Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test |
| ISO 7206-1:2008 | Implants for surgery — Partial and total hip joint prostheses — Part 1: Classification and designation of dimensions |
| ISO 14243-1:2009 | Implants for surgery Wear of total knee-joint prostheses Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test |
| ASTM F 604 : 1994 | Specification for Silicone Elastomers Used in Medical Applications (Withdrawn 2001) |
| ISO 14243-2:2016 | Implants for surgery — Wear of total knee-joint prostheses — Part 2: Methods of measurement |
| BS 6324-4:1983 | Terms relating to surgical implants Glossary of orthopaedic surgical terms |
| NFS 94 065 : 1998 | MATERIALS FOR SURGICAL IMPLANTS - DETERMINATION OF ARSENIC, MERCURY, CADMIUM AND LEAD ON COATINGS BASED ON PHOSPHATE OF CALCIUM |
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