BS EN 12010:1998
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Non-active surgical implants. Joint replacement implants. Particular requirements
Hardcopy , PDF
30-09-2008
English
15-07-1998
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Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Intended performance
5 Design attributes
6 Materials
7 Design evaluation
8 Manufacture and inspection
9 Sterilization
10 Packaging
11 Information supplied by the manufacturer
Annex A (informative) List of materials found acceptable
for the manufacture of implants
Annex B (informative) List of materials found acceptable or
not acceptable for articulating surfaces of implants
Annex C (informative) List of materials found acceptable or
non-acceptable for metallic combinations for nonarticulating
contacting surfaces of implants
Annex D (informative) Bibliography
Annex ZA (informative) Clauses of this European Standard
addressing essential requirements or other provisions of
EU Directives
Defines particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement. Defines requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturers.
| Committee |
CH/150/4
|
| DevelopmentNote |
Supersedes 95/561848 DC. (08/2005)
|
| DocumentType |
Standard
|
| Pages |
12
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| UNE-EN 12010:1998 | Identical |
| NEN EN 12010 : 1998 | Identical |
| NBN EN 12010 : 1998 | Identical |
| SN EN 12010 : 1998 | Identical |
| NS EN 12010 : 1ED 1998 | Identical |
| NF EN 12010 : 1998 | Identical |
| UNI EN 12010 : 2000 | Identical |
| I.S. EN 12010:1998 | Identical |
| EN 12010 : 1998 | Identical |
| DIN EN 12010:1998-05 | Identical |
| BS 6324-3:1983 | Terms relating to surgical implants Glossary of terms relating to materials |
| ISO 5832-1:2016 | Implants for surgery — Metallic materials — Part 1: Wrought stainless steel |
| BS 6324-2:1983 | Terms relating to surgical implants Glossary of terms relating to mechanics |
| ISO 5834-1:2005 | Implants for surgery Ultra-high-molecular-weight polyethylene Part 1: Powder form |
| ISO 5832-11:2014 | Implants for surgery — Metallic materials — Part 11: Wrought titanium 6-aluminium 7-niobium alloy |
| 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 |
| ISO 5832-6:1997 | Implants for surgery Metallic materials Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy |
| ASTM F 1351 : 1996 | Standard Practice for Determination of the Effect of Hard Creasing Paper on Images Produced by Business Imaging Systems |
| ISO 5832-5:2005 | Implants for surgery Metallic materials Part 5: Wrought cobalt-chromium-tungsten-nickel alloy |
| BS 6324-5:1990 | Terms relating to surgical implants Guidance on the usage of the terms \'valgus\' and \'varus\' in orthopaedic surgery |
| ISO 5832-3:2016 | Implants for surgery Metallic materials Part 3: Wrought titanium 6-aluminium 4-vanadium alloy |
| ISO 7206-5:1992 | Implants for surgery Partial and total hip joint prostheses Part 5: Determination of resistance to static load of head and neck region of stemmed femoral components |
| ISO 5832-10:1996 | Implants for surgery — Metallic materials — Part 10: Wrought titanium 5-aluminium 2,5-iron alloy |
| 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 7206-9:1994 | Implants for surgery Partial and total hip joint prostheses Part 9: Determination of resistance to torque of head fixation of stemmed femoral components |
| 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 5832-8:1997 | Implants for surgery Metallic materials Part 8: Wrought cobalt-nickel-chromium-molybdenum- tungsten-iron alloy |
| 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 13356:2015 | Implants for surgery — Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) |
| 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 |
| ISO 5833:2002 | Implants for surgery — Acrylic resin cements |
| ISO 5832-4:2014 | Implants for surgery — Metallic materials — Part 4: Cobalt-chromium-molybdenum casting alloy |
| 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 |
| ISO 5834-2:2011 | Implants for surgery Ultra-high-molecular-weight polyethylene Part 2: Moulded forms |
| ISO 5832-2:1999 | Implants for surgery Metallic materials Part 2: Unalloyed titanium |
| ISO 6474:1994 | Implants for surgery Ceramic materials based on high purity alumina |
| ISO 5832-7:2016 | Implants for surgery — Metallic materials — Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy |
| ASTM F 1223 : 2014 : REDLINE | Standard Test Method for Determination of Total Knee Replacement Constraint |
| 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 6018:1987 | Orthopaedic implants General requirements for marking, packaging and labelling |
| ISO 7206-1:2008 | Implants for surgery — Partial and total hip joint prostheses — Part 1: Classification and designation of dimensions |
| ASTM F 604 : 1994 | Specification for Silicone Elastomers Used in Medical Applications (Withdrawn 2001) |
| ISO 5832-12:2007 | Implants for surgery Metallic materials Part 12: Wrought cobalt-chromium-molybdenum alloy |
| EN ISO 14630:2012 | Non-active surgical implants - General requirements (ISO 14630:2012) |
| ISO 5832-9:2007 | Implants for surgery Metallic materials Part 9: Wrought high nitrogen stainless steel |
| 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 |
| ISO 5839:1985 | Implants for surgery Orthopaedic joint prostheses Basic requirements |
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