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BS EN 12010:1998

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Non-active surgical implants. Joint replacement implants. Particular requirements
Available format(s)

Hardcopy , PDF

Superseded date

30-09-2008

Language(s)

English

Published date

15-07-1998

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Superseded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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