BS EN 12011:1998
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Instrumentation to be used in association with non-active surgical implants. General requirements
Hardcopy , PDF
05-31-2009
English
05-15-1998
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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
9 Sterilization
10 Packaging
11 Information supplied by the manufacturer
Annex A (informative) Bibliography
Annex B (informative) A listing of some of the materials
found acceptable for instrument manufacture together with
typical applications
Annex C (informative) Clauses of this European Standard
addressing essential requirements or other provisions of
EU Directives
Defines general requirements for instruments for use in association with non-active surgical implants. Applicable to instruments at the time of manufacture and when they are re-supplied following refurbishment. Applicable to instruments for connection to powered driven systems, but not to the powered driven system itself. Does not apply to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants. Regarding safety, states requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer.
| Committee |
CH/150
|
| DevelopmentNote |
Supersedes 95/561813 DC. (08/2005)
|
| DocumentType |
Standard
|
| Pages |
14
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| UNE-EN 12011:1998 | Identical |
| NEN EN 12011 : 1998 | Identical |
| I.S. EN 12011:1998 | Identical |
| UNI EN 12011 : 2000 | Identical |
| NBN EN 12011 : 1998 | Identical |
| SN EN 12011 : 1998 | Identical |
| NS EN 12011 : 1ED 1998 | Identical |
| EN 12011 : 1998 | Identical |
| NF EN 12011 : 1998 | Identical |
| DIN EN 12011:1998-03 | Identical |
| EN ISO 14602:2011 | Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010) |
| EN 556:1994 + A1:1998 | STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE" |
| ISO 10993-3:2014 | Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity |
| ISO 10993-4:2017 | Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood |
| EN 550 : 1994 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION |
| EN 30993-4 : 1993 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD |
| EN ISO 10993-11:2009 | Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006) |
| EN 1441 : 1997 | MEDICAL DEVICES - RISK ANALYSIS |
| ISO 7151:1988 | Surgical instruments — Non-cutting, articulated instruments — General requirements and test methods |
| EN 46001 : 1996 | QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001 |
| EN 30993-3 : 1993 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY |
| EN 540 : 1993 | CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS |
| EN 868-1 : 1997 | PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - GENERAL REQUIREMENTS AND TEST METHODS |
| EN 724 : 1994 | GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR NON-ACTIVE MEDICAL DEVICES |
| EN 1174-1 : 1996 | STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - REQUIREMENTS |
| EN 12010 : 1998 | NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - PARTICULAR REQUIREMENTS |
| ISO 4957:1999 | Tool steels |
| ISO 10993-2:2006 | Biological evaluation of medical devices — Part 2: Animal welfare requirements |
| ISO 14630:2012 | Non-active surgical implants — General requirements |
| EN 30993-6 : 1994 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| EN 60068-2-27:2009 | Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock |
| ISO 14602:2010 | Non-active surgical implants — Implants for osteosynthesis — Particular requirements |
| EN 552:1994/A2:2000 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION |
| ISO 10993-10:2010 | Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization |
| ISO 10993-11:2017 | Biological evaluation of medical devices — Part 11: Tests for systemic toxicity |
| ISO 10993-12:2012 | Biological evaluation of medical devices Part 12: Sample preparation and reference materials |
| ISO 10993-7:2008 | Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| EN 46002 : 1996 | QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002 |
| ISO 7153-1:2016 | Surgical instruments Materials Part 1: Metals |
| ISO 7740:1985 | Instruments for surgery Scalpels with detachable blades Fitting dimensions |
| ISO 10993-9:2009 | Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products |
| EN ISO 10993-12:2012 | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012) |
| ISO 8319-2:1986 | Orthopaedic instruments — Drive connections — Part 2: Screwdrivers for single slot head screws, screws with cruciate slot and cross-recessed head screws |
| EN 30993-5 : 1994 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - TESTS FOR CYTOTOXICITY - IN VITRO METHODS |
| EN 60068-2-32:1993 | Basic environmental testing procedures - Part 2: Tests - Test Ed: Free fall |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
| ISO 10993-6:2016 | Biological evaluation of medical devices Part 6: Tests for local effects after implantation |
| EN 554 : 1994 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT |
| EN ISO 14630:2012 | Non-active surgical implants - General requirements (ISO 14630:2012) |
| EN 60068-2-47:2005 | Environmental testing - Part 2-47: Tests - Mounting of specimens for vibration, impact and similar dynamic tests |
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