I.S. 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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
02-02-2009
English
01-01-1998
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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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 Manufacturing
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 to be used in association with non-active surgical implants.
| DocumentType |
Standard
|
| Pages |
30
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NF EN 12011 : 1998 | Identical |
| UNE-EN 12011:1998 | Identical |
| NEN EN 12011 : 1998 | Identical |
| NBN EN 12011 : 1998 | Identical |
| UNI EN 12011 : 2000 | Identical |
| SN EN 12011 : 1998 | Identical |
| NS EN 12011 : 1ED 1998 | Identical |
| EN 12011 : 1998 | Identical |
| BS 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 |
| EN ISO 10993-10:2013 | Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010) |
| EN ISO 10993-7 : 2008 COR 2009 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS (ISO 10993-7:2008/COR 1:2009) |
| 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 |
| 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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