EN ISO 14630:2012
Withdrawn
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Non-active surgical implants - General requirements (ISO 14630:2012)
Withdrawn date
30-06-2013
Published date
01-12-2012
Publisher
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 Design attributes
6 Materials
7 Design evaluation
8 Manufacture
9 Sterilization
10 Packaging
11 Information supplied by the manufacturer
Bibliography
Annex ZA (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive 93/42/EEC
ISO 14630:2012 specifies general requirements for non-active surgical implants. ISO 14630:2012 is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal tissue.With regard to safety, ISO 14630:2012 specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements.
| Committee |
CEN/TC 285
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Withdrawn
|
| Standards | Relationship |
| SS-EN ISO 14630:2012 | Identical |
| UNI EN ISO 14630 : 2013 | Identical |
| ISO 14630:2012 | Identical |
| NBN EN ISO 14630 : 2013 | Identical |
| UNE-EN ISO 14630:2013 | Identical |
| I.S. EN ISO 14630:2012 | Identical |
| NF EN ISO 14630 : 2013 | Identical |
| NS EN ISO 14630 : 2012 | Identical |
| SN EN ISO 14630:2013 | Identical |
| NEN EN ISO 14630 : 2012 | Identical |
| BS EN ISO 14630:2012 | Identical |
| PN EN ISO 14630 : 2013 | Identical |
| DIN EN ISO 14630:2013-03 | Identical |
| I.S. EN 12180:2000 | NON-ACTIVE SURGICAL IMPLANTS - BODY CONTOURING IMPLANTS - SPECIFIC REQUIREMENTS FOR MAMMARY IMPLANTS |
| BS EN ISO 16671 : 2015 | OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY |
| I.S. CEN TS 15277:2006 | NON-ACTIVE SURGICAL IMPLANTS - INJECTABLE IMPLANTS |
| I.S. EN 16844:2017+A2:2019 | Aesthetic medicine services - Non-surgical medical treatments |
| BS EN 12006-2 : 1998 | NON-ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - PART 2: VASCULAR PROSTHESES INCLUDING CARDIAC VALVE CONDUITS |
| UNE-EN ISO 16672:2016 | Ophthalmic implants - Ocular endotamponades (ISO 16672:2015) |
| EN 12011 : 1998 | INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| EN 12564 : 1998 | NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR KNEE JOINT REPLACEMENT IMPLANTS |
| EN ISO 11979-8:2017 | Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2017) |
| EN 12180 : 2000 | NON-ACTIVE SURGICAL IMPLANTS - BODY CONTOURING IMPLANTS - SPECIFIC REQUIREMENTS FOR MAMMARY IMPLANTS |
| EN 12006-3:1998+A1:2009 | Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices |
| I.S. EN 12563:1999 | NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR HIP JOINT REPLACEMENT IMPLANTS |
| 01/564791 DC : DRAFT NOV 2001 | BS EN 14299 - NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - SPECIFIC REQUIREMENTS FOR ARTERIAL STENTS |
| 13/30278952 DC : 0 | BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES |
| I.S. EN 16844:2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
| BS EN ISO 21535 : 2009 | NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR HIP-JOINT REPLACEMENT IMPLANTS (ISO 21535:2007) |
| BS EN 14299:2004 | Non-active surgical implants. Particular requirements for cardiac and vascular implants. Specific requirements for arterial stents |
| BS EN 12564:1999 | Non-active surgical implants. Joint replacement implants. Specific requirements for knee joint replacement implants |
| BS EN 12010:1998 | Non-active surgical implants. Joint replacement implants. Particular requirements |
| DIN EN 12006-3:2009-08 | NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - PART 3: ENDOVASCULAR DEVICES |
| DIN EN 12006-3:1999-01 | NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - PART 3: ENDOVASCULAR DEVICES |
| I.S. EN ISO 11979-8:2017 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS (ISO 11979-8:2017) |
| I.S. EN ISO 16672:2015 | OPHTHALMIC IMPLANTS - OCULAR ENDOTAMPONADES (ISO 16672:2015) |
| DIN EN 14299:2004-08 | NON-ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - SPECIFIC REQUIREMENTS FOR ARTERIAL STENTS |
| I.S. EN 14299:2004 | NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - SPECIFIC REQUIREMENTS FOR ARTERIAL STENTS |
| I.S. EN 12010:1998 | NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - PARTICULAR REQUIREMENTS |
| 15/30317874 DC : 0 | BS EN 16844 - AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
| UNE-EN 16372:2015 | Aesthetic surgery services |
| 12/30254927 DC : 0 | BS EN 16372 - AESTHETIC SURGERY SERVICES |
| I.S. EN 16372:2014 | AESTHETIC SURGERY SERVICES |
| EN 16844:2017 | Aesthetic medicine services - Non-surgical medical treatments |
| I.S. EN ISO 16671:2015 | OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY (ISO 16671:2015) |
| BS EN 12006-1:1999 | Non-active surgical implants. Particular requirements for cardiac and vascular implants Heart valve substitutes |
| I.S. EN 12006-2:1998 | NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - PART 2: VASCULAR PROSTHESES INCLUDING CARDIAC VALVE CONDUITS |
| UNI EN 12006-3 : 2009 | NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - PART 3: ENDOVASCULAR DEVICES |
| UNI EN 12006-2 : 2009 | NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - PART 2: VASCULAR PROSTHESES INCLUDING CARDIAC VALVE CONDUITS |
| UNI CEN/TS 15277 : 2007 | NON-ACTIVE SURGICAL IMPLANTS - INJECTABLE IMPLANTS |
| I.S. EN 12564:1999 | NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR KNEE JOINT REPLACEMENT IMPLANTS |
| I.S. EN 12011:1998 | INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| UNE-EN ISO 7198:2017 | Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016) |
| I.S. EN ISO 15798:2013 | OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013) |
| I.S. EN ISO 25539-1:2017 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
| BS EN 12011:1998 | Instrumentation to be used in association with non-active surgical implants. General requirements |
| ISO 16672:2015 | Ophthalmic implants Ocular endotamponades |
| BS EN 12180:2000 | Non-active surgical implants. Body contouring implants. Specific requirements for mammary implants |
| EN 16372:2014 | Aesthetic surgery services |
| EN ISO 7198:2017 | Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016) |
| EN 12006-2:1998+A1:2009 | Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits |
| EN 14299:2004 | Non active surgical implants - Particular requirements for cardiac and vascular implants - Specific requirements for arterial stents |
| BS EN ISO 25539-1:2017 | Cardiovascular implants. Endovascular devices Endovascular prostheses |
| BS EN ISO 7198:2017 | Cardiovascular implants and extracorporeal systems. Vascular prostheses. Tubular vascular grafts and vascular patches |
| BS EN 16372:2014 | Aesthetic surgery services |
| BIP 0113 : 2012 | GUIDE TO EUROPEAN MEDICAL DEVICE TRIALS AND BS EN ISO 14155 |
| UNE-EN ISO 16671:2016 | Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015) |
| I.S. EN ISO 7198:2017 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR PROSTHESES - TUBULAR VASCULAR GRAFTS AND VASCULAR PATCHES (ISO 7198:2016) |
| ISO 16671:2015 | Ophthalmic implants — Irrigating solutions for ophthalmic surgery |
| BS EN 16844 : 2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS |
| DIN EN 12006-2:2009-08 | NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - PART 2: VASCULAR PROSTHESES INCLUDING CARDIAC VALVE CONDUITS |
| BS EN 12006-3 : 1999 | NON-ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - PART 3: ENDOVASCULAR DEVICES |
| BS EN 12563:1999 | Non-active surgical implants. Joint replacement implants. Specific requirements for hip joint replacement implants |
| EN 12010 : 1998 | NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - PARTICULAR REQUIREMENTS |
| CEN/TS 15277:2006 | Non-active surgical implants - Injectable implants |
| EN 12006-1 : 1999 | NON-ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - HEART VALVE SUBSTITUTES |
| ISO 11137-1:2006 | Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 14160:2011 | Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices |
| IEC 60068-2-27:2008 | Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock |
| MEDDEV 2.12-1 : REV 8 : 2013 | GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM |
| EN 12006-2:1998+A1:2009 | Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits |
| ISO 21534:2007 | Non-active surgical implants Joint replacement implants Particular requirements |
| ISO 5840:2005 | Cardiovascular implants Cardiac valve prostheses |
| ASTM F 2503 : 2013 : REDLINE | Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO 14937:2009 | Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
| CFR 21(PTS800-1299) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299 |
| IEC 60601-2-33:2010+AMD1:2013+AMD2:2015 CSV | Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis |
| ISO 21536:2007 | Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants |
| IEC 60068-2-31:2008 | Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-type specimens |
| ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management |
| ISO 11135-1:2007 | Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO/TR 14283:2004 | Implants for surgery Fundamental principles |
| ISO/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in standards |
| ISO 14602:2010 | Non-active surgical implants — Implants for osteosynthesis — Particular requirements |
| ASTM F 2052 : 2015 : REDLINE | Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment |
| IEC 60068-2-47:2005 | Environmental testing - Part 2-47: Test - Mounting of specimens for vibration, impact and similar dynamic tests |
| ISO 16061:2015 | Instrumentation for use in association with non-active surgical implants General requirements |
| ISO 8601:2004 | Data elements and interchange formats Information interchange Representation of dates and times |
| ISO 13408-1:2008 | Aseptic processing of health care products — Part 1: General requirements |
| ASTM F 2213 : 2017 : REDLINE | Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment |
| ISO 10993-7:2008 | Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals |
| ISO 11137-2:2013 | Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 22442-2:2015 | Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling |
| ISO 25539-3:2011 | Cardiovascular implants — Endovascular devices — Part 3: Vena cava filters |
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects Good clinical practice |
| ISO 22442-3:2007 | Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents |
| ISO 7197:2006 | Neurosurgical implants — Sterile, single-use hydrocephalus shunts and components |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 7000:2014 | Graphical symbols for use on equipment Registered symbols |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ISO 14607:2007 | Non-active surgical implants Mammary implants Particular requirements |
| ISO 17664:2017 | Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices |
| ISO 12891-1:2015 | Retrieval and analysis of surgical implants — Part 1: Retrieval and handling |
| ISO 21535:2007 | Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants |
| ISO 17665-1:2006 | Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO 16429:2004 | Implants for surgery — Measurements of open-circuit potential to assess corrosion behaviour of metallic implantable materials and medical devices over extended time periods |
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