EN ISO 14630:2012
Current
The latest, up-to-date edition.
Non-active surgical implants - General requirements (ISO 14630:2012)
01-12-2012
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 |
Current
|
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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