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Withdrawn
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Non-active surgical implants — General requirements
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Withdrawn date
09-04-2025
Superseded by
Language(s)
French, English, Russian
Published date
28-11-2012
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 |
ISO/TC 150
|
| DevelopmentNote |
Supersedes ISO/DIS 14630. (12/2012)
|
| DocumentType |
Standard
|
| Pages |
15
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| UNE-EN ISO 14630:2013 | Identical |
| NF EN ISO 14630 : 2013 | Identical |
| NBN EN ISO 14630 : 2013 | Identical |
| NEN EN ISO 14630 : 2012 | Identical |
| NS EN ISO 14630 : 2012 | Identical |
| I.S. EN ISO 14630:2012 | Identical |
| AS ISO 14630:2015 | Identical |
| PN EN ISO 14630 : 2013 | Identical |
| SN EN ISO 14630:2013 | Identical |
| UNI EN ISO 14630 : 2013 | Identical |
| SS-EN ISO 14630:2012 | Identical |
| BS EN ISO 14630:2012 | Identical |
| EN ISO 14630:2012 | Identical |
| DIN EN ISO 14630:2013-03 | Identical |
| DS EN ISO 14630 : 2013 | Identical |
| ONORM EN ISO 14630 : 2013 | Identical |
| IS 18076 : 2023 | Identical |
| GOST R ISO 14630 : 2011 | Identical |
| ANSI Z80.27 : 2014 | OPHTHALMICS - IMPLANTABLE GLAUCOMA DEVICES |
| DIN EN ISO 21536 E : 2014 | NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR KNEE JOINT REPLACEMENT IMPLANTS (ISO 21536:2007 + AMD.1:2014) |
| I.S. EN 12180:2000 | NON-ACTIVE SURGICAL IMPLANTS - BODY CONTOURING IMPLANTS - SPECIFIC REQUIREMENTS FOR MAMMARY IMPLANTS |
| BS EN ISO 5840-2:2015 | Cardiovascular implants. Cardiac valve prostheses Surgically implanted heart valve substitutes |
| DIN EN ISO 12417-1:2016-02 | Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015) |
| UNE-EN ISO 25539-3:2012 | Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011) |
| 01/563350 DC : DRAFT AUG 2001 | BS ISO 25539-1 - CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES |
| DIN EN ISO 7197:2009-08 | Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007) |
| 14/30295064 DC : 0 | BS EN ISO 16672 - OPHTHALMIC IMPLANTS - OCULAR ENDOTAMPONADES |
| 17/30336577 DC : 0 | BS EN ISO 20697 - STERILE DRAINAGE CATHETERS AND ACCESSORY DEVICES FOR SINGLE USE |
| I.S. EN 16844:2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
| BS EN ISO 25539-2:2012 | Cardiovascular implants. Endovascular devices Vascular stents |
| ANSI/AAMI/ISO 25539-1:2017 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES |
| ISO/TR 12417-2:2017 | Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information |
| I.S. EN ISO 14607:2009 | NON-ACTIVE SURGICAL IMPLANTS - MAMMARY IMPLANTS - PARTICULAR REQUIREMENTS (ISO 14607:2018) |
| DIN EN ISO 5840-3:2013-06 | Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013) |
| ANSI/AAMI/ISO 5840-3:2013 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES |
| UNE-EN ISO 21535:2009 | Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2007) |
| ISO/TS 17137:2014 | Cardiovascular implants and extracorporeal systems Cardiovascular absorbable implants |
| ISO 16142-1:2016 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
| ONORM EN ISO 14607 : 2009 | NON-ACTIVE SURGICAL IMPLANTS - MAMMARY IMPLANTS - PARTICULAR REQUIREMENTS |
| BIS IS/ISO 11979-8 : 2006 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS |
| NF EN ISO 25539-1 : 2018 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES |
| UNE-EN ISO 7198:2017 | Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016) |
| ISO 14607:2007 | Non-active surgical implants Mammary implants Particular requirements |
| ISO 15798:2013 | Ophthalmic implants — Ophthalmic viscosurgical devices |
| ISO/TS 12417:2011 | Cardiovascular implants and extracorporeal systems Vascular device-drug combination products |
| PD ISO/TS 17137:2014 | Cardiovascular implants and extracorporeal systems. Cardiovascular absorbable implants |
| ASTM F 3036 : 2013 | Standard Guide for Testing Absorbable Stents |
| DIN EN ISO 10555-4:2013-11 | Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2013) |
| 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 14602:2012 | Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010) |
| ISO 7198:2016 | Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches |
| BS EN ISO 22803:2005 | Dentistry. Membrane materials for guided tissue regeneration in oral and maxillofacial surgery. Contents of a technical file |
| ISO 25539-3:2011 | Cardiovascular implants — Endovascular devices — Part 3: Vena cava filters |
| UNE-EN ISO 16672:2016 | Ophthalmic implants - Ocular endotamponades (ISO 16672:2015) |
| I.S. EN ISO 10555-4:2013 | INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 4: BALLOON DILATATION CATHETERS (ISO 10555-4:2013) |
| EN 12011 : 1998 | INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| EN ISO 11979-8:2017 | Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2017) |
| EN ISO 25539-3:2011 | Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011) |
| DIN EN ISO 21535:2017-04 | Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2007 + Amd 1:2016) (includes Amendment :2016) |
| 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 |
| UNE-EN ISO 25539-2:2013 | Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012) |
| ISO 18192-1:2011 | Implants for surgery Wear of total intervertebral spinal disc prostheses Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test |
| 14/30251609 DC : 0 | BS EN ISO 12417-1 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS |
| BS ISO 5838-1:2013 | Implants for surgery. Metallic skeletal pins and wires General requirements |
| 06/30143831 DC : DRAFT JUN 2006 | ISO 21535 - NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR HIP-JOINT REPLACEMENT IMPLANTS |
| I.S. EN ISO 5840-3:2013 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES (ISO 5840-3:2013) |
| 14/30295067 DC : 0 | BS EN ISO 16671 - OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY |
| 13/30278952 DC : 0 | BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES |
| DIN EN ISO 25539-3:2012-03 | Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011) |
| 03/103026 DC : DRAFT JAN 2003 | BS EN ISO 5840 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
| AAMI ISO 5840 : 2005 : R2010 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
| BS ISO 15142-1:2003 | Implants for surgery. Metal intramedullary nailing systems Intramedullary nails |
| ANSI/AAMI/ISO 25539-2:2012 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS |
| AAMI ISO 5840 :2005 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
| ISO 5910:2018 | Cardiovascular implants and extracorporeal systems — Cardiac valve repair devices |
| UNI EN ISO 5840-3 : 2013 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES |
| ISO 8828:2014 | Implants for surgery Guidance on care and handling of orthopaedic implants |
| BS EN ISO 21535 : 2009 | NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR HIP-JOINT REPLACEMENT IMPLANTS (ISO 21535:2007) |
| AAMI ISO TIR 17137 : 2014 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CARDIOVASCULAR ABSORBABLE IMPLANTS |
| I.S. EN ISO 5840-1:2015 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS (ISO 5840-1:2015) |
| ISO 15142-2:2003 | Implants for surgery Metal intramedullary nailing systems Part 2: Locking components |
| ISO/TS 15539:2000 | Cardiovascular implants Endovascular prostheses |
| BS EN ISO 14607:2009 | Non-active surgical implants. Mammary implants. Particular requirements |
| UNI EN ISO 14607 : 2009 | NON-ACTIVE SURGICAL IMPLANTS - MAMMARY IMPLANTS - PARTICULAR REQUIREMENTS |
| ASTM F 2502 : 2017 : REDLINE | Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants |
| DIN EN ISO 22803:2006-01 | Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004) |
| DIN EN ISO 16672:2015-12 | Ophthalmic implants - Ocular endotamponades (ISO 16672:2015) |
| DIN EN ISO 9713:2009-08 | Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2002) |
| BS EN ISO 9713:2009 | Neurosurgical implants. Self-closing intracranial aneurysm clips |
| BS EN 14299:2004 | Non-active surgical implants. Particular requirements for cardiac and vascular implants. Specific requirements for arterial stents |
| BS EN ISO 7439:2015 | Copper-bearing contraceptive intrauterine devices. Requirements and tests |
| 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 |
| EN ISO 25539-2:2012 | Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012) |
| I.S. EN ISO 14602:2011 | NON-ACTIVE SURGICAL IMPLANTS - IMPLANTS FOR OSTEOSYNTHESIS - PARTICULAR REQUIREMENTS (ISO 14602:2010) |
| EN ISO 5840-2:2015 | Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015) |
| I.S. EN ISO 22794:2009 | DENTISTRY - IMPLANTABLE MATERIALS FOR BONE FILLING AND AUGMENTATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE |
| I.S. EN ISO 7439:2015 | COPPER-BEARING CONTRACEPTIVE INTRAUTERINE DEVICES - REQUIREMENTS AND TESTS (ISO 7439:2015) |
| DIN EN 12006-3:2009-08 | NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - PART 3: ENDOVASCULAR DEVICES |
| EN ISO 5840-1:2015 | Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015) |
| 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) |
| EN ISO 5840-3:2013 | Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013) |
| I.S. EN ISO 9713:2009 | NEUROSURGICAL IMPLANTS - SELF-CLOSING INTRACRANIAL ANEURYSM CLIPS |
| 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 |
| NF EN ISO 9713 : 2009 | NEUROSURGICAL IMPLANTS - SELF-CLOSING INTRACRANIAL ANEURYSM CLIPS |
| UNE-EN ISO 5840-2:2016 | Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015) |
| 16/30339831 DC : 0 | PD ISO/TR 14283 - IMPLANTS FOR SURGERY - ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE |
| 13/30242570 DC : 0 | BS ISO 8828 - IMPLANTS FOR SURGERY - GUIDANCE ON CARE AND HANDLING OF ORTHOPAEDIC IMPLANTS |
| 14/30270462 DC : 0 | BS EN ISO 5840-1 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS |
| BS EN ISO 7197:2009 | Neurosurgical implants. Sterile, single-use hydrocephalus shunts and components |
| 14/30290166 DC : 0 | BS ISO 16142-1 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 1: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL NON-IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
| BS ISO 18192-1 : 2011 | IMPLANTS FOR SURGERY - WEAR OF TOTAL INTERVERTEBRAL SPINAL DISC PROSTHESES - PART 1: LOADING AND DISPLACEMENT PARAMETERS FOR WEAR TESTING AND CORRESPONDING ENVIRONMENTAL CONDITIONS FOR TEST |
| I.S. EN ISO 21536:2009 | NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR KNEE-JOINT REPLACEMENT IMPLANTS (ISO 21536:2007) |
| BS EN ISO 12417-1:2015 | Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products General requirements |
| 17/30250386 DC : 0 | BS ISO 17327-1 - NON-ACTIVE SURGICAL IMPLANTS - IMPLANT COATING - PART 1: GENERAL REQUIREMENTS |
| DIN EN ISO 21534:2009-08 | NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - PARTICULAR REQUIREMENTS |
| 11/30217696 DC : 0 | BS ISO 23317 - IMPLANTS FOR SURGERY - IN VITRO EVALUATION FOR APATITE-FORMING ABILITY OF IMPLANT MATERIALS |
| BS ISO 16142-1:2016 | Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
| NF EN ISO 25539-2 : 2013 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS |
| UNE-EN 16372:2015 | Aesthetic surgery services |
| BS EN ISO 5840-1:2015 | Cardiovascular implants. Cardiac valve prostheses General requirements |
| 12/30254927 DC : 0 | BS EN 16372 - AESTHETIC SURGERY SERVICES |
| BS ISO 25539-1 : 2003 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES |
| BS EN ISO 5840-3:2013 | Cardiovascular implants. Cardiac valve prostheses Heart valve substitutes implanted by transcatheter techniques |
| 08/30178723 DC : DRAFT AUG 2008 | BS ISO 15798 - OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES |
| BS EN ISO 21536 : 2009 | NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR KNEE-JOINT REPLACEMENT IMPLANTS (ISO 21536:2007) |
| UNE-EN ISO 5840-1:2016 | Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015) |
| ISO 23317:2014 | Implants for surgery — In vitro evaluation for apatite-forming ability of implant materials |
| ISO 5838-1:2013 | Implants for surgery Metallic skeletal pins and wires Part 1: General requirements |
| DIN EN ISO 5840-2:2016-05 | Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015) |
| DIN EN ISO 5840-1:2015-12 | Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015) |
| AAMI ISO 25539-3 : 2011 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS |
| I.S. EN ISO 5840-2:2015 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES (ISO 5840-2:2015) |
| I.S. EN ISO 25539-2:2012 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS (ISO 25539-2:2012) |
| AAMI ISO 5840-1 : 2016 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS |
| I.S. EN 16372:2014 | AESTHETIC SURGERY SERVICES |
| NF EN ISO 7197 : 2009 | NEUROSURGICAL IMPLANTS - STERILE, SINGLE-USE HYDROCEPHALUS SHUNTS AND COMPONENTS |
| DIN EN ISO 14607:2009-08 | NON-ACTIVE SURGICAL IMPLANTS - MAMMARY IMPLANTS - PARTICULAR REQUIREMENTS |
| ISO 15142-1:2003 | Implants for surgery Metal intramedullary nailing systems Part 1: Intramedullary nails |
| NF EN ISO 14607 : 2009 | NON-ACTIVE SURGICAL IMPLANTS - MAMMARY IMPLANTS - PARTICULAR REQUIREMENTS |
| I.S. EN ISO 25539-3:2011 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS (ISO 25539-3:2011) |
| UNI EN ISO 25539-3 : 2012 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS |
| I.S. EN ISO 7197:2009 | NEUROSURGICAL IMPLANTS - STERILE, SINGLE-USE HYDROCEPHALUS SHUNTS AND COMPONENTS |
| 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) |
| DIN EN ISO 22794:2009-11 | Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007, corrected version 2009-01-15) |
| DIN EN ISO 7439:2015-08 | Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2015) |
| BS EN ISO 10555-4:2013 | Intravascular catheters. Sterile and single-use catheters Balloon dilatation catheters |
| ISO 7197:2006 | Neurosurgical implants — Sterile, single-use hydrocephalus shunts and components |
| ISO 5840:2005 | Cardiovascular implants Cardiac valve prostheses |
| UNE-EN ISO 7439:2015 | Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2015) |
| 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 ISO 5840 : 2009 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
| ONORM EN ISO 15798 : 2013 AMD 1 2018 | OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013) |
| 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 EN ISO 14602 : 2012 | NON-ACTIVE SURGICAL IMPLANTS - IMPLANTS FOR OSTEOSYNTHESIS - PARTICULAR REQUIREMENTS |
| UNI EN ISO 21534 : 2009 | NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - PARTICULAR REQUIREMENTS |
| UNI EN ISO 10555-4 : 2013 | INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 4: BALLOON DILATATION CATHETERS |
| DIN EN ISO 21535:2009-08 | NICHTAKTIVE CHIRURGISCHE IMPLANTATE - IMPLANTATE ZUM GELENKERSATZ - BESONDERE ANFORDERUNGEN AN IMPLANTATE FUER DEN HUEFTGELENKERSATZ (ISO 21535:2007 + AMD 1:2016) |
| 10/30196945 DC : 0 | BS ISO 25539-3 - CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS |
| BS ISO 15142-2:2003 | Implants for surgery. Metal intramedullary nailing systems Locking components |
| 99/565665 DC : DRAFT NOV 1999 | BS ISO 9713 NEUROSURGICAL IMPLANTS - SELF-CLOSING INTRACRANIAL ANEURYSM CLIPS |
| DIN EN ISO 21536:2014-07 | Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2007 + Amd.1:2014) (includes Amendment :2014) |
| UNI CEN/TS 15277 : 2007 | NON-ACTIVE SURGICAL IMPLANTS - INJECTABLE IMPLANTS |
| 06/30148728 DC : DRAFT APR 2006 | ISO 18192 - IMPLANTS FOR SURGERY - WEAR OF TOTAL INTERVERTEBRAL SPINAL DISC PROSTHESES - PART 1: LOADING AND DISPLACEMENT PARAMETERS FOR WEAR TESTING AND CORRESPONDING ENVIRONMENTAL CONDITIONS FOR TEST |
| I.S. EN 12010:1998 | NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - PARTICULAR REQUIREMENTS |
| I.S. EN 12011:1998 | INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| ISO 20697:2018 | Sterile drainage catheters and accessory devices for single use |
| BS ISO 23317:2014 | Implants for surgery. In vitro evaluation for apatite-forming ability of implant materials |
| BS EN ISO 25539-3:2011 | Cardiovascular implants. Endovascular devices Vena cava filters |
| 15/30316683 DC : 0 | BS EN ISO 21535:2009/AMD 1 - NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR HIP-JOINT REPLACEMENT IMPLANTS |
| 11/30219211 DC : 0 | BS EN ISO 5840-3 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY MINIMALLY INVASIVE TECHNIQUES |
| DIN EN ISO 7198:2017-07 | Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016) |
| UNI EN ISO 7197 : 2009 | NEUROSURGICAL IMPLANTS - STERILE, SINGLE-USE HYDROCEPHALUS SHUNTS AND COMPONENTS |
| 16/30337200 DC : 0 | BS EN ISO 11979-8 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS |
| BS EN ISO 21534:2009 | Non-active surgical implants. Joint replacement implants. Particular requirements |
| UNE-EN ISO 12417-1:2016 | Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015) |
| I.S. EN 16844:2017+A2:2019 | Aesthetic medicine services - Non-surgical medical treatments |
| UNI EN ISO 25539-2 : 2013 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS |
| DIN EN ISO 25539-2:2013-05 | Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012) |
| NF EN ISO 25539-3 : 2012 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS |
| AAMI ISO 12417-1 : 2015 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS |
| 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) |
| ISO 16671:2015 | Ophthalmic implants — Irrigating solutions for ophthalmic surgery |
| BS EN ISO 16671 : 2015 | OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY |
| EN ISO 14607:2018 | Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2018, Corrected version 2018-08) |
| DIN EN ISO 14602:2012-06 | Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010) |
| ISO 10555-4:2013 | Intravascular catheters — Sterile and single-use catheters — Part 4: Balloon dilatation catheters |
| ISO 21534:2007 | Non-active surgical implants Joint replacement implants Particular requirements |
| BS EN 12011:1998 | Instrumentation to be used in association with non-active surgical implants. General requirements |
| ISO 5840-3:2013 | Cardiovascular implants Cardiac valve prostheses Part 3: Heart valve substitutes implanted by transcatheter techniques |
| BS EN ISO 14602:2011 | Non-active surgical implants. Implants for osteosynthesis. Particular requirements |
| ISO 11979-8:2017 | Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements |
| ISO 16672:2015 | Ophthalmic implants — Ocular endotamponades |
| ISO 25539-2:2012 | Cardiovascular implants — Endovascular devices — Part 2: Vascular stents |
| ISO 7439:2015 | Copper-bearing contraceptive intrauterine devices — Requirements and tests |
| DIN EN ISO 11979-8:2016-04 (Draft) | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS (ISO 11979-8:2017) |
| ISO 5840-2:2015 | Cardiovascular implants Cardiac valve prostheses Part 2: Surgically implanted heart valve substitutes |
| BS EN ISO 5840:2009 | Cardiovascular implants. Cardiac valve prostheses |
| ISO 21536:2007 | Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants |
| ISO 12417-1:2015 | Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: General requirements |
| BS EN 12180:2000 | Non-active surgical implants. Body contouring implants. Specific requirements for mammary implants |
| UNE-EN ISO 11979-8:2017 | Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2017) |
| BS EN ISO 22794:2009 | Dentistry. Implantable materials for bone filling and augmentation in oral and maxillofacial surgery. Contents of a technical file |
| ISO 21535:2007 | Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants |
| ISO 22794:2007 | Dentistry Implantable materials for bone filling and augmentation in oral and maxillofacial surgery Contents of a technical file |
| EN 16372:2014 | Aesthetic surgery services |
| EN ISO 7197:2009 | Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007) |
| EN ISO 7198:2017 | Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016) |
| EN ISO 22803:2005 | Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004) |
| UNI EN ISO 9713 : 2009 | NEUROSURGICAL IMPLANTS - SELF-CLOSING INTRACRANIAL ANEURYSM CLIPS |
| EN ISO 14602:2011 | Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010) |
| 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 |
| EN ISO 22794:2009 | Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007, corrected version 2009-01-15) |
| EN ISO 12417-1:2015 | Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015) |
| EN ISO 9713:2009 | Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2002) |
| EN ISO 7439:2015 | Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2015) |
| EN ISO 10555-4:2013 | Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2013) |
| BS ISO 8828:2014 | Implants for surgery. Guidance on care and handling of orthopaedic implants |
| 11/30242625 DC : 0 | BS ISO 5838-1 - IMPLANTS FOR SURGERY - METALLIC SKELETAL PINS AND WIRES - PART 1: GENERAL REQUIREMENTS |
| AAMI ISO TIR 12417 : 2011 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS |
| 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 |
| DD ISO/TS 12417:2011 | Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products |
| UNE-EN ISO 5840-3:2013 | Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013) |
| 14/30281557 DC : 0 | BS EN ISO 7198 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR PROSTHESES - TUBULAR VASCULAR GRAFTS AND VASCULAR PATCHES |
| 06/30143888 DC : DRAFT JUN 2006 | ISO 21536 - NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR KNEE-JOINT REPLACEMENT IMPLANTS |
| 16/30310949 DC : 0 | BS ISO 5910 - CARDIOVASCULAR IMPLANTS AND EXTRACOPOREAL SYSTEMS - CARDIAC VALVE REPAIR DEVICES |
| 14/30281560 DC : 0 | BS EN ISO 5840-2 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES |
| 06/30094541 DC : DRAFT JUN 2006 | ISO 21534 - NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - PARTICULAR REQUIREMENTS |
| 02/560790 DC : DRAFT FEB 2002 | BS EN ISO 16671 - OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY |
| UNE-EN ISO 16671:2016 | Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015) |
| ONORM EN ISO 5840-2 : 2015 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES (ISO 5840-2:2015) |
| DIN EN ISO 25539-1:2015-07 (Draft) | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
| ISO 17327-1:2018 | Non-active surgical implants — Implant coating — Part 1: General requirements |
| I.S. EN ISO 7198:2017 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR PROSTHESES - TUBULAR VASCULAR GRAFTS AND VASCULAR PATCHES (ISO 7198:2016) |
| I.S. EN ISO 21535:2009 | NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR HIP-JOINT REPLACEMENT IMPLANTS (ISO 21535:2007) |
| I.S. CEN TS 15277:2006 | NON-ACTIVE SURGICAL IMPLANTS - INJECTABLE IMPLANTS |
| ISO/TR 14283:2018 | Implants for surgery — Essential principles of safety and performance |
| I.S. EN ISO 12417-1:2015 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015) |
| UNI EN ISO 22794 : 2009 | DENTISTRY - IMPLANTABLE MATERIALS FOR BONE FILLING AND AUGMENTATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE |
| 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 |
| ISO 9713:2002 | Neurosurgical implants Self-closing intracranial aneurysm clips |
| ISO 25539-1:2017 | Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses |
| BS EN 12006-3 : 1999 | NON-ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - PART 3: ENDOVASCULAR DEVICES |
| UNE-EN ISO 10555-4:2014 | Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2013) |
| ISO 22803:2004 | Dentistry — Membrane materials for guided tissue regeneration in oral and maxillofacial surgery — Contents of a technical file |
| ISO 5840-1:2015 | Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements |
| BS EN ISO 16672:2015 | Ophthalmic implants. Ocular endotamponades |
| BS EN 12563:1999 | Non-active surgical implants. Joint replacement implants. Specific requirements for hip joint replacement implants |
| DIN EN ISO 5840:2009-08 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
| EN 12010 : 1998 | NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - PARTICULAR REQUIREMENTS |
| CEN/TS 15277:2006 | Non-active surgical implants - Injectable implants |
| EN ISO 21534:2009 | Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007) |
| DIN EN ISO 25539-1:2017-09 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
| ONORM EN ISO 21536 : SEP 2014 | NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR KNEE-JOINT REPLACEMENT IMPLANTS (ISO 21536:2007 + AMD 1:2014) |
| 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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