ISO/TS 12417:2011
Withdrawn
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Cardiovascular implants and extracorporeal systems Vascular device-drug combination products
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27-03-2019
French, English, Russian
23-05-2011
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ISO/TS 12417:2011 specifies requirements for vascular device-drug combination products (VDDCPs) based upon current technical and medical knowledge. VDDCPs are medical devices with various clinical indications for use in the human vascular blood system. A VDDCP incorporates, as an integral part, substance(s) which, if used separately, can be considered to be a medicinal product (drug product) but the action of the medicinal substance is ancillary to that of the device and supports the primary mode of action of the device. With regard to safety, ISO/TS 12417 outlines requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization packaging, and information supplied by the manufacturer. For implanted products, ISO/TS 12417 should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. ISO/TS 12417 should also be considered as a supplement to relevant device-specific standards, such as the ISO 25539 series specifying requirements for endovascular devices. Requirements listed in ISO/TS 12417 also address VDDCPs that are not necessarily permanent implants.
Delivery systems or parts of the delivery system are included in the scope of ISO/TS 12417 if they comprise an integral component of the vascular device and if they are drug-covered (e.g. drug-covered balloon catheters and drug-covered guidewires).
Pumps and infusion catheters which do not contain drug coverings, and whose primary mode of action is to deliver a drug, are not addressed in ISO/TS 12417.
Procedures and devices used prior to and following the introduction of the VDDCP (e.g. balloon angioplasty devices) are excluded from the scope of ISO/TS 12417 if they do not affect the drug-related aspects of the device.
ISO/TS 12417 is not comprehensive with respect to the pharmacological evaluation of VDDCPs. Some information on the requirements of different related national and regional authorities is given in an annex.
Bioabsorbable components of VDDCPs (e.g. coatings) are addressed by ISO/TS 12417 in their connection with drug-related aspects of the device.
ISO/TS 12417 does not address issues associated with viable tissues and non-viable biological materials.
| DocumentType |
Technical Specification
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| Pages |
49
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| PublisherName |
International Organization for Standardization
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| Status |
Withdrawn
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| SupersededBy |
| Standards | Relationship |
| NEN NPR ISO/TS 12417 : 2011 | Identical |
| AAMI ISO TIR 12417 : 2011 | Identical |
| DD ISO/TS 12417:2011 | Identical |
| BS EN ISO 5840-2:2015 | Cardiovascular implants. Cardiac valve prostheses Surgically implanted heart valve substitutes |
| UNE-EN ISO 25539-3:2012 | Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011) |
| I.S. EN ISO 10555-1:2013 | INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS (ISO 10555-1:2013/AMD 1:2017) |
| AAMI ISO 5840-1 : 2016 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS |
| I.S. EN ISO 5840-1:2015 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS (ISO 5840-1:2015) |
| PD ISO/TS 17137:2014 | Cardiovascular implants and extracorporeal systems. Cardiovascular absorbable implants |
| DIN EN ISO 10555-4:2013-11 | Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2013) |
| ISO 25539-3:2011 | Cardiovascular implants — Endovascular devices — Part 3: Vena cava filters |
| I.S. EN ISO 10555-4:2013 | INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 4: BALLOON DILATATION CATHETERS (ISO 10555-4:2013) |
| EN ISO 25539-3:2011 | Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011) |
| 14/30281560 DC : 0 | BS EN ISO 5840-2 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES |
| DIN EN ISO 25539-3:2012-03 | Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011) |
| BS EN ISO 10555-1 : 2013 | INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS |
| AAMI ISO TIR 17137 : 2014 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CARDIOVASCULAR ABSORBABLE IMPLANTS |
| EN ISO 5840-2:2015 | Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015) |
| EN ISO 5840-1:2015 | Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015) |
| UNE-EN ISO 5840-2:2016 | Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015) |
| 14/30270462 DC : 0 | BS EN ISO 5840-1 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS |
| 17/30250386 DC : 0 | BS ISO 17327-1 - NON-ACTIVE SURGICAL IMPLANTS - IMPLANT COATING - PART 1: GENERAL REQUIREMENTS |
| BS EN ISO 5840-1:2015 | Cardiovascular implants. Cardiac valve prostheses General requirements |
| UNE-EN ISO 5840-1:2016 | Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015) |
| 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 25539-3:2011 | 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 |
| BS EN ISO 10555-4:2013 | Intravascular catheters. Sterile and single-use catheters Balloon dilatation catheters |
| UNI EN ISO 10555-4 : 2013 | INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 4: BALLOON DILATATION CATHETERS |
| ISO 10555-4:2013 | Intravascular catheters — Sterile and single-use catheters — Part 4: Balloon dilatation catheters |
| ISO 5840-2:2015 | Cardiovascular implants Cardiac valve prostheses Part 2: Surgically implanted heart valve substitutes |
| EN ISO 10555-4:2013 | Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2013) |
| BS EN ISO 25539-3:2011 | Cardiovascular implants. Endovascular devices Vena cava filters |
| ISO/TS 17137:2014 | Cardiovascular implants and extracorporeal systems Cardiovascular absorbable implants |
| ISO 10555-1:2013 | Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements |
| UNE-EN ISO 10555-4:2014 | Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2013) |
| ISO 5840-1:2015 | Cardiovascular implants Cardiac valve prostheses Part 1: General requirements |
| ISO 11070:2014 | Sterile single-use intravascular introducers, dilators and guidewires |
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| 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 25539-2:2012 | Cardiovascular implants Endovascular devices Part 2: Vascular stents |
| CFR 21(PTS200-299) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 200-299 |
| 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 |
| ISO 16054:2000 | Implants for surgery Minimum data sets for surgical implants |
| ISO 13960:2010 | Cardiovascular implants and extracorporeal systems Plasmafilters |
| ISO 5840:2005 | Cardiovascular implants Cardiac valve prostheses |
| ISO 10555-2:1996 | Sterile, single-use intravascular catheters Part 2: Angiographic catheters |
| ISO 7198:2016 | Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches |
| ASTM F 2503 : 2013 : REDLINE | Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment |
| ISO 17475:2005 | Corrosion of metals and alloys — Electrochemical test methods — Guidelines for conducting potentiostatic and potentiodynamic polarization measurements |
| 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 |
| ISO 25539-1:2017 | Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses |
| 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 14630:2012 | Non-active surgical implants — General requirements |
| ISO 5841-2:2014 | Implants for surgery — Cardiac pacemakers — Part 2: Reporting of clinical performance of populations of pulse generators or leads |
| ISO/TR 14283:2004 | Implants for surgery Fundamental principles |
| ASTM F 2052 : 2015 : REDLINE | Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment |
| ISO/TS 15539:2000 | Cardiovascular implants Endovascular prostheses |
| ISO 13781:2017 | Implants for surgery — Homopolymers, copolymers and blends on poly(lactide) — In vitro degradation testing |
| ISO 7199:2016 | Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators) |
| 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 10555-3:2013 | Intravascular catheters — Sterile and single-use catheters — Part 3: Central venous catheters |
| ISO 10555-1:2013 | Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements |
| ISO 15814:1999 | Implants for surgery Copolymers and blends based on polylactide In vitro degradation testing |
| MEDDEV 2.13 : REV 1 | COMMISSION COMMUNICATION ON THE APPLICATION OF TRANSITIONAL PROVISION OF DIRECTIVE 93/42/EEC RELATING TO MEDICAL DEVICES (OJ 98/C 242/05) |
| 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 16428:2005 | Implants for surgery — Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ASTM D 638 : 2014 : REDLINE | Standard Test Method for Tensile Properties of Plastics |
| 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 10555-4:2013 | Intravascular catheters — Sterile and single-use catheters — Part 4: Balloon dilatation catheters |
| 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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