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ISO/TS 12417:2011

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

View Superseded by
withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Cardiovascular implants and extracorporeal systems Vascular device-drug combination products

Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Withdrawn date

27-03-2019

Language(s)

French, English, Russian

Published date

23-05-2011

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
Pages
49
PublisherName
International Organization for Standardization
Status
Withdrawn
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
DIN EN ISO 5840-2 E : 2016 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES (ISO 5840-2:2015)
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)
EN ISO 10555-1:2013/A1:2017 INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS (ISO 10555-1:2013/AMD 1:2017)
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)
DIN EN ISO 5840-1 E : 2015 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS (ISO 58401:2015)
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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