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ISO 7198:2016

Current
Current

The latest, up-to-date edition.

Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches
Available format(s)

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

Language(s)

French, English

Published date

21-07-2016

ISO 7198:2016 specifies requirements for the evaluation of vascular prostheses and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer, based upon current medical knowledge. Guidance for the development of in vitro test methods is included in an informative annex to ISO 7198:2016. It can be considered as a supplement to ISO 14630:2012, which specifies general requirements for the performance of non-active surgical implants.

NOTE Due to the variations in the design of implants covered by ISO 7198 :2016 and, in some cases, due to the relatively recent development of some of these implants (e.g. bioabsorbable vascular prostheses, cell based tissue engineered vascular prostheses), acceptable standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become available, appropriate revision of ISO 7198 :2016 will be necessary.

It is applicable to sterile tubular vascular grafts implanted by direct visualization surgical techniques as opposed to fluoroscopic or other non-direct imaging (e.g. computerized tomography or magnetic resonance imaging), intended to replace, bypass, or form shunts between segments of the vascular system in humans and vascular patches intended for repair and reconstruction of the vascular system.

Vascular prostheses that are made of synthetic textile materials and synthetic non-textile materials are within the scope of ISO 7198:2016.

While vascular prostheses that are made wholly or partly of materials of non-viable biological origin, including tissue engineered vascular prostheses are within the scope, ISO 7198:2016 does not address sourcing, harvesting, manufacturing and all testing requirements for biological materials. It is further noted that different regulatory requirements might exist for tissues from human and animal sources.

Compound, coated, composite, and externally reinforced vascular prostheses are within the scope of ISO 7198:2016.

Endovascular prostheses implanted using catheter delivery and non-direct visualization are excluded from the scope of ISO 7198:2016. It includes information on the development of appropriate test methods for graft materials, referenced in ISO 25539‑1 for materials used in the construction of endovascular prostheses (i.e. stent-grafts).

NOTE Requirements for endovascular prostheses are specified in ISO 25539‑1.

The valve component of valved conduits constructed with a tubular vascular graft component, and the combination of the valved component and the tubular vascular graft component, are excluded from the scope of ISO 7198:2016. It can be helpful in identifying the appropriate evaluation of the tubular vascular graft component of a valved conduit but specific requirements and testing are not described for these devices.

Cardiac and pericardial patches, vascular stents, accessory devices such as anastomotic devices, staplers, tunnelers and sutures, and pledgets are excluded from the scope of ISO 7198:2016.

NOTE Requirements for vascular stents are specified in ISO 25539‑2.

Requirements regarding cell seeding are excluded from the scope of ISO 7198:2016. Tissue engineered vascular prostheses that contain or are manufactured using cells present many distinct manufacturing (e.g. aseptic processing, cell seeding, etc.) and testing issues than those produced with synthetic or non-viable biological materials. The in vitro testing requirements that are outlined in ISO 7198:2016 can be a useful guide for certain testing requirements for these cell-based products.

Pharmacological aspects of drug-eluting or drug-coated vascular prostheses are not addressed in ISO 7198:2016.

NOTE Requirements for vascular device-drug combination products are specified in ISO 12417-1.

Degradation, tissue ingrowth and/or tissue replacement, and other time-dependent aspects of absorbable vascular prostheses are not addressed in ISO 7198:2016.

Committee
ISO/TC 150/SC 2
DevelopmentNote
Supersedes ISO/DIS 7198. (07/2016)
DocumentType
Standard
Pages
56
ProductNote
THIS STANDARD ALSO REFERS TO: ISO 7198,ISO 11137,ISO 17665
PublisherName
International Organization for Standardization
Status
Current
Supersedes

UNE-EN ISO 25539-2:2013 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012)
DD ISO/TS 12417:2011 Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products
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)
ANSI/AAMI/ISO 25539-2:2012 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS
NF EN ISO 25539-1 : 2018 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES
ASTM F 2477 : 2007 Standard Test Methods for <i>in vitro</i> Pulsatile Durability Testing of Vascular Stents
ISO/TS 12417:2011 Cardiovascular implants and extracorporeal systems Vascular device-drug combination products
ISO 10993-4:2017 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
BS EN 12006-2 : 1998 NON-ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - PART 2: VASCULAR PROSTHESES INCLUDING CARDIAC VALVE CONDUITS
14/30251609 DC : 0 BS EN ISO 12417-1 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS
AAMI ISO 12417-1 : 2015 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS
ANSI/AAMI/ISO 25539-1:2017 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES
15/30290736 DC : 0 BS EN ISO 10993-4 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD
ASTM F 2477 : 2007 : R2013 Standard Test Methods for <emph type="bdit">in vitro</emph> Pulsatile Durability Testing of Vascular Stents
ANSI/AAMI/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
EN ISO 25539-2:2012 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012)
DIN EN ISO 12417-1 E : 2016 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015)
BS EN ISO 12417-1:2015 Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products General requirements
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
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
BS ISO 25539-1 : 2003 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES
I.S. EN ISO 25539-2:2012 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS (ISO 25539-2:2012)
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)
AAMI ISO 14708-5 : 2010 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 5: CIRCULATORY SUPPORT DEVICES
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
EN ISO 10993-4:2017 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
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 12006-2 : 2009 NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - PART 2: VASCULAR PROSTHESES INCLUDING CARDIAC VALVE CONDUITS
BS EN ISO 25539-1:2017 Cardiovascular implants. Endovascular devices Endovascular prostheses
08/30192448 DC : DRAFT DEC 2008 BS ISO 14708-5 - IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 5: CIRCULATORY SUPPORT DEVICES
01/563350 DC : DRAFT AUG 2001 BS ISO 25539-1 - CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES
BS EN ISO 10993-4:2017 Biological evaluation of medical devices Selection of tests for interactions with blood
ASTM F 3225 : 2017 Standard Guide for Characterization and Assessment of Vascular Graft Tissue Engineered Medical Products (TEMPs)
UNE-EN ISO 12417-1:2016 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015)
UNI EN ISO 25539-2 : 2013 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS
ISO/TR 12417-2:2017 Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information
DIN EN ISO 25539-2:2013-05 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012)
DIN EN ISO 25539-1:2015-07 (Draft) CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)
I.S. EN ISO 25539-1:2017 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)
ISO 14708-5:2010 Implants for surgery Active implantable medical devices Part 5: Circulatory support devices
ISO 25539-2:2012 Cardiovascular implants Endovascular devices Part 2: Vascular stents
AAMI ISO 10993-4 : 2002 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD
ISO 12417-1:2015 Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: General requirements
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 ISO 12417-1:2015 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015)
AAMI ISO TIR 12417 : 2011 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS
BS EN ISO 25539-2:2012 Cardiovascular implants. Endovascular devices Vascular stents
UNE-EN ISO 10993-4:2018 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
I.S. EN ISO 10993-4:2017 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD (ISO 10993-4:2017)
ISO 25539-1:2017 Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses
DIN EN ISO 25539-1:2017-09 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)

ISO 25539-2:2012 Cardiovascular implants Endovascular devices Part 2: Vascular stents
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 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
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
ISO 25539-1:2017 Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses
ISO 14630:2012 Non-active surgical implants General requirements
ISO 12417-1:2015 Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: General requirements
ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
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

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