GDPR

projektai-lsd Lithuanian Standards Board
Portal for draft standards

Extended search

till

Results

Showing:
prEN ISO 7198 Public enquiry
Comment end date 2026-07-30
Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO/DIS 7198:2026)

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 7198:201

Quick filters

Technical Committee
TK 1 Electronics (13) TK 4 Information technology (7) TK 5 Electrical engineering (44) TK 6 Fruit and vegetables products (2) TK 12 Motor - roads (2) TK 13 Agricultural engineering (9) TK 15 Cereals, cereal products, bread and animal feeding stuffs (1) TK 18 Telecommunications (11) TK 20 Toys, child use articles, sports and other recreational equipment (3) TK 22 Fire safety (4) TK 23 Ceramic tiles, masonry and natural stones (3) TK 24 Quality management and quality assurance (2) TK 25 Matrix, gypsum and gypsum based products (1) TK 28 Gas systems (2) TK 29 Water supply (2) TK 31 Acoustics (1) TK 32 Health (9) TK 35 Safety of machinery (4) TK 36 Environmental protection (3) TK 38 Building constructions (13) TK 39 Protection (1) TK 40 Petroleuml, petroleum products, lubricants and alternative fuels (1) TK 41 Welding (1) TK 42 Packaging (1) TK 45 Electric power (4) TK 46 Roofs and building waterproof isolation (1) TK 49 Metallic materials (2) TK 50 Heating and Ventilation Systems (2) TK 51 Food analysis- Horizontal methods (4) TK 52 Ophthalmic optics and lasers (4) TK 54 Assistive products for persons with disability (1) TK 57 Fertilizers (2) TK 59 Geotechnics (1) TK 60 Windows and doors (2) TK 63 Gas cylinders and cryogenic vessels (2) TK 66 Non-destructive testing (1) TK 68 Plastics (7) TK 70 Pulp, paper, board, adhesives (2) TK 79 IT security techniques (11) TK 80 Road transport and traffic telematics (3) TK 82 Safety of trackless overground vehicles (2) TK 83 Assessment of workplace exposure to chemical and biological agents (1) TK 87 Biotechnology (1) TK 88 Building Information Modelling (BIM) (1) TK 89 Risk management and organizational governance (1) TK 99 Health Informatics (3)
ICS
Plonasis popierius (1) Advanced ceramics (2) Aerospace electric equipment and systems (4) Alarm and warning systems (1) Alkaline secondary cells and batteries (1) Aluminium products (1) Application of information technology in general (2) Binders. Sealing materials (1) Biological evaluation of medical devices (1) Biology. Botany. Zoology (1) Bolts, screws, studs (4) Bolts, screws, studs (1) Bridge construction (1) Building accessories (2) Buildings in general (1) Cables (1) Car informatics. On board computer systems (1) Cement. Gypsum. Lime. Mortar (4) Cereals, pulses and derived products (1) Company organization and management in general (1) Concrete structures (2) Cooking ranges, working tables, ovens and similar appliances (20) Cranes (1) Dental materials (1) Dentistry in general (1) Dishwashers (1) Domestic electrical appliances in general (3) Earthworks. Excavations. Foundation construction. Underground works (2) Electric road vehicles (1) Electric tools (3) Electric traction equipment (1) Electrical accessories in general (1) Electrical and electronic equipment (1) Electrical engineering (Vocabularies) (1) Electrical equipment of ships and of marine structure (1) Electricity supply systems (2) Electroacoustics (1) Electronics (Vocabularies) (2) Emission (3) Environment. Health protection. Safety (Vocabularies) (1) Environmental testing (1) Equipment for children (3) Explosives. Pyrotechnics and fireworks (3) Fibre optic interconnecting devices (4) Fibre optic systems in general (1) Fire protection (3) Fire-resistance of building materials and elements (1) First aid (1) Fixed capacitors (1) Flat steel products and semi-products (2) Food microbiology (1) Gas cylinders (1) Generators (1) High voltage switchgear and controlgear (1) Hospital equipment (1) Immunity (1) Implants for surgery, prosthetics and orthotics (1) In vitro diagnostic test systems (1) Industrial automation systems in general (1) Industrial robots. Manipulators (1) Industrial trucks (1) Inland navigation vessels (1) Insulating materials in general (1) Iron and steel forgings (1) IT applications in education (1) IT applications in health care technology (2) IT applications in information, documentation and publishing (1) IT applications in office work (1) IT applications in transport (2) IT Security (12) Kitchen furniture (3) Laundry appliances (1) Legal aspects (1) Liquid wastes. Sludge (1) Management systems (3) Materials and articles in contact with foodstuffs (1) Measurement of electrical and magnetic quantities (4) Mechanical testing of metals (1) Medical equipment in general (1) Metal fittings (1) Natural gas (1) Networking (2) Non-destructive testing (1) Oilseeds (1) Open systems interconnection in general (1) Optoelectronics. Laser equipment (2) Other fasteners (2) Other fibre optic equipment (2) Other lifting equipment (1) Other medical equipment (1) Other services (1) Other switchgear and controlgear (1) Paint coating equipment (1) Paper and board (1) Passenger cars. Caravans and light trailers (1) Pipelines and its parts for external sewage systems (1) Plastics in general (1) Plug-and-socket devices. Connectors (2) Potentiometers, variable resistors (1) Pressure regulators (2) Properties of surfaces (1) Protection against falling and slipping (1) Public buildings (2) Quantities and units (1) Radiation measurements (2) Radiographic equipment (1) Road construction materials (1) Safety of machinery (5) Seismic and vibration protection (1) Small craft (1) Small kitchen appliances (9) Solar energy engineering (1) Spices and condiments (2) Stationary source emissions (1) Steel pipes and tubes for specific use (1) Sterilization and disinfection in general (1) Surgical instruments and materials (1) Technical aspects (7) Technical product documentation (1) TELECOMMUNICATIONS. AUDIO AND VIDEO ENGINEERING (11) Therapy equipment (1) Thermoplastic materials (4) Valves in general (2) Ventilation and air-conditioning systems (1) Ventilators. Fans. Air-conditioners (1) Vibration and shock with respect to human beings (1) Water supply systems (1) Waxes, bituminous materials and other petroleum products (1) Welded joints and welds (1) Woodworking machines (3) Workplace atmospheres (1)