ISO 25539-1/Amd1:2005 - $185.00   BUY NOW

Amendment 1: Test methods

ISO 25539-1/Amd1:2005 Publication Description:

--- Abstract Source: ISO 25539-1/Amd1:2005 ---

ISO 25539-1:2017 specifies requirements for the evaluation of endovascular systems (prostheses and delivery systems) 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 this document. This document can be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.

ISO 25539-1:2017 is applicable to endovascular systems used to treat aneurysms, stenoses or other vascular anomalies or pathologies (e.g. dissections, transections) or to create shunts between vessels [e.g. creation of transjugular intrahepatic portosystemic shunting (TIPS)]. Some of the requirements are specific to endovascular treatment of arterial aneurysms or stenoses. Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses (e.g. dissections, transections, shunts) are within the scope of this document, the specific requirements and testing are not described. Similarly, specific prosthesis configurations (e.g. fenestrated, branched) are within the scope, but specific requirements and testing are not described for these devices.

ISO 25539-1:2017 is not applicable to vascular occluders, with the exception of contra-lateral iliac artery occluders when used as an integral part of aorto-uni-iliac endovascular prosthesis. Although contra-lateral iliac artery occluders when used as an integral part of aorto-uni-iliac endovascular prosthesis are within the scope of this document, specific requirements and testing are not described for these devices.

Balloons used to achieve adequate apposition of the prosthesis with the vessel wall or overlapping components are within the scope of this document, even if they are not integral to the endovascular system. This document provides requirements beyond the requirements of ISO 10555‑4, specific to the use of balloons with endovascular prostheses.

ISO 25539-1:2017 is not applicable to procedures and devices used prior to the introduction of the endovascular system, such as balloon angioplasty devices.

The valve component of valved conduits constructed with an endovascular prosthesis component and the combination of the valved component and the endovascular prosthesis component are excluded from the scope of this document. This document can be helpful in identifying the appropriate evaluation of the endovascular prosthesis component of a valved conduit, but specific requirements and testing are not described for these devices.

NOTE 1 Cardiac valved conduits are within the scope of ISO 5840‑1.

Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in this document.

NOTE 2 Vascular device-drug combination products are within the scope of ISO 12417.

ISO 25539-1:2017 does not address the requirements for, and the evaluation of, viable tissues and non-viable biologic materials used in the construction of endovascular prostheses.

The requirements for, and the evaluation of, degradation and other time-dependant aspects of absorbable materials used in the construction of endovascular prostheses are not addressed in this document.

NOTE 3 Absorbable materials are within the scope of ISO/TS 17137 and ISO/TR 37137.

International Classification for Standards (ICS)

ICS Classification Field ICS Field Sub-Group and Number
ICS-11-Health ICS Implants for Surgery (11.040.40)

ICS Related Standards

Cart Document Number Document Title
$232.00 ISO 10328:2016 Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods
$265.00 ISO 10328:2006 Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods
$45.00 ISO 10334:1994 Implants for surgery -- Malleable wires for use as sutures and other surgical applications
$232.00 ISO/TS 10974:2012 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
$138.00 ISO 11318:2002 Cardiac defibrillators - Connector assembly DF-1 for implantable defibrillators - Dimensions and test requirements
$45.00 ISO 11658:2012 Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
$103.00 ISO 11663:2014 Quality of dialysis fluid for haemodialysis and related therapies
$68.00 ISO 12189:2008 Implants for surgery - Mechanical testing of implantable spinal devices - Fatigue test method for spinal implant assemblies using an anterior support
$200.00 ISO/TS 12417:2011 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products
$185.00 ISO 12417-1:2015 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements
$138.00 ISO 12891-1:2015 Retrieval and analysis of surgical implants - Part 1: Retrieval and handling
$149.00 ISO 12891-1:2011 Implants for surgery - Retrieval and analysis of surgical implants - Part 1: Retrieval and handling
$162.00 ISO 12891-2:2014 Retrieval and analysis of surgical implants - Part 2: Analysis of retrieved surgical implants
$88.00 ISO 12891-2:2000 Retrieval and analysis of surgical implants - Part 2: Analysis of retrieved metallic surgical implants
$99.00 ISO 12891-3:2000 Retrieval and analysis of surgical implants - Part 3: Analysis of retrieved polymeric surgical implants
$99.00 ISO 12891-4:2000 Retrieval and analysis of surgical implants -- Part 4: Analysis of retrieved ceramic surgical implants
$103.00 ISO 13175-3:2012 Implants for surgery - Calcium phosphates - Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutes
$45.00 ISO 13179-1:2014 Implants for surgery - Plasma-sprayed unalloyed titanium coatings on metallic surgical implants - Part 1: General requirements
$103.00 ISO 13356:2015 Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)
$123.00 ISO 13356:2008 Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)
$68.00 ISO 13404:2007 Prosthetics and orthotics - Categorization and description of external orthoses and orthotic components
$45.00 ISO 13405-1:2015 Prosthetics and orthotics - Classification and description of prosthetic components - Part 1: Classification of prosthetic components
$58.00 ISO 13405-1:1996 Prosthetics and orthotics -- Classification and description of prosthetic components -- Part 1: Classification of prosthetic components
$103.00 ISO 13405-2:2015 Prosthetics and orthotics - Classification and description of prosthetic components - Part 2: Description of lower limb prosthetic components
$88.00 ISO 13405-2:1996 Prosthetics and orthotics -- Classification and description of prosthetic components -- Part 2: Description of lower-limb prosthetic components
$103.00 ISO 13405-3:2015 Prosthetics and orthotics - Classification and description of prosthetic components - Part 3: Description of upper limb prosthetic components
$99.00 ISO 13405-3:1996 Prosthetics and orthotics -- Classification and description of prosthetic components -- Part 3: Description of upper-limb prosthetic components
$51.00 ISO 13779-1:2008 Implants for surgery - Hydroxyapatite - Part 1: Ceramic hydroxyapatite
$45.00 ISO 13779-2:2008 Implants for surgery - Hydroxyapatite - Part 2: Coatings of hydroxyapatite
$138.00 ISO 13779-3:2008 Implants for surgery - Hydroxyapatite - Part 3: Chemical analysis and characterization of crystallinity and phase purity
$68.00 ISO 13779-4:2002 Implants for surgery - Hydroxyapatite - Part 4: Determination of coating adhesion strength
$68.00 ISO 13779-6:2015 Implants for surgery - Hydroxyapatite - Part 6: Powders
$68.00 ISO 13781:1997 Poly(L-lactide) resins and fabricated forms for surgical implants -- In vitro degradation testing
$45.00 ISO 13782:1996 Implants for surgery -- Metallic materials -- Unalloyed tantalum for surgical implant applications
$138.00 ISO 13958:2014 Concentrates for haemodialysis and related therapies
$103.00 ISO 13959:2014 Water for haemodialysis and related therapies
$68.00 ISO 13960:2010 Cardiovascular implants and extracorporeal systems - Plasmafilters
$232.00 ISO 14117:2012 Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
$68.00 ISO 14242-1:2014 Implants for surgery - Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test
$88.00 ISO 14242-1:2012 Implants for surgery - Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test
$45.00 ISO 14242-2:2016 Implants for surgery - Wear of total hip-joint prostheses - Part 2: Methods of measurement
$51.00 ISO 14242-2:2000 Implants for surgery -- Wear of total hip-joint prostheses -- Part 2: Methods of measurement
$68.00 ISO 14242-3:2009 Implants for surgery - Wear of total hip-joint prostheses - Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test
$103.00 ISO 14243-1:2009 Implants for surgery - Wear of total knee-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test
$45.00 ISO 14243-2:2016 Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurement
$51.00 ISO 14243-2:2009 Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurement
$103.00 ISO 14243-3:2014 Implants for surgery - Wear of total knee-joint prostheses - Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test
$114.00 ISO 14243-3:2004 Implants for surgery - Wear of total knee-joint prostheses - Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test
$103.00 ISO/TR 14283:2004 Implants for surgery - Fundamental principles
$103.00 ISO 14602:2010 Non-active surgical implants - Implants for osteosynthesis - Particular requirements
$162.00 ISO 14607:2007 Non-active surgical implants - Mammary implants - Particular requirements
$103.00 ISO 14630:2012 Non-active surgical implants - General requirements
$209.00 ISO 14708-1:2014 Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
$180.00 ISO 14708-1:2000 Implants for surgery -- Active implantable medical devices -- Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
$209.00 ISO 14708-2:2012 Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers
$185.00 ISO 14708-3:2008 Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
$185.00 ISO 14708-4:2008 Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pumps
$185.00 ISO 14708-5:2010 Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices
$232.00 ISO 14708-6:2010 Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
$209.00 ISO 14708-7:2013 Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear implant systems
$68.00 ISO 14879-1:2000 Implants for surgery -- Total knee-joint prostheses -- Part 1: Determination of endurance properties of knee tibial trays
$103.00 ISO 14949:2001 Implants for surgery - Two-part addition-cure silicone elastomers
$185.00 ISO 15032:2000 Prostheses -- Structural testing of hip units
$68.00 ISO 15142-1:2003 Implants for surgery -- Metal intramedullary nailing systems -- Part 1: Intramedullary nails
$45.00 ISO 15142-2:2003 Implants for surgery -- Metal intramedullary nailing systems -- Part 2: Locking components
$45.00 ISO 15142-3:2003 Implants for surgery -- Metal intramedullary nailing systems -- Part 3: Connection devices and reamer diameter measurements
$45.00 ISO 15309:2013 Implants for surgery - Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in implantable medical devices
$45.00 ISO 15374:1998 Implants for surgery -- Requirements for production of forgings
$149.00 ISO/TS 15539:2000 Cardiovascular implants -- Endovascular prostheses
$68.00 ISO 15674:2016 Cardiovascular implants and artificial organs - Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
$88.00 ISO 15674:2009 Cardiovascular implants and artificial organs - Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
$68.00 ISO 15675:2016 Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters
$88.00 ISO 15675:2009 Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters
$68.00 ISO 15676:2016 Cardiovascular implants and artificial organs - Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
$88.00 ISO 15676:2005 Cardiovascular implants and artificial organs - Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
$68.00 ISO 15814:1999 Implants for surgery -- Copolymers and blends based on polylactide -- In vitro degradation testing
$45.00 ISO 16054:2000 Implants for surgery -- Minimum data sets for surgical implants
$138.00 ISO 16061:2015 Instrumentation for use in association with non-active surgical implants - General requirements
$149.00 ISO 16061:2008 Instrumentation for use in association with non-active surgical implants - General requirements
$68.00 ISO 16087:2013 Implants for surgery - Roentgen stereophotogrammetric analysis for the assessment of migration of orthopaedic implants
$138.00 ISO/TR 16379:2014 Tissue-engineered medical products - Evaluation of anisotropic structure of articular cartilage using DT (Diffusion Tensor)-MR Imaging
$45.00 ISO 16402:2008 Implants for surgery - Acrylic resin cement - Flexural fatigue testing of acrylic resin cements used in orthopaedics
$68.00 ISO 16428:2005 Implants for surgery - Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices
$68.00 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
$103.00 ISO/TS 16955:2016 Prosthetics - Quantification of physical parameters of ankle foot devices and foot units
$138.00 ISO/TS 17137:2014 Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants
$103.00 ISO 17853:2011 Wear of implant materials - Polymer and metal wear particles - Isolation and characterization
$138.00 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
$68.00 ISO 18192-2:2010 Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 2: Nucleus replacements
$68.00 ISO 18241:2016 Cardiovascular implants and extracorporeal systems - Cardiopulmonary bypass systems - Venous bubble traps
$68.00 ISO 18242:2016 Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps
$68.00 ISO/TR 19024:2016 Evaluation of CPB devices relative to their capabilities of reducing the transmission of gaseous microemboli (GME) to a patient during cardiopulmonary bypass
$68.00 ISO 20160:2006 Implants for surgery - Metallic materials - Classification of microstructures for alpha+beta titanium alloy bars
$103.00 ISO 21534:2007 Non-active surgical implants - Joint replacement implants - Particular requirements
$68.00 ISO 21535:2007 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants
$19.00 ISO 21535:2007/Amd1:2016 - Amendment 1
$45.00 ISO 21536:2007 Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants
$19.00 ISO 21536:2007/Amd1:2014 - Amendment 1
$232.00 ISO 22523:2006 External limb prostheses and external orthoses - Requirements and test methods
$232.00 ISO 22675:2016 Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods
$265.00 ISO 22675:2006 Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods
$209.00 ISO/TR 22676:2006 Prosthetics - Testing of ankle-foot devices and foot units - Guidance on the application of the test loading conditions of ISO 22675 and on the design of appropriate test equipment
$103.00 ISO 23317:2014 Implants for surgery - In vitro evaluation for apatite-forming ability of implant materials
$108.00 ISO 23317:2012 Implants for surgery - In vitro evaluation for apatite-forming ability of implant materials
$232.00 ISO 23500:2014 Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
$68.00 ISO/TS 23810:2012 Cardiovascular implants and artificial organs - Checklist for preoperative extracorporeal circulation equipment setup
$232.00 ISO 25539-1:2017 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
$185.00 ISO 25539-1:2003 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
$232.00 ISO 25539-2:2012 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
$232.00 ISO 25539-3:2011 Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters
$162.00 ISO 26722:2014 Water treatment equipment for haemodialysis applications and related therapies
$162.00 ISO 27185:2012 Cardiac rhythm management devices - Symbols to be used with cardiac rhythm management device labels, and information to be supplied - General requirements
$232.00 ISO 27186:2010 Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
$45.00 ISO 29781:2008 Prostheses and orthoses - Factors to be included when describing physical activity of a person who has had a lower limb amputation(s) or who has a deficiency of a lower limb segment(s) present at birth
$45.00 ISO 29782:2008 Prostheses and orthoses - Factors to be considered when specifying a prosthesis for a person who has had a lower limb amputation
$68.00 ISO 29783-1:2008 Prosthetics and orthotics - Vocabulary - Part 1: Normal gait
$45.00 ISO 29783-2:2015 Prosthetics and orthotics - Vocabulary - Part 2: Prosthetic gait
$45.00 ISO 29783-3:2016 Prosthetics and orthotics - Vocabulary - Part 3: Pathological gait (excluding prosthetic gait)
$103.00 ISO/TR 37137:2014 Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants
$45.00 ISO 5832-1:2016 Implants for surgery - Metallic materials - Part 1: Wrought stainless steel
$51.00 ISO 5832-1:2007 Implants for surgery - Metallic materials - Part 1: Wrought stainless steel
$45.00 ISO 5832-11:2014 Implants for surgery - Metallic materials - Part 11: Wrought titanium 6-aluminium 7-niobium alloy
$51.00 ISO 5832-11:1994 Implants for surgery -- Metallic materials -- Part 11: Wrought titanium 6-aluminium 7-niobium alloy
$45.00 ISO 5832-12:2007 Implants for surgery - Metallic materials - Part 12: Wrought cobalt-chromium-molybdenum alloy
$45.00 ISO 5832-14:2007 Implants for surgery - Metallic materials - Part 14: Wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy
$45.00 ISO 5832-2:1999 Implants for surgery -- Metallic materials -- Part 2: Unalloyed titanium
$68.00 ISO 5832-3:2016 Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
$51.00 ISO 5832-3:1996 Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
$45.00 ISO 5832-4:2014 Implants for surgery - Metallic materials - Part 4: Cobalt-chromium-molybdenum casting alloy
$51.00 ISO 5832-4:1996 Implants for surgery -- Metallic materials -- Part 4: Cobalt-chromium-molybdenum casting alloy
$45.00 ISO 5832-5:2005 Implants for surgery - Metallic materials - Part 5: Wrought cobalt-chromium-tungsten-nickel alloy
$45.00 ISO 5832-6:1997 Implants for surgery -- Metallic materials -- Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy
$45.00 ISO 5832-7:2016 Implants for surgery - Metallic materials - Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy
$51.00 ISO 5832-7:1994 Implants for surgery -- Metallic materials -- Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy
$45.00 ISO 5832-8:1997 Implants for surgery -- Metallic materials -- Part 8: Wrought cobalt-nickel-chromium-molybdenum- tungsten-iron alloy
$45.00 ISO 5832-9:2007 Implants for surgery - Metallic materials - Part 9: Wrought high nitrogen stainless steel
$138.00 ISO 5833:2002 Implants for surgery - Acrylic resin cements
$45.00 ISO 5834-1:2005 Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 1: Powder form
$45.00 ISO 5834-2:2011 Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 2: Moulded forms
$45.00 ISO 5834-3:2005 Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 3: Accelerated ageing methods
$68.00 ISO 5834-4:2005 Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 4: Oxidation index measurement method
$45.00 ISO 5834-5:2005 Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 5: Morphology assessment method
$68.00 ISO 5835:1991 Implants for surgery -- Metal bone screws with hexagonal drive connection, spherical under-surface of head, asymmetrical thread -- Dimensions
$45.00 ISO 5836:1988 Implants for surgery -- Metal bone plates -- Holes corresponding to screws with asymmetrical thread and spherical under-surface
$45.00 ISO 5837-1:1985 Implants for surgery -- Intramedullary nailing systems -- Part 1: Intramedullary nails with cloverleaf or V-shaped cross-section
$45.00 ISO 5838-1:2013 Implants for surgery - Metallic skeletal pins and wires - Part 1: General requirements
$45.00 ISO 5838-2:1991 Implants for surgery -- Skeletal pins and wires -- Part 2: Steinmann skeletal pins -- Dimensions
$45.00 ISO 5838-3:1993 Implants for surgery -- Skeletal pins and wires -- Part 3: Kirschner skeletal wires
$265.00 ISO 5840:2005 Cardiovascular implants - Cardiac valve prostheses
$209.00 ISO 5840-1:2015 Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
$209.00 ISO 5840-2:2015 Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
$232.00 ISO 5840-3:2013 Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques
$138.00 ISO 5841-2:2014 Implants for surgery - Cardiac pacemakers - Part 2: Reporting of clinical performance of populations of pulse generators or leads
$132.00 ISO 5841-2:2000 Implants for surgery -- Cardiac pacemakers -- Part 2: Reporting of clinical performance of populations of pulse generators or leads
$68.00 ISO 5841-3:2013 Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors (IS-1) for implantable pacemakers
$68.00 ISO 6474-1:2010 Implants for surgery - Ceramic materials - Part 1: Ceramic materials based on high purity alumina
$68.00 ISO 6474-2:2012 Implants for surgery - Ceramic materials - Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement
$45.00 ISO 6475:1989 Implants for surgery -- Metal bone screws with asymmetrical thread and spherical under-surface -- Mechanical requirements and test methods
$45.00 ISO 7197:2006 Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components
$209.00 ISO 7198:2016 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches
$200.00 ISO 7198:1998 Cardiovascular implants -- Tubular vascular prostheses
$103.00 ISO 7199:2016 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
$88.00 ISO 7199:2009 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
$22.00 ISO 7199/Amd1:2012 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) - Amendment 1: Clarifications for test methodologies, labelling, and sampling schedule
$103.00 ISO 7206-1:2008 Implants for surgery - Partial and total hip joint prostheses - Part 1: Classification and designation of dimensions
$68.00 ISO 7206-10:2003 Implants for surgery - Partial and total hip-joint prostheses - Part 10: Determination of resistance to static load of modular femoral heads
$68.00 ISO 7206-12:2016 Implants for surgery - Partial and total hip joint prostheses - Part 12: Deformation test method for acetabular shells
$45.00 ISO 7206-13:2016 Implants for surgery - Partial and total hip joint prostheses - Part 13: Determination of resistance to torque of head fixation of stemmed femoral components
$45.00 ISO 7206-2:2011 Implants for surgery - Partial and total hip joint prostheses - Part 2: Articulating surfaces made of metallic, ceramic and plastics materials
$19.00 ISO 7206-2:2011/Amd1:2016 - Amendment 1
$103.00 ISO 7206-4:2010 Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components
$19.00 ISO 7206-4:2010/Amd1:2016 - Amendment 1
$103.00 ISO 7206-6:2013 Implants for surgery - Partial and total hip joint prostheses - Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components
$103.00 ISO 7207-1:2007 Implants for surgery - Components for partial and total knee joint prostheses - Part 1: Classification, definitions and designation of dimensions
$45.00 ISO 7207-2:2011 Implants for surgery - Components for partial and total knee joint prostheses - Part 2: Articulating surfaces made of metal, ceramic and plastics materials
$19.00 ISO 7207-2:2011/Amd1:2016 - Amendment 1
$45.00 ISO 8319-1:1996 Orthopaedic instruments -- Drive connections -- Part 1: Keys for use with screws with hexagon socket heads
$68.00 ISO 8319-2:1986 Orthopaedic instruments -- Drive connections -- Part 2: Screwdrivers for single slot head screws, screws with cruciate slot and cross-recessed head screws
$45.00 ISO 8548-1:1989 Prosthetics and orthotics -- Limb deficiencies -- Part 1: Method of describing limb deficiencies present at birth
$103.00 ISO 8548-2:1993 Prosthetics and orthotics -- Limb deficiencies -- Part 2: Method of describing lower limb amputation stumps
$103.00 ISO 8548-3:1993 Prosthetics and orthotics -- Limb deficiencies -- Part 3: Method of describing upper limb amputation stumps
$45.00 ISO 8548-4:1998 Prosthetics and orthotics -- Limb deficiencies -- Part 4: Description of causal conditions leading to amputation
$45.00 ISO 8548-5:2003 Prosthetics and orthotics - Limb deficiencies - Part 5: Description of the clinical condition of the person who has had an amputation
$45.00 ISO 8549-1:1989 Prosthetics and orthotics -- Vocabulary -- Part 1: General terms for external limb prostheses and external orthoses
$45.00 ISO 8549-2:1989 Prosthetics and orthotics -- Vocabulary -- Part 2: Terms relating to external limb prostheses and wearers of these prostheses
$45.00 ISO 8549-3:1989 Prosthetics and orthotics -- Vocabulary -- Part 3: Terms relating to external orthoses
$45.00 ISO 8549-4:2014 Prosthetics and orthotics - Vocabulary - Part 4: Terms relating to limb amputation
$68.00 ISO 8551:2003 Prosthetics and orthotics -- Functional deficiencies -- Description of the person to be treated with an orthosis, clinical objectives of treatment, and functional requirements of the orthosis
$68.00 ISO 8615:1991 Implants for surgery -- Fixation devices for use in the ends of the femur in adults
$103.00 ISO 8637:2010 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
$19.00 ISO 8637:2010/Amd1:2013 - Amendment 1: Revision to Figure 2 - Main fitting dimensions of dialysis fluid inlet and outlet ports
$103.00 ISO 8638:2010 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
$45.00 ISO 8827:1988 Implants for surgery -- Staples with parallel legs for orthopaedic use -- General requirements
$45.00 ISO 8828:2014 Implants for surgery - Guidance on care and handling of orthopaedic implants
$58.00 ISO 8828:1988 Implants for surgery -- Guidance on care and handling of orthopaedic implants
$68.00 ISO 9268:1988 Implants for surgery -- Metal bone screws with conical under-surface of head -- Dimensions
$45.00 ISO 9269:1988 Implants for surgery -- Metal bone plates -- Holes and slots corresponding to screws with conical under-surface
$45.00 ISO 9583:1993 Implants for surgery -- Non-destructive testing -- Liquid penetrant inspection of metallic surgical implants
$45.00 ISO 9584:1993 Implants for surgery -- Non-destructive testing -- Radiographic examination of cast metallic surgical implants
$45.00 ISO 9585:1990 Implants for surgery -- Determination of bending strength and stiffness of bone plates
$51.00 ISO/TR 9586:1988 Implants for surgery -- Usage of terms valgus and varus in orthopaedic surgery
$68.00 ISO 9713:2002 Neurosurgical implants - Self-closing intracranial aneurysm clips
$68.00 ISO 9714-1:2012 Orthopaedic drilling instruments - Part 1: Drill bits, taps and countersink cutters
$194.00 JIS T 0112:2002 Prostheses -- Structural testing of hip units
$58.00 JIS T 3231:2011 Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
$58.00 JIS T 3232:2011 Blood filters for cardiopulmonary bypass systems
$78.00 JIS T 3248:2012 Extracorporeal blood circuit
$29.00 JIS T 7401-4:2009 Titanium materials for surgical implant applications Part 4: Wrought titanium 15-zirconium 4-niobium 4-tantalum alloy
$68.00 ISO 11491:2017 Implants for surgery - Determination of impact resistance of ceramic femoral heads for hip joint prostheses
$103.00 ISO 13781:2017 Implants for surgery - Homopolymers, copolymers and blends on poly(lactide) - In vitro degradation testing
$209.00 ISO 14708-3:2017 Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
$103.00 ISO 18192-3:2017 Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 3: Impingement-wear testing and corresponding environmental conditions for test of lumbar prostheses under adverse kinematic conditions
$103.00 ISO 19213:2017 Implants for surgery - Test methods of material for use as a cortical bone model
$68.00 ISO 19233-1:2017 Implants for surgery - Orthopaedic joint prosthesis - Part 1: Procedure for producing parametric 3D bone models from CT data of the knee
$45.00 ISO 21063:2017 Prosthetics and orthotics - Soft orthoses - Uses, functions, classification and description
$45.00 ISO 21064:2017 Prosthetics and orthotics - Foot orthotics - Uses, functions classification and description
$45.00 ISO 21065:2017 Prosthetics and orthotics - Terms relating to the treatment and rehabilitation of persons having a lower limb amputation