Orthotics — Method for testing the reliability of microprocessor-controlled ankle moment units of ankle-foot orthoses

Additive manufacturing for medical — General principles — Additive manufacturing of non-active implants

Implants for surgery — Metallic materials — Part 1: Wrought stainless steel

Implants for surgery — Metallic materials — Part 1: Wrought stainless steel

Implants for surgery — Metallic materials — Part 1: Wrought stainless steel

Implants for surgery — Metallic materials — Part 1: Wrought stainless steel

Implants for surgery — Metallic materials — Part 1: Wrought stainless steel — Technical Corrigendum 1

Implants for surgery — Metallic materials — Part 1: Wrought stainless steel

Implants for surgery — Metallic materials — Part 1: Wrought stainless steel

Implants for surgery — Metallic materials — Part 2: Unalloyed titanium

Implants for surgery — Metallic materials — Part 2: Unalloyed titanium

Implants for surgery — Metallic materials — Part 2: Unalloyed titanium

Implants for surgery — Metallic materials — Part 2: Unalloyed titanium

Implants for surgery — Metallic materials — Part 3: Wrought titanium 6-aluminium 4-vanadium alloy

Implants for surgery — Metallic materials — Part 3: Wrought titanium 6-aluminium 4-vanadium alloy

Implants for surgery — Metallic materials — Part 3: Wrought titanium 6-aluminium 4-vanadium alloy

Implants for surgery — Metallic materials — Part 3: Wrought titanium 6-aluminium 4-vanadium alloy

Implants for surgery — Metallic materials — Part 3: Wrought titanium 6-aluminium 4-vanadium alloy

Implants for surgery — Metallic materials — Part 4: Cobalt-chromium-molybdenum casting alloy

Implants for surgery — Metallic materials — Part 4: Cobalt-chromium-molybdenum casting alloy

Implants for surgery — Metallic materials — Part 4: Cobalt-chromium-molybdenum casting alloy

Implants for surgery — Metallic materials — Part 4: Cobalt-chromium-molybdenum casting alloy

Implants for surgery — Metallic materials — Part 5: Wrought cobalt-chromium-tungsten- nickel alloy

Implants for surgery — Metallic materials — Part 5: Wrought cobalt-chromium-tungsten-nickel alloy

Implants for surgery — Metallic materials — Part 5: Wrought cobalt-chromium-tungsten-nickel alloy

Implants for surgery — Metallic materials — Part 5: Wrought cobalt-chromium-tungsten-nickel

Implants for surgery — Metallic materials — Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy

Implants for surgery — Metallic materials — Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy

Implants for surgery — Metallic materials — Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy

Implants for surgery — Metallic materials — Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy

Implants for surgery — Metallic materials — Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy

Implants for surgery — Metallic materials — Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy

Implants for surgery — Metallic materials — Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy

Implants for surgery — Metallic materials — Part 8: Wrought cobalt-nickel-chromium-molybdenum- tungsten-iron alloy

Implants for surgery — Metallic materials — Part 8: Wrought cobalt-nickel-chromium-molybdenum- tungsten-iron alloy

Implants for surgery — Metallic materials — Part 9: Wrought high nitrogen stainless steel

Implants for surgery — Metallic materials — Part 9: Wrought high nitrogen stainless steel

Implants for surgery — Metallic materials — Part 9: Wrought high nitrogen stainless steel

Implants for surgery — Metallic materials — Part 10: Wrought titanium 5-aluminium 2,5-iron alloy

Implants for surgery — Metallic materials — Part 10: Wrought titanium 5-aluminium 2,5-iron alloy

Implants for surgery — Metallic materials — Part 11: Wrought titanium 6-aluminium 7-niobium alloy

Implants for surgery — Metallic materials — Part 11: Wrought titanium 6-aluminium 7-niobium alloy

Implants for surgery — Metallic materials — Part 11: Wrought titanium 6-aluminium 7-niobium alloy

Implants for surgery — Metallic materials — Part 12: Wrought cobalt-chromium-molybdenum alloy

Implants for surgery — Metallic materials — Part 12: Wrought cobalt-chromium-molybdenum alloy

Implants for surgery — Metallic materials — Part 12: Wrought cobalt-chromium-molybdenum alloy — Technical Corrigendum 1

Implants for surgery — Metallic materials — Part 12: Wrought cobalt-chromium-molybdenum alloy

Implants for surgery — Metallic materials — Part 14: Wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy

Implants for surgery — Metallic materials — Part 14: Wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy

Implants for surgery — Acrylic resin cements — Part 1: Orthopaedic applications

Implants for surgery — Acrylic resin cements

Implants for surgery — Acrylic resin cements

Implants for surgery — Ultra-high molecular weight polyethylene — Part 1: Powder form

Implants for surgery — Ultra-high molecular weight polyethylene — Part 1: Powder form

Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 1: Powder form

Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 1: Powder form — Technical Corrigendum 1

Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 1: Powder form

Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 1: Powder form

Implants for surgery — Ultra-high molecular weight polyethylene — Part 2: Moulded forms

Implants for surgery — Ultra-high molecular weight polyethylene — Part 2: Moulded forms

Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 2: Moulded forms

Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 2: Moulded forms

Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 2: Moulded forms

Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 2: Moulded forms

Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 3: Accelerated ageing methods

Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 3: Accelerated ageing methods

Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 3: Accelerated ageing methods

Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 4: Oxidation index measurement method

Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 4: Oxidation index measurement method

Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 4: Oxidation index measurement method

Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 5: Morphology assessment method

Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 5: Morphology assessment method

Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 5: Morphology assessment method

Implants for surgery — Metal bone screws — Dimensions — Part 1: Screws with asymmetrical thread, spherical under-surfaces

Implants for surgery — Metal bone screws — Dimensions — Part 2: Screws with asymmetrical thread, constant fitting (spherical)

Implants for surgery — Metal bone screws — Dimensions — Part 4: Screws with symmetrical thread, conical under-surfaces

Implants for surgery — Metal bone screws with hexagonal drive connection, spherical under-surface of head, asymmetrical thread — Dimensions

Implants for surgery — Metal bone plates — Part 4: Holes and slots corresponding to screws with symmetrical thread and conical under-surfaces

Implants for surgery — Metal bone plates — Holes corresponding to screws with asymmetrical thread and spherical under-surface

Implants for surgery — Intramedullary nailing systems — Part 1: Intramedullary nails with cloverleaf or V-shaped cross-section

Implants for surgery — Intramedullary nailing systems — Part 2: Medullary pins

Implants for surgery — Skeletal pins and wires — Part 1: Material and mechanical requirements

Implants for surgery — Skeletal pins and wires — Part 1: Material and mechanical requirements

Implants for surgery — Metallic skeletal pins and wires — Part 1: General requirements

Implants for surgery — Skeletal pins and wires — Part 2: Steinmann skeletal pins — Dimensions

Implants for surgery — Skeletal pins and wires — Part 3: Kirschner skeletal wires

Implants for surgery — Orthopaedic joint prostheses — Basic requirements

Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements

Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements

Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements — Amendment 1

Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes

Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes

Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes — Amendment 1

Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques

Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques

Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques — Amendment 1

Implants for surgery — Cardiovascular implants — Cardiac valve prostheses

Cardiovascular implants — Cardiac valve prostheses

Cardiovascular implants — Cardiac valve prostheses

Cardiovascular implants — Cardiac valve prostheses

Implants for surgery — Cardiac pacemakers — Part 1: Implantable ventricular pacemakers

Cardiac pacemakers — Part 1: Implantable pacemakers

Implants for surgery — Cardiac pacemakers — Part 2: Reporting of the clinical performance of populations of pulse generators

Implants for surgery — Cardiac pacemakers — Part 2: Reporting of clinical performance of populations of pulse generators or leads

Implants for surgery — Cardiac pacemakers — Part 2: Reporting of clinical performance of populations of pulse generators or leads

Cardiac pacemakers — Part 3: Low-profile connectors (IS-1) for implantable pacemakers

Implants for surgery — Cardiac pacemakers — Part 3: Low-profile connectors (IS-1) for implantable pacemakers

Implants for surgery — Cardiac pacemakers — Part 3: Low-profile connectors (IS-1) for implantable pacemakers — Technical Corrigendum 1

Implants for surgery — Cardiac pacemakers — Part 3: Low-profile connectors (IS-1) for implantable pacemakers

Cardiovascular implants and extracorporeal systems — Cardiac valve repair devices

Cardiovascular implants and extracorporeal systems — Cardiac valve repair devices

Orthopaedic implants — General requirements for marking, packaging and labelling

Implants for surgery — Ceramic materials — Part 1: Ceramic materials based on high purity alumina

Implants for surgery — Ceramic materials — Part 1: Ceramic materials based on high purity alumina

Implants for surgery — Ceramic materials — Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement

Implants for surgery — Ceramic materials — Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement

Implants for surgery — Ceramic materials based on alumina

Implants for surgery — Ceramic materials based on high purity alumina

Implants for surgery — Metal bone screws — Mechanical requirements and methods of test — Part 1: Screws with asymmetrical thread, variable fitting (spherical), stainless steel

Implants for surgery — Metal bone screws — Mechanical requirements and methods of test — Part 2: Screws with asymmetrical thread, constant fitting (spherical), stainless steel

Implants for surgery — Metal bone screws with asymmetrical thread and spherical under-surface — Mechanical requirements and test methods

Sizing parameters of surgical valve prostheses: Requirements regarding the application of ISO 5840-2

Neurosurgical implants — Sterile, single-use hydrocephalus shunts and components

Neurosurgical implants — Sterile, single-use hydrocephalus shunts and components

Neurosurgical implants — Sterile, single-use hydrocephalus shunts and components

Neurosurgical implants — Sterile, single-use hydrocephalus shunts and components — Technical Corrigendum 1

Neurosurgical implants — Sterile, single-use hydrocephalus shunts

Cardiovascular implants — Tubular vascular prostheses

Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches

Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators)

Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators)

Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators) — Amendment 1: Clarifications for test methodologies, labelling, and sampling schedule

Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators)

Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators) — Amendment 1: Connectors

Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators)

Implants for surgery — Partial and total hip joint prostheses — Part 1: Classification, designation of dimensions and requirements

Implants for surgery — Partial and total hip joint prostheses — Part 1: Classification and designation of dimensions

Implants for surgery — Partial and total hip joint prostheses — Part 1: Classification and designation of dimensions

Implants for surgery — Partial and total hip joint prostheses — Part 2: Bearing surfaces made of metallic and plastics materials

Implants for surgery — Partial and total hip joint prostheses — Part 2: Articulating surfaces made of metallic, ceramic and plastics materials

Implants for surgery — Partial and total hip joint prostheses — Part 2: Articulating surfaces made of metallic, ceramic and plastics materials

Implants for surgery — Partial and total hip joint prostheses — Part 2: Articulating surfaces made of metallic, ceramic and plastics materials — Amendment 1

Implants for surgery — Partial and total hip joint prostheses — Part 3: Determination of endurance properties of stemmed femoral components without application of torsion

Implants for surgery — Partial and total hip joint prostheses — Part 4: Determination of endurance properties of stemmed femoral components with application of torsion

Implants for surgery — Partial and total hip joint prostheses — Part 4: Determination of endurance properties of stemmed femoral components

Implants for surgery — Partial and total hip joint prostheses — Part 4: Determination of endurance properties and performance of stemmed femoral components

Implants for surgery — Partial and total hip joint prostheses — Part 4: Determination of endurance properties and performance of stemmed femoral components — Amendment 1

Implants for surgery — Partial and total hip joint prostheses — Part 5: Determination of resistance to static load of head and neck region of stemmed femoral components

Implants for surgery — Partial and total hip joint prostheses — Part 6: Determination of endurance properties of head and neck region of stemmed femoral components

Implants for surgery — Partial and total hip joint prostheses — Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components

Implants for surgery — Partial and total hip joint prostheses — Part 7: Endurance performance of stemmed femoral components without application of torsion

Implants for surgery — Partial and total hip joint prostheses — Part 8: Endurance performance of stemmed femoral components with application of torsion

Implants for surgery — Partial and total hip joint prostheses — Part 9: Determination of resistance to torque of head fixation of stemmed femoral components

Implants for surgery — Partial and total hip-joint prostheses — Part 10: Determination of resistance to static load of modular femoral heads

Implants for surgery — Partial and total hip-joint prostheses — Part 10: Determination of resistance to static load of modular femoral heads

Implants for surgery — Partial and total hip-joint prostheses — Part 10: Determination of resistance to static load of modular femoral heads — Amendment 1

Implants for surgery — Partial and total hip joint prostheses — Part 12: Deformation test method for acetabular shells

Implants for surgery — Partial and total hip joint prostheses — Part 12: Deformation test method for press-fit acetabular components

Implants for surgery — Partial and total hip joint prostheses — Part 13: Determination of resistance to torque of head fixation of stemmed femoral components

Implants for surgery — Partial and total hip joint prostheses — Part 13: Determination of resistance to torque of head fixation of stemmed femoral components — Amendment 1

Implants for surgery — Partial and total knee joint prostheses — Part 1: Classification, definitions and designation of dimensions

Implants for surgery — Components for partial and total knee joint prostheses — Part 1: Classification, definitions and designation of dimensions

Implants for surgery — Components for partial and total knee joint prostheses — Part 1: Classification, definitions and designation of dimensions

Implants for surgery — Components for partial and total knee joint prostheses — Part 2: Articulating surfaces made of metal, ceramic and plastics materials

Implants for surgery — Components for partial and total knee joint prostheses — Part 2: Articulating surfaces made of metal, ceramic and plastics materials

Implants for surgery — Components for partial and total knee joint prostheses — Part 2: Articulating surfaces made of metal, ceramic and plastics materials — Amendment 1

Implants for surgery — Components for partial and total knee joint prostheses — Part 2: Articulating surfaces made of metal, ceramic and plastics materials — Amendment 2

Implants for surgery — Components for partial and total knee joint prostheses — Part 2: Articulating surfaces made of metal, ceramic and plastics materials

Orthopaedic instruments — Drive connections — Part 1: Keys for use with screws with hexagon socket heads

Orthopaedic instruments — Drive connections — Part 1: Keys for use with screws with hexagon socket heads

Orthopaedic instruments — Drive connections — Part 2: Screwdrivers for single slot head screws, screws with cruciate slot and cross-recessed head screws

Prosthetics and orthotics — Limb deficiencies — Part 1: Method of describing limb deficiencies present at birth

Prosthetics and orthotics — Limb deficiencies — Part 2: Method of describing lower limb amputation stumps

Prosthetics and orthotics — Limb deficiencies — Part 2: Method of describing lower limb amputation stumps

Prosthetics and orthotics — Limb deficiencies — Part 3: Method of describing upper limb amputation stumps

Prosthetics and orthotics — Limb deficiencies — Part 3: Method of describing the residual limb after upper limb amputation

Prosthetics and orthotics — Limb deficiencies — Part 4: Description of causal conditions leading to amputation

Prosthetics and orthotics — Limb deficiencies — Part 5: Description of the clinical condition of the person who has had an amputation

Prosthetics and orthotics — Vocabulary — Part 1: General terms for external limb prostheses and external orthoses

Prosthetics and orthotics — Vocabulary — Part 1: General terms for external limb prostheses and external orthoses

Prosthetics and orthotics — Vocabulary — Part 2: Terms relating to external limb prostheses and wearers of these prostheses

Prosthetics and orthotics — Vocabulary — Part 2: Terms relating to external limb prostheses and wearers of these prostheses

Prosthetics and orthotics — Vocabulary — Part 2: Terms relating to external limb prostheses

Prosthetics and orthotics — Vocabulary — Part 3: Terms relating to external orthoses

Prosthetics and orthotics — Vocabulary — Part 3: Terms relating to orthoses

Prosthetics and orthotics — Vocabulary — Part 4: Terms relating to limb amputation

Prosthetics and orthotics — Vocabulary — Part 4: Terms relating to limb amputation

Prosthetics and orthotics — Vocabulary — Part 4: Terms relating to limb amputation

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

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

Implants for surgery — Fixation devices for use in the ends of the femur in adults

Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

Extracorporeal systems for blood purification — Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

Extracorporeal systems for blood purification — Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

Extracorporeal systems for blood purification — Part 3: Plasmafilters

Extracorporeal systems for blood purification — Part 3: Plasmafilters

Haemodialysers, haemofilters and haemoconcentrators

Cardiovascular implants and artificial organs — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

Cardiovascular implants and extracorporeal systems — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

Cardiovascular implants and extracorporeal systems — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators — Amendment 1: Revision to Figure 2 — Main fitting dimensions of dialysis fluid inlet and outlet ports

Extracorporeal blood circuit for haemodialysers, haemofilters and haemoconcentrators

Cardiovascular implants and artificial organs — Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

Implants for surgery — Staples with parallel legs for orthopaedic use — General requirements

Implants for surgery — Guidance on care and handling of orthopaedic implants

Implants for surgery — Guidance on care and handling of orthopaedic implants

Implants for surgery — Metal bone screws with conical under-surface of head — Dimensions

Implants for surgery — Metal bone plates — Holes and slots corresponding to screws with conical under-surface

Implants for surgery — Partial and total hip joint prostheses — Recommendations for simulators for evaluation of hip joint prostheses

Implants for surgery — Partial and total hip joint prostheses — Guidance for laboratory evaluation of change of form of bearing surfaces

Implants for surgery — Non-destructive testing — Liquid penetrant inspection of metallic surgical implants

Implants for surgery — Non-destructive testing — Radiographic examination of cast metallic surgical implants

Implants for surgery — Non-destructive testing — Radiographic examination of cast metallic surgical implants

Implants for surgery — Determination of bending strength and stiffness of bone plates

Implants for surgery — Usage of terms "valgus" and "varus" in orthopaedic surgery

Neurosurgical implants — Self-closing intracranial aneurysm clips

Neurosurgical implants — Self-closing intracranial aneurysm clips

Neurosurgical implants — Self-closing intracranial aneurysm clips

Orthopaedic drilling instruments — Part 1: Drill bits, taps and countersink cutters

Orthopaedic drilling instruments — Part 1: Drill bits, taps and countersink cutters

Implants for surgery — Biocompatibility — Selection of biological test methods for materials and devices

Neurosurgical implants — Marking and packaging of implantable neural stimulators

Prosthetics — Structural testing of lower-limb prostheses — Part 1: Test configurations

Prosthetics — Structural testing of lower-limb prostheses — Part 2: Test samples

Prosthetics — Structural testing of lower-limb prostheses — Part 3: Principal structural tests

Prosthetics — Structural testing of lower-limb prostheses — Part 4: Loading parameters of principal structural tests

Prosthetics — Structural testing of lower-limb prostheses — Part 5: Supplementary structural tests

Prosthetics — Structural testing of lower-limb prostheses — Part 6: Loading parameters of supplementary structural tests

Prosthetics — Structural testing of lower-limb prostheses — Part 7: Test submission document

Prosthetics — Structural testing of lower-limb prostheses — Part 8: Test report

Prosthetics — Structural testing of lower-limb prostheses — Requirements and test methods

Prosthetics — Structural testing of lower-limb prostheses — Requirements and test methods

Prosthetics — Structural testing of lower-limb prostheses — Requirements and test methods

Implants for surgery — Malleable wires for use as sutures and other surgical applications

Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device

Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device

Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device

Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device

Cardiac defibrillators — Connector assembly for implantable defibrillators — Dimensional and test requirements

Cardiac defibrillators — Connector assembly for implantable defibrillators — Dimensional and test requirements — Amendment 1

Cardiac defibrillators — Connector assembly DF-1 for implantable defibrillators — Dimensions and test requirements

Implants for surgery — Determination of impact resistance of ceramic femoral heads for hip joint prostheses

Cardiovascular implants and extracorporeal systems — Blood/tissue contact surface modifications for extracorporeal perfusion systems

Quality of dialysis fluid for haemodialysis and related therapies

Quality of dialysis fluid for haemodialysis and related therapies

Implants for surgery — Mechanical testing of implantable spinal devices — Fatigue test method for spinal implant assemblies using an anterior support

Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: General requirements

Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: General requirements

Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information

Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information

Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products

Retrieval and analysis of surgical implants — Part 1: Retrieval and handling

Implants for surgery — Retrieval and analysis of surgical implants — Part 1: Retrieval and handling

Retrieval and analysis of surgical implants — Part 1: Retrieval and handling

Retrieval and analysis of surgical implants — Part 2: Analysis of retrieved metallic surgical implants

Retrieval and analysis of surgical implants — Part 2: Analysis of retrieved surgical implants

Retrieval and analysis of surgical implants — Part 2: Analysis of retrieved surgical implants

Retrieval and analysis of surgical implants — Part 3: Analysis of retrieved polymeric surgical implants

Retrieval and analysis of surgical implants — Part 4: Analysis of retrieved ceramic surgical implants

Tissue-engineered medical products — Quantification of sulfated glycosaminoglycans (sGAG) for evaluation of chondrogenesis

Implants for surgery — Calcium phosphates — Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutes

Implants for surgery — Plasma-sprayed unalloyed titanium coatings on metallic surgical implants — Part 1: General requirements

Implants for surgery — Coatings on metallic surgical implants — Part 1: Plasma-sprayed coatings derived from titanium or titanium-6 aluminum-4 vanadium alloy powders

Implants for surgery — Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)

Implants for surgery — Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)

Implants for surgery — Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)

Prosthetics and orthotics — External orthoses and orthotic components — Uses, classification and description — Part 1: Lower limb orthoses

Prosthetics and orthotics — Categorization and description of external orthoses and orthotic components

Prosthetics and orthotics — Classification and description of prosthetic components — Part 1: Classification of prosthetic components

Prosthetics and orthotics — Classification and description of prosthetic components — Part 1: Classification of prosthetic components

Prosthetics and orthotics — Classification and description of prosthetic components — Part 2: Description of lower-limb prosthetic components

Prosthetics and orthotics — Classification and description of prosthetic components — Part 2: Description of lower limb prosthetic components

Prosthetics and orthotics — Classification and description of prosthetic components — Part 3: Description of upper-limb prosthetic components

Prosthetics and orthotics — Classification and description of prosthetic components — Part 3: Description of upper limb prosthetic components

Implants for surgery — Hydroxyapatite — Part 1: Ceramic hydroxyapatite

Implants for surgery — Hydroxyapatite — Part 1: Ceramic hydroxyapatite

Implants for surgery — Hydroxyapatite — Part 2: Coatings of hydroxyapatite

Implants for surgery — Hydroxyapatite — Part 2: Coatings of hydroxyapatite

Implants for surgery — Hydroxyapatite — Part 2: Thermally sprayed coatings of hydroxyapatite

Implants for surgery — Hydroxyapatite — Part 3: Chemical analysis and characterization of crystallinity and phase purity

Implants for surgery — Hydroxyapatite — Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity

Implants for surgery — Hydroxyapatite — Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity — Amendment 1

Implants for surgery — Hydroxyapatite — Part 4: Determination of coating adhesion strength

Implants for surgery — Hydroxyapatite — Part 4: Determination of coating adhesion strength

Implants for surgery — Hydroxyapatite — Part 6: Powders

Poly(L-lactide) resins and fabricated forms for surgical implants — In vitro degradation testing

Implants for surgery — Homopolymers, copolymers and blends on poly(lactide) — In vitro degradation testing

Implants for surgery — Metallic materials — Unalloyed tantalum for surgical implant applications

Implants for surgery — Metallic materials — Unalloyed tantalum for surgical implant applications

Concentrates for haemodialysis and related therapies

Concentrates for haemodialysis and related therapies

Concentrates for haemodialysis and related therapies

Water for haemodialysis and related therapies

Water for haemodialysis and related therapies

Water for haemodialysis and related therapies

Cardiovascular implants and artificial organs — Plasmafilters

Cardiovascular implants and extracorporeal systems — Plasmafilters

Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices

Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices

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

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

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

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 — Amendment 1

Implants for surgery — Wear of total hip-joint prostheses — Part 2: Methods of measurement

Implants for surgery — Wear of total hip-joint prostheses — Part 2: Methods of measurement

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

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 — Amendment 1

Implants for surgery — Wear of total hip-joint prostheses — Part 4: Testing hip prostheses under variations in component positioning which results in direct edge loading

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

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

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 — Amendment 1

Implants for surgery — Wear of total knee-joint prostheses — Part 2: Methods of measurement

Implants for surgery — Wear of total knee-joint prostheses — Part 2: Methods of measurement

Implants for surgery — Wear of total knee-joint prostheses — Part 2: Methods of measurement

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

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 — Technical Corrigendum 1

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

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 — Amendment 1

Implants for surgery — Wear of total knee prostheses — Part 5: Durability performance of the patellofemoral joint

Implants for surgery — Fundamental principles

Implants for surgery — Fundamental principles

Implants for surgery — Essential principles of safety and performance

Non-active surgical implants — Implants for osteosynthesis — Particular requirements

Non-active surgical implants — Implants for osteosynthesis — Particular requirements

Implants for surgery — Specific requirements for mammary implants

Non-active surgical implants — Mammary implants — Particular requirements

Non-active surgical implants — Mammary implants — Particular requirements

Non-active surgical implants — Mammary implants — Specific requirements

Non-active surgical implants — General requirements

Non-active surgical implants — General requirements

Non-active surgical implants — General requirements

Non-active surgical implants — General requirements

Non-active surgical implants — General requirements

Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers

Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers

Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers

Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators

Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators

Implants for surgery — Active implantable medical devices — Part 4: Implantable infusion pumps

Implants for surgery — Active implantable medical devices — Part 4: Implantable infusion pump systems

Implants for surgery — Active implantable medical devices — Part 5: Circulatory support devices

Implants for surgery — Active implantable medical devices — Part 5: Circulatory support devices

Implants for surgery — Active implantable medical devices — Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)

Implants for surgery — Active implantable medical devices — Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)

Implants for surgery — Active implantable medical devices — Part 7: Particular requirements for cochlear implant systems

Implants for surgery — Active implantable medical devices — Part 7: Particular requirements for cochlear and auditory brainstem implant systems

Implants for surgery — Total knee-joint prostheses — Part 1: Determination of endurance properties of knee tibial trays

Implants for surgery — Total knee-joint prostheses — Part 1: Determination of endurance properties of knee tibial trays

Implants for surgery — Two-part addition-cure silicone elastomers

Prostheses — Structural testing of hip units

Implants for surgery — Metal intramedullary nailing systems — Part 1: Intramedullary nails

Implants for surgery — Metal intramedullary nailing systems — Part 2: Locking components

Implants for surgery — Metal intramedullary nailing systems — Part 3: Connection devices and reamer diameter measurements

Implants for surgery — Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in implantable medical devices

Implants for surgery — Requirements for production of forgings

Cardiovascular implants — Endovascular prostheses

Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags

Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags

Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags

Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags — Amendment 1: Connectors

Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial line blood filters

Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters

Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters

Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters — Amendment 1: Connectors

Cardiovascular implants and artificial organs — Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)

Cardiovascular implants and artificial organs — Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)

Implants for surgery — Copolymers and blends based on polylactide — In vitro degradation testing

Implants for surgery — Minimum data sets for surgical implants

Implants for surgery — Minimum data sets for surgical implants

Instrumentation for use in association with non-active surgical implants — General requirements

Instrumentation for use in association with non-active surgical implants — General requirements

Instrumentation for use in association with non-active surgical implants — General requirements

Instruments for use in association with non-active surgical implants — General requirements

Implants for surgery — Roentgen stereophotogrammetric analysis for the assessment of migration of orthopaedic implants

Tissue-engineered medical products — Evaluation of anisotropic structure of articular cartilage using DT (Diffusion Tensor)-MR Imaging

Implants for surgery — Acrylic resin cement — Flexural fatigue testing of acrylic resin cements used in orthopaedics

Implants for surgery — Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices

Implants for surgery — Measurements of open-circuit potential to assess corrosion behaviour of metallic implantable materials and medical devices over extended time periods

Implants for surgery — Wear of total shoulder-joint prostheses — Part 1: Force and displacement parameters for wear-testing machines and corresponding environmental conditions for test of anatomic total shoulder-joint prostheses

Prosthetics — Quantification of physical parameters of ankle foot devices and foot units

Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable implants

Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable implants

Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable implants

Non-active surgical implants — Implant coating — Part 1: General requirements

Non-active surgical implants — Implant coating — Part 2: Reference standards related to coatings

Wear of implant materials — Polymer and metal wear particles — Isolation, characterization and quantification

Wear of implant materials — Polymer and metal wear particles — Isolation, characterization and quantification — Technical Corrigendum 1

Wear of implant materials — Polymer and metal wear particles — Isolation and characterization

Wear of implant materials — Polymer and metal wear particles — Isolation and characterization

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

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

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 — Amendment 1

Implants for surgery — Wear of total intervertebral spinal disc prostheses — Part 2: Nucleus replacements

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

Cardiovascular implants and artificial organs — Cannulae for extracorporeal circulation

Cardiovascular implants and extracorporeal systems — Cardiopulmonary bypass systems — Venous bubble traps

Cardiovascular implants and extracorporeal systems — Cardiopulmonary bypass systems — Venous bubble traps — Amendment 1: Connectors

Cardiovascular implants and extracorporeal systems — Centrifugal blood pumps

Cardiovascular implants and extracorporeal systems — Centrifugal blood pumps — Amendment 1: Worst-case conditions for testing

Cardiac valve manufacturing risk management

Evaluation of CPB devices relative to their capabilities of reducing the transmission of gaseous microemboli (GME) to a patient during cardiopulmonary bypass

Tissue-engineered medical products — Bioactive ceramics — Method to measure cell migration in porous materials

Implants for surgery — Test methods of material for use as a cortical bone model

Implants for surgery — Cleanliness of orthopedic implants — General requirements

Implants for surgery — Orthopaedic joint prosthesis — Part 1: Procedure for producing parametric 3D bone models from CT data of the knee

Implants for surgery — Metallic materials — Classification of microstructures for alpha+beta titanium alloy bars

Implants for surgery — General guidelines and requirements for assessment of absorbable metallic implants

Prosthetics and orthotics — Soft orthoses — Uses, functions, classification and description

Prosthetics and orthotics — Foot orthotics — Uses, functions classification and description

Prosthetics and orthotics — Terms relating to the treatment and rehabilitation of persons having a lower limb amputation

Non-active surgical implants — Joint replacement implants — Particular requirements

Non-active surgical implants — Joint replacement implants — Particular requirements

Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants

Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants — Amendment 1

Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants

Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants

Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants

Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants — Amendment 1

Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants

General requirements of tissue-engineered medical products

Guidance for uncertainty analysis regarding the application of ISO/TS 10974

Anaesthetic and respiratory equipment — Voice prostheses

External limb prostheses and external orthoses — Requirements and test methods

External limb prostheses and external orthoses — Requirements and test methods

Implants for surgery — Wear of total ankle-joint prostheses — Loading and displacement parameters for wear-testing machines with load or displacement control and corresponding environmental conditions for test

Prosthetics — Testing of ankle-foot devices and foot units — Requirements and test methods

Prosthetics — Testing of ankle-foot devices and foot units — Requirements and test methods

Prosthetics — Testing of ankle-foot devices and foot units — Requirements and test methods

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

Cardiovascular implants — Transcatheter cardiac occluders

Implants for surgery — Specification and verification of synthetic anatomical bone models for testing

Implants for surgery — Pre-clinical mechanical assessment of spinal implants and particular requirements — Part 2: Spinal intervertebral body fusion devices

Implants for surgery — In vitro evaluation for apatite-forming ability of implant materials

Implants for surgery — In vitro evaluation for apatite-forming ability of implant materials

Implants for surgery — In vitro evaluation for apatite-forming ability of implant materials

Implants for surgery — In vitro evaluation for apatite-forming ability of implant materials

Preparation and quality management of fluids for haemodialysis and related therapies — Part 1: General requirements

Preparation and quality management of fluids for haemodialysis and related therapies — Part 1: General requirements

Preparation and quality management of fluids for haemodialysis and related therapies — Part 2: Water treatment equipment for haemodialysis applications and related therapies

Preparation and quality management of fluids for haemodialysis and related therapies — Part 2: Water treatment equipment for haemodialysis applications and related therapies

Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies

Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies

Preparation and quality management of fluids for haemodialysis and related therapies — Part 4: Concentrates for haemodialysis and related therapies

Preparation and quality management of fluids for haemodialysis and related therapies — Part 4: Concentrates for haemodialysis and related therapies

Preparation and quality management of fluids for haemodialysis and related therapies — Part 5: Quality of dialysis fluid for haemodialysis and related therapies

Preparation and quality management of fluids for haemodialysis and related therapies — Part 5: Quality of dialysis fluid for haemodialysis and related therapies

Guidance for the preparation and quality management of fluids for haemodialysis and related therapies

Guidance for the preparation and quality management of fluids for haemodialysis and related therapies

Cardiovascular implants and artificial organs — Checklist for preoperative extracorporeal circulation equipment setup

Cardiovascular implants and artificial organs — Checklist for preoperative extracorporeal circulation equipment setup

Cardiovascular implants and artificial organs — Checklists for use of extracorporeal circulation equipment

Tissue-engineered medical products — MRI evaluation of cartilage — Part 1: Clinical evaluation of regenerative knee articular cartilage using delayed gadolinium-enhanced MRI of cartilage (dGEMRIC) and T2 mapping

Prosthetics — Geometrical aspects of lower limb prosthetic adapters

Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses

Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses — Amendment 1: Test methods

Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses

Cardiovascular implants — Endovascular devices — Part 2: Vascular stents

Cardiovascular implants — Endovascular devices — Part 2: Vascular stents

Cardiovascular implants — Endovascular devices — Part 2: Vascular stents

Cardiovascular implants — Endovascular devices — Part 3: Vena cava filters

Cardiovascular implants — Endovascular devices — Part 3: Vena cava filters

Cardiovascular implants — Endovascular devices — Part 4: Application of ISO 17327-1 for coated endovascular devices

Water treatment equipment for haemodialysis applications and related therapies

Water treatment equipment for haemodialysis applications and related therapies

Cardiac rhythm management devices — Symbols to be used with cardiac rhythm management device labels, and information to be supplied — General requirements

Cardiac rhythm management devices — Symbols to be used with cardiac rhythm management device labels, and information to be supplied — General requirements

Active implantable medical devices — Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements

Active implantable medical devices — Four-pole connector system for implantable cardiac rhythm management devices — Dimensional and test requirements

Active implantable medical devices — Four-pole connector system for implantable cardiac rhythm management devices — Dimensional and test requirements

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

Prostheses and orthoses — Factors to be considered when specifying a prosthesis for a person who has had a lower limb amputation

Prostheses and orthoses — Factors to be considered when specifying a prosthesis for a person who has had a lower limb amputation

Prosthetics and orthotics — Vocabulary — Part 1: Normal gait

Prosthetics and orthotics — Vocabulary — Part 2: Prosthetic gait

Prosthetics and orthotics — Vocabulary — Part 3: Pathological gait (excluding prosthetic gait)

Biological evaluation of absorbable medical devices — Part 1: General requirements

Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants

Guidelines for the safe use of medical products in dialysis treatment

Medical electrical equipment — Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source