Source: https://committee.iso.org/ics/11.040.40/x/
Timestamp: 2019-10-16 06:19:40
Document Index: 85261332

Matched Legal Cases: ['art 10', 'art 11', 'art 12', 'art 12', 'art 14', 'art 1', 'art 2', 'art 3', 'art 4', 'art 5', 'art 5', 'art 6', 'art 7', 'art 8', 'art 9', 'art 1', 'art 1', 'art 1', 'art 1', 'art 2', 'art 2', 'art 3', 'art 4', 'art 5', 'art 1', 'art 1', 'art 2', 'art 3', 'art 1', 'art 2', 'art 1', 'art 2', 'art 3', 'art 5', 'art 1', 'art 2', 'art 3', 'art 4', 'art 1', 'art 2', 'art 1', 'art 2', 'art 3', 'art 4', 'art 5', 'art 6', 'art 7', 'art 8', 'art 2', 'art 1', 'art 1', 'art 2', 'art 2', 'art 3', 'art 4', 'art 3', 'art 1', 'art 1', 'art 2', 'art 2', 'art 3', 'art 3', 'art 1', 'art 2', 'art 3', 'art 3', 'art 4', 'art 6', 'art 2', 'art 3', 'art 4', 'art 5', 'art 1', 'art 1', 'art 1', 'art 3', 'art 1', 'art 2', 'art 3', 'art 2', 'art 1']

ISO - 11.040.40 - Implants for surgery, prosthetics and orthotics
11.040.40 
Implants for surgery, prosthetics and orthotics Including pacemakers
ISO 5832-10:1993
Implants for surgery — Metallic materials — Part 10: Wrought titanium 5-aluminium 2,5-iron alloy
95.99 ISO/TC 150/SC 1
ISO 5832-10:1996
Implants for surgery — Metallic materials — Part 11: Wrought titanium 6-aluminium 7-niobium alloy
ISO 5832-11:2014
90.20 ISO/TC 150/SC 1
ISO 5832-12:1996
Implants for surgery — Metallic materials — Part 12: Wrought cobalt-chromium-molybdenum alloy
ISO 5832-12:2007/Cor 1:2008
Implants for surgery — Metallic materials — Part 12: Wrought cobalt-chromium-molybdenum alloy — Technical Corrigendum 1
ISO 5832-12:2019
60.60 ISO/TC 150/SC 1
ISO 5832-14:2007
Implants for surgery — Metallic materials — Part 14: Wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy
ISO 5832-14:2019
ISO 5832-1:1980
95.99 ISO/TC 150
ISO 5832-1:1987
ISO 5832-1:2007/Cor 1:2008
Implants for surgery — Metallic materials — Part 1: Wrought stainless steel — Technical Corrigendum 1
ISO 5832-1:2016
ISO 5832-2:1978
Implants for surgery — Metallic materials — Part 2: Unalloyed titanium
ISO 5832-2:1993
ISO 5832-2:2018
ISO 5832-3:1978
Implants for surgery — Metallic materials — Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
ISO 5832-3:2016
90.92 ISO/TC 150/SC 1
ISO 5832-4:1978
Implants for surgery — Metallic materials — Part 4: Cobalt-chromium-molybdenum casting alloy
ISO 5832-4:2014
ISO 5832-5:1978
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
90.60 ISO/TC 150/SC 1
ISO 5832-6:1980
Implants for surgery — Metallic materials — Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy
ISO 5832-7:1984
Implants for surgery — Metallic materials — Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy
ISO 5832-7:1994
ISO 5832-7:2016
ISO 5832-8:1987
Implants for surgery — Metallic materials — Part 8: Wrought cobalt-nickel-chromium-molybdenum- tungsten-iron alloy
ISO 5832-8:1997
ISO 5832-9:1992
Implants for surgery — Metallic materials — Part 9: Wrought high nitrogen stainless steel
ISO 5832-9:2019
ISO/WD 5832-3
20.00 ISO/TC 150/SC 1
ISO 5833-1:1979
Implants for surgery — Acrylic resin cements — Part 1: Orthopaedic applications
ISO 5833:1992
Implants for surgery — Acrylic resin cements
ISO 5833:2002
ISO 5834-1:1985
Implants for surgery — Ultra-high molecular weight polyethylene — Part 1: Powder form
ISO 5834-1:1998
ISO 5834-1:2005
Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 1: Powder form
ISO 5834-1:2005/Cor 1:2007
Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 1: Powder form — Technical Corrigendum 1
ISO 5834-1:2019
ISO 5834-2:1985
Implants for surgery — Ultra-high molecular weight polyethylene — Part 2: Moulded forms
ISO 5834-2:1998
ISO 5834-2:2006
Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 2: Moulded forms
ISO 5834-3:2005
Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 3: Accelerated ageing methods
ISO 5834-4:2005
Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 4: Oxidation index measurement method
ISO 5834-4:2019
ISO 5834-5:2005
Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 5: Morphology assessment method
ISO 5834-5:2019
95.99 ISO/TC 150/SC 5
90.93 ISO/TC 150/SC 5
95.99 ISO/TC 150/SC 4
90.92 ISO/TC 150/SC 2
ISO 5840:1984
Implants for surgery — Cardiovascular implants — Cardiac valve prostheses
95.99 ISO/TC 150/SC 2
ISO 5840:1989
40.60 ISO/TC 150/SC 2
ISO/DIS 5840-2
ISO 5841-1:1985
Implants for surgery — Cardiac pacemakers — Part 1: Implantable ventricular pacemakers
Cardiac pacemakers — Part 1: Implantable pacemakers
ISO 5841-2:1986
Implants for surgery — Cardiac pacemakers — Part 2: Reporting of the clinical performance of populations of pulse generators
90.20 ISO/TC 150/SC 6
ISO 5841-3:1992
Cardiac pacemakers — Part 3: Low-profile connectors (IS-1) for implantable pacemakers
90.93 ISO/TC 150/SC 6
60.60 ISO/TC 150/SC 2
ISO 6018:1987
Orthopaedic implants — General requirements for marking, packaging and labelling
Implants for surgery — Ceramic materials — Part 1: Ceramic materials based on high purity alumina
ISO 6474-1:2019
Implants for surgery — Ceramic materials — Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement
ISO 6474-2:2019
ISO 6474:1981
Implants for surgery — Ceramic materials based on alumina
ISO 6474:1994
Implants for surgery — Ceramic materials based on high purity alumina
90.92 ISO/TC 150/SC 5
40.99 ISO/TC 150/SC 5
ISO 7197:1989
Neurosurgical implants — Sterile, single-use hydrocephalus shunts and components
90.93 ISO/TC 150
Neurosurgical implants — Sterile, single-use hydrocephalus shunts and components — Technical Corrigendum 1
60.60 ISO/TC 150
Cardiovascular implants — Tubular vascular prostheses
ISO 7199:1996
Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators)
ISO 7199:2009/Amd 1:2012
Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators) — Amendment 1: Clarifications for test methodologies, labelling, and sampling schedule
ISO 7199:2016
ISO 7199:2016/FDAmd 1
Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators) — Amendment 1: Connectors
50.00 ISO/TC 150/SC 2
60.60 ISO/TC 150/SC 4
90.93 ISO/TC 150/SC 4
90.60 ISO/TC 150/SC 4
40.60 ISO/TC 150/SC 4
Prosthetics and orthotics — Limb deficiencies — Part 1: Method of describing limb deficiencies present at birth
90.93 ISO/TC 168
Prosthetics and orthotics — Limb deficiencies — Part 2: Method of describing lower limb amputation stumps
90.92 ISO/TC 168
Prosthetics and orthotics — Limb deficiencies — Part 3: Method of describing upper limb amputation stumps
Prosthetics and orthotics — Limb deficiencies — Part 5: Description of the clinical condition of the person who has had an amputation
ISO/DIS 8548-2
40.60 ISO/TC 168
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 3: Terms relating to external orthoses
Prosthetics and orthotics — Vocabulary — Part 4: Terms relating to limb amputation
90.20 ISO/TC 168
ISO/CD 8549-1
30.20 ISO/TC 168
ISO/CD 8549-2
ISO/CD 8549-3
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
ISO/DIS 8551
Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO 8637-2:2018
Extracorporeal systems for blood purification — Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
ISO 8637:1989
Haemodialysers, haemofilters and haemoconcentrators
ISO 8637:2004
Cardiovascular implants and artificial organs — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO 8637:2010
Cardiovascular implants and extracorporeal systems — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
Extracorporeal blood circuit for haemodialysers, haemofilters and haemoconcentrators
Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
ISO 8828:1988
Implants for surgery — Guidance on care and handling of orthopaedic implants
90.60 ISO/TC 150
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
ISO/TR 9586:1988
Implants for surgery — Usage of terms "valgus" and "varus" in orthopaedic surgery
ISO 9713:1990
Neurosurgical implants — Self-closing intracranial aneurysm clips
ISO 9713:2002
90.92 ISO/TC 150
ISO/WD 9713
20.20 ISO/TC 150
ISO/TR 9966:1989
Implants for surgery — Biocompatibility — Selection of biological test methods for materials and devices
Prosthetics — Structural testing of lower-limb prostheses — Part 1: Test configurations
95.99 ISO/TC 168
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
60.60 ISO/TC 168
Cardiac defibrillators — Connector assembly for implantable defibrillators — Dimensional and test requirements
Cardiac defibrillators — Connector assembly for implantable defibrillators — Dimensional and test requirements — Amendment 1
ISO 11658:2012
Cardiovascular implants and extracorporeal systems — Blood/tissue contact surface modifications for extracorporeal perfusion systems
90.93 ISO/TC 150/SC 2
ISO 11663:2014
ISO/TR 12417-2:2017
Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information
ISO 12891-1:1998
Retrieval and analysis of surgical implants — Part 1: Retrieval and handling
ISO 12891-1:2011
Implants for surgery — Retrieval and analysis of surgical implants — Part 1: Retrieval and handling
ISO 12891-1:2015
Retrieval and analysis of surgical implants — Part 2: Analysis of retrieved metallic surgical implants
ISO 12891-2:2014
Retrieval and analysis of surgical implants — Part 2: Analysis of retrieved surgical implants
ISO 12891-3:2000
Retrieval and analysis of surgical implants — Part 3: Analysis of retrieved polymeric surgical implants
ISO 12891-4:2000
Retrieval and analysis of surgical implants — Part 4: Analysis of retrieved ceramic surgical implants
ISO 13019:2018
Tissue-engineered medical products — Quantification of sulfated glycosaminoglycans (sGAG) for evaluation of chondrogenesis
60.60 ISO/TC 150/SC 7
Implants for surgery — Calcium phosphates — Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutes
ISO/WD 13175-3
ISO 13179-1:2014
Implants for surgery — Plasma-sprayed unalloyed titanium coatings on metallic surgical implants — Part 1: General requirements
ISO 13356:1997
Implants for surgery — Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)
ISO 13356:2008
ISO 13356:2015
Prosthetics and orthotics — Categorization and description of external orthoses and orthotic components
90.60 ISO/TC 168
ISO 13405-1:1996
Prosthetics and orthotics — Classification and description of prosthetic components — Part 1: Classification of prosthetic components
ISO 13405-2:1996
Prosthetics and orthotics — Classification and description of prosthetic components — Part 2: Description of lower-limb prosthetic components
ISO 13405-2:2015
Prosthetics and orthotics — Classification and description of prosthetic components — Part 2: Description of lower limb prosthetic components
ISO 13405-3:1996
Prosthetics and orthotics — Classification and description of prosthetic components — Part 3: Description of upper-limb prosthetic components
ISO 13405-3:2015
Prosthetics and orthotics — Classification and description of prosthetic components — Part 3: Description of upper limb prosthetic components
ISO 13779-1:2000
Implants for surgery — Hydroxyapatite — Part 1: Ceramic hydroxyapatite
ISO 13779-1:2008
ISO 13779-2:2000
Implants for surgery — Hydroxyapatite — Part 2: Coatings of hydroxyapatite
ISO 13779-3:2008
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
ISO 13779-4:2002
Implants for surgery — Hydroxyapatite — Part 4: Determination of coating adhesion strength
ISO 13779-6:2015
Implants for surgery — Hydroxyapatite — Part 6: Powders
Poly(L-lactide) resins and fabricated forms for surgical implants — In vitro degradation testing
Implants for surgery — Metallic materials — Unalloyed tantalum for surgical implant applications
ISO 13782:2019
ISO 13959:2002
ISO 13959:2014
ISO 13960:2003
Cardiovascular implants and artificial organs — Plasmafilters
Cardiovascular implants and extracorporeal systems — Plasmafilters
90.20 ISO/TC 150/SC 4
50.00 ISO/TC 150/SC 4
Implants for surgery — Fundamental principles
Implants for surgery — Essential principles of safety and performance
Implants for surgery — Specific requirements for mammary implants
Non-active surgical implants — Mammary implants — Particular requirements
20.00 ISO/TC 150
60.00 ISO/TC 150/SC 6
40.99 ISO/TC 150/SC 6
90.92 ISO/TC 150/SC 4
ISO 14949:2001
Implants for surgery — Two-part addition-cure silicone elastomers
ISO 15032:2000
Prostheses — Structural testing of hip units
90.60 ISO/TC 150/SC 5
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
ISO 15674:2016/FDAmd 1
Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags — Amendment 1: Connectors
ISO 15675:2001
Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial line blood filters
ISO 15675:2009
Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters
ISO 15675:2016
ISO 15675:2016/FDAmd 1
Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters — Amendment 1: Connectors
ISO 15676:2005
Cardiovascular implants and artificial organs — Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
ISO 15676:2016
Implants for surgery — Copolymers and blends based on polylactide — In vitro degradation testing
Implants for surgery — Minimum data sets for surgical implants
30.60 ISO/TC 150
ISO/TR 16379:2014
Tissue-engineered medical products — Evaluation of anisotropic structure of articular cartilage using DT (Diffusion Tensor)-MR Imaging
ISO 16402:2008
Implants for surgery — Acrylic resin cement — Flexural fatigue testing of acrylic resin cements used in orthopaedics
90.93 ISO/TC 150/SC 1
ISO/TS 16955:2016
Prosthetics — Quantification of physical parameters of ankle foot devices and foot units
ISO/TS 17137:2019
60.60 ISO/TC 150/SC 5
ISO 18241:2016
Cardiovascular implants and extracorporeal systems — Cardiopulmonary bypass systems — Venous bubble traps
ISO 18241:2016/FDAmd 1
Cardiovascular implants and extracorporeal systems — Cardiopulmonary bypass systems — Venous bubble traps — Amendment 1: Connectors
50.20 ISO/TC 150/SC 2
ISO 18242:2016
Cardiovascular implants and extracorporeal systems — Centrifugal blood pumps
ISO 19090:2018
Tissue-engineered medical products — Bioactive ceramics — Method to measure cell migration in porous materials
Implants for surgery — Cleanliness of orthopedic implants — General requirements
ISO 20160:2006
Implants for surgery — Metallic materials — Classification of microstructures for alpha+beta titanium alloy bars
ISO 21063:2017
Prosthetics and orthotics — Soft orthoses — Uses, functions, classification and description
ISO 21064:2017
Prosthetics and orthotics — Foot orthotics — Uses, functions classification and description
ISO 21065:2017
Prosthetics and orthotics — Terms relating to the treatment and rehabilitation of persons having a lower limb amputation
20.00 ISO/TC 150/SC 4
ISO/CD TS 21560
General requirements of TEMPs
30.92 ISO/TC 150/SC 7
External limb prostheses and external orthoses — Requirements and test methods
ISO 22675:2006
Prosthetics — Testing of ankle-foot devices and foot units — Requirements and test methods
ISO/WD 22675
20.00 ISO/TC 168
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
30.60 ISO/TC 150/SC 5
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 2: Water treatment equipment for haemodialysis applications and related therapies
ISO 23500-3:2019
Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies
ISO 23500-4:2019
Preparation and quality management of fluids for haemodialysis and related therapies — Part 4: Concentrates for haemodialysis and related therapies
ISO 23500-5:2019
Preparation and quality management of fluids for haemodialysis and related therapies — Part 5: Quality of dialysis fluid for haemodialysis and related therapies
ISO/TS 23810:2006
Cardiovascular implants and artificial organs — Checklist for preoperative extracorporeal circulation equipment setup
ISO/TS 23810:2012
ISO/TS 23810:2018
Cardiovascular implants and artificial organs — Checklists for use of extracorporeal circulation equipment
ISO/CD TR 24560-1
Tissue engineered medical products — MRI evaluation of cartilage — Part 1: Clinical evaluation of regenerative knee articular cartilage using delayed gadolimium-enhanced MRI of cartilage (dGEMRIC) and T2 mapping
30.60 ISO/TC 150/SC 7
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 3: Vena cava filters
30.99 ISO/TC 150/SC 6
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
ISO/NP 29782
10.99 ISO/TC 168
ISO 29783-1:2008
Prosthetics and orthotics — Vocabulary — Part 1: Normal gait
ISO 29783-2:2015
Prosthetics and orthotics — Vocabulary — Part 2: Prosthetic gait
Prosthetics and orthotics — Vocabulary — Part 3: Pathological gait (excluding prosthetic gait)
ISO/DTR 37137-2
Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants — Part 2: Standard guide for absorbable metals
30.60 ISO/TC 194
ISO/DTS 37137-1
Biological evaluation of medical devices — Part 1: Guidance for absorbable implants
ISO/TR 37137:2014
Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants
90.92 ISO/TC 194
IEC/TR 62653:2013
Guidelines for the safe use of medical products in dialysis treatment
11.040.40 - Implants for surgery, prosthetics …