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11.040.40: Implants for surgery, prosthetics and orthotics

Including pacemakers
Ophthalmic implants, see 11.040.70

Items to be displayed:

Standard and/or projectStage TC
ISO/CD 5832-2
Implants for surgery -- Metallic materials -- Part 2: Unalloyed titanium
30.99 ISO/TC 150/SC 1
ISO/FDIS 5832-3
Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
50.20 ISO/TC 150/SC 1
ISO/DIS 5832-7
Implants for surgery -- Metallic materials -- Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy
40.99 ISO/TC 150/SC 1
ISO/NP 5840-3
Cardiovascular implants -- Cardiac valve prostheses -- Part 3: Heart valve substitutes implanted by transcatheter techniques
10.99 ISO/TC 150/SC 2
ISO/CD 5910
Cardiovascular implants and extracoporeal systems -- Cardiac valve repair devices
30.99 ISO/TC 150/SC 2
ISO/DIS 6474-1
Implants for surgery -- Ceramic materials -- Part 1: Ceramic materials based on high purity alumina
40.20 ISO/TC 150/SC 1
ISO/FDIS 7199
Cardiovascular implants and artificial organs -- Blood-gas exchangers (oxygenators)
50.00 ISO/TC 150/SC 2
ISO 7206-2:2011/PRF Amd 1
50.20 ISO/TC 150/SC 4
ISO/DIS 7206-10
Implants for surgery -- Partial and total hip-joint prostheses -- Part 10: Determination of resistance to static load of modular femoral heads
40.20 ISO/TC 150/SC 4
ISO/FDIS 7206-12
Implants for surgery -- Partial and total hip joint prostheses -- Part 12: Deformation test method for acetabular shells
50.20 ISO/TC 150/SC 4
ISO 7207-2:2011/Amd 1
60.00 ISO/TC 150/SC 4
ISO/DIS 8637-1
Extracorporeal systems for blood purification -- Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
40.60 ISO/TC 150/SC 2
ISO/DIS 8637-2
Extracorporeal systems for blood purification -- Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
40.60 ISO/TC 150/SC 2
ISO/DIS 8637-3
Extracorporeal systems for blood purification -- Part 3: Plasmafilters
40.60 ISO/TC 150/SC 2
ISO/NP TS 10974
Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
10.99 ISO/TC 150/SC 6
ISO/DIS 11491.2
Implants for surgery -- Test method for impact resistance of ceramic femoral heads for hip joint prostheses
40.60 ISO/TC 150/SC 4
ISO/DTR 12417-2
Cardiovascular implants and extracorporeal systems -- Vascular device-drug combination products -- Part 2: Local regulatory guidance
30.60 ISO/TC 150/SC 2
ISO/CD 13019
Tissue-engineered medical products -- Quantification of sulphated glycosaminoglycans (sGAG) for evaluation of chondrogenesis
30.20 ISO/TC 150/SC 7
ISO/CD 13779-2
Implants for surgery -- Hydroxyapatite -- Part 2: Coatings of hydroxyapatite
30.20 ISO/TC 150/SC 1
ISO/CD 13779-3
Implants for surgery -- Hydroxyapatite -- Part 3: Chemical analysis and characterization of crystallinity and phase purity
30.20 ISO/TC 150/SC 1
ISO/CD 13779-4
Implants for surgery -- Hydroxyapatite -- Part 4: Determination of coating adhesion strength
30.20 ISO/TC 150/SC 1
ISO/DIS 13781.2
Implants for surgery -- Homopolymers, copolymers and blends on poly(lactide) -- In vitro degradation testing
40.60 ISO/TC 150/SC 1
ISO/CD 14117
Active implantable medical devices -- Electromagnetic compatibility -- EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
30.20 ISO/TC 150/SC 6
ISO 14242-1:2014/DAmd 1
40.20 ISO/TC 150/SC 4
ISO 14242-2
Implants for surgery -- Wear of total hip-joint prostheses -- Part 2: Methods of measurement
60.00 ISO/TC 150/SC 4
ISO 14242-3:2009/CD Amd 1
30.99 ISO/TC 150/SC 4
ISO/CD 14242-4
Implants for surgery -- Wear of total hip-joint prostheses -- Part 4: Loading and displacement parameters for wear testing machines under edge loading conditions due to translational (displacement controlled) and rotational mal-positioning
30.60 ISO/TC 150/SC 4
ISO 14243-2
Implants for surgery -- Wear of total knee-joint prostheses -- Part 2: Methods of measurement
60.00 ISO/TC 150/SC 4
ISO/CD 14243-5
Implants for surgery -- Wear of total knee prostheses -- Part 5: Durability performance of the patellofemoral joint -- Loading and displacement parameters for testing machines and corresponding environmental conditions for test
30.60 ISO/TC 150/SC 4
ISO/DTR 14283
Implants for surgery -- Fundamental principles
30.60 ISO/TC 150
ISO/CD 14607
Non-active surgical implants -- Mammary implants -- Particular requirements
30.60 ISO/TC 150
ISO/CD 14708-2
Implants for surgery -- Active implantable medical devices -- Part 2: Cardiac pacemakers
30.20 ISO/TC 150/SC 6
ISO/DIS 14708-3
Implants for surgery -- Active implantable medical devices -- Part 3: Implantable neurostimulators
40.99 ISO/TC 150/SC 6
ISO/NP 14708-5
Implants for surgery -- Active implantable medical devices -- Part 5: Circulatory support devices
10.99 ISO/TC 150/SC 6
ISO/CD 14708-6
Implants for surgery -- Active implantable medical devices -- Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
30.20 ISO/TC 150/SC 6
ISO/NP 14708-7
Implants for surgery -- Active implantable medical devices -- Part 7: Particular requirements for cochlear implant systems
10.99 ISO/TC 150/SC 6
ISO 15674
Cardiovascular implants and artificial organs -- Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
60.00 ISO/TC 150/SC 2
ISO 15675
Cardiovascular implants and artificial organs -- Cardiopulmonary bypass systems -- Arterial blood line filters
60.00 ISO/TC 150/SC 2
ISO 15676
Cardiovascular implants and artificial organs -- Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
60.00 ISO/TC 150/SC 2
ISO/AWI 16054
Implants for surgery -- Minimum data sets for surgical implants
20.00 ISO/TC 150
ISO/CD 17327-1
Non-active surgical implants -- Implant coating -- Part 1: General requirements
30.60 ISO/TC 150
ISO/DIS 18192-3
Implants for surgery -- Wear of total intervertebral spinal disc prostheses -- Part 3: Loading and displacement parameters for impingement-wear testing and corresponding environmental conditions for test of lumbar prostheses under adverse kinematic conditions
40.60 ISO/TC 150/SC 5
ISO 18241
Cardiovascular implants and extracorporeal systems -- Cardiopulmonary bypass systems -- Venous bubble traps
60.00 ISO/TC 150/SC 2
ISO 18242
Cardiovascular implants and extracorporeal systems -- Centrifugal blood pumps
60.00 ISO/TC 150/SC 2
ISO/DIS 18531
Implants for surgery -- Calcium phosphate bioceramics -- Characterization of hardening bone paste materials
40.60 ISO/TC 150/SC 1
ISO/TR 19024
Evaluation of CPB devices relative to their capabilities of reducing the transmission of Gaseous MicroEmboli (GME) to a patient during cardiopulmonary bypass
60.00 ISO/TC 150/SC 2
ISO/CD 19090
Tissue-engineered medical products -- Bioactive ceramics -- Cell migration ability test for porous body
30.60 ISO/TC 150/SC 7
ISO/DIS 19213
Implants for surgery -- Test methods of material for use as a cortical bone model
40.60 ISO/TC 150/SC 5
ISO/DIS 19227
Cleaning of orthopedic implants - General Requirements
40.60 ISO/TC 150
ISO/DIS 19233-1
Implants for surgery -- Orthopaedic joint prosthesis -- Part 1: Procedure for producing parametric 3D bone models from CT data of the knee
40.20 ISO/TC 150/SC 4
ISO 21535:2007/FDAmd 1
50.20 ISO/TC 150/SC 4
ISO/CD 23500-1
Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
30.60 ISO/TC 150/SC 2
ISO/CD 23500-2
Guidance for the preparation and quality management of fluids for haemodialysis and related therapies -- Part 2: Water treatment equipment for haemodialysis applications and related therapies
30.60 ISO/TC 150/SC 2
ISO/CD 23500-3
Guidance for the preparation and quality management of fluids for haemodialysis and related therapies -- Part 3: Water for haemodialysis and related therapies
30.60 ISO/TC 150/SC 2
ISO/CD 23500-4
Guidance for the preparation and quality management of fluids for haemodialysis and related therapies -- Part 4: Concentrates for haemodialysis and related therapies
30.60 ISO/TC 150/SC 2
ISO/CD 23500-5
Guidance for the preparation and quality management of fluids for haemodialysis and related therapies -- Part 5: Quality of dialysis fluid for haemodialysis and related therapies
30.60 ISO/TC 150/SC 2
ISO/AWI TS 23810
Cardiovascular implants and artificial organs -- Checklist for extracorporeal circulation equipment
20.00 ISO/TC 150/SC 2
ISO/DIS 25539-1
Cardiovascular implants -- Endovascular devices -- Part 1: Endovascular prostheses
40.99 ISO/TC 150/SC 2
ISO/CD 27186
Active implantable medical devices -- Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
30.00 ISO/TC 150/SC 6
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