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ISO/TC 150/SC 2  - Cardiovascular implants and extracorporeal systems

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Standards and projects under the direct responsibility of ISO/TC 150/SC 2 Secretariat

Standard and/or projectStageICS
ISO 5840:2005
Cardiovascular implants -- Cardiac valve prostheses
90.92 11.040.40
ISO/DIS 5840-1
Cardiovascular implants -- Cardiac valve prostheses -- Part 1: General requirements
40.99 11.040.40
ISO/DIS 5840-2
Cardiovascular implants -- Cardiac valve prostheses -- Part 2: Surgically implanted heart valve substitutes
40.99 11.040.40
ISO 5840-3:2013
Cardiovascular implants -- Cardiac valve prostheses -- Part 3: Heart valve substitutes implanted by transcatheter techniques
90.92 11.040.40
ISO/NP 5840-3
Cardiovascular implants -- Cardiac valve prostheses -- Part 3: Heart valve substitutes implanted by transcatheter techniques
10.99 11.040.40
ISO/WD 5910
Cardiovascular implants and extracoporeal systems -- Cardiac valve repair devices
20.20
ISO 7198:1998
Cardiovascular implants -- Tubular vascular prostheses
90.92 11.040.40
ISO/DIS 7198
Cardiovascular implants and extracorporeal systems -- Vascular Prostheses -- Tubular vascular grafts and vascular patches
40.20 11.040.40
ISO 7199:2009
Cardiovascular implants and artificial organs -- Blood-gas exchangers (oxygenators)
90.92 11.040.40
ISO/NP 7199
Cardiovascular implants and artificial organs -- Blood-gas exchangers (oxygenators)
10.99 11.040.40
ISO 7199:2009/Amd 1:2012
Clarifications for test methodologies, labelling, and sampling schedule
60.60 11.040.40
ISO 8637:2010
Cardiovascular implants and extracorporeal systems -- Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
60.60 11.040.40
ISO 8637:2010/Amd 1:2013
Revision to Figure 2 -- Main fitting dimensions of dialysis fluid inlet and outlet ports
60.60 11.040.40
ISO 8638:2010
Cardiovascular implants and extracorporeal systems -- Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
60.60 11.040.40
ISO 11658:2012
Cardiovascular implants and extracorporeal systems -- Blood/tissue contact surface modifications for extracorporeal perfusion systems
60.60 11.040.40
ISO 11663:2014
Quality of dialysis fluid for haemodialysis and related therapies
90.92 11.040.40
ISO/TS 12417:2011
Cardiovascular implants and extracorporeal systems -- Vascular device-drug combination products
90.92 11.040.40
ISO/DIS 12417-1
Cardiovascular implants and extracorporeal systems -- Vascular device-drug combination products -- Part 1: General requirements
40.99 11.040.40
ISO/NP TR 12417-2
Cardiovascular implants and extracorporeal systems -- Vascular device-drug combination products -- Part 2: Local regulatory guidance
10.99
ISO 13958:2014
Concentrates for haemodialysis and related therapies
90.92 11.040.40
ISO 13959:2014
Water for haemodialysis and related therapies
90.92 11.040.40
ISO 13960:2010
Cardiovascular implants and extracorporeal systems -- Plasmafilters
60.60 11.040.40
ISO/TS 15539:2000
Cardiovascular implants -- Endovascular prostheses
90.93 11.040.40
ISO 15674:2009
Cardiovascular implants and artificial organs -- Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
90.92 11.040.40
ISO/NP 15674
Cardiovascular implants and artificial organs -- Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
10.99 11.040.40
ISO/NP 15675
Cardiovascular implants and artificial organs -- Cardiopulmonary bypass systems -- Arterial blood line filters
10.99 11.040.40
ISO 15675:2009
Cardiovascular implants and artificial organs -- Cardiopulmonary bypass systems -- Arterial blood line filters
90.92 11.040.40
ISO/CD 15676
Cardiovascular implants and artificial organs -- Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
30.99 11.040.40
ISO 15676:2005
Cardiovascular implants and artificial organs -- Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
90.92 11.040.40
ISO/TS 17137:2014
Cardiovascular implants and extracorporeal systems -- Cardiovascular absorbable implants
60.60 11.040.40
ISO/CD 18241
Cardiovascular implants and extracorporeal systems -- Cardiopulmonary bypass systems -- Venous bubble traps
30.99 11.040.40
ISO/CD 18242
Cardiovascular implants and extracorporeal systems -- Centrifugal blood pumps
30.99 11.040.40
ISO/DTR 19024
Evaluation of CPB devices relative to their capabilities of reducing the transmission of Gaseous MicroEmboli(GME)to a patient during cardiopulmonary bypass
30.99 11.040.40
ISO 23500:2014
Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
90.92 11.040.40
ISO/NP 23500-1
Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
10.99 11.040.40
ISO/NP 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
10.99 11.040.40
ISO/NP 23500-3
Guidance for the preparation and quality management of fluids for haemodialysis and related therapies -- Part 3: Water for haemodialysis and related therapies
10.99 11.040.40
ISO/NP 23500-4
Guidance for the preparation and quality management of fluids for haemodialysis and related therapies -- Part 4: Concentrates for haemodialysis and related therapies
10.99 11.040.40
ISO/NP 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
10.99 11.040.40
ISO/TS 23810:2012
Cardiovascular implants and artificial organs -- Checklist for preoperative extracorporeal circulation equipment setup
60.60 11.040.40
ISO 25539-1:2003
Cardiovascular implants -- Endovascular devices -- Part 1: Endovascular prostheses
90.92 11.040.40
ISO/CD 25539-1
Cardiovascular implants -- Endovascular devices -- Part 1: Endovascular prostheses
30.99 11.040.40
ISO 25539-1:2003/Amd 1:2005
Test methods
60.60 11.040.40
ISO 25539-2:2012
Cardiovascular implants -- Endovascular devices -- Part 2: Vascular stents
60.60 11.040.40
ISO 25539-3:2011
Cardiovascular implants -- Endovascular devices -- Part 3: Vena cava filters
60.60 11.040.40
ISO 26722:2014
Water treatment equipment for haemodialysis applications and related therapies
90.92 11.040.40
IEC/TR 62653:2013
Guidelines for the safe use of medical products in dialysis treatment
60.60 11.040.40