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Standard and/or project under the direct responsibility of ISO/TC 150/SC 2 Secretariat Stage ICS
ISO 5840-1:2015
Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements
90.92
ISO 5840-2:2015
Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes
90.92
ISO 5840-3:2013
Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques
90.92
ISO 5840:1984
Implants for surgery — Cardiovascular implants — Cardiac valve prostheses
95.99
ISO 5840:1989
Cardiovascular implants — Cardiac valve prostheses
95.99
ISO 5840:1996
Cardiovascular implants — Cardiac valve prostheses
95.99
ISO 5840:2005
Cardiovascular implants — Cardiac valve prostheses
95.99
ISO/DIS 5840-1
Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements
40.60
ISO/DIS 5840-2
Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes
40.60
ISO/DIS 5840-3
Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques
40.60
ISO 5841-1:1985
Implants for surgery — Cardiac pacemakers — Part 1: Implantable ventricular pacemakers
95.99
ISO 5841-1:1989
Cardiac pacemakers — Part 1: Implantable pacemakers
95.99
ISO 5841-2:1986
Implants for surgery — Cardiac pacemakers — Part 2: Reporting of the clinical performance of populations of pulse generators
95.99
ISO 5841-3:1992
Cardiac pacemakers — Part 3: Low-profile connectors (IS-1) for implantable pacemakers
95.99
ISO 5910:2018
Cardiovascular implants and extracorporeal systems — Cardiac valve repair devices
60.60
ISO 7198:1998
Cardiovascular implants — Tubular vascular prostheses
95.99
ISO 7198:2016
Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches
60.60
ISO 7199:1996
Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators)
95.99
ISO 7199:2009
Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators)
95.99
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
95.99
ISO 7199:2016
Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators)
60.60
ISO 7199:2016/FDAmd 1
Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators) — Amendment 1: Connectors
50.00
ISO 8637-1:2017
Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
60.60
ISO 8637-2:2018
Extracorporeal systems for blood purification — Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
60.60
ISO 8637-3:2018
Extracorporeal systems for blood purification — Part 3: Plasmafilters
60.60
ISO 8637:1989
Haemodialysers, haemofilters and haemoconcentrators
95.99
ISO 8637:2004
Cardiovascular implants and artificial organs — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
95.99
ISO 8637:2010
Cardiovascular implants and extracorporeal systems — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
95.99
ISO 8637:2010/Amd 1:2013
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
95.99
ISO 8638:1989
Extracorporeal blood circuit for haemodialysers, haemofilters and haemoconcentrators
95.99
ISO 8638:2004
Cardiovascular implants and artificial organs — Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
95.99
ISO 8638:2010
Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
95.99
ISO 11318:1993
Cardiac defibrillators — Connector assembly for implantable defibrillators — Dimensional and test requirements
95.99
ISO 11318:1993/Amd 1:1996
Cardiac defibrillators — Connector assembly for implantable defibrillators — Dimensional and test requirements — Amendment 1
95.99
ISO 11658:2012
Cardiovascular implants and extracorporeal systems — Blood/tissue contact surface modifications for extracorporeal perfusion systems
90.93
ISO 11663:2009
Quality of dialysis fluid for haemodialysis and related therapies
95.99
ISO 11663:2014
Quality of dialysis fluid for haemodialysis and related therapies
95.99
ISO 12417-1:2015
Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: General requirements
60.60
ISO/TR 12417-2:2017
Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information
60.60
ISO/TS 12417:2011
Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products
95.99
ISO 13958:2002
Concentrates for haemodialysis and related therapies
95.99
ISO 13958:2009
Concentrates for haemodialysis and related therapies
95.99
ISO 13958:2014
Concentrates for haemodialysis and related therapies
95.99
ISO 13959:2002
Water for haemodialysis and related therapies
95.99
ISO 13959:2009
Water for haemodialysis and related therapies
95.99
ISO 13959:2014
Water for haemodialysis and related therapies
95.99
ISO 13960:2003
Cardiovascular implants and artificial organs — Plasmafilters
95.99
ISO 13960:2010
Cardiovascular implants and extracorporeal systems — Plasmafilters
95.99
ISO/TS 15539:2000
Cardiovascular implants — Endovascular prostheses
95.99
ISO 15674:2001
Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
95.99
ISO 15674:2009
Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
95.99
ISO 15674:2016
Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
60.60
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
50.00
ISO 15675:2001
Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial line blood filters
95.99
ISO 15675:2009
Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters
95.99
ISO 15675:2016
Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters
60.60
ISO 15675:2016/FDAmd 1
Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters — Amendment 1: Connectors
50.00
ISO 15676:2005
Cardiovascular implants and artificial organs — Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
95.99
ISO 15676:2016
Cardiovascular implants and artificial organs — Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
60.60
ISO/TS 17137:2014
Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable implants
95.99
ISO/TS 17137:2019
Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable implants
60.60
ISO/WD 18193
Cardiovascular implants and artificial organs — Cannulae for cardiopulmonary bypass and short-term extracorporeal circulation
20.20
ISO 18241:2016
Cardiovascular implants and extracorporeal systems — Cardiopulmonary bypass systems — Venous bubble traps
60.60
ISO 18241:2016/FDAmd 1
Cardiovascular implants and extracorporeal systems — Cardiopulmonary bypass systems — Venous bubble traps — Amendment 1: Connectors
50.20
ISO 18242:2016
Cardiovascular implants and extracorporeal systems — Centrifugal blood pumps
60.60
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
60.60
ISO/WD 22679
Cardiovascular implants — Cardiac occluders
20.20
ISO/WD 23433
Cardiovascular implants and artificial organs — Cannulae for long-term extracorporeal circulation
20.20
ISO 23500-1:2019
Preparation and quality management of fluids for haemodialysis and related therapies — Part 1: General requirements
60.60
ISO 23500-2:2019
Preparation and quality management of fluids for haemodialysis and related therapies — Part 2: Water treatment equipment for haemodialysis applications and related therapies
60.60
ISO 23500-3:2019
Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies
60.60
ISO 23500-4:2019
Preparation and quality management of fluids for haemodialysis and related therapies — Part 4: Concentrates for haemodialysis and related therapies
60.60
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
60.60
ISO 23500:2011
Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
95.99
ISO 23500:2014
Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
95.99
ISO/TS 23810:2006
Cardiovascular implants and artificial organs — Checklist for preoperative extracorporeal circulation equipment setup
95.99
ISO/TS 23810:2012
Cardiovascular implants and artificial organs — Checklist for preoperative extracorporeal circulation equipment setup
95.99
ISO/TS 23810:2018
Cardiovascular implants and artificial organs — Checklists for use of extracorporeal circulation equipment
60.60
ISO 25539-1:2003
Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses
95.99
ISO 25539-1:2003/Amd 1:2005
Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses — Amendment 1: Test methods
95.99
ISO 25539-1:2017
Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses
60.60
ISO 25539-2:2008
Cardiovascular implants — Endovascular devices — Part 2: Vascular stents
95.99
ISO 25539-2:2012
Cardiovascular implants — Endovascular devices — Part 2: Vascular stents
90.92
ISO 25539-3:2011
Cardiovascular implants — Endovascular devices — Part 3: Vena cava filters
90.93
ISO/AWI 25539-4
Cardiovascular implants — Endovascular devices — Part 4: Part 4: Application of ISO 17327-1 for coated endovascular devices
20.00
ISO/DIS 25539-2
Cardiovascular implants — Endovascular devices — Part 2: Vascular stents
40.60
ISO 26722:2009
Water treatment equipment for haemodialysis applications and related therapies
95.99
ISO 26722:2014
Water treatment equipment for haemodialysis applications and related therapies
95.99
IEC/TR 62653:2013
Guidelines for the safe use of medical products in dialysis treatment
60.60

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