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

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

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

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

Cardiovascular implants — Tubular vascular prostheses

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

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)

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 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 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

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

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

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

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

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

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

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)

Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable implants

Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable implants

Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable implants

Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable implants

Cardiovascular implants and artificial organs — Cannulae for extracorporeal circulation

Cardiovascular implants and artificial organs — Cannulae for extracorporeal circulation — Amendment 1

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

Medical devices — Examples of the application of the risk management process to cardiac valve replacement and repair systems

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

Cardiovascular implants — Transcatheter cardiac occluders

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 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 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 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 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

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

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

Device output-parameters, abbreviations, and units for displaying and storage in extracorporeal life support

Ventricular assist devices and total artificial hearts

Water treatment equipment for haemodialysis applications and related therapies

Water treatment equipment for haemodialysis applications and related therapies

Guidelines for the safe use of medical products in dialysis treatment