Projects

Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO/FDIS 21535:2023)

50.60 Close of voting. Proof returned by secretariat

Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO/FDIS 21536:2023)

50.60 Close of voting. Proof returned by secretariat

External limb prostheses and external orthoses - Requirements and test methods (ISO/DIS 22523:2022)

40.60 Close of voting

Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO/DIS 12417-1:2021)

40.60 Close of voting

Non-active surgical implants - General requirements (ISO/DIS 14630:2022)

40.60 Close of voting

Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO/DIS 22675:2021)

45.99 Dispatch of FV draft to CCMC

Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements (ISO/DIS 23500-1:2022)

40.60 Close of voting

Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies (ISO/DIS 23500-2:2022)

40.60 Close of voting

Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO/DIS 23500-3:2022)

40.60 Close of voting

Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO/DIS 23500-4:2022)

40.60 Close of voting

Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO/DIS 23500-5:2022)

40.60 Close of voting

Implants for surgery - Metallic materials - Part 1: Wrought stainless steel (ISO/DIS 5832-1:2023)

40.60 Close of voting

Implants for surgery - Metallic materials - Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy (ISO/DIS 5832-7:2023)

40.60 Close of voting

Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO/DIS 8637-2:2022)

40.60 Close of voting

Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters

30.99 CD approved for registration as DIS

Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components

30.99 CD approved for registration as DIS

Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)

30.99 CD approved for registration as DIS

Non-active surgical implants - Mammary implants - Particular requirements

10.99 New project approved