Tecnología Médica
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ISO 8637-1 - Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
22/04/2024 -
Status: Under development
ISO 8637-3 - Extracorporeal systems for blood purification — Part 3: Plasmafilters
22/04/2024 -
Status: Under development
ISO 23500-3:2024 - Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies
18/04/2024 -
This document specifies the minimum chemical and microbiological quality requirements, for water used for preparation of dialysis fluids, concentrates, and for the reprocessing of haemodialysers,...
ISO 23500-1 - Preparation and quality management of fluids for haemodialysis and related therapies — Part 1: General requirements
18/04/2024 -
Status: Under development
ISO 23500-4:2024 - Preparation and quality management of fluids for haemodialysis and related therapies — Part 4: Concentrates for haemodialysis and related therapies
18/04/2024 -
This document specifies the chemical and microbiological requirements for concentrates used for haemodialysis and related therapies and applies to the manufacturer of such...
ISO 23500-5:2024 - Preparation and quality management of fluids for haemodialysis and related therapies — Part 5: Quality of dialysis fluid for haemodialysis and related therapies
18/04/2024 -
This document specifies the minimum chemical and microbiological quality requirements for dialysis fluids used in haemodialysis and related therapies.
This document applies...
ISO 5362 - Anaesthetic and respiratory equipment – Anaesthetic reservoir bags
15/04/2024 -
Status: Under development
ISO 8637-2:2024 - Extracorporeal systems for blood purification — Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
11/04/2024 -
This document specifies requirements for disposable extracorporeal blood and fluid circuits and accessories used in combination with haemodialysis equipment intended for extracorporeal blood...
ISO 5832-7:2024 - Implants for surgery — Metallic materials — Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy
11/04/2024 -
This document specifies the characteristics of, and corresponding test methods for, forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy for use in the manufacture of surgical...
ISO/PRF 17256 - Anaesthetic and respiratory equipment — Respiratory therapy tubing and connectors
11/04/2024 -
Status: Under development
ISO/FDIS 10555-8 - Intravascular catheters — Sterile and single-use catheters — Part 8: Catheters for extracorporeal blood treatment
11/04/2024 -
Status: Under development
ISO 5832-4:2024 - Implants for surgery — Metallic materials — Part 4: Cobalt-chromium-molybdenum casting alloy
04/04/2024 -
This document specifies the characteristics of, and corresponding test methods for, cobalt-chromium-molybdenum casting alloy for use in the manufacture of surgical implants.
NOTE: The...
ISO 5832-1:2024 - Implants for surgery — Metallic materials — Part 1: Wrought stainless steel
04/04/2024 -
This document specifies the characteristics of, and corresponding test methods for, wrought stainless steel for use in the manufacture of surgical implants.
NOTE 1: The mechanical...
ISO 16571:2024 - Systems for evacuation of plume generated by medical devices
03/04/2024 -
This document specifies requirements and guidelines for systems and equipment used to evacuate plume generated by medical devices.
This document applies to all...
ISO/PRF 19211 - Anaesthetic and respiratory equipment — Fire-activated oxygen shut-off devices for use during oxygen therapy
03/04/2024 -
Status: Under development
ISO 15223-1:2021/DAmd 1 - Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements — Amendment 1: Addition of defined term for authorized representative and Modified EC REP symbol to not be country or region specific
03/04/2024 -
Status: Under development
ISO 7151 - Surgical instruments — Non-cutting, articulated instruments — General requirements and test methods
03/04/2024 -
Status: Under development
ISO/FDIS 80369-1 - Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements
25/03/2024 -
Status: Under development
ISO 5832-11:2024 - Implants for surgery — Metallic materials — Part 11: Wrought titanium 6-aluminium 7-niobium alloy
21/03/2024 -
This document specifies the characteristics of, and corresponding test methods for, the wrought titanium alloy known as titanium 6-aluminium 7-niobium alloy (Ti-6Al-7Nb) for use in the manufacture...
