Tecnología Médica
Mapa TecMedTecnología Médica
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 23500-1 - Preparation and quality management of fluids for haemodialysis and related therapies — Part 1: General requirements
18/04/2024 -
Status: Under development
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 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 5362 - Anaesthetic and respiratory equipment – Anaesthetic reservoir bags
15/04/2024 -
Status: Under development
ISO/PRF 17256 - Anaesthetic and respiratory equipment — Respiratory therapy tubing and connectors
11/04/2024 -
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 7151 - Surgical instruments — Non-cutting, articulated instruments — General requirements and test methods
03/04/2024 -
Status: Under development
ISO/DIS 8600-1 - Endoscopes — Medical endoscopes and endotherapy devices — Part 1: General requirements
14/03/2024 -
Status: Under development
ISO 18562-1:2024 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process
12/03/2024 -
This document specifies:
the general principles governing the biological evaluation within a risk management process of the gas pathways of a medical...
IEC 80601-2-58:2024 - Medical electrical equipment — Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
12/03/2024 -
This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic surgery (as defined in 201.3.209 and 201.3.217) and associated...
ISO 18562-4:2024 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate
12/03/2024 -
This document specifies tests for substances leached by liquid water condensing in gas pathways of a medical device, its parts or accessories, which are intended to...
ISO 18562-2:2024 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter
12/03/2024 -
This document specifies tests for the emissions of particulate matter from the gas pathways of a medical device, its parts or accessories, which are intended to...
ISO 18562-3:2024 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic substances
11/03/2024 -
This document specifies tests for the emissions of volatile organic substances from the gas pathways of a medical device, its parts or accessories, which are...
