Tecnología Médica

Tecnología Médica

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...
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...
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 18562-2:2024 - 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...
ISO 23217:2024 - Injection systems for self-administration by paediatric patients — Requirements and guidelines for design
20/02/2024 - This document provides requirements and guidelines on the development of drug delivery systems intended for self-administration of medicinal products by the specific demographic group of...
ISO 7921:2024 - Ophthalmic optics and instruments — Near reading charts
14/02/2024 - This document applies to printed, projected, and electronic displays of high-contrast text that are designed for assessment and measurement of near reading acuity under photopic...