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ISO - IBNORCA "Respiradores y dispositivos médicos esenciales"

ISO - IBNORCA "Respiradores y dispositivos médicos esenciales" - 100%
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1.- ISO 10651-3:1997 : Lung ventilators for medical use — Part 3: Particular requirements for emergency and transport ventilators

2.- ISO 10651-4:2002 : Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators

3.- ISO 10651-5:2006 : Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 5: Gas-powered emergency resuscitators

4.- ISO 13485 : Medical devices — Quality management systems — Requirements for regulatory purposes

5.- ISO 17510:2015 : Medical devices — Sleep apnoea breathing therapy — Masks and application accessories

6.- ISO 18082:2014 : Anaesthetic and respiratory equipment — Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases [Including ISO 18082:2014/Amd.1:2017, AMENDMENT 1]

7.- ISO 18562-1:2017 : Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process

8.- ISO 18562-2:2017 : Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter

9.- ISO 18562-3:2017 : Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic compounds (VOCs)

10.- ISO 18562-4:2017 : Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate

11.- ISO 19223:2019 : Lung ventilators and related equipment — Vocabulary and semantics

12.- ISO 20395:2019 : Biotechnology — Requirements for evaluating the performance of quantification methods for nucleic acid target sequences — qPCR and dPCR

13.- ISO 5356-1:2015 : Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets

14.- ISO 80601-2-12:2020 : Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators

15.- ISO 80601-2-13:2011 : Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation [Including: ISO 80601-2-13:2011/Amd.1:2015, AMENDMENT 1 and ISO 80601-2-13:2011/Amd.2:2018, AMENDMENT 2]

16.- ISO 80601-2-70:2015 : Medical electrical equipment — Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment

17.- ISO 80601-2-74:2017 : Medical electrical equipment — Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment

18.- ISO 80601-2-79:2018 : Medical electrical equipment — Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment

19.- ISO 80601-2-80:2018 : Medical electrical equipment — Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency

20.- ISO/TS 16976-8:2013 : Respiratory protective devices — Human factors — Part 8: Ergonomic factors