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28 - 04 - 2020

Normas ISO y UNIT-ISO de acceso gratis.

En el contexto de la crisis COVID-19, la Organización Internacional de Normalización (ISO), ha decidido poner a disposición del público, en forma gratuita, una serie de normas que pueden apoyar los esfuerzos globales para mitigar los efectos de esta crisis en las organizaciones.

Apoyando esta iniciativa, UNIT está en condiciones de ofrecer en estos momentos, además de la norma UNIT-ISO 22301 sobre Continuidad del Negocio (ya disponible en estas condiciones), las siguientes normas en forma gratuita:

UNIT-ISO 31000 - Gestión del Riesgo. Directrices
UNIT-ISO 13688 - Ropa de protección - Requisitos generales


A éstas se sumarán próximamente otras normas UNIT-ISO que actualmente se encuentran en proceso de traducción y adopción.

NORMAS ISO que se pueden solicitar en forma gratuita:

• ISO 374-5:2016, Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risks
• ISO 10993-1:2018, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
• ISO 22395:2018, Security and resilience – Community resilience – Guidelines for supporting vulnerable persons in an emergency
• ISO 22320:2018, Security and resilience – Emergency management – Guidelines for incident management
• ISO 22316:2017, Security and resilience – Organizational resilience – Principles and attributes

Lista de normas relacionadas con respiradores y equipos médicos escenciales


• ISO 10651-3:1997, Lung ventilators for medical use — Part 3: Particular requirements for emergency and transport ventilators
• ISO 10651-4:2002, Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators
• ISO 10651-5:2006, Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 5: Gas-powered emergency resuscitators
• ISO 13485:2016, Medical devices — Quality management systems - Requirements for regulatory purposes
• ISO 17510:2015, Medical devices — Sleep apnoea breathing therapy — Masks and application accessories
• 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]
• ISO 18562-1:2017, Biocompatibility evaluation of brea thing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process
• ISO 18562-2:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter
• ISO 18562-3:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic compounds (VOCs)
• ISO 18562-4:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate
• ISO 19223:2019, Lung ventilators and related equipment — Vocabulary and semantics
• ISO 20395:2019, Biotechnology — Requirements for evaluating the performance of quantification methods for nucleic acid target sequences — qPCR and dPCR
• ISO 5356-1:2015, Anaesthetic and respiratory equipment — Conical conn ectors — Part 1: Cones and sockets
• ISO 80601-2-12:2020, Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
• 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]
• 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
• ISO 80601-2-74:2017, Medical electrical equipment — Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
• ISO 80601-2-79:2018, Medical electrical equipment — Part 2-79: Particular requirements for basic safe ty and essential performance of ventilatory support equipment for ventilatory impairment
• 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
• ISO/TS 16976-8:2013, Respiratory protective devices — Human factors — Part 8: Ergonomic factors


Las normas pueden solicitarse al Centro de Documentación de UNIT por el mail biblioteca@unit-iso.org.uy


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