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Plan Nacional De Normalización 2021-09-23

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Plan Nacional De Normalización 2021-09-23 PLAN NACIONAL DE NORMALIZACIÓN 2021-09-23 Sistema de códigos de las etapas: 00) Etapa preliminar 10) Etapa de propuesta Código: FS-NO-03 20) Etapa de preparación Versión: 01 30) Etapa de comité Dirección: Ciudad Científica de la 40) Etapa de encuesta o consulta pública Universidad de Costa Rica. 50) Etapa de aprobación (50.1 con observaciones, 50.2 voto OE, 50.3 voto nivel 2) www.inteco.org 60) Etapa de publicación 90) Etapa de revisión o actualización 95) Etapa de retiro o anulación FECHA INICIO DE FECHA INICIO FECHA FINAL FECHA PREVISTA PERIODO OE CÓDIGO INTE PROYECTO DE NORMA ICS ANTECEDENTES ETAPA LA ETAPA CP CP DE PUBLICACIÓN ENDOSO Prácticas de normalización recomendadas por parte de 2021 ENDOSO PN INTE/ISO/IEC GUÍA 59:2021 01.120 ISO/IEC GUIDE 59:2019 90.40 2021-09-21 2021-09-21 2021-10-11 2021-12 la ISO y la IEC a los organismos nacionales. Uso y referencia a normas ISO e IEC en la 2021 ENDOSO APN INTE DN 11:2021 01.120 Documento ISO/IEC 10 2020-03-31 reglamentación técnica Seguridad de la maquinaria. Normas para la redacción y 2020 ENDOSO INTE/ISO Guía 78:2020 01.120; 13.110 ISO GUIDE 78:2012 60 2020-12-04 2020-10-30 2020-11-29 2020-12 presentación de normas de seguridad. Guía para el desarrollo e inclusión de aspectos de la 2020 ENDOSO INTE/ISO Guía 63:2020 seguridad en las Normas Internacionales para 01.120; 11.040.01 ISO/IEC GUIDE 63:2019 60 2020-09-25 2020-08-21 2020-09-20 2020-09 dispositivos médicos. 01.120; 13.180; 2020 ENDOSO INTE/ISO Guía 71:2020 Guía para abordar la accesibilidad en las normas. ISO IEC Guide 71 2014 60 2020-11-21 2020-08-28 2020-09-27 2020-11 11.180.01 Seguridad para productos de consumo. Directrices para 2020 ENDOSO INTE/ISO 10377:2020 13.120; 97.020; 03.080.30 ISO 10377:2013 60 2020-06-22 2020-05-14 2020-06-13 2020-06 los proveedores. Retiro de productos de consumo. Directrices para 2020 ENDOSO INTE/ISO 10393:2020 13.120; 03.080.30 ISO 10393:2013 60 2020-06-22 2020-05-14 2020-06-13 2020-06 proveedores. Competencia para profesionales en normas — Parte 1: 2020 ENDOSO INTE/IWA 30-1:2020 01.120; 03.100.30 IWA 30-1:2019 60 2020-10-16 2020-09-10 2020-10-10 2020-10 Para empresas. Competencia de profesionales en las normas - 2020 ENDOSO INTE/IWA 30-2:2020 Parte 2: En las organizaciones relacionadas con las 01.120; 03.100.30 IWA 30-2:2019 60 2020-12-18 2020-11-17 2020-12-17 2020-12 normas. Evaluación de biocompatibilidad de vías de gases respiratorios en aplicaciones sanitarias. Parte 1: 2020 ENDOSO INTE/ISO 18562-1:2020 11.040.10 ISO 18562-1 60 2020-04-17 Evaluación y pruebas dentro de un proceso de gestión de riesgos. Ventiladores pulmonares para uso médico. Requisitos 2020 ENDOSO INTE/ISO 10651-5:2020 particulares para la seguridad básica y el rendimiento 11.040.10 ISO 10651-5 60 2020-04-17 esencial. Parte 5: Resucitadores de emergencia a gas. Dispositivos médicos. Terapia respiratoria para la apnea 2020 ENDOSO INTE/ISO 17510:2020 11.040.10 ISO 17510 60 2020-04-17 del sueño. Máscaras y accesorios de aplicación. Evaluación de biocompatibilidad de las vías de gases 2020 ENDOSO INTE/ISO 18562-2:2020 respiratorios en aplicaciones sanitarias. Parte 2: 11.040.10 ISO 18562-2 60 2020-04-17 Pruebas de emisiones de partículas. Evaluación de biocompatibilidad de vías de gases respiratorios en aplicaciones sanitarias. Parte 3: 2020 ENDOSO INTE/ISO 18562-3:2020 11.040.10 ISO 18562-3 60 2020-04-17 Pruebas de emisiones de compuestos orgánicos volátiles (COV). Evaluación de biocompatibilidad de vías de gases 2020 ENDOSO INTE/ISO 18562-4:2020 respiratorios en aplicaciones sanitarias. Parte 4: 11.040.10 ISO 18562-4 60 2020-04-17 Pruebas de lixiviación en condensado. Equipos electromédicos. Parte 2-12: Requisitos 2020 ENDOSO INTE/ISO 80601-2-12:2020 particulares para la seguridad básica y el rendimiento 11.040.10 ISO 80601-2-12 60 2020-04-17 esencial de los ventiladores de cuidados críticos. Equipos electromédicos. Parte 2-13: Requisitos 2020 ENDOSO INTE/ISO 80601-2-13:2020 particulares para la seguridad básica y el rendimiento 11.040.10 ISO 80601-2-13 60 2020-04-17 esencial de una estación de trabajo anestésico. Equipos electromédicos. Parte 2-69: Requisitos 2020 ENDOSO INTE/ISO 80601-2-69:2020 particulares para la seguridad básica y el rendimiento 11.040.10 ISO 80601-2-69 60 2020-04-17 esencial de los equipos concentradores de oxígeno. Equipos electromédicos. Parte 2-70: Requisitos particulares para la seguridad básica y el rendimiento 2020 ENDOSO INTE/ISO 80601-2-70:2020 11.040.10 ISO 80601-2-70 60 2020-04-17 esencial de los equipos de terapia respiratoria para la apnea del sueño. Equipos electromédicos. Parte 2-74: Requisitos 2020 ENDOSO INTE/ISO 80601-2-74:2020 particulares para la seguridad básica y funcionamiento 11.040.10 ISO 80601-2-74 60 2020-04-17 esencial de los equipos de humidificación respiratoria. Equipos electromédicos. Parte 2-79: Requisitos particulares para la seguridad básica y rendimiento 2020 ENDOSO INTE/ISO 80601-2-79:2020 11.040.10 ISO 80601-2-79 60 2020-04-17 esencial de los equipos de soporte ventilatorio para el deterioro ventilatorio. Equipos electromédicos. Parte 2-80: Requisitos particulares para la seguridad básica y rendimiento 2020 ENDOSO INTE/ISO 80601-2-80:2020 11.040.10 ISO 80601-2-80 60 2020-04-17 esencial de los equipos de soporte ventilatorio para la insuficiencia ventilatoria. Equipos electromédicos. Parte 2-61: Requisitos 2020 ENDOSO INTE/ISO 80601-2-61:2020 particulares para la seguridad básica y el rendimiento 11.040.10 ISO 80601-2-61:2017 60 2020-04-17 esencial de los equipos de oxímetro de pulso. Equipo respiratorio y de anestesia. Compatibilidad con 2020 ENDOSO INTE/ISO 15001:2020 11.040.10 ISO 15001 60 2020-04-17 oxígeno. Equipo anestésico y respiratorio. Tubos traqueales y 2020 ENDOSO INTE/ISO 5361:2020 11.040.10 ISO 5361:2016; 60 2020-04-17 conectores. Equipo respiratorio y de anestesia. Elementos del 2020 ENDOSO INTE/ISO 5367:2020 11.040.10 ISO 5367:2014 60 2020-04-17 circuito respiratorio y conectores. Respiradores pulmonares. Parte 4: Requisitos 2020 ENDOSO INTE/ISO 10651-4:2020 particulares para resucitadores accionados por el 11.040.10 ISO 10651-4:2002 60 2020-04-17 operador. Equipo respiratorio y de anestesia. Cánulas 2020 ENDOSO INTE/ISO 5364:2020 11.040.10 ISO 5364; 60 2020-04-17 orofaríngeas. Guantes médicos para un solo uso. Parte 3: Requisitos 2020 ENDOSO INTE S78:2020 11.040.10 UNE-EN 455-3:2015 60 2020-04-17 y ensayos para la evaluación biológica. Guantes de protección contra los productos químicos y 2020 ENDOSO INTE T108:2020 los microorganismos. Parte 2: Determinación de la 11.040.10 UNE-EN 374-2:2016 60 2020-04-17 resistencia a la penetración. Guantes de protección contra los productos químicos y los microorganismos. Parte 4: Determinación de la 2020 ENDOSO INTE/ISO 374-4:2020 resistencia a la degradación por productos químicos. 11.040.10 UNE-EN ISO 374-4:2019 60 2020-04-17 (ISO 374-4:2019) (Ratificada por la Asociación Española de Normalización en enero de 2020.) 2020 ENDOSO INTE T109:2020 Ropa de protección. Protección contra la lluvia. 11.040.10 EN 343 60 2020-04-17 Ventiladores pulmonares para uso médico. Parte 3: 2020 ENDOSO INTE/ISO 10651-3:2020 Requisitos particulares para ventiladores de emergencia 11.040.10 ISO 10651-3:1997 60 2020-06-30 y transporte. Equipo de anestesia y respiratorio. Dimensiones de 2020 ENDOSO INTE/ISO 18082:2020 conectores de baja presión de rosca no intercambiables 11.040.10 ISO 18082:2014 60 2020-06-30 (NIST) para gases medicinales. Ventiladores pulmonares y equipos relacionados - 2020 ENDOSO INTE/ISO 19223:2020 11.040.10 ISO 19223:2019 60 2020-06-30 Vocabulario y semántica. Biotecnología: requisitos para evaluar el rendimiento de 2020 ENDOSO INTE/ISO 20395:2020 los métodos de cuantificación de secuencias diana de 11.040.10 ISO 20395:2019 60 2020-06-30 ácido nucleico: qPCR y dPCR. Dispositivos de protección respiratoria. Factores 2020 ENDOSO INTE/ISO/TS 16976-8:2020 11.040.10 ISO/TS 16976-8:2013 60 2020-06-30 humanos. Parte 8: Factores ergonómicos. Ropa de protección contra productos químicos, líquidos y gaseosos, incluyendo aerosoles líquidos y partículas sólidas. Parte 1: Requisitos de prestaciones de los 2020 ENDOSO INTE S70:2020 trajes de protección química, ventilados y no ventilados, 13.340.30 UNE-EN 943-1:2015 +/A1:2019 60 2020-04-17 herméticos a gases (Tipo 1) y no herméticos a gases (Tipo 2). (Ratificada por AENOR en noviembre de 2015.) Paños y sábanas quirúrgicas. Requisitos y métodos de 2020 ENDOSO INTE S77-2:2020 11.140 UNE-EN 13795-2:2020 60 2020-04-17 ensayo. Parte 2: Trajes de aire limpio. Guantes de protección. Requisitos generales y métodos UNE-EN 420:2004+A1:2010 2020 ENDOSO INTE S75:2020 13.340.30 60 2020-04-17 de ensayo. (+/ERRATUM 2011) PLAN NACIONAL DE NORMALIZACIÓN 2021-09-23 Sistema de códigos de las etapas: 00) Etapa preliminar 10) Etapa de propuesta Código: FS-NO-03 20) Etapa de preparación Versión: 01 30) Etapa de comité Dirección: Ciudad Científica de la 40) Etapa de encuesta o consulta pública Universidad de Costa Rica.
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