{"id":771,"date":"2026-02-22T17:33:23","date_gmt":"2026-02-22T22:33:23","guid":{"rendered":"https:\/\/www.grupoc4.co\/standards\/"},"modified":"2026-05-03T15:20:16","modified_gmt":"2026-05-03T20:20:16","slug":"normativas","status":"publish","type":"page","link":"https:\/\/www.grupoc4.co\/en\/recursos\/normativas\/","title":{"rendered":"Normativas"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"771\" class=\"elementor elementor-771 elementor-62\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4e9b90b e-con-full e-flex e-con e-parent\" data-id=\"4e9b90b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4212a5d elementor-widget__width-inherit elementor-widget elementor-widget-html\" data-id=\"4212a5d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t\t<style>\n.c4nm{\n  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.exp-meta{display:flex;gap:16px;flex-wrap:wrap;margin-top:12px;padding-top:12px;border-top:1px solid var(--bdr-f);font-size:0.76rem;color:var(--tx-muted)}\n.c4nm .exp-meta span{display:flex;align-items:center;gap:4px}\n.c4nm .cta-band{padding:60px 0;background:linear-gradient(135deg,var(--c4-navy),var(--c4-blue))}\n.c4nm .cta-band .container{text-align:center}\n.c4nm .cta-band h2{font-family:var(--fn-d);font-size:clamp(1.3rem,3vw,1.7rem);font-weight:800;color:#fff;margin-bottom:10px}\n.c4nm .cta-band p{color:rgba(255,255,255,0.7);font-size:0.9rem;margin-bottom:24px}\n<\/style>\n\n<div class=\"c4nm\">\n\n<div class=\"breadcrumbs\"><div class=\"container\"><a href=\"\/\">Inicio<\/a><span class=\"sep\">\u203a<\/span><a href=\"\/recursos\/\">Recursos<\/a><span class=\"sep\">\u203a<\/span><span>Normativas<\/span><\/div><\/div>\n\n<section class=\"page-hero\">\n<div class=\"container\">\n  <div class=\"sec-label\"><div class=\"sec-dot\"><\/div><span class=\"label\">Normativas<\/span><\/div>\n  <h1>Gu\u00eda de normativas <span>internacionales<\/span><\/h1>\n  <p>Referencia r\u00e1pida de las principales normativas internacionales aplicables a control de contaminaci\u00f3n, cuartos limpios, cabinas de seguridad y sistemas HVAC.<\/p>\n<\/div>\n<\/section>\n\n<section class=\"section\"><div class=\"container\">\n  <h2>Normativas de referencia<\/h2>\n  <p class=\"lead\">Haga clic en cada normativa para ver su descripci\u00f3n y aplicaciones.<\/p>\n  <div class=\"exp-list\">\n    <div class=\"exp-item\">\n      <div class=\"exp-head\"><div class=\"exp-head-left\"><span class=\"exp-tag\">Clasificaci\u00f3n<\/span><h3>ISO 14644 \u2014 Clasificaci\u00f3n de salas limpias<\/h3><\/div><svg viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\"><polyline points=\"6 9 12 15 18 9\"\/><\/svg><\/div>\n      <div class=\"exp-body\">\n        <p>Norma internacional que define las clases de limpieza del aire en ambientes controlados, desde ISO 1 hasta ISO 9. Establece m\u00e9todos de medici\u00f3n, l\u00edmites de part\u00edculas por clasificaci\u00f3n, requisitos de monitoreo continuo y pruebas de verificaci\u00f3n.<\/p>\n        <div class=\"exp-meta\"><span>\ud83d\udd2c Aplicaci\u00f3n: Cuartos limpios, \u00e1reas clasificadas, producci\u00f3n farmac\u00e9utica<\/span><\/div>\n      <\/div>\n    <\/div>\n    <div class=\"exp-item\">\n      <div class=\"exp-head\"><div class=\"exp-head-left\"><span class=\"exp-tag\">Bioseguridad<\/span><h3>NSF\/ANSI 49 \u2014 Cabinas de bioseguridad<\/h3><\/div><svg viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\"><polyline points=\"6 9 12 15 18 9\"\/><\/svg><\/div>\n      <div class=\"exp-body\">\n        <p>Est\u00e1ndar norteamericano para dise\u00f1o, construcci\u00f3n, certificaci\u00f3n y mantenimiento de cabinas de bioseguridad Clase II. Define pruebas de rendimiento incluyendo velocidad facial, contenci\u00f3n, integridad de filtros HEPA y niveles de ruido.<\/p>\n        <div class=\"exp-meta\"><span>\ud83d\udd2c Aplicaci\u00f3n: Laboratorios microbiolog\u00eda, cultivo celular, pat\u00f3genos<\/span><\/div>\n      <\/div>\n    <\/div>\n    <div class=\"exp-item\">\n      <div class=\"exp-head\"><div class=\"exp-head-left\"><span class=\"exp-tag\">Bioseguridad<\/span><h3>EN 12469 \u2014 Cabinas de seguridad microbiol\u00f3gica<\/h3><\/div><svg viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\"><polyline points=\"6 9 12 15 18 9\"\/><\/svg><\/div>\n      <div class=\"exp-body\">\n        <p>Norma europea para requisitos de rendimiento de cabinas de seguridad microbiol\u00f3gica. Complementa la NSF\/ANSI 49 con criterios espec\u00edficos para el mercado europeo.<\/p>\n        <div class=\"exp-meta\"><span>\ud83d\udd2c Aplicaci\u00f3n: Laboratorios BSL-2 y BSL-3 en Europa<\/span><\/div>\n      <\/div>\n    <\/div>\n    <div class=\"exp-item\">\n      <div class=\"exp-head\"><div class=\"exp-head-left\"><span class=\"exp-tag\">Cabinas<\/span><h3>ASHRAE 110 \u2014 M\u00e9todo de prueba para cabinas extractoras<\/h3><\/div><svg viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\"><polyline points=\"6 9 12 15 18 9\"\/><\/svg><\/div>\n      <div class=\"exp-body\">\n        <p>Protocolo est\u00e1ndar para evaluar el rendimiento de contenci\u00f3n de cabinas extractoras de laboratorio. Incluye pruebas de velocidad facial, visualizaci\u00f3n de flujo y prueba de contenci\u00f3n con SF6 (trazador).<\/p>\n        <div class=\"exp-meta\"><span>\ud83d\udd2c Aplicaci\u00f3n: Laboratorios qu\u00edmicos, QC farmac\u00e9utico, investigaci\u00f3n<\/span><\/div>\n      <\/div>\n    <\/div>\n    <div class=\"exp-item\">\n      <div class=\"exp-head\"><div class=\"exp-head-left\"><span class=\"exp-tag\">Cabinas<\/span><h3>EN 14175 \u2014 Cabinas de gases para laboratorio<\/h3><\/div><svg viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\"><polyline points=\"6 9 12 15 18 9\"\/><\/svg><\/div>\n      <div class=\"exp-body\">\n        <p>Norma europea que establece requisitos para cabinas de extracci\u00f3n de gases en laboratorios. Define clasificaciones, m\u00e9todos de prueba de contenci\u00f3n y requisitos de dise\u00f1o y fabricaci\u00f3n.<\/p>\n        <div class=\"exp-meta\"><span>\ud83d\udd2c Aplicaci\u00f3n: Laboratorios de investigaci\u00f3n y an\u00e1lisis en Europa<\/span><\/div>\n      <\/div>\n    <\/div>\n    <div class=\"exp-item\">\n      <div class=\"exp-head\"><div class=\"exp-head-left\"><span class=\"exp-tag\">Filtraci\u00f3n<\/span><h3>ISO 16890 \u2014 Filtros de aire para ventilaci\u00f3n general<\/h3><\/div><svg viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\"><polyline points=\"6 9 12 15 18 9\"\/><\/svg><\/div>\n      <div class=\"exp-body\">\n        <p>Sistema de clasificaci\u00f3n para filtros de part\u00edculas en sistemas HVAC de ventilaci\u00f3n general. Reemplaza la norma EN 779 y clasifica los filtros seg\u00fan su eficiencia para part\u00edculas ePM1, ePM2.5 y ePM10.<\/p>\n        <div class=\"exp-meta\"><span>\ud83d\udd2c Aplicaci\u00f3n: Sistemas HVAC, pre-filtraci\u00f3n, ventilaci\u00f3n general<\/span><\/div>\n      <\/div>\n    <\/div>\n    <div class=\"exp-item\">\n      <div class=\"exp-head\"><div class=\"exp-head-left\"><span class=\"exp-tag\">Farmac\u00e9utica<\/span><h3>GMP \/ Anexo 1 EMA \u2014 Buenas Pr\u00e1cticas de Manufactura<\/h3><\/div><svg viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\"><polyline points=\"6 9 12 15 18 9\"\/><\/svg><\/div>\n      <div class=\"exp-body\">\n        <p>Marco regulatorio para la fabricaci\u00f3n de medicamentos est\u00e9riles y no est\u00e9riles. El Anexo 1 (2022) establece requisitos espec\u00edficos para \u00e1reas clasificadas, monitoreo ambiental, vestimenta y control de contaminaci\u00f3n.<\/p>\n        <div class=\"exp-meta\"><span>\ud83d\udd2c Aplicaci\u00f3n: Producci\u00f3n farmac\u00e9utica, cosm\u00e9ticos, veterinarios<\/span><\/div>\n      <\/div>\n    <\/div>\n    <div class=\"exp-item\">\n      <div class=\"exp-head\"><div class=\"exp-head-left\"><span class=\"exp-tag\">Farmacia<\/span><h3>USP 797 \/ USP 800 \u2014 Preparaci\u00f3n de compuestos est\u00e9riles<\/h3><\/div><svg viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\"><polyline points=\"6 9 12 15 18 9\"\/><\/svg><\/div>\n      <div class=\"exp-body\">\n        <p>Cap\u00edtulos de la Farmacopea de EE.UU. para preparaci\u00f3n de compuestos est\u00e9riles (797) y manejo de medicamentos peligrosos (800). Establece requisitos de \u00e1reas clasificadas, equipos y procedimientos.<\/p>\n        <div class=\"exp-meta\"><span>\ud83d\udd2c Aplicaci\u00f3n: Farmacias hospitalarias, centrales de mezclas<\/span><\/div>\n      <\/div>\n    <\/div>\n  <\/div>\n<\/div><\/section>\n\n<section class=\"cta-band\"><div class=\"container\">\n  <h2>\u00bfNecesita cumplir con alguna normativa espec\u00edfica?<\/h2>\n  <p>Nuestros equipos se dise\u00f1an bajo las normativas internacionales m\u00e1s exigentes.<\/p>\n  <a href=\"\/contacto\/\" class=\"btn btn-glow\">Consultar con ingenier\u00eda \u2192<\/a>\n<\/div><\/section>\n\n<\/div>\n\n<script>\ndocument.querySelectorAll('.exp-head').forEach(function(h){\n  h.addEventListener('click',function(){\n    var item=h.parentElement;\n    item.classList.toggle('open');\n  });\n});\n<\/script>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Inicio\u203aRecursos\u203aNormativas Normativas Gu\u00eda de normativas internacionales Referencia r\u00e1pida de las principales normativas internacionales aplicables a control de contaminaci\u00f3n, cuartos limpios, cabinas de seguridad y sistemas HVAC. Normativas de referencia Haga clic en cada normativa para ver su descripci\u00f3n y aplicaciones. Clasificaci\u00f3n ISO 14644 \u2014 Clasificaci\u00f3n de salas limpias Norma internacional que define las clases de [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":954,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"content-type":"","site-sidebar-layout":"no-sidebar","site-content-layout":"","ast-site-content-layout":"full-width-container","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"class_list":["post-771","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Standards | C4 \u2014 Technical Standards Guide<\/title>\n<meta name=\"description\" content=\"Guide to international standards: ISO 14644, NSF\/ANSI 49, ASHRAE 110, GMP, and more. 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