{"id":13097,"date":"2021-03-03T10:34:51","date_gmt":"2021-03-03T09:34:51","guid":{"rendered":"https:\/\/www.m-q.ch\/?p=13097"},"modified":"2021-03-08T10:59:46","modified_gmt":"2021-03-08T09:59:46","slug":"nuovo-standard-per-i-ventilatori-covid","status":"publish","type":"post","link":"https:\/\/www.m-q.ch\/it\/nuovo-standard-per-i-ventilatori-covid\/","title":{"rendered":"Nuovo standard per i ventilatori Covid"},"content":{"rendered":"
\"Ventilatori
\u00a9 Depositphotos, Patrik Slezak<\/figcaption><\/figure>\n

 <\/p>\n

Coloro che sono colpiti duramente dal virus e devono essere ricoverati in ospedale, non di rado sono anche collegati a un ventilatore. Sullo sfondo della sicurezza dei pazienti, il \"Comitato tecnico 121 \/ Sottocomitato 3 sui ventilatori\" dell'ISO ha iniziato a redigere una norma per la fabbricazione di ventilatori medici nuovi, affidabili e di alta qualit\u00e0, come scrive la Societ\u00e0 svizzera di normalizzazione (SNV).<\/p>\n

Ancora disponibile quest'anno<\/strong><\/p>\n

Lo standard \u00a0\"ISO\/DIS 80601-2-90 Apparecchiature elettromedicali - Parte 2-90: Requisiti particolari per la sicurezza e le prestazioni essenziali delle apparecchiature per la terapia ventilatoria ad alto flusso\".<\/a>\u00a0\u00e8 in lavorazione e dovrebbe essere reso disponibile pi\u00f9 tardi quest'anno, secondo SNV. L'ISO ha lavorato con due esperti - membri del\u00a0Sottocomitati ISO ISO\/TC 121\/SC 3<\/a>\u00a0per i ventilatori - ha parlato del ruolo dei suddetti e di altri standard correlati nella crisi attuale e di cosa possono fare.<\/p>\n

\"Non solo sono necessari pi\u00f9 ventilatori di vari tipi, ma pi\u00f9 professionisti medici devono essere addestrati su come usarli correttamente\", dice l'esperto Bob Kopotic, manager di assistenza critica negli affari clinici e medici di Edwards Lifesciences, al Intervista<\/a>, <\/strong>che \u00e8 pubblicato sul sito web della SNV. Gli standard internazionali come quelli dell'ISO aiuterebbero i produttori a produrre tali dispositivi pi\u00f9 rapidamente e con alta qualit\u00e0 e prestazioni. \u00c8 importante che anche loro rispettino i regolamenti necessari. Tuttavia, gli standard aiuterebbero anche a garantire che l'attrezzatura sia usata correttamente e per lo scopo previsto, ha continuato Kopotic.<\/p>\n

Sandy Weininger, Senior Regulatory Engineer presso il Center for Devices and Radiological Health della U.S. Food and Drug Administration (FDA) e membro del sottocomitato ISO, sottolinea anche in un'intervista: \"Se questi standard rilevanti per i ventilatori sono liberamente disponibili, i produttori possono usarli per progettare i loro dispositivi in modo pi\u00f9 sicuro. D\u00e0 loro anche dati tecnici aggiornati e standardizzati e informazioni che sono ampiamente comprese e accettate, cos\u00ec come i metodi di prova per verificare le prestazioni\".<\/p>\n

Norme per i ventilatori<\/strong><\/p>\n

Coloro che sono gravemente malati di Covid-19 possono avere bisogno di respirazione artificiale, a seconda del decorso della malattia. Il SNV offre una selezione di standard SN validi per i ventilatori (cfr. qui<\/a>).<\/p>\n

Fonte: SNV \/ rs<\/em><\/p>","protected":false},"excerpt":{"rendered":"

  Le persone colpite dal virus e che devono essere ricoverate in ospedale sono spesso collegate a un ventilatore. Tenendo conto della sicurezza dei pazienti, il Comitato Tecnico ISO 121 \/ Sottocomitato 3 sui ventilatori ha iniziato a sviluppare uno standard per la produzione di nuovi ventilatori medici affidabili e di alta qualit\u00e0, come l'Associazione Svizzera per la Standardizzazione [...].<\/p>","protected":false},"author":35,"featured_media":13098,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[3303,4],"tags":[4830,4281,3458,4829,3615],"class_list":["post-13097","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-qualitaetsmanagement","category-risikomanagement","tag-beatmungsgeraet","tag-covid-19","tag-iso","tag-iso-dis-80601-2-90","tag-norm"],"acf":[],"yoast_head":"\nNeue Norm f\u00fcr Covid-Beatmungsger\u00e4te - MQ Management und Qualit\u00e4t<\/title>\n<meta name=\"description\" content=\"Mit dem Ausbruch der Covid-19-Pandemie stieg der Bedarf an Beatmungsger\u00e4ten weltweit. 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