標(biāo)準(zhǔn)解讀
《YY 9706.233-2021 醫(yī)用電氣設(shè)備 第2-33部分:醫(yī)療診斷用磁共振設(shè)備的基本安全和基本性能專用要求》相較于《YY 0319-2008 醫(yī)用電氣設(shè)備 第2-33部分:醫(yī)療診斷用磁共振設(shè)備安全專用要求》,在內(nèi)容上進(jìn)行了多方面的更新與擴(kuò)展。這些變化主要體現(xiàn)在以下幾個(gè)方面:
一、標(biāo)準(zhǔn)編號(hào)及名稱的變化,新的標(biāo)準(zhǔn)采用了國(guó)際電工委員會(huì)(IEC)的標(biāo)準(zhǔn)編號(hào)體系,并且在標(biāo)題中加入了“基本性能”這一關(guān)鍵詞,強(qiáng)調(diào)了對(duì)于設(shè)備性能的要求。
二、增加了對(duì)患者舒適度的關(guān)注,新版本更加注重于改善患者的檢查體驗(yàn),比如規(guī)定了更嚴(yán)格的噪音控制措施以及提出了關(guān)于提高掃描速度以減少患者等待時(shí)間的具體建議。
三、強(qiáng)化了信息安全保護(hù)條款,隨著信息技術(shù)的發(fā)展,《YY 9706.233-2021》特別強(qiáng)調(diào)了MRI系統(tǒng)中數(shù)據(jù)傳輸?shù)陌踩詥栴},包括但不限于個(gè)人信息保護(hù)、防止未授權(quán)訪問等方面的內(nèi)容。
四、提高了電磁兼容性的測(cè)試標(biāo)準(zhǔn),針對(duì)日益復(fù)雜的醫(yī)院環(huán)境,新版標(biāo)準(zhǔn)加強(qiáng)了對(duì)MRI設(shè)備抗干擾能力的要求,確保其能夠在各種條件下穩(wěn)定運(yùn)行。
五、擴(kuò)大了適用范圍,不僅限于傳統(tǒng)意義上的全身成像裝置,還涵蓋了專用于特定部位如心臟、乳腺等的小型化或?qū)S眯痛殴舱癯上裣到y(tǒng)。
六、細(xì)化了一些具體的技術(shù)參數(shù)要求,例如磁場(chǎng)均勻度、圖像質(zhì)量評(píng)價(jià)方法等,使得制造商能夠根據(jù)明確的指導(dǎo)原則來設(shè)計(jì)和生產(chǎn)符合市場(chǎng)需求的產(chǎn)品。
七、增強(qiáng)了操作者與維修人員的安全保障措施,通過提供更加詳盡的操作指南和技術(shù)支持文檔,幫助相關(guān)人員更好地理解和執(zhí)行安全規(guī)范。
八、引入了風(fēng)險(xiǎn)管理的概念,鼓勵(lì)企業(yè)從產(chǎn)品開發(fā)階段就將潛在風(fēng)險(xiǎn)納入考量,采取預(yù)防措施降低事故發(fā)生概率。
如需獲取更多詳盡信息,請(qǐng)直接參考下方經(jīng)官方授權(quán)發(fā)布的權(quán)威標(biāo)準(zhǔn)文檔。
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- 2021-03-09 頒布
- 2023-05-01 實(shí)施
文檔簡(jiǎn)介
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