新冠肺炎疫情發(fā)生以來(lái)，經(jīng)與ISO積極溝通，在獲得ISO授權(quán)后，我國(guó)在網(wǎng)上免費(fèi)公開(kāi)了ISO 10993-1:2018《醫(yī)療器械生物學(xué)評(píng)價(jià)-第1部分：風(fēng)險(xiǎn)管理過(guò)程中的評(píng)價(jià)與試驗(yàn)》、ISO 13688:2013《防護(hù)服-一般要求》等8項(xiàng)疫情防控相關(guān)標(biāo)準(zhǔn)。4月7日，經(jīng)ISO和IEC授權(quán)同意，我國(guó)再次免費(fèi)公開(kāi)了20項(xiàng)醫(yī)用肺呼吸機(jī)等醫(yī)療器械相關(guān)ISO標(biāo)準(zhǔn)，以及5項(xiàng)醫(yī)用電氣設(shè)備IEC標(biāo)準(zhǔn)，為打贏疫情防控阻擊戰(zhàn)持續(xù)貢獻(xiàn)標(biāo)準(zhǔn)力量。
|
20項(xiàng)呼吸機(jī)和基本醫(yī)療器械相關(guān)ISO標(biāo)準(zhǔn)和5項(xiàng)醫(yī)用電氣設(shè)備IEC標(biāo)準(zhǔn)清單
|
|||
|
序號(hào)
|
標(biāo)準(zhǔn)號(hào)
|
標(biāo)準(zhǔn)名稱（英文）
|
標(biāo)準(zhǔn)名稱（中文）
|
|
1
|
ISO 10651-3:1997
|
Lung ventilators for medical use — Part 3: Particular requirements for emergency and transport ventilators
|
醫(yī)用肺呼吸機(jī) 第3部分：急救和運(yùn)送用呼吸機(jī)的特殊要求
|
|
2
|
ISO 10651-4:2002
|
Lung ventilators — Part 4: Particular requirements for operatorpowered resuscitators
|
肺呼吸機(jī) 第4部分：操作員控制用人工呼吸機(jī)的特殊要求
|
|
3
|
ISO 10651-5:2006
|
Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 5: Gas-powered emergency resuscitators
|
醫(yī)用肺呼吸機(jī) 基本安全和基本性能的特殊要求.第5部分：氣動(dòng)急救人工呼吸器
|
|
4
|
ISO 13485:2016
|
Medical devices — Quality management systems — Requirements for regulatory purposes
|
醫(yī)療器械 - 質(zhì)量管理體系 - 用于法規(guī)的要求
|
|
5
|
ISO 17510:2015
|
Medical devices — Sleep apnoea breathing therapy — Masks and application accessories
|
醫(yī)療器械 - 睡眠窒息呼吸治療 - 面罩和應(yīng)用附件
|
|
6
|
ISO 18082:2014
|
Anaesthetic and respiratory equipment — Dimensions of noninterchangeable screw-threaded (NIST) low-pressure connectors for medical gases
[Including ISO 18082:2014/Amd.1:2017, AMENDMENT 1] |
麻醉劑和呼吸設(shè)備. 醫(yī)療氣體用非交替式螺栓. 螺紋(NIST)低壓力連接器尺寸 [包括ISO 18082:2014/Amd.1:2017, 修訂 1]
|
|
7
|
ISO 18562-1:2017
|
Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: evaluation and testing within a risk management process
|
醫(yī)療保健應(yīng)用中呼吸氣體通道的生物相容性評(píng)估. 第1部分: 風(fēng)險(xiǎn)管理過(guò)程中的評(píng)估和試驗(yàn)
|
|
8
|
ISO 18562-2:2017
|
Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter
|
醫(yī)療保健應(yīng)用中呼吸氣體通道的生物相容性評(píng)估. 第2部分: 顆粒物排放試驗(yàn)
|
|
9
|
ISO 18562-3:2017
|
Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic compounds (VOCs)
|
醫(yī)療保健應(yīng)用中呼吸氣體通道的生物相容性評(píng)估. 第3部分: 揮發(fā)性有機(jī)化合物(VOC)排放試驗(yàn)
|
|
10
|
ISO 18562-4:2017
|
Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate
|
醫(yī)療保健應(yīng)用中呼吸氣體通道的生物相容性評(píng)估. 第4部分: 冷凝物中的析出物試驗(yàn)
|
|
11
|
ISO 19223:2019
|
Lung ventilators and related equipment — Vocabulary and semantics
|
呼吸機(jī)及相關(guān)設(shè)備 - 詞匯和語(yǔ)義
|
|
12
|
ISO 20395:2019
|
Biotechnology — Requirements for evaluating the performance of quantification methods for nucleic acid target sequences — qPCR and dPCR
|
生物技術(shù) - 核酸目標(biāo)序列量化方法性能評(píng)估要求 - qPCR和dPCR
|
|
13
|
ISO 5356-1:2015
|
Anaesthetic and respiratory equipment — Conical connectors — Part1: Cones and sockets
|
麻醉劑和呼吸設(shè)備 - 錐形連接器 - 第1部分: 錐體和插孔
|
|
14
|
ISO 80601-2-12:2020
|
Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
|
醫(yī)用電氣設(shè)備 - 第2-12部分：重癥監(jiān)護(hù)呼吸機(jī)基本安全和基本性能的特殊要求
|
|
15
|
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] |
醫(yī)療電氣設(shè)備 - 第2-13部分: 麻醉工作站的基本安全和基本性能的特殊要求
[包括 ISO 80601-2-13:2011/Amd.1:2015, 修訂 1 和 ISO 80601-2- 13:2011/Amd.2:2018, 修訂 2] |
|
16
|
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
|
醫(yī)療電氣設(shè)備 - 第2-70部分：睡眠窒息呼吸治療設(shè)備的基本安全和基本性能的特殊要求
|
|
17
|
ISO 80601-2-74:2017
|
Medical electrical equipment — Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
|
醫(yī)療電氣設(shè)備 - 第2-74部分: 呼吸加濕器基本安全和基本性能的特殊要求
|
|
18
|
ISO 80601-2-79:2018
|
Medical electrical equipment — Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
|
醫(yī)療電氣設(shè)備 - 第2-79部分：呼吸受損的呼吸支持設(shè)備基本安全和基本性能的特殊要求
|
|
19
|
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
|
醫(yī)療電氣設(shè)備 - 第2-80部分：呼吸功能不全的呼吸支持設(shè)備基本安全和基本性能的特殊要求
|
|
20
|
ISO/TS 16976-8:2013
|
Respiratory protective devices — Human factors — Part 8:Ergonomic factors
|
呼吸保護(hù)裝置 - 人為因素 - 第8部分:人體工學(xué)因素
|
|
21
|
IEC 60601-1:2005+AMD1:2012 CSV
|
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
|
醫(yī)用電氣設(shè)備 第1部分_基本安全和基本性能
|
|
22
|
IEC 60601-1-2:2014
|
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
|
醫(yī)用電氣設(shè)備 第1-2部分：基本安全和基本性能的通用要求 匯編標(biāo)準(zhǔn)：電磁干擾-要求和測(cè)試
|
|
23
|
IEC 60601-1-6:2010
|
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
|
醫(yī)用電氣設(shè)備 第1-6部分：基本安全性和必要性能的通用要求 匯編標(biāo)準(zhǔn):可用性
|
|
24
|
IEC 60601-1-8:2006
|
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements,tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
|
醫(yī)用電氣設(shè)備 第1-8部分：基本安全和基本性能的通用要求 匯編標(biāo)準(zhǔn)：醫(yī)療電氣設(shè)備和醫(yī)療電氣系統(tǒng)報(bào)警系統(tǒng)的通用要求、試驗(yàn)和指南
|
|
25
|
IEC 60601-1-11:2015
|
Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
|
醫(yī)療電氣設(shè)備 第1-11部分：基本安全和基本性能的通用要求 匯編標(biāo)準(zhǔn)：家庭保健用醫(yī)療電氣設(shè)備和醫(yī)療電氣系統(tǒng)的要求
|
中企檢測(cè)認(rèn)證網(wǎng)提供iso體系認(rèn)證機(jī)構(gòu)查詢，檢驗(yàn)檢測(cè)、認(rèn)證認(rèn)可、資質(zhì)資格、計(jì)量校準(zhǔn)、知識(shí)產(chǎn)權(quán)貫標(biāo)一站式行業(yè)企業(yè)服務(wù)平臺(tái)。中企檢測(cè)認(rèn)證網(wǎng)為檢測(cè)行業(yè)相關(guān)檢驗(yàn)、檢測(cè)、認(rèn)證、計(jì)量、校準(zhǔn)機(jī)構(gòu)，儀器設(shè)備、耗材、配件、試劑、標(biāo)準(zhǔn)品供應(yīng)商，法規(guī)咨詢、標(biāo)準(zhǔn)服務(wù)、實(shí)驗(yàn)室軟件提供商提供包括品牌宣傳、產(chǎn)品展示、技術(shù)交流、新品推薦等全方位推廣服務(wù)。這個(gè)問(wèn)題就給大家解答到這里了，如還需要了解更多專業(yè)性問(wèn)題可以撥打中企檢測(cè)認(rèn)證網(wǎng)在線客服13550333441。為您提供全面檢測(cè)、認(rèn)證、商標(biāo)、專利、知識(shí)產(chǎn)權(quán)、版權(quán)法律法規(guī)知識(shí)資訊，包括商標(biāo)注冊(cè)、食品檢測(cè)、第三方檢測(cè)機(jī)構(gòu)、網(wǎng)絡(luò)信息技術(shù)檢測(cè)、環(huán)境檢測(cè)、管理體系認(rèn)證、服務(wù)體系認(rèn)證、產(chǎn)品認(rèn)證、版權(quán)登記、專利申請(qǐng)、知識(shí)產(chǎn)權(quán)、檢測(cè)法、認(rèn)證標(biāo)準(zhǔn)等信息，中企檢測(cè)認(rèn)證網(wǎng)為檢測(cè)認(rèn)證商標(biāo)專利從業(yè)者提供多種檢測(cè)、認(rèn)證、知識(shí)產(chǎn)權(quán)、版權(quán)、商標(biāo)、專利的轉(zhuǎn)讓代理查詢法律法規(guī)，咨詢輔導(dǎo)等知識(shí)。
本文內(nèi)容整合網(wǎng)站：中國(guó)政府網(wǎng)、百度百科、最高人民法院、知乎、國(guó)家認(rèn)證認(rèn)可監(jiān)督管理委員會(huì)、國(guó)家知識(shí)產(chǎn)權(quán)局、市場(chǎng)監(jiān)督總局
免責(zé)聲明：本文部分內(nèi)容根據(jù)網(wǎng)絡(luò)信息整理，文章版權(quán)歸原作者所有。向原作者致敬！發(fā)布旨在積善利他，如涉及作品內(nèi)容、版權(quán)和其它問(wèn)題，請(qǐng)跟我們聯(lián)系刪除并致歉！
本文來(lái)源： http://bqlw.net/news/202004/xwif_755.html
