Standards Projects For Medical Devices
Standards Projects For Medical Devices
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| Technical Committee / Working Team | Project Number | Project Name | Project Name - English | Announcement Date | Announcement End Date | Project Status | About project |
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| GSO TC 11 | GSO 11.DS. ISO 11663:2014 ISO11663:2014 | N/A | Quality of dialysis fluid for haemodialysis and related therapie | 2014-06-26 | Finished |
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| GSO TC 11 | GSO 11.DS. ISO 11138-4:2014 ISO 11138-4:2006 | N/A | Sterilization of health care products -- Biological indicators -- Part 4: Biological indicators for dry heat sterilization processes | 2014-06-26 | Finished |
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| GSO TC 11 | GSO 11.DS. ISO 11138-3 :2014 ISO 11138-3:2006 | N/A | Sterilization of health care products -- Biological indicators -- Part 3: Biological indicators for moist heat sterilization processes | 2014-06-26 | Finished |
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| GSO TC 11 | GSO 11.DS. ISO 11138-2:2014 ISO 11138-2:2006 | N/A | Sterilization of health care products -- Biological indicators -- Part 2: Biological indicators for ethylene oxide sterilization processes | 2014-06-26 | Finished |
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| GSO TC 11 | GSO 11.DS. ISO 11138-1:2014 ISO 11138-1:2006 | N/A | Sterilization of health care products -- Biological indicators -- Part 1: General requirements | 2014-06-26 | Finished |
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| GSO TC 11 | GSO 11.DS. ISO 11137-3:2014 ISO 11137-3:2006 | N/A | Sterilization of health care products -- Radiation -- Part 3: Guidance on dosimetric aspects | 2014-06-26 | Finished |
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| GSO TC 11 | GSO 11.DS. ISO 11137-2:2014 ISO 11137-2:2013 | N/A | Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose | 2014-06-26 | Finished |
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| GSO TC 11 | GSO 11.DS. ISO/TS 11135-2:2014 ISO/TS 11135-2:2008 | N/A | Sterilization of health care products -- Ethylene oxide -- Part 2: Guidance on the application of ISO 11135-1 | 2014-06-26 | Finished |
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| GSO TC 11 | GSO 11.DS.ISO 11135-1:2014 ISO 11135-1-2007 | N/A | Sterilization of health care products -- Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices | 2014-06-26 | Finished |
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| SFDA/MDS/TC121 | SFDA.MD.121.DS.ISO10651-2:2014 ISO 10651-2:2004 | أجهزة التنفس الرئوية للاستخدام الطبي -المتطلبات الأساسية المحددة للسلامة وكفاءة الأداء- الجزء2- أجهزة التنفس المنزلية للمرضى المعتمدين على التنفس الصناعي | Lung ventilators for medical use -particular requirements for basic safety and essential performance-part 2 : home care ventilators for ventilator dependent patient | 2014-07-30 | Finished |