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医疗设备

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标准编号 标准名称 状态 发布日期
ISO 21292:2020 EN Traditional Chinese medicine -- Electric heating moxibustion equipment 现行 2020-07-08
ISO/TR 20416:2020 EN Medical devices -- Post-market surveillance for manufacturers 现行 2020-07-08
ISO 16672:2020 EN Ophthalmic implants -- Ocular endotamponades 现行 2020-06-26
ISO 7207-2:2011/Amd 2:2020 EN ISO 7207-2:2011/Amd 2:2020 EN 现行 2020-06-24
ISO 8624:2020 EN Ophthalmic optics -- Spectacle frames -- Measuring system and vocabulary 现行 2020-06-22
IEC 62366-1 ed1.1 EN-FR Medical devices - Part 1: Application of usability engineering to medical devices 现行 2020-06-17
IEC 62366-1-am1 ed1.0 EN-FR Amendment 1 - Medical devices - Part 1: Application of usability engineering to medical devices 现行 2020-06-17
ISO/TR 24971:2020 EN Medical devices -- Guidance on the application of ISO 14971 现行 2020-06-16
ISO 22236:2020 EN Traditional Chinese medicine —Thread-embedding acupuncture needle for single use 现行 2020-06-02
ISO 8871-2:2020 EN Elastomeric parts for parenterals and for devices for pharmaceutical use-- Part 2:Identification and characterization 现行 2020-05-14
ISO 14708-5:2020 EN Implants for surgery -- Active implantable medical devices-- Part 5:Circulatory support devices 现行 2020-05-12
ISO 7886-3:2020 EN Sterile hypodermic syringes for single use-- Part 3:Auto-disabled syringes for fixed-dose immunization 现行 2020-05-05
ISO 12891-2:2020 EN Retrieval and analysis of surgical implants-- Part 2:Analysis of retrieved surgical implants 现行 2020-04-30
ISO 7886-2:2020 EN Sterile hypodermic syringes for single use-- Part 2:Syringes for use with power-driven syringe pumps 现行 2020-04-24
ISO 81060-2-am1 ed3.0 EN Amendment 1 - Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type 现行 2020-04-20
IEC/TR 62653 ed2.0 EN Guideline for safe operation of medical equipment used for haemodialysis treatments 现行 2020-04-17
ISO/TS 20498-3:2020 EN Traditional Chinese medicine -- Computerized tongue image analysis system-- Part 3:Colour chart 现行 2020-04-17
IEC/TR 62653 ed2.0 RLV EN Guideline for safe operation of medical equipment used for haemodialysis treatments 现行 2020-04-17
ISO 8548-2:2020 EN Prosthetics and orthotics -- Limb deficiencies-- Part 2:Method of describing lower limb amputation stumps 现行 2020-04-01
ISO 20695:2020 EN Enteral feeding systems -- Design and testing 现行 2020-03-27
ISO 7199:2016/Amd 1:2020 EN Connectors 现行 2020-03-16
ISO 8551:2020 EN Prosthetics and orthotics -- Functional deficiencies -- Description of the person to be treated with an orthosis, clinical objectives of treatment, and functional requirements of the orthosis 现行 2020-03-09
ISO 11040-4:2015/Amd 1:2020 EN ISO 11040-4:2015/Amd 1:2020 EN 现行 2020-02-28
ISO 80601-2-12:2020 EN Medical electrical equipment-- Part 2-12:Particular requirements for basic safety and essential performance of critical care ventilators 现行 2020-02-25
ISO 15674:2016/Amd 1:2020 EN Connectors 现行 2020-02-17
ISO 15675:2016/Amd 1:2020 EN Connectors 现行 2020-02-17
IEC 61223-3-6 ed1.0 EN-FR Evaluation and routine testing in medical imaging departments - Part 3-6: Acceptance and constancy tests - Imaging performance of mammographic X-ray equipment used in a mammographic tomosynthesis mode of operation 现行 2020-02-07
ISO 24157:2008/Amd 1:2020 EN ISO 24157:2008/Amd 1:2020 EN 现行 2020-02-06
ISO/TS 81060-5 ed1.0 EN Non-invasive sphygmomanometers - Part 5: Requirements for the repeatability and reproducibility of NIBP simulators for testing of automated non-invasive sphygmomanometers 现行 2020-02-03
ISO/TS 81060-5:2020 EN Non-invasive sphygmomanometers-- Part 5:Requirements for the repeatability and reproducibility of NIBP simulators for testing of automated non-invasive sphygmomanometers 现行 2020-02-03

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