医疗器械与血小板相互作用试验　第2部分：体外血小板激活产物(β-TG、PF4和TxB2)的测定
Test method for interactions of medical devices with platelet—Part 2:In vitro platelet activation products(β-TG,PF4 and TxB2)assay

2019-10-23

无菌医疗器械包装试验方法　第1部分：加速老化试验指南
Test methods for sterile medical device package—Part 1:Test guide for accelerated aging

2018-12-20

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006)
医疗器械的生物学评价第4部分:与血液相互作用试验的选择

2009-09-23

医疗器械免疫原性评价方法　第1部分：体外T淋巴细胞转化试验
Immunogenic evaluation method of medical devices —Part 1:T Lymphocyte transformation test in vitro

2016-01-26

PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED. PART 1: GENERAL REQUIREMENTS AND TEST METHODS.
待灭菌医疗器械的包装材料和系统 第1部分:一般要求和试验方法

1997-11-28

医疗器械致敏反应试验　第1部分：小鼠局部淋巴结试验(LLNA)放射性同位素掺入法
Test for sensitization of medical devices—Part 1:Murine local lymph node assay (LLNA):Radioisotope incorporation method

2013-10-21

Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 1: General requirements and common test methods
医疗器械.医疗保健用储液罐输送系统用连接器.第1部分:一般要求和通用试验方法

2018-12-03

医疗器械　医用贮液容器输送系统用连接件　第1部分：通用要求和通用试验方法
Medical devices—Connectors for reservoir delivery systems for healthcare applications—Part 1:General requirements and common test methods

2022-05-18

最终灭菌医疗器械包装材料　第1部分：吸塑包装共挤塑料膜　要求和试验方法
Packaging materials for terminal sterilized medical devices—Part 1:Co-extrusion plastic films used for vacuum forming packaging—Requirements and test methods

2011-12-31

BS EN 14079-1. Non-active medical devices. Properties for compresses and wound packing products for medical use. Part 1. Test methods and requirements for absorbent cotton gauze and absorbent cotton and viscose gauzes used in the manufacturing of compresses and wound packing products
英国标准EN 14079-1 非活动医疗设备 医用压缩材料和伤口包装产品的性能 第一部分 用于压缩和伤口包装产品制造的脱脂棉纱布、脱脂棉和粘胶纱布的试验方法和要求

2006-09-21

Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Medical Body Area Network Systems (MBANSs) operating in the 2 483,5 MHz to 2 500 MHz range; Part 1: Technical characteristics and test methods
电磁兼容性和无线电频谱管理（ERM）；短程设备（SRD）；在2483.5MHz至2500 MHz范围内运行的医疗机构区域网络系统（MBANSs）；第1部分:技术特性和试验方法

2014-11-01

Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Low Power Active Medical Implants (LP-AMI) operating in the frequency range 2 483,5 MHz to 2 500 MHz; Part 1: Technical characteristics and test methods
电磁兼容性和无线电频谱管理（ERM）；短程设备（SRD）；低功率有源医用植入物（LP-AMI） 工作频率范围为2483.5MHz至2500 MHz；第1部分:技术特性和试验方法

2012-06-01

Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Ultra Low Power Medical Data Service Systems operating in the frequency range 401 MHz to 402 MHz and 405 MHz to 406 MHz; Part 1: Technical characteristics and test methods
电磁兼容性和无线电频谱管理（ERM）；短程设备（SRD）；在401 MHz至402 MHz和405 MHz至406 MHz频率范围内运行的超低功率医疗数据服务系统；第1部分:技术特性和试验方法

2007-12-01

Electromagnetic compatibility and Radio spectrum Matters (ERM) - Short Range Devices (SRD) - Radio equipment in the frequency range 30 MHz to 37.5 MHz for Ultra Low Power Active Medical Membrane Implants and Accessories - Part 1: Technical characteristics and test methods (Endorsement of the English version EN 302510-1 V1.1.1 (2007-07) as German standard)
电磁兼容性和无线电频谱管理（ERM）.短程设备（SRD）.超低功率有源医用薄膜植入物和附件用30MHz至37.5MHz频率范围内的无线电设备.第1部分:技术特性和试验方法（英文认可）

2007-11-01

Electromagnetic compatibility and Radio spectrum Matters (ERM) - Short Range Devices (SRD) - Medical Body Area Network Systems (MBANSs) operating in the 2 483.5 MHz to 2 500 MHz range - Part 1: Technical characteristics and test methods (Endorsement of the English version EN 303 203-1 V1.1.1 (2014-11) as German standard)
电磁兼容性和无线电频谱管理（ERM）.短程设备（SRD）.在2483.5MHz至2500 MHz范围内运行的医疗机构局域网系统（MBANSs）.第1部分:技术特性和试验方法（英文版EN 303 203-1 V1.1.1（2014-1）的认可

2015-04-01