| 编号 | 中文名称 | 英文名称 |
|---|---|---|
| GB 15980-1995 | 一次性使用医疗用品卫生标准 | Hygienic standard of disinfection for single use medical products |
| GB 16352-1996 | 一次性医疗用品γ射线辐射灭菌标准 | Standards for γ-rays radiation sterilization of disposable medical appliances |
| GB 16383-1996 | 医疗卫生用品辐射灭菌消毒质量控制标准 | Quality control standards for radiation sterilization of medical and hygienical products |
| GB 16895.24-2005 | 建筑物电气装置第7-710部分:特殊装置或场所的要求-医疗场所 | Electrical installations of buildings-Part 7-710:Requirements for special installations or locations-Medical locations |
| GB 18278-2000 | 医疗保健产品灭菌确认和常规控制要求工业湿热灭菌 | Sterilization of health care products--Requirements for validation and routine control--Industrial moist heat sterilization |
| GB 18279-2000 | 医疗器械环氧乙烷灭菌确认和常规控制 | Medical devices--Validation androutine control of ethylene oxide sterilization |
| GB 18280-2000 | 医疗保健产品灭菌确认和常规控制要求辐射灭菌 | Sterilization of healthcare products--Requirement for validation and routine control--Radiation sterilization |
| GB 18281.1-2000 | 医疗保健产品灭菌生物指示物第1部分:通则 | Sterilization of health care products--Biological indicators--Part 1:General |
| GB 18281.2-2000 | 医疗保健产品灭菌生物指示物第2部分:环氧乙烷灭菌用生物指示物 | Sterilization of health care products--Biological indicators--Part 2:Biological indicators for ethylene oxide sterilization |
| GB 18281.3-2000 | 医疗保健产品灭菌生物指示物第3部分:湿热灭菌用生物指示物 | Sterilization of health care products--Biological indicators--Part 3:Biological indicators for moist heat sterilization |
| GB 18282.1-2000 | 医疗保健产品灭菌化学指示物第1部分:通则 | Sterilization of health care products--Chemical indicators--Part 1:General requirements |
| GB 18282.3-2009 | 医疗保健产品灭菌 化学指示物 第3部分：用于BD类蒸汽渗透测试的二类指示物系统 | Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test |
| GB 18282.4-2009 | 医疗保健产品灭菌 化学指示物 第4部分：用于替代性BD类蒸汽渗透测试的二类指示物 | Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration |
| GB 18457-2001 | 制造医疗器械用不锈钢针管 | Stainless steel needle tubing for manufactureof medical devices |
| GB 18466-2005 | 医疗机构水污染物排放标准 | Discharge standard of water pollutants for medical organization |
| GB 19212.16-2005 | 电力变压器、电源装置和类似产品的安全第16部分：医疗场所供电用隔离变压器的特殊要求 | Safety of power transformers ,power supply units and similar devices -- Part 16: Particular requirements for isolating transformers for the supply of medical locations |
| GB 19217-2003 | 医疗废物转运车技术要求(试行) | Technical standard for medical waste transport vehicle |
| GB 19218-2003 | 医疗废物焚烧炉技术要求(试行) | Technical standard for medical waste incinerator |
| GB 24627-2009 | 医疗器械和外科植入物用镍-钛形状记忆合金加工材 | Standard specification for wrought nickel-titanium shape memory alloys for medical devices and surgical implants |
| GB 4824-2004 | 工业、科学和医疗(ISM)射频设备电磁骚扰特性限值和测量方法 | Industrial，scientific and medical(ISM)radio-frequency equipment--Electromagnetic disturbance characteristics--Limits and methods of measurement |
| GB/T 10001.6-2006 | 标志用公共信息图形符号 第6部分： 医疗保健符号 | Public information graphical symbols for use on sign―Part 6: Symbols for medical treatment and health care |
| GB/T 15566.6-2007 | 公共信息导向系统 设置原则与要求 第6部分: 医疗场所 | Guidance system for public information - Setting principles and requirements - Part 6: Medical site |
| GB/T 16886.1-2001 | 医疗器械生物学评价第1部分:评价与试验 | Biological evaluation of medical devices--Part 1:Evaluation and testing |
| GB/T 16886.10-2005 | 医疗器械生物学评价第10部分:刺激与迟发型超敏反应试验 | Biological evaluation of medical devices-Part 10:Tests for irritation and delayed-type hypersensitivity |
| GB/T 16886.11-1997 | 医疗器械生物学评价第11部分:全身毒性试验 | Biological evaluation of medical devices--Part 11:Tests for systemic toxicity |
| GB/T 16886.12-2005 | 医疗器械生物学评价第12部分:样品制备与参照样品 | Biological evaluation of medical devices-Part 12:Sample preparation and reference materials |
| GB/T 16886.13-2001 | 医疗器械生物学评价第13部分:聚合物医疗器械的降解产物的定性与定量 | Biological evaluation of medical devices--Part 13:Identification and quantification of degradation products from polymeric medical devices |
| GB/T 16886.14-2003 | 医疗器械生物学评价第14部分:陶瓷降解产物的定性与定量 | Biological evaluation of medical devices--Part 14:Identification and quantification of degradation products from ceramics |
| GB/T 16886.15-2003 | 医疗器械生物学评价第15部分:金属与合金降解产物的定性与定量 | Biological evaluation of medical devices--Part 15:Identification and quantification of degradation products from metals and alloys |
| GB/T 16886.16-2003 | 医疗器械生物学评价第16部分:降解产物和可溶出物的毒代动力学研究设计 | Biological evaluation of medical devices--Part 16: Toxicokinetic study design fordegradation products and leachables |
| GB/T 16886.17-2005 | 医疗器械生物学评价第17部分：可沥滤物允许限量的建立 | Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances |
| GB/T 16886.2-2000 | 医疗器械生物学评价第2部分:动物保护要求 | Biological evaluation of medical devices--Part 2:Animal welfare requirements |
| GB/T 16886.3-2008 | 医疗器械生物学评价 第3部分：遗传毒性、致癌性和生殖毒性试验 | Biological evaluation of medical devices - Part 3: Tests for genotoxicity,carcinogenicity and reproductive toxicity |
| GB/T 16886.4-2003 | 医疗器械生物学评价第4部分: 与血液相互作用试验选择 | Biological evaluation of medical devices--Part 4:Selection of tests for interactions with blood |
| GB/T 16886.5-2003 | 医疗器械生物学评价第5部分: 体外细胞毒性试验 | Biological evaluation ofmedical devices--Part 5: Test for in vitro cytotoxicity |
| GB/T 16886.6-1997 | 医疗器械生物学评价第6部分:植入后局部反应试验 | Biological evaluation of medical devices--Part 6:Tests for local effects after implantation |
| GB/T 16886.7-2001 | 医疗器械生物学评价第7部分:环氧乙烷灭菌残留量 | Biological evaluation of medical devices--Part 7:Ethylene oxide sterilization residuals |
| GB/T 16886.9-2001 | 医疗器械生物学评价第9部分:潜在降解产物的定性和定量框架 | Biological evaluation of medical devices--Part 9:Framework for identification and quantification of potential degradation product |
| GB/T 17995-1999 | 管理、医疗、护理人员安全使用医用电气设备导则 | Guidelines for administrative，medical，and nursing staffconcerned with the safe use of medical electrical equipment |
| GB/T 18773-2008 | 医疗废物焚烧环境卫生标准 | Environmental sanitation standard for incineration of medical treatment wastes |
| GB/T 1962.1-2001 | 注射器、注射针及其他医疗器械6%(鲁尔)圆锥接头第1部分:通用要求 | The conical fittings with a 6%(Luer)taper for syringes，needles and certain other medical equipment--Part 1:General requirement |
| GB/T 1962.2-2001 | 注射器、注射针及其他医疗器械6%(鲁尔)圆锥接头第2部分:锁定接头 | The conical fittings with a 6%(Luer)taper for syringes，needles and certain other medical equipment--Part 2:Lock fittings |
| GB/T 19633-2005 | 最终灭菌医疗器械的包装 | Packaging for terminally sterilized medical devices |
| GB/T 19702-2005 | 体外诊断医疗器械生物源性样品中量的测量参考测量程序的说明 | In vitro diagnostic medical devices-Measurement of quantities in samples of biological origin-Presentation of reference measurement procedures |
| GB/T 19703-2005 | 体外诊断医疗器械生物源性样品中量的测量参考物质的说明 | In vitro diagnostic medical devices-Measurement of quantities in samples of biological origin-Description of reference materials |
| GB/T 19971-2005 | 医疗保健产品灭菌术语汇编 | Sterilization of health care products -- Vocabulary |
| GB/T 19972-2005 | 医疗保健产品灭菌生物指示物选择、使用及检验结果判断指南 | Sterilization of health care products -- Biological indicators --Guidance for the selection, use and interpretation of results |
| GB/T 19974-2005 | 医疗保健产品灭菌灭菌因子的特性及医疗器械灭菌工艺的设定、确认和常规控制的通用要求 | Sterilization of health care products -- General requirement for characterization of a sterilizing agent and the development ,validation and routine controlofasterilization process for medical devices |
| GB/T 20367-2006 | 医疗保健产品灭菌医疗保健机构湿热灭菌的确认和常规控制要求 | Sterilization of health care products - Requirement for validation and routine control of moist heat sterilization in health care facilities |
| GB/T 21415-2008 | 体外诊断医疗器械 生物样品中量的测量 校准品和控制物质赋值的计量学溯源性 | In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials |
| GB/T 24628-2009 | 医疗保健产品灭菌 生物与化学指示物 测试设备 | Sterilization of health care products - Biological and chemical indicators - Test equipment |
| GB/T 24791.1-2009 | 摄影 医疗X射线成像用屏/片系统的感光测定 第1部分：感光特性曲线形状、感光度与平均斜率的测定 | Photography - Sensitometry of screen/film systems for medical X-radiography - Part 1: Determination of sensitometric curve shape, speed and average gradient |
| GB/T 24791.3-2009 | 摄影 医疗X射线成像用屏/片系统的感光测定 第3部分：乳腺X射线成像感光特性曲线形状、感光度与平均斜率的测 | () |
| GB/Z 18732-2002 | 工业、科学和医疗设备限值的确定方法 | Determination of limits for industrial，scientific and medical equipment |
| GB/Z 19031-2009 | 质量管理体系 医疗服务组织过程改进指南 | Quality management systems - Guidelines for process improvements in health service organizations |
| GB/Z 19511-2004 | 工业、科学和医疗设备(ISM)国际电信联盟(ITU)指定频段内的辐射电平指南 | Industrial，scientific and medical equipment(ISM)--Guidelines for emission levels within the bands designated by the ITU |
| GBZ 179-2006 | 医疗照射放射防护基本要求 | Basic principles for radiological protection of medical exposure |
| 编号 | 中文名称 | 英文名称 |