| 編號 | 中文名稱 | 英文名稱 |
|---|---|---|
| GB 15980-1995 | 一次性使用醫(yī)療用品衛(wèi)生標準 | Hygienic standard of disinfection for single use medical products |
| GB 16352-1996 | 一次性醫(yī)療用品γ射線輻射滅菌標準 | Standards for γ-rays radiation sterilization of disposable medical appliances |
| GB 16383-1996 | 醫(yī)療衛(wèi)生用品輻射滅菌消毒質量控制標準 | Quality control standards for radiation sterilization of medical and hygienical products |
| GB 16895.24-2005 | 建筑物電氣裝置第7-710部分:特殊裝置或場所的要求-醫(yī)療場所 | Electrical installations of buildings-Part 7-710:Requirements for special installations or locations-Medical locations |
| GB 18278-2000 | 醫(yī)療保健產(chǎn)品滅菌確認和常規(guī)控制要求工業(yè)濕熱滅菌 | Sterilization of health care products--Requirements for validation and routine control--Industrial moist heat sterilization |
| GB 18279-2000 | 醫(yī)療器械環(huán)氧乙烷滅菌確認和常規(guī)控制 | Medical devices--Validation androutine control of ethylene oxide sterilization |
| GB 18280-2000 | 醫(yī)療保健產(chǎn)品滅菌確認和常規(guī)控制要求輻射滅菌 | Sterilization of healthcare products--Requirement for validation and routine control--Radiation sterilization |
| GB 18281.1-2000 | 醫(yī)療保健產(chǎn)品滅菌生物指示物第1部分:通則 | Sterilization of health care products--Biological indicators--Part 1:General |
| GB 18281.2-2000 | 醫(yī)療保健產(chǎn)品滅菌生物指示物第2部分:環(huán)氧乙烷滅菌用生物指示物 | Sterilization of health care products--Biological indicators--Part 2:Biological indicators for ethylene oxide sterilization |
| GB 18281.3-2000 | 醫(yī)療保健產(chǎn)品滅菌生物指示物第3部分:濕熱滅菌用生物指示物 | Sterilization of health care products--Biological indicators--Part 3:Biological indicators for moist heat sterilization |
| GB 18282.1-2000 | 醫(yī)療保健產(chǎn)品滅菌化學指示物第1部分:通則 | Sterilization of health care products--Chemical indicators--Part 1:General requirements |
| GB 18282.3-2009 | 醫(yī)療保健產(chǎn)品滅菌 化學指示物 第3部分：用于BD類蒸汽滲透測試的二類指示物系統(tǒng) | 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 | 醫(yī)療保健產(chǎn)品滅菌 化學指示物 第4部分：用于替代性BD類蒸汽滲透測試的二類指示物 | 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 | 制造醫(yī)療器械用不銹鋼針管 | Stainless steel needle tubing for manufactureof medical devices |
| GB 18466-2005 | 醫(yī)療機構水污染物排放標準 | Discharge standard of water pollutants for medical organization |
| GB 19212.16-2005 | 電力變壓器、電源裝置和類似產(chǎn)品的安全第16部分：醫(yī)療場所供電用隔離變壓器的特殊要求 | 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 | 醫(yī)療廢物轉運車技術要求(試行) | Technical standard for medical waste transport vehicle |
| GB 19218-2003 | 醫(yī)療廢物焚燒爐技術要求(試行) | Technical standard for medical waste incinerator |
| GB 24627-2009 | 醫(yī)療器械和外科植入物用鎳-鈦形狀記憶合金加工材 | Standard specification for wrought nickel-titanium shape memory alloys for medical devices and surgical implants |
| GB 4824-2004 | 工業(yè)、科學和醫(yī)療(ISM)射頻設備電磁騷擾特性限值和測量方法 | Industrial，scientific and medical(ISM)radio-frequency equipment--Electromagnetic disturbance characteristics--Limits and methods of measurement |
| GB/T 10001.6-2006 | 標志用公共信息圖形符號 第6部分： 醫(yī)療保健符號 | Public information graphical symbols for use on sign―Part 6: Symbols for medical treatment and health care |
| GB/T 15566.6-2007 | 公共信息導向系統(tǒng) 設置原則與要求 第6部分: 醫(yī)療場所 | Guidance system for public information - Setting principles and requirements - Part 6: Medical site |
| GB/T 16886.1-2001 | 醫(yī)療器械生物學評價第1部分:評價與試驗 | Biological evaluation of medical devices--Part 1:Evaluation and testing |
| GB/T 16886.10-2005 | 醫(yī)療器械生物學評價第10部分:刺激與遲發(fā)型超敏反應試驗 | Biological evaluation of medical devices-Part 10:Tests for irritation and delayed-type hypersensitivity |
| GB/T 16886.11-1997 | 醫(yī)療器械生物學評價第11部分:全身毒性試驗 | Biological evaluation of medical devices--Part 11:Tests for systemic toxicity |
| GB/T 16886.12-2005 | 醫(yī)療器械生物學評價第12部分:樣品制備與參照樣品 | Biological evaluation of medical devices-Part 12:Sample preparation and reference materials |
| GB/T 16886.13-2001 | 醫(yī)療器械生物學評價第13部分:聚合物醫(yī)療器械的降解產(chǎn)物的定性與定量 | Biological evaluation of medical devices--Part 13:Identification and quantification of degradation products from polymeric medical devices |
| GB/T 16886.14-2003 | 醫(yī)療器械生物學評價第14部分:陶瓷降解產(chǎn)物的定性與定量 | Biological evaluation of medical devices--Part 14:Identification and quantification of degradation products from ceramics |
| GB/T 16886.15-2003 | 醫(yī)療器械生物學評價第15部分:金屬與合金降解產(chǎn)物的定性與定量 | Biological evaluation of medical devices--Part 15:Identification and quantification of degradation products from metals and alloys |
| GB/T 16886.16-2003 | 醫(yī)療器械生物學評價第16部分:降解產(chǎn)物和可溶出物的毒代動力學研究設計 | Biological evaluation of medical devices--Part 16: Toxicokinetic study design fordegradation products and leachables |
| GB/T 16886.17-2005 | 醫(yī)療器械生物學評價第17部分：可瀝濾物允許限量的建立 | Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances |
| GB/T 16886.2-2000 | 醫(yī)療器械生物學評價第2部分:動物保護要求 | Biological evaluation of medical devices--Part 2:Animal welfare requirements |
| GB/T 16886.3-2008 | 醫(yī)療器械生物學評價 第3部分：遺傳毒性、致癌性和生殖毒性試驗 | Biological evaluation of medical devices - Part 3: Tests for genotoxicity,carcinogenicity and reproductive toxicity |
| GB/T 16886.4-2003 | 醫(yī)療器械生物學評價第4部分: 與血液相互作用試驗選擇 | Biological evaluation of medical devices--Part 4:Selection of tests for interactions with blood |
| GB/T 16886.5-2003 | 醫(yī)療器械生物學評價第5部分: 體外細胞毒性試驗 | Biological evaluation ofmedical devices--Part 5: Test for in vitro cytotoxicity |
| GB/T 16886.6-1997 | 醫(yī)療器械生物學評價第6部分:植入后局部反應試驗 | Biological evaluation of medical devices--Part 6:Tests for local effects after implantation |
| GB/T 16886.7-2001 | 醫(yī)療器械生物學評價第7部分:環(huán)氧乙烷滅菌殘留量 | Biological evaluation of medical devices--Part 7:Ethylene oxide sterilization residuals |
| GB/T 16886.9-2001 | 醫(yī)療器械生物學評價第9部分:潛在降解產(chǎn)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、醫(yī)療、護理人員安全使用醫(yī)用電氣設備導則 | Guidelines for administrative，medical，and nursing staffconcerned with the safe use of medical electrical equipment |
| GB/T 18773-2008 | 醫(yī)療廢物焚燒環(huán)境衛(wèi)生標準 | Environmental sanitation standard for incineration of medical treatment wastes |
| GB/T 1962.1-2001 | 注射器、注射針及其他醫(yī)療器械6%(魯爾)圓錐接頭第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、注射針及其他醫(yī)療器械6%(魯爾)圓錐接頭第2部分:鎖定接頭 | The conical fittings with a 6%(Luer)taper for syringes，needles and certain other medical equipment--Part 2:Lock fittings |
| GB/T 19633-2005 | 最終滅菌醫(yī)療器械的包裝 | Packaging for terminally sterilized medical devices |
| GB/T 19702-2005 | 體外診斷醫(yī)療器械生物源性樣品中量的測量參考測量程序的說明 | In vitro diagnostic medical devices-Measurement of quantities in samples of biological origin-Presentation of reference measurement procedures |
| GB/T 19703-2005 | 體外診斷醫(yī)療器械生物源性樣品中量的測量參考物質的說明 | In vitro diagnostic medical devices-Measurement of quantities in samples of biological origin-Description of reference materials |
| GB/T 19971-2005 | 醫(yī)療保健產(chǎn)品滅菌術語匯編 | Sterilization of health care products -- Vocabulary |
| GB/T 19972-2005 | 醫(yī)療保健產(chǎn)品滅菌生物指示物選擇、使用及檢驗結果判斷指南 | Sterilization of health care products -- Biological indicators --Guidance for the selection, use and interpretation of results |
| GB/T 19974-2005 | 醫(yī)療保健產(chǎn)品滅菌滅菌因子的特性及醫(yī)療器械滅菌工藝的設定、確認和常規(guī)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 | 醫(yī)療保健產(chǎn)品滅菌醫(yī)療保健機構濕熱滅菌的確認和常規(guī)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 | 體外診斷醫(yī)療器械 生物樣品中量的測量 校準品和控制物質賦值的計量學溯源性 | 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 | 醫(yī)療保健產(chǎn)品滅菌 生物與化學指示物 測試設備 | Sterilization of health care products - Biological and chemical indicators - Test equipment |
| GB/T 24791.1-2009 | 攝影 醫(yī)療X射線成像用屏/片系統(tǒng)的感光測定 第1部分：感光特性曲線形狀、感光度與平均斜率的測定 | 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 | 攝影 醫(yī)療X射線成像用屏/片系統(tǒng)的感光測定 第3部分：乳腺X射線成像感光特性曲線形狀、感光度與平均斜率的測 | () |
| GB/Z 18732-2002 | 工業(yè)、科學和醫(yī)療設備限值的確定方法 | Determination of limits for industrial，scientific and medical equipment |
| GB/Z 19031-2009 | 質量管理體系 醫(yī)療服務組織過程改進指南 | Quality management systems - Guidelines for process improvements in health service organizations |
| GB/Z 19511-2004 | 工業(yè)、科學和醫(yī)療設備(ISM)國際電信聯(lián)盟(ITU)指定頻段內的輻射電平指南 | Industrial，scientific and medical equipment(ISM)--Guidelines for emission levels within the bands designated by the ITU |
| GBZ 179-2006 | 醫(yī)療照射放射防護基本要求 | Basic principles for radiological protection of medical exposure |
| 編號 | 中文名稱 | 英文名稱 |