消毒剂产品认证相关国内外标准汇编
当前，一场防控新型冠状病毒肺炎的全民阻击战已经打响，全国上下众志成城，共克时艰。本文将消毒剂产品相关国内外标准进行整理汇编，供参考。| 类别 | 标准号 | 中文题名 | 英文题名 |
| 中国 | GB/T 10666-2019 | 次氯酸钙（漂粉精） | Calcium hypochlorite |
| GB 16383-2014 | 医疗卫生用品辐射灭菌消毒质量控制 | Quality control for radiation sterilization of medical and hygienical products | |
| 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 health care products--Requirement for validation and routine control--Radiation sterilization | |
| GB/T 19104-2008 | 过氧乙酸溶液 | Peracetic acid solution | |
| GB/T 19106-2013 | 次氯酸钠 | Sodium hypochlorite | |
| GB 19193-2015 | 疫源地消毒总则 | General principle on disinfection for infectious focus | |
| GB/T 19633-2005 | 最终灭菌医疗器械的包装 | Packaging for terminally sterilized medical devices | |
| GB/T 20468-2006 | 临床实验室定量测定室内质量控制指南 | Guideline for internal quality control for quantitative measurements in clinical laboratory | |
| GB/T 20469-2006 | 临床实验室设计总则 | General guideline of the clinical laboratory design | |
| GB/T 20470-2006 | 临床实验室室间质量评价要求 | Requirements of external quality assessment for clinical laboratories | |
| GB/T 23854-2009 | 溴氯海因 | Bromochloro-5,5-dimethylhydantoin | |
| GB/T 23854-2019 | 溴氯海因 | Bromochloro-5,5-dimethylhydantoin | |
| GB/T 26366-2010 | 二氧化氯消毒剂卫生标准 | Hygienic standard for chlorine dioxide disinfectant | |
| GB/T 26367-2010 | 胍类消毒剂卫生标准 | Hygienic standard for biguanides disinfectants | |
| GB/T 26368-2010 | 含碘消毒剂卫生标准 | Hygienic standard for iodine disinfectants | |
| GB/T 26369-2010 | 季铵盐类消毒剂卫生标准 | Hygienic standard for quaternary ammonium disinfectant | |
| GB/T 26370-2010 | 含溴消毒剂卫生标准 | Hygienic standard for disinfectants with bromine | |
| GB/T 26371-2010 | 过氧化物类消毒剂卫生标准 | Hygienic standard for peroxide disinfectants | |
| GB/T 26372-2010 | 戊二醛消毒剂卫生标准 | Hygienic standard for glutaraldehyde disinfectant | |
| GB/T 26373-2010 | 乙醇消毒剂卫生标准 | Hygienic standard for alcohol disinfectants | |
| GB/T 27947-2011 | 酚类消毒剂卫生要求 | Hygienic requirements for phenol disinfectant | |
| GB 27948-2011 | 空气消毒剂卫生要求 | Hygienic requirements for air disinfectant | |
| GB/T 27949-2011 | 医疗器械消毒剂卫生要求 | Hygienic requirements for medical items disinfection | |
| GB 27950-2011 | 手消毒剂卫生要求 | Hygienic requirements for hand antiseptic agents | |
| GB 27951-2011 | 皮肤消毒剂卫生要求 | Hygiene requirements for skin disinfectant | |
| GB 27952-2011 | 普通物体表面消毒剂的卫生要求 | Hygienic requirements for surface disinfectants | |
| GB 27953-2011 | 疫源地消毒剂卫生要求 | Hygienic requirements of disinfectant for infectious focus | |
| GB 27954-2011 | 黏膜消毒剂通用要求 | General standard for disinfectant of mucous membrane | |
| GB 27955-2011 | 过氧化氢气体等离子体低温灭菌装置的通用要求 | General requirements for low-temperature hydrogen peroxide gas plasma sterilizer | |
| GB 28232-2011 | 臭氧发生器安全与卫生标准 | Safety and sanitation standard for ozone generator | |
| GB 28233-2011 | 次氯酸钠发生器安全与卫生标准 | Safety and hygienic standard for disinfection by sodium hypochlorite generator | |
| GB 28234-2011 | 酸性氧化电位水生成器安全与卫生标准 | Safety and sanitation standard for acidic electrolyzed-oxidizing water generator | |
| GB 28235-2011 | 紫外线空气消毒器安全与卫生标准 | Safety and sanitary standard for ultraviolet appliance for air disinfection | |
| GB 28931-2012 | 二氧化氯消毒剂发生器安全与卫生标准 | Safety and sanitation standard for chlorine dioxide disinfectant generator | |
| GB/T 30224-2013 | 刚地弓形虫试验临床应用 | Clinical use of tests for Toxoplasma gondii | |
| GB 30689-2014 | 内镜自动清洗消毒机卫生要求 | Hygienic requirements for washer-disinfectors employing chemical disinfection for thermolabile endoscopes | |
| GB/T 30690-2014 | 小型压力蒸汽灭菌器灭菌效果监测方法和评价要求 | Monitoring requirements and evaluation of sterilization effect of small steam sterilizer | |
| GB/T 33417-2016 | 过氧化氢气体灭菌生物指示物检验方法 | Test method of biological indicator for hydrogen peroxide vapour sterilization processes | |
| GB/T 33418-2016 | 环氧乙烷灭菌化学指示物检验方法 | Test method of chemical indicator for ethylene oxide sterilization processes | |
| GB/T 33419-2016 | 环氧乙烷灭菌生物指示物检验方法 | Test method of biological indicator for ethylene oxide sterilization processes | |
| GB/T 33420-2016 | 压力蒸汽灭菌生物指示物检验方法 | Evaluation standard of biological for moist heat sterilization processes | |
| GB/T 36758-2018 | 含氯消毒剂卫生要求 | Hygienic requirements for disinfectants with chlorine | |
| YY/T 0215-2016 | 医用臭氧消毒设备 | Ozone disinfector for medical purpose | |
| YY 0970-2013 | 含动物源材料的一次性使用医疗器械的灭菌液体灭菌剂灭菌的确认与常规控制 | Sterilization of single-use medical devices incorporating materials of animal origin.Validation and routine control of sterilization by liquid sterilants | |
| WS/T 327-2011 | 消毒剂杀灭分枝杆菌实验评价要求 | Requirements of mycobactericidal evaluation for disinfectant in laboratory | |
| WS/T 466-2014 | 消毒专业名词术语 | Disinfection professional terms | |
| WS/T 496-2017 | 临床实验室质量指标 | Quality indicators in clinical laboratories | |
| WS/T 497-2017 | 侵袭性真菌病临床实验室诊断操作指南 | Performance guideline for clinical laboratory diagnosis of invasive fungal diseases | |
| WS/T 498-2017 | 细菌性腹泻临床实验室诊断操作指南 | Performance guideline for clinical laboratory diagnosis of bacterial diarrhea | |
| WS/T 508-2016 | 医院医用织物洗涤消毒技术规范 | Regulation for washing and disinfection technique of medical textiles in healthcare facilities | |
| WS/T 514-2017 | 临床检验方法检出能力的确立和验证 | Establishment and verification of detection capability for clinical laboratory measurement procedures | |
| WS 628-2018 | 消毒产品卫生安全评价技术要求 | ||
| WS/T 646-2019 | 过碳酸钠消毒剂卫生要求 | ||
| WS/T 648-2019 | 空气消毒机通用卫生要求 | ||
| GA/T 933-2011 | 生物样品中氟乙酸根离子的气相色谱和气相色谱-质谱联用检验方法 | GC and GC-MS examination methods for monofluorocetate anion in biological samples | |
| GA/T 934-2011 | 生物样品中次乌头碱、乌头碱、中乌头碱的液相色谱-串联质谱检验方法 | ||
| SN/T 1823-2006 | 医学媒介生物卫生处理常用药物及处理方法 | Common drugs and methods of sanitary treatment for medical vectors | |
| SN/T 2064-2008 | 国际直达列车突发公共卫生事件处理规程 | Codes for the rapid response to the public health emergency occurred in international trains | |
| SN/T 2069-2008 | 国际旅行卫生保健中心 质量管理标准及评价 | Quanlity management criterion and evaluation of international travel healthcare centre | |
| SN/T 4387-2015 | 进出口一次性使用卫生用品检验规程 | Rules for inspection of disposable sanitary products for import and export | |
| DB11/ 116-1999 | 送餐企业卫生规范 | ||
| DB65/T 2176-2004 | 高原地区医疗机构消毒灭菌工作规程 | Rules of Disinfecting Sterilization in Medical Institute on Plateau | |
| DB65/T 2203-2005 | 海拔2000m以上地区压力蒸汽灭菌效果评价方法与标准 | Methods and Standards to Evaluting the Efficacy of High.pressure Steam Sterilization at Altitude Above 2000m | |
| DB13/T 491-2003 | 有害生物防制服务质量要求 | ||
| DB31/ 405-2008 | 公共场所空调通风系统运行卫生要求 | ||
| DB31/ 358-2006 | 驱避剂卫生安全要求 | ||
| DB31/ 354-2005 | 消毒剂生产环境卫生要求 | ||
| DB31/ 486-2010 | 献血屋(点)安全卫生要求 | Requirements for Fixed Collection Sites | |
| DB31/T 794-2014 | 老年护理院分级护理要求 | Requirments of grading nursing in Geriatric Nursing Hospital | |
| DB34/T 1352-2011 | 住宿业卫生服务规范 | Hygienic Service Specification for Lodging Industry | |
| DB44/T 951-2011 | 水产品加工过程臭氧及过氧化氢使用准则 | Guidelines for the use of ozone and hydrogen peroxide in fishery products | |
| CNS 5937-1980 | 灭菌盘（消毒盘） | Sterilizing Trays | |
| CNS 14622-1-2002 | 保健产品之灭菌─生物指示剂─第一部份：通则 | Sterilization of health care products-biological indicators-part 1：General | |
| CNS 14622-2-2002 | 保健产品之灭菌─生物指示剂─第二部分：使用环氧乙烷灭菌的生物指示剂 | Sterilization of health care products-biological indicators-part 2：Biological indicators for ethylene oxide sterilization | |
| CNS 14622-3-2002 | 保健产品之灭菌─生物指示剂─第三部分：用于湿热灭菌的生物指示剂 | Sterilization of health care products-biological indicators-part 3：Biological indicators for moist heat sterilization | |
| CNS 14623-1-2002 | 保健产品之灭菌─化学指示剂─第一部分：一般规定 | Sterilization of health care products-chemical indicators-Part 1：General requirements | |
| CNS 14708-2002 | 医疗器材－环氧乙烷灭菌确效与例行管制 | Medical decice-validation and routine control of ethylene oxide strilization | |
| CNS 14709-2002 | 保健产品之灭菌－辐射灭菌确效与例行管制规定 | Sterilization of health care products-requirements for validation and routine control-radiation sterliization | |
| 国际 | ISO 6579 CORR 1-2004 | 食品和动物饲料的微生物学.沙门氏菌属检测的水平法.技术勘误1 | Microbiology of food and animal feeding stuffs - Horizontal method for the detection of Salmonella spp,; Technical Corrigendum 1 |
| ISO 11140-1:2014 | 保健品消毒. 化学指示物. 通用要求 | Sterilization of health care products — Chemical indicators — Part 1: General requirements | |
| ISO 11140-3-2007 | 卫生保健品的灭菌.化学指示剂.第3部分:布维-狄克(Bowie and Dick-type)蒸汽穿透试验用2级指示剂体系 | Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test | |
| ISO 11140-4-2007 | 卫生保健品的灭菌.化学指示剂.第4部分:蒸汽穿透检测布维-狄(Bowie and Dick)形式试验的2级指示剂 | 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 | |
| ISO 11140-5-2007 | 卫生保健品的灭菌.化学指示剂.第5部分:布维-狄克形式(Bowie and Dick-type)除气试验的2级指示剂 | Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal tests | |
| ISO 11607-1:2019 | 最终灭菌医疗器械的包装. 第1部分：材料、无菌屏障系统和包装系统的要求 | Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems | |
| ISO 13408-1-2008 | 医疗保健产品的无菌加工.第1部分:一般要求 | Aseptic processing of health care products - Part 1: General requirements | |
| ISO 13408-2-2018 | 医疗保健产品的无菌加工.第2部分:除菌过滤 | Aseptic processing of health care products - Part 2: Sterilizing filtration | |
| ISO 13408-3-2006 | 卫生保健产品的无菌工艺.第3部分:冻干法 | Aseptic processing of health care products - Part 3: Lyophilization | |
| ISO 13408-6-2005 | 保健产品的无菌加工.第6部分:隔离器系统 | Aseptic processing of health care products - Part 6: Isolator systems | |
| ISO 18472:2018 | 保健品消毒. 化学指示物. 试验设备 | Sterilization of health care products — Biological and chemical indicators — Test equipment | |
| CIE 155-2003 | 紫外线空气消毒法 | ULTRAVIOLET AIR DISINFECTION (G) | |
| 欧洲 | EN 1499-2013 | 化学消毒剂和防腐剂.消毒洗手液.检验方法和要求(第2阶段/2级) | Chemical Disinfectants and Antiseptics - Hygienic Handwash - Test Method and Requirements (Phase 2/Step 2) |
| EN 1811:2011+A1:2015 | 从插入人体穿孔部分和与皮肤直接和长期接触的物品的所有柱组件中释放镍的参考试验方法 | Reference test method for release of nickel from all post assemblies which are inserted into pierced parts of the human body and articles intended to come into direct and prolonged contact with the skin | |
| 美国 | ANSI/AAMI/ISO 13408-2-2003 | 医疗保健产品的无菌加工.第2部分:过滤 | Aseptic Processing of health care products - Part 2: Filtration |
| ANSI/AAMI/ISO 13408-3-2006 | 卫生保健产品的无菌工艺.第3部分:冻干法 | Aseptic Processing of health care products - Part 3: Lyophilization | |
| ANSI/AAMI/ISO 13408-4-2005 | 保健产品的无菌加工.第4部分:就地清洗技术 | Aseptic Processing of health care products - Part 4: Clean-in-place technologies | |
| ANSI/AAMI/ISO 13408-5-2006 | 保健产品的无菌加工.第5部分:现场消毒 | Aseptic Processing of health care products - Part 5: Sterilization in place | |
| ANSI/AAMI/ISO 13408-6-2005 | 保健产品的无菌加工.第6部分:隔离器系统 | Aseptic Processing of health care products - Part 6: Isolator systems | |
| ANSI/AAMI/ISO 13408-6/A1-2013 | 保健产品的防腐处理.第6部分:隔离器.修改件1 | Aseptic processing of health care products - Part 6: Isolator systems - Amendment 1 | |
| ANSI/AAMI/ISO 13408-7-2012 | 保健产品的无菌加工.第7部分:非典型医疗设备和组合产品用替换加工 | Aseptic processing of health care products - Part 7: Alternative processes for atypical medical devices and combination products | |
| ANSI/AAMI ST79/A 3.1-2012 | 卫生医疗设施蒸汽灭菌法和无菌保证综合指南 | Comprehensive guide to steam sterilization and sterility assurance in health care facilities | |
| ANSI/AAMI ST79/A 3.3-2012 | 卫生医疗设施蒸汽灭菌法和无菌保证综合指南 | Comprehensive guide to steam sterilization and sterility assurance in health care facilities | |
| ANSI/AAMI ST79/A 3.4-2012 | 卫生医疗设施蒸汽灭菌法和无菌保证综合指南 | Comprehensive guide to steam sterilization and sterility assurance in health care facilities | |
| ANSI/AAMI ST79/A 3.6-2012 | 卫生医疗设施蒸汽灭菌法和无菌保证综合指南 | Comprehensive guide to steam sterilization and sterility assurance in health care facilities | |
| ANSI/AAMI ST79/A 3.7-2012 | 卫生医疗设施蒸汽灭菌法和无菌保证综合指南 | Comprehensive guide to steam sterilization and sterility assurance in health care facilities | |
| ANSI/American Society of Sanitary Engineering SERIES 12000-2018 | 所有建筑系统感染控制风险评估专业资格标准 | Professional Qualifications Standard for Infection Control Risk Assessment for All Building Systems | |
| ANSI/ASTM E2553-2007 | 自动通用卫生保健识别系统实施用指南 | Standard Guide for Implementation of a Voluntary Universal Healthcare Identification System | |
| ANSI/MEDBIQ PP.10.1-2008 | 卫生保健专业简介 | Healthcare Professional Profile | |
| ANSI/NSF 49(i14)-2008 | II级(层流)生物安全室 | Class II (laminar flow) biosafety cabinetry | |
| ANSI/NSF 49(i15r2)-2008 | 生物安全柜:设计,制作,性能和行业认证 | Biosafety Cabinetry: Design, Construction, Performance, and Field Certification | |
| ANSI/NSF 49(i27)-2011 | 生物安全柜:设计,制作,性能和行业认证 | Biosafety Cabinetry: Design, Construction, Performance and Field Certification | |
| ANSI/NSF 49(i42)-2011 | 生物安全柜:设计,制作,性能和行业认证 | Biosafety Cabinetry: Design, Construction, Performance and Field Certification | |
| ANSI/NSF 49(i43)-2011 | 生物安全厨柜:设计,建造,性能和实地认证 | Biosafety Cabinetry: Design, Construction, Performance and Field Certification | |
| ASHRAE QC-06-066-2006 | 在飞机舱实体模拟的空降疾病传播的示踪研究 | Tracer Study of Airborne Disease Transmission in an Aircraft Canin Mock-Up | |
| CFR 42-70.1-2017 | 公共卫生.第70部分：州际隔离.第70.1节：一般定义. | Public health. Part 70: Interstate quarantine. Section 70.1: General definitions. | |
| CFR 42-70.5-2017 | 公共卫生.第70部分：州际隔离.第70.5节：与联邦隔离、隔离或有条件释放令下的旅行者有关的要求. | Public health. Part 70: Interstate quarantine. Section 70.5: Requirements relating to travelers under a Federal order of isolation, quarantine, or conditional release. | |
| CFR 42-70.6-2017 | 公共卫生.第70部分：州际隔离.第70.6节：逮捕和拘留患有可隔离传染病的人. | Public health. Part 70: Interstate quarantine. Section 70.6: Apprehension and detention of persons with quarantinable communicable diseases. | |
| CFR 42-70.10-2017 | 公共卫生.第70部分：州际隔离.第70.10节：公共卫生预防措施，以发现传染病. | Public health. Part 70: Interstate quarantine. Section 70.10: Public health prevention measures to detect communicable disease. | |
| CFR 42-70.11-2017 | 公共卫生.第70部分：州际隔离.第70.11节：航空公司经营的飞机上死亡或生病的报告. | Public health. Part 70: Interstate quarantine. Section 70.11: Report of death or illness onboard aircraft operated by an airline. | |
| CFR 42-70.12-2017 | 公共卫生.第70部分：州际隔离.第70.12节：体检. | Public health. Part 70: Interstate quarantine. Section 70.12: Medical examinations. | |
| CFR 42-70.13-2017 | 公共卫生.第70部分：州际隔离.第70.13节：支付护理和治疗费用. | Public health. Part 70: Interstate quarantine. Section 70.13: Payment for care and treatment. | |
| CFR 42-70.14-2017 | 公共卫生.第70部分：州际隔离.第70.14节：有关发出联邦检疫、隔离或有条件释放令的要求. | Public health. Part 70: Interstate quarantine. Section 70.14: Requirements relating to the issuance of a Federal order for quarantine, isolation, or conditional release. | |
| CFR 42-70.15-2017 | 公共卫生.第70部分：州际隔离.第70.15节：强制重新评估用于隔离、隔离或条件释放的联邦订单. | Public health. Part 70: Interstate quarantine. Section 70.15: Mandatory reassessment of a Federal order for quarantine, isolation, or conditional release. | |
| CFR 42-70.16-2017 | 公共卫生.第70部分：州际隔离.第70.16节：对联邦隔离令、隔离令或有条件释放令的医学审查. | Public health. Part 70: Interstate quarantine. Section 70.16: Medical review of a Federal order for quarantine, isolation, or conditional release. | |
| CFR 42-70.17-2017 | 公共卫生.第70部分：州际隔离.第70.17节：与联邦检疫、隔离或有条件释放有关的行政记录. | Public health. Part 70: Interstate quarantine. Section 70.17: Administrative records relating to Federal quarantine, isolation, or conditional release. | |
| CFR 42-405.373-2017 | 公共卫生.第405部分：老年人和残疾人联邦医疗保险.第C子部分：暂停付款，追回多付款项，偿还奖学金和贷款.第405.37节：程序用于抵销或收回的定金. | Public health. Part405: Federal health insurance for the aged and disabled. Subpart C: Suspension of payment, recovery of overpayments, and repayment of scholarships and loans. Section405.373 : Proceeding for offset or recoupment. | |
| CFR 42-405.2413-2017 | 公共卫生.第405部分：老年人和残疾人联邦医疗保险.第X子部分：农村卫生诊所和联邦合格医疗中心服务.第405.2413节：与医生服务有关的服务和用品. | Public health. Part405: Federal health insurance for the aged and disabled. Subpart X: Rural health clinic and federally qualified health center services. Section405.2413 : Services and supplies incident to a physician's services. | |
| CFR 42-405.2415-2017 | 公共卫生.第405部分：老年人和残疾人联邦医疗保险.第X子部分：农村卫生诊所和联邦合格医疗中心服务.第405.2415节：服务事故和直接监督. | Public health. Part405: Federal health insurance for the aged and disabled. Subpart X: Rural health clinic and federally qualified health center services. Section405.2415 : Incident to services and direct supervision. | |
| CFR 42-410.26-2017 | 公共卫生.第410部分：补充医疗保险福利.第 B子部分：医疗和其他卫生服务.第410.26节：向医生提供的服务和用品事件：条件. | Public health. Part 410: Supplementary medical insurance (smi) benefits . Subpart B: Medical and other health services. Section 410.26 : Services and supplies incident to a physician's professional services: Conditions. | |
| CFR 42-410.79-2017 | 公共卫生.第410部分：补充医疗保险福利.第 B子部分：医疗和其他卫生服务.第410.79节：医疗保健糖尿病预防方案扩大模式：覆盖条件. | Public health. Part 410: Supplementary medical insurance (smi) benefits . Subpart B: Medical and other health services. Section 410.79 : Medicare Diabetes Prevention Program expanded model: Conditions of coverage. | |
| CFR 42-411.357-2017 | 公共卫生.第411部分：医疗保险除外和医疗保险支付的限制.第 J子部分：提供指定保健服务的医生和实体之间的财务关系.第411.357 节：与赔偿安排有关的禁止转介的例外情况. | Public health. Part 411: Exclusions from medicare and limitations on medicare payment. Subpart J: Financial relationships between physicians and entities furnishing designated health services. Section 411.357: Exceptions to the referral prohibition related to compensation arrangements. | |
| CFR 42-411.372-2017 | 公共卫生.第411部分：医疗保险除外和医疗保险支付的限制.第 J子部分：提供指定保健服务的医生和实体之间的财务关系.第411.372 节：提交请求的程序. | Public health. Part 411: Exclusions from medicare and limitations on medicare payment. Subpart J: Financial relationships between physicians and entities furnishing designated health services. Section 411.372: Procedure for submitting a request. | |
| CFR 42-414.22-2017 | 公共卫生.第414部分：支付b部分医疗和其他卫生服务费用.第B子部分：医生和其他从业人员.第411.372 节：相对价值单位(RVU). | Public health. Part 414: Payment for part b medical and other health services. Subpart B: Physicians and other practitioners. Section 414.22: Relative value units (RVUs). | |
| CFR 42-414.90-2017 | 公共卫生.第414部分：支付b部分医疗和其他卫生服务费用.第B子部分：医生和其他从业人员.第414.90节：医师质量报告制度. | Public health. Part 414: Payment for part b medical and other health services. Subpart B: Physicians and other practitioners. Section 414.90: Physician Quality Reporting System (PQRS). | |
| CFR 42-414.94-2017 | 公共卫生.第414部分：支付b部分医疗和其他卫生服务费用.第B子部分：医生和其他从业人员.第414.94节：先进诊断成像服务的适当使用标准. | Public health. Part 414: Payment for part b medical and other health services. Subpart B: Physicians and other practitioners. Section 414.94: Appropriate use criteria for advanced diagnostic imaging services. | |
| ANSI/AAMI/ISO 13408-6-2005 | 保健产品的无菌加工.第6部分:隔离器系统 | Aseptic Processing of health care products - Part 6: Isolator systems | |
| ANSI/AAMI/ISO 13408-7-2012 | 保健产品的无菌加工.第7部分:非典型医疗设备和组合产品用替换加工 | Aseptic processing of health care products - Part 7: Alternative processes for atypical medical devices and combination products | |
| ASTM E1327-2007 | 利用手指甲区域评估抗菌洗手液配方的标准试验方法 | Standard Test Method for Evaluation of Antimicrobial Handwash Formulations by Utilizing Fingernail Regions | |
| ASTM E1714-2000 | 通用保健识别符(UHTD)特性的标准指南 | Standard Guide for Properties of a Universal Healthcare Identifier (UHID) | |
| ASTM E1891-2010a | 测定抗菌剂抗选定微生物的生存曲线和计算D值及浓度系数的标准指南 | Standard Guide for Determination of a Survival Curve for Antimicrobial Agents Against Selected Microorganisms and Calculation of a D-Value and Concentration Coefficient | |
| ASTM E2042-1999 | 可控区域和清洁室的清洁和维修的标准实施规程 | Standard Practice for Cleaning and Maintaining Controlled Areas and Clean Rooms | |
| ASTM E2720-2010 | 当表层沾有人体病原性病毒时用于评估透气材料净化程序效能的标准试验方法 | Standard Test Method for Evaluation of Effectiveness of Decontamination Procedures for Air-Permeable Materials when Challenged with Biological Aerosols Containing Human Pathogenic Viruses | |
| ASTM E2721-2010 | 评定遭到含有人类致病性病毒的飞沫攻击时表面净化程序效能的标准试验方法 | Standard Test Method for Evaluation of Effectiveness of Decontamination Procedures for Surfaces When Challenged with Droplets Containing Human Pathogenic Viruses | |
| ASTM E2799-2011 | 用 MBEC 化验测试消毒剂对绿脓杆菌(Pseudomonas aeruginosa)生物膜功效的标准试验方法 | Standard Test Method for Testing Disinfectant Efficacy against Pseudomonas aeruginosa Biofilm using the MBEC Assay | |
| ASTM E3058-2016 | 手消毒剂杀伤活性测定方法 | Standard Test Method for Determining the Residual Kill Activity of Hand Antiseptic Formulations | |
| ASTM F1114-2006 | 商业用的热消毒筒,槽和架式水驱动旋转喷射器皿站 | Standard Specification for Heat Sanitizing Commercial Pot, Pan, and Utensil Station Rack Type Water-Driven Rotary Spray | |
| 英国 | BS 3970-1-1990 | 医疗制品用灭菌消毒设备.第1部分:一般要求规范 | Sterilizing and disinfecting equipment for medical products. Specification for general requirements |
| BS 3970-2-1991 | 医疗制品用灭菌消毒设备.第2部分:装含水液体的密封硬质容器用蒸汽消毒器规范 | Sterilizing and disinfecting equipment for medical products. Specification for steam sterilizers for aqueous fluids in sealed rigid containers | |
| BS 6256-1989 | 医用蒸汽消毒纸袋、纸盒和纸筒用纸规范 | Specification for paper for steam sterilization paper bags, pouches and reels for medical use | |
| BS CWA 15793-2011 | 实验室生物危害管理 | Laboratory biorisk management | |
| BS CWA 16833-2014 | 整体管理棕色地带更新的术语表 (GoT-HOMBRE) | Glossary of Terms for Holistic Management of Brownfield Regeneration (GoT-HOMBRE) | |
| BS DD CEN ISO/TS 17665-2-2009 | 保健产品的消毒.潮热.ISO 17665-1应用指南 | Sterilization of health care products - Moist heat - Guidance on the application of ISO 17665-1 | |
| BS EN 13549-2001 | 清洁服务.质量度量系统的基本要求和推荐方法 | Cleaning services - Basic requirements and recommendations for quality measuring systems | |
| BS EN ISO 11137-3-2007 | 卫生保健产品的灭菌.辐射.剂量测定方面的指南 | Sterilization of health care products - Radiation - Guidance on dosimetric aspects | |
| BS EN ISO 11140-3-2009 | 保健品灭菌.化学指示剂.蒸汽渗透布维-狄(Bowie和Dick)型试验2级指示剂系统 | Sterilization of health care products - Chemical indicators - Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test | |
| BS EN ISO 15882-2008 | 保健产品的消毒.化学指示剂.选择、使用和结果说明用指南 | Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results | |
| BS ISO 11140-5-2007 | 卫生保健品灭菌.化学指示剂.布维-狄(Bowie和Dick)型除气试验用2级指示剂 | Sterilization of health care products - Chemical indicators - Class 2 indicators for Bowie and Dick-type air removal tests | |
| BS ISO 21527-1-2008 | 食品和动物饲料的微生物学.酵母和霉菌的计数用水平方法.水活性大于0.95的产品用菌落计数技术 | Microbiology of food and animal feeding stuffs - Horizontal method for the enumeration of yeasts and moulds - Colony count technique in products with water activity greater than 0,95 | |
| BS PAS 5748-2014 | 医院清洁服务的规划, 应用, 测量以及审查规格 | Specification for the planning, application, measurement and review of cleanliness services in hospitals | |
| 德国 | DIN 58949-2-2014 | 消毒。蒸汽消毒仪 第二部分：要求 德语和英语文本 | Disinfection. Steam disinfection apparatus. Part2: Requirements; Text in German and English |
| DIN 58949-3-2012 | 消毒 蒸汽消毒装置 第三部分：效率测试 | Disinfection. Steam disinfection apparatus. Part3: Efficiency testing | |
| DIN 58949-4-2014 | 消毒。蒸汽消毒仪 第4部分：功效测试的生物指标 | Disinfection. Steam disinfection-apparatus. Part4: Biological indicators for efficacy tests | |
| DIN 58949-6-2015 | 消毒。蒸汽消毒仪 第六部分：蒸汽消毒设备的运行，其安装要求及其供应来源 | Disinfection. Steam disinfection apparatus. Part6: Operation of steam disinfection apparatus, their requirements for the installation and their supply sources | |
| DIN EN 285-2016 | 灭菌。蒸汽灭菌器。大型消毒器 | Sterilization. Steam sterilizers. Large sterilizers; German version EN285:2015 | |
| DIN V ENV 12612-1997 | 医疗信息技术.卫生行业行政管理信息交换报文 | Medical informatics - Messages for the exchange of healthcare administrative information; English version ENV 12612:1997 | |
| 法国 | NF S98-101-2-2008 | 卫生保健品的消毒.环氧乙烷.第2部分:ISO 11135-1应用指南 | Sterilization of health care products - Ethylene oxide - Part 2 : guidance on the application of ISO 11135-1. |
| NF V08-040-1-2008 | 食品和动物饲料的微生物学.酵母和霉菌的计数的水平方法.第1部分:水活性大于0.95的产品用菌落计数技术 | Microbiology of food and animal feeding stuffs - Horizontal method for the enumeration of yeasts and moulds - Part 1 : colony count technique in products with water activity greater than 0,95. | |
| 日本 | JIS K3801-2000 | 微生物用HEPA过滤器的试验方法 | Test method of HEPA filters for microbiological use |
| JIS T7328-2005 | 医用甲醛气消毒器 | Formaldehyde gas disinfecters for medical use | |
| 韩国 | KS P 6115-2006 | 医用氧化乙烯气体消毒器 | Ethylene oxide gas sterilizers for medical use |
| KS P 6116-2006 | 医用氧化乙烯气体消毒器(小型) | Ethylene oxide gas sterilizers for medical use(Small size) | |
| 其他国家 | CAN/CSA-ISO 13958-2011 | 主要用于血液分析和相关治疗(第一版) | Concentrés pour hémodialyse et thérapies apparentées (Première édition) |
| CAN/CSA-Z22870-2007 | 重点护理即时检验(POCT). 质量和能力的要求(第一版) | Point-of-care testing (POCT) - Requirements for quality and competence (First Edition) | |
| CSA EXP06-2015 | 评价预防感染和控制感染的新材料和技术(第一版) | Evaluating emerging materials and technologies for infection prevention and control (First Edition) | |
| GOST 10385-2014 | 鱼类综合饲养人员. 通用规格 | Combined feeding staffs for fishes. General specifications | |
| GOST 32375-2013 | 人类危险化学品检测. 皮肤过敏 | Testing of chemicals of human hazard. Skin sensitisation | |
| GOST R 56677-2015 | 人身防范工程手段. 编码, 标识和标记. 通用要求 | Means of physical protection engineering. Coding, identification and marking. General requirements | |
| AS/NZS 3896-2008 | 水.包括嗜肺军团菌的在内的军团菌的检查 | Waters—Examination for Legionella | |
| spp. including Legionella pneumophila | |||
| SNZ PAS 8170-2005 | 初级卫生保健实践管理系统 | PRIMARY HEALTHCARE PRACTICE MANAGEMENT SYSTEMS | |
| SANS 1780-2018 | 一般用途过氧化氢和过氧乙酸产品的杀菌效果 | Bactericidal efficacy of peroxide and peracetic acid based products for general use. | |
| UL 2783 BULLETIN-2015 | UL安全标准 即时性手消毒产品的可持续性 | Ul Standard For Safety Sustainability Of Instant Hand Antiseptic Products (Comments Due: March 16, 2015) |
信息来源：国家标准馆