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)

国别

标准号

中文题名

英文题名

中国

GB 7543-2006

一次性使用灭菌橡胶外科手套

Single-use sterile rubber surgical gloves

GB 10213-2006

一次性使用医用橡胶检查手套

Single-use medical rubber examination gloves

GB/T 21869-2008

医用手套表面残余粉末的测定

Medical gloves.Determination of removable surface powder

GB/T 21870-2008

天然胶乳医用手套水抽提蛋白质的测定. 改进Lowry法

Medical gloves made from natural rubber latex.Determination of water-extractable protein using the modified lowry method 

GB 24786-2009

一次性使用聚氯乙烯医用检查手套

Single-use medical poly (vinyl chloride) examination gloves

GB 24788-2009

医用手套表面残余粉末、水抽提蛋白质限量

Limit for the removable surface powder and water-extractable protein of medical gloves

YY/T 0616.1-2016

一次性使用医用手套.第1部分: 生物学评价要求与试验

Medical gloves for single use.Part 1:Requirements and testing for biological evaluation

YY/T 0616.2-2016

一次性使用医用手套 第2部分: 测定货架寿命的要求和试验

Medical glove for single use.Part 2:Requirements and testing for shelf life determination

YY/T 0616.3-2018

 一次性使用医用手套 第3部分: 用仓贮中的成品手套确定实际时间失效日期的方法

Medical gloves for single use.Part 3:Determination of real time expiration dating of mature medical gloves stored under typical warehouse conditions

YY/T 0616.4-2018

一次性使用医用手套 第4部分: 抗穿刺试验方法

Medical glove for single use.Part 4:Test method for the puncturation resistance

YY/T 0616.5-2019

一次性使用医用手套 第5部分: 抗化学品渗透 持续接触试验方法

Medical gloves for single use Part 5: Test Method for Permeation of Chemicals under Conditions of Continuous Contact

CNS 12543-1997

外科手術用橡膠手套

Surgical rubber gloves

CNS 12837-1991

一般医疗用聚氯乙烯手套

Polyvinyl Chloride Medical Gloves

CNS 12838-1991

一般医疗用聚氯乙烯手套检验法

Method of Test for Polyvinyl Chloride Medical Gloves

国际

ISO 11193-1-2008

一次性医用检验手套. 第1部分: 橡胶乳胶或胶液制手套规范

Single-use medical examination gloves - Part 1: Specification for gloves made from rubber latex or rubber solution

ISO 11193-1 AMD 1-2012

一次性医用检验手套. 第1部分: 橡胶乳胶或胶液制手套规格.修改件1

Single-use medical examination gloves - Part 1: Specification for gloves made from rubber latex or rubber solution; Amendment 1

ISO 11193-2-2006

一次性医用检查手套

第2部分: 聚乙烯(氯乙烯)制手套规范

Single-use medical examination gloves - Part 2: Specification for gloves made from poly(vinyl chloride)

ISO 12243-2003

医用天然胶乳手套 

用改性格雷法测量可水萃取的蛋白质

Medical gloves made from natural rubber latex determination of water-extractable protein using the modified lowry method first edition

ISO 21171-2006

医疗专用手套.可移动表面粉末的测定

Medical gloves - Determination of removable surface powder

欧洲　

EN 455-1-2000

一次性医用手套

第1部分: 无孔试验和要求

Medical gloves for single use. Part 1: Requirements and testing for freedom from holes

EN 455-2-2015

一次性医用手套

第2部分: 物理性能要求和试验

Medical gloves for single use - Part 2: Requirements and testing for physical properties

EN 455-3-2015

一次性医用手套

第3部分:生物评定要求和试验

Medical gloves for single use. Part 3:Requirements and testing for biological evaluation

EN 455-4-2009

一次性医用手套

第4部分: 保质期测定要求和检验

Medical gloves for single use - Part 4: Requirements and testing for shelf life determination

CEN/TR 16953-2017

一次性医用手套. 选择指南

Medical gloves for single use - Guidance for selection

EN ISO 21171-2006

医疗专用手套.可移动表面粉末的测定 ISO 21171-2006

Medical gloves Determination of removable surface powder

美国

ASTM D3578-2019

橡胶检验手套标准规范

Standard Specification for Rubber Examination Gloves

ASTM D5151-2006(2015)

检测医用手套漏孔的标准试验方法

Standard Test Method for Detection of Holes in Medical Gloves

ASTM D5250-2019

医用聚氯乙烯手套的标准规范

Standard Specification for Poly(vinyl chloride) Gloves for Medical Application

ASTM D6124-2006(2017)

医用手套残余粉末的标准试验方法

Standard Test Method for Residual Powder on Medical Gloves

ASTM D6319-2000a(2005)

医用腈橡胶检验手套的标准规范

Standard Specification for Nitrile Examination Gloves for Medical Application 

ASTM D6319-2010

医用腈类检验手套的标准规范

Standard   Specification for Nitrile Examination Gloves for Medical Application

ASTM D6319-2019

医用腈检验手套规格

Standard Specification for Nitrile Examination Gloves for Medical Application

ASTM D6355-1998(2003)

医用手套人重复损害修补试验的标准试验方法

Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves

ASTM D6977-2019

医疗检查用氯丁橡胶手套的标准规格

Standard Specification for Polychloroprene Examination Gloves for Medical Application

ASTM D6978-2005(2019)

医用手套对化疗药物渗透阻力的评价的标准操作规程

Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs

ASTM D7102-2010

测定无菌医用手套上的内毒素的标准指南

Standard   Guide for Determination of Endotoxin on Sterile Medical Gloves

ASTM D7103-2018

医用手套评定的标准指南

Standard Guide for Assessment of Medical Gloves

ASTM D7160-2016

医用手套有效期测定的标准实施规程

 Standard Practice for Determination of Expiration Dating for Medical Gloves

ASTM D7161-2016

测定典型仓库条件下存放的成熟医用手套实时有效期的标准实施规程

Standard Practice for Determination of Real Time Expiration Dating of Mature Medical ;Gloves Stored Under Typical Warehouse Conditions

ASTM D7907-2014

测定医用检查手套表面杀菌作用的标准试验方法

Standard Test Methods for Determination of Bactericidal Efficacy on the Surface of Medical Examination Gloves

ANSI/ADA 102-1998

牙医用无菌丁二烯手套

Non-Sterile Nitrile Gloves for Dentistry

ANSI/ADA 103-2001

牙医用无菌增塑聚氯乙烯手套

 Non-Sterile ;Polyvinyl Chloride Gloves for Dentistry

英国

BS EN 455-1-2000

一次性医用手套 无孔要求和测试

Medical gloves for single use. Requirements and testing for freedom from holes

BS EN 455-2-2015

一次性医用手套.物理性质的要求和测定

Medical gloves for single use. Requirements and testing for physical properties

BS EN 455-3-2015

一次性医用手套

第3部分:生物评定要求和试验

Medical gloves for single use. Requirements and testing for biological evaluation

BS EN 455-4-2009

一次性医用手套

第4部分: 测定货架寿命的试验和要求

Medical gloves for single use Part 4: Requirements and testing for shelf life determination

BS EN ISO 21171-2006

医疗专用手套.可移动表面粉末的测定

Medical gloves - Determination of removable surface powder 

BS ISO 12243-2003+A1-2012

医用天然胶乳手套   

用改良的半细胞法测定水可萃取蛋白质

Medical gloves made from natural rubber latex. Determination of water-extractable protein using the modified Lowry method

BS PD CEN/TR 16953-2017

一次性医用手套. 选择指南

Medical gloves for single use. Guidance for selection 

德国

DIN 58133-2008

医疗压缩袜

Medical compression hosiery

DIN EN 455-1-2001

一次性医用手套

第1部分:密封性要求和检验

Medical gloves for single use - Part 1: Requirements and testing for freedom from holes; German version EN 455-1:2000

DIN EN 455-2-2015

一次性医用手套

第2部分:物理特性用要求和试验.德文版本EN 455-2-2015

Medical gloves for single use - Part 2: Requirements and testing for physical properties; German version EN 455-2:2015

DIN EN 455-3-2015

一次性医用手套

第3部分:生物评定要求和试验;德文版本EN 455-3-2015

Medical gloves for single use - Part 3: Requirements and testing for biological evaluation; German version EN 455-3:2015

DIN EN 455-4-2009

医用手套一次性使用

第4部分：保质期确定的要求和测试;

Medical gloves for single use. Part4: Requirements and testing for shelf life determination; German version EN455-4:2009

DIN EN ISO 21171-2006

医疗专用手套. 可移动表面粉末的测定 (ISO 21171-2006)

Medical gloves - Determination of removable surface powder (ISO 21171:2006) English version of DIN EN ISO 21171:2006-08

法国

NF S97-004-2006

医疗专用手套. 可移动表面粉末的测定

Medical gloves - Determination of removable surface powder. 

泰国

TIS 1056.1-2013

一次性医用检查手套

第1部分: 橡胶乳胶或橡胶溶液制手套规范

 Single-use medical examination gloves part 1: specification for gloves made from rubber latex or rubber solution

TIS 1056-2005

一次性医用检查手套

第1部分: 橡胶乳胶或橡胶溶液制手套规范

Single.use medical examination gloves.part 1: specification for gloves made from rubber latex or rubber solution

越南

TCVN 6343-1-2007

一次性医用检查手套

第1部分: 橡胶胶乳或胶液制手套规范

Single-use medical examination gloves.Part 1: Specification for gloves made from rubber latex or rubber solution

TCVN 6343-2-2007

一次性医用检查手套

第2部分: 聚乙烯(氯乙烯)制手套规范

 Single-use medical examination gloves.Part 2: Specification for gloves made from poly (vinyl chloride)

其他国家

GOST EN 455-1-2014

一次性医用手套

第1部分. 紧密性的测定方法

Medical gloves for single use. Part 1. Method for determination of tightness

GOST EN 455-2-2014

一次性医用手套

第2部分. 物理特性的测定方法

Medical gloves for single use. Part 2. Method for determination of physical-mechanical properties

GOST R 52239-2004

一次性医疗检查手套

第1部分: 橡胶乳胶或橡胶胶浆制手套规范

Single-use medical examination gloves. Part 1. Specification for gloves made from rubber latex or rubber solution

GOST R 57397-2017

医疗检查用橡胶手套. 技术要求

Rubber examination medical gloves. Technical requirements

GOST R 57402-2017

医用手套. 使用期限的测定

Medical gloves. Determination of expiration dating

GOST R 57403-2017

医用聚氯乙稀手套. 技术要求

Poly(vinyl chloride) medical gloves. Technical requirements 

GOST R 57404-2017

医用手套. 质量评估指南

Medical gloves. Quality assessment guide

SANS 11193-1-2010

一次性使用医用检查手套

第1部分：橡胶胶乳或橡胶溶液制成的手套规范

Single-Use Medical Examination Gloves Part 1: Specification For Gloves Made From Rubber Latex Or Rubber Solution

SANS 15190-2016

医用手套 安全要求

Medical laboratories - Requirements for safety

LST EN 455-1-2001

一次性医用手套

第1部分:孔自由度试验和要求

Medical gloves for single use - Part 1: Requirements and testing for freedom from holes

LST EN 455-2-2015

一次性医用手套

第2部分: 物理特性的要求和检验

Medical gloves for single use - Part 2: Requirements and testing for physical properties

LST EN 455-3-2015

一次性医用手套

第3部分: 生物评价的要求和试验

Medical gloves for single use - Part 3: Requirements and testing for biological evaluation

LST EN ISO 21171-2006

医用手套表面残余粉末的测定(ISO 21171-2006)

Medical gloves - Determination of removable surface powder (ISO 21171:2006)

SNI ISO 11193.1-2010

一次性医用检验手套

第1部分:用橡胶乳和胶液制成的手套规范

Single-use medical examination gloves - Part 1: Specification for gloves made from rubber latex or rubber solution

SNI ISO 11193.2-2010

一次性医用检查手套

第2部分: 聚氯乙烯制成的手套规格

Single-use medical examination gloves - Part 2: Specification for gloves made from poly(vinyl chloride)

STN EN 455-1-2002

一次性医用手套

第1部分: 指孔间自由度的要求和试验

Medical gloves for single use. Part 1: Requirements and testing for freedom from holes

STN EN 455-2-2015

一次性医用手套

第2部分: 物理特性的要求和检验

Medical gloves for single use - Part 2: Requirements and testing for physical properties

STN EN 455-4-2009

一次性医用手套

第4部分: 测定货架寿命的要求和试验

Medical gloves for single use - Part 4: Requirements and testing for shelf life determination

ABNT NBR ISO 11193-1-2009/Amd 1-2015 

一次性医用检验手套

第1部分：用胶乳或胶水制成的手套规范

ABNT NBR ISO 11193-1-2015

一次性医用检验手套

Single-use medical examination gloves

ABNT NBR ISO 11193-2-2013

一次性使用的医疗检查手套

第2部分：由聚氯乙烯制成的手套

Single-use medical examination gloves Part 2: Specification for gloves made from poly (vinyl chloride)

DS/EN 455-3-2007

一次性使用医用手套

第3部分:生物学评价要求和测试

Medical gloves for single use - Part 3: Requirements and testing for biological evaluation

DS/EN ISO 21171-2006

医用手套可移动表面粉末的测定

 Medical gloves - Determination of removable surface powder

国别

标准号

中文题名

英文题名

中国

GB 19082-2009

医用一次性防护服技术要求

Technical requirements for single-use protective clothing for medical use

GB/T 20097-2006

防护服一般要求

 Protective clothing - General requirements

YY 0318-2000

医用诊断X射线辐射防护器具.第3部分:防护服和性腺防护器具

Protective device against diagnostic medical X-radiation.Part 3:Protective clothing and protective devices for gonads

YY/T 0506.1-2005

病人、医护人员和器械用手术单、手术衣和洁净服   

第1部分:制衣厂、处理厂和产品的通用要求

Surgical ;drapes,gowns and clean air suits for patients,clinical staff and equipment. Part 1:General requirements for manufacturers,processors and products

YY/T 0506.2-2016

病人、医护人员和器械用手术单、手术衣和洁净服   

第2部分：性能要求和试验方法

Surgical drapes,gowns and clean air suits for patients,clinical staff and equipment. Part 2: Performance requirements and test methods

YY/T 0506.4-2016

病人、医护人员和器械用手术单、手术衣和洁净服   

第4部分：干态落絮试验方法

Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment. Part 4: Test method for linting in the dry state

YY/T 0506.5-2009

病人、医护人员和器械用手术单、手术衣和洁净服   

第5部分:阻干态微生物穿透试验方法

Surgical drapes,gowns and clean air suits for patients,clinical staff and equipment. Part 5:Test method for resistance to dry microbial penetration

YY/T 0506.6-2009

病人、医护人员和器械用手术单、手术衣和洁净服   

第6部分:阻湿态微生物穿透试验方法

Surigical drapes,gowns and clean air suits,used as medical devices,for patients,clinical staff and equipment. Part 6:Test method to determine the resistance to wet bacterial penetration

YY/T 0506.7-2014

病人、医护人员和器械用手术单、手术衣和洁净服   

第7部分:洁净度-微生物试验方法

Surgical drapes,gowns and clean air suits for patients,clinical staff and equipment. Part 7:Test methods for determination of cleanliness-mircrobial

YY/T 0506.8-2019

病人、医护人员和器械用手术单、手术衣和洁净服   

第8部分：产品专用要求

Surgical drapes,gowns and clean air suits for patients,clinical staff and equipment. Part 8-Special requirements for products

YY/T 0689-2008

血液和体液防护装备.防护服材料抗血液传播病原体穿透性能测试.Phi-X174噬菌体试验方法   

Clothing for protection against contact with blood and body fluids.Determination of resistance of protective clothing materials to penetration by blood-borne pathogens.Test method using Phi-X174 bacteriophage

YY/T 0699-2008

液态化学品防护装备.防护服材料抗加压液体穿透性能测试方法

Clothing for protection against liquid chemicals.Determination of the resistance of protective clothing materials to penetration by liquids under pressure

YY/T 0700-2008

血液和体液防护装备.防护服材料抗血液和体液穿透性能测试.合成血试验方法

Clothing for protection against contact with blood and body fluids.Determination of the resistance of protective clothing materials to penetration by blood and body fluids.Test method using synthetic blood

YY/T 1425-2016

血液和体液防护装备.防护服材料抗血液和体液穿透性能测试.合成血试验方法

Clothing for protection against contact with blood and body fluids.Determination of the resistance of protective clothing materials to penetration by blood and   body fluids.Test method using synthetic blood

YY/T 1498-2016

医用防护服的选用评估指南

Guideline for evaluation of selection and use of medical protective clothing

YY/T 1499-2016

医用防护服的液体阻隔性能和分级

Liquid barrier performance and classification of protective apparel intended for use in health care facilities

YY/T 1632-2018

医用防护服材料的阻水性:冲击穿透测试方法

Water resistance of textiles for medical protective apparel.Impact penetration test

国际

ISO 16603-2004

防止接触血液和体液的防护服.防护服材料防止血液和体液渗透性的测定.使用人造血液的试验方法

Clothing for protection against contact with blood and body fluids - Determination of the resistance of protective clothing materials to penetration by blood and body fluids - Test method using synthetic blood

ISO 16604-2004

防止接触血液和体液的防护服.防护服材料防止血液病原渗透性的测定.使用Phi-X 174噬菌体的试验方法

Clothing for protection against contact with blood and body fluids - Determination of resistance of protective clothing materials to penetration by blood-borne pathogens - Test method using Phi-X 174 bacteriophage

ISO 22609-2004

传染试剂防护服.医疗面罩.防人造血渗透的试验方法(固定容积,水平喷射)

Clothing for protection against infectious agents - Medical face masks - Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected)

ISO 22612-2005

防传感病病原体的防护服   

防干微生物侵入能力的试验方法

Clothing for protection against infectious agents test method for resistance to dry microbial penetration first edition

欧洲

EN 14126-2003

防护服.防传病毒防护服的性能要求和试验方法.合并勘误表2004年9月

Protective clothing - Performance requirements and tests methods for protective clothing against infective agents (Incorporating corrigendum September 2004) 

EN 14126-2003+AC-2004

防护服 抗感染防护服的性能要求和试验方法

 Protective clothing. Performance requirements and tests methods for protective clothing against infective agents

EN ISO 22612-2005

防传感病病原体的防护服   

防干微生物侵入能力的试验方法

Clothing for protection against infectious agents. Test method for resistance to dry microbial penetration ISO 22612:2005

EN 61331-3-2014

医用诊断x射线辐射防护器具.第3部分: 防护服, 护目镜和患者防护罩

Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing@ eyewear and protective patient shields

美国

AAMI PB70-2012

FDA认可的用于卫生保健设施的防护服和防护单的液体阻隔性能及分类

Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities FDA RECOGNIZED

ANSI/PB70-2012

旨在用于医疗保健设施的防护服和防护层的液体屏障性能和分类（FDA认可）

Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (FDA RECOGNIZED)

ANSI/AAMI PB70-2012

医疗保健设施中使用的防护服和防护布的液体阻挡层性能和分类

Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities

ANSI/NFPA 1999-2008

急救医疗手术用防护服的标准

 Standard on Protective Clothing for Emergency Medical Operations

ASTM F903-2018

防护服用材料耐液体渗透性的试验方法

Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Liquids

ASTM F1670/F1670M-2017a

防护服材料对合成血液渗透的阻力的标准试验方法

Standard ;Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood

ASTM F1671/F1671M-2013

使用Phi-X174噬菌体渗透作为试验系统的血源性病原体对防护服使用的抗渗透材料用标准试验方法

Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System

ASTM F2878-2019

防护服材料耐皮下注射针头剌破性试验方法

Standard Test Method for Protective Clothing Material Resistance to Hypodermic Needle Puncture 

ASTM F3050-2017

个人防护服及设备合格评定指南

Standard Guide for Conformity Assessment of Personal Protective Clothing and Equipment

NFPA 1999-2018

紧急医疗服务用防护服和服装标准

Standard on Protective Clothing and Ensembles for Emergency Medical Operations   (Effective Date: 8/21/2017)

英国

BS EN 14325-2018

化学药品防护服 化学防护服装材料、缝合线、联结和组合的试验方法和性能分类 

Protective clothing against chemicals. Test methods and performance classification of chemical protective clothing materials,seams,joins and assemblages 

BS EN 61331-3-2014

防医疗诊断用X射线的防护装置. 防护服, 护目镜和患者防护罩

Protective devices against diagnostic medical X-radiation. Protective clothing, eyewear ;and protective patient shields

BS EN ISO 13688-2013

防护服 通用要求

Protective clothing. General requirements

BS EN ISO 22612-2005

传染介质防护服.防干微生物渗入的试验方法

Clothing for protection against infectious agents. Test method for resistance to dry microbial penetration

BS ISO 16603-2004

防止接触血液和体液的防护服.防护服材料防止血液和体液渗透性的测定.使用人造血液的试验方法

Clothing   for protection against contact with blood and body fluids. Determination of   the resistance of protective clothing materials to penetration by blood and   body fluids. Test method using synthetic blood

德国

DIN EN 61331-3-2016

防医疗诊断用X射线的防护装置.第3部分:防护服,护目镜和患者防护罩(IEC   61331-3-2014).德文版本EN 61331-3-2014

Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing, eyewear and protective patient shields (IEC 61331-3:2014); German version EN 61331-3:2014

DIN EN ISO 22612-2005

防传感病病原体的防护服   

防干微生物侵入能力的试验方法

Clothing for protection against infectious agents. Test method for resistance to dry microbial penetration (ISO22612:2005); German version ENISO22612:2005

日本

JIS T8060-2015

血液和体液接触的防护用服装.血液和体液渗透防护服装材料

 Clothing for protection against contact with blood and body fluids -- Determination of the resistance of protective clothing materials to penetration by blood and body fluids -- Test method using synthetic blood

JIS T8061-2015

防止接触血液和体液的防护服

测定防护服材料对血源性病原体渗透的抵抗力 使用Phi-X174噬菌体的测试方法

Clothing for protection against contact with blood and body fluids. Determination of resistance of protective clothing materials to penetration by blood-borne pathogens. Test method using Phi-X174 bacteriophage

JIS T8062-2010

预防传染性病原体的防护服.面罩.防止人造血浆渗透的试验方法（确定容量,平行注射）

Clothing for protection against infectious agents -- Face masks -- Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected)

JIS T61331-3-2016

医疗诊断用X射线防护装置. 第3部分: 防护服, 护目镜和患者防护罩

Protective devices against diagnostic medical X-radiation -- Part 3: Protective clothing, eyewear and protective patient shields

韩国

KS K ISO 22609-2012

传染试剂防护服.医疗面罩.防人造血渗透的试验方法(固定容积、水平喷射)

Clothing for protection against infectious agents－Medical face masks－Test method for resistance against penetration by synthetic blood(fixed volume, horizontally projected)

其他国家

DS/EN 61331-3-1999

防止诊断医疗X射线辐射的保护装置 - 第3部分:生殖器防护服和保护装置

Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing and protective devices for gonads

GOST R 57493-2017

医疗器械. 放射科材料防护服. 政府采购技术要求

Medical devices. Protective garments for radiology department stuff. Technical requirements for governmental purchases

GOST R 57503-2017

医疗器械. 放射科患者防护服. 政府采购技术要求

Medical devices. Protective garments for radiology department patients. Technical requirements for governmental purchases

ABNT NBR IEC 61331-3-2004

防护服和性腺防护装置-对诊断医用X射线防护装置第3部分

Protective devices against diagnostic medical X-radiation Part 3- Protective clothing and protective devices for gonads

LST EN 61331-3-2014

医用诊断x射线辐射防护器具. 第3部分: 防护服, 护目镜和患者防护罩(IEC 61331-3-2014)

Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing, eyewear and protective patient shields (IEC 61331-3:2014)

UAE.S/GSO ISO 22609-2010

传染试剂防护服.医疗面罩.防人造血渗透的试验方法(固定容积,水平喷射)

Clothing for protection against infectious agents -Medical face masks - Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected)

STN EN 61331-3-2001

医用诊断X射线辐射防护器具. 第3部分: 防护服和性腺防护器具

Protective devices against diagnostic medical X-radiation. Part 3: Protective clothing and protective devices for gonads

STN EN 61331-3-2015

医用诊断X射线辐射防护器具. 第3部分: 防护服, 护目镜和患者防护罩

Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing, eyewear and protective patient shields

IS 16545-2016

防止接触血液和体液的衣服-血传播致病菌对防护服材料渗透性的测定-Phi-X174噬菌体试验方法

Clothing for Protection Against Contact with Blood and Body Fluids - Determination of Resistance of Protective Clothing Materials to Penetration by Blood-Borne Pathagens - Test Method Using Phi-X174 Bacteriophage

IS 16546-2016

防止接触血液和体液的衣服-血液和体液渗透性测定防护服材料的渗透性-合成血液的试验方法 

Clothing for Protection Against Contact with Blood and Body Fluids - Determination of the Resistance of Protective Clothing Materials to Penetration by Blood and Body Fluids - Test Method Using Synthetic Blood

国别

标准号

中文题名

英文题名

中国

GB 14866-2006

个人用眼护具 技术要求

The specifications for personal eye-protectors

国际

ISO 4849-1981

个人用护目镜 技术要求

Personal eye-protectors. Specifications first edition 

ISO 12609-1-2013

第1部分: 产品规范. 防护人体和动物用强光源用于化妆品和医疗用途的护目镜. 第1部分: 产品规范

Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications. Part 1: Specification for products

欧洲

EN 166-2001

个人眼睛保护 - 规格

Personal Eye-Protection. Specifications

英国

BS EN 61331-3-2014

防医疗诊断用X射线的防护装置. 防护服, 护目镜和患者防护罩

Protective devices against diagnostic medical X-radiation. Protective clothing, eyewear and protective patient shields

德国

DIN EN 61331-3-2016

防医疗诊断用X射线的防护装置.第3部分:防护服,护目镜和患者防护罩(IEC   61331-3-2014).德文版本EN 61331-3-2014

Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing,eyewear and protective patient shields (IEC 61331-3:2014); German version EN 61331-3:2014

法国

NF C74-228-3-2015

防医疗诊断用X射线的防护装置. 第3部分: 防护服, 护目镜和患者防护罩 

Protective devices against diagnostic medical X-radiation - Part 3 : protective clothing, eyewear and protective patient shields

日本

JIS T8147-2016

个人眼睛防护

Personal eye protectors

韩国

KS G ISO 12609-1-2014

 第1部分:产品规范。防护人体和动物用强光源用于化妆品和医疗用途的护目镜。第1部分:产品规范 

Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications — Part 1: Specification for products

其他国家

LST EN 61331-3-2014

医用诊断x射线辐射防护器具. 第3部分: 防护服, 护目镜和患者防护罩(IEC   61331-3-2014)

Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing, eyewear and protective patient shields (IEC 61331-3:2014) 

STN EN 61331-3-2015

医用诊断X射线辐射防护器具. 第3部分: 防护服, 护目镜和患者防护罩

 Protective devices against diagnostic medical X-radiation-Part3:Protectiveclothing,eyewear and protective patient shields