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口罩、手套、消毒剂、护目镜、防护服等国内外标准

2020-03-14 22:32:55 青岛永和国际货运代理有限公司 9
本文将口罩、消毒剂、手套、护目镜、防护服等防护产品相关国内外标准进行整理汇编,供参考。欢迎转发分享


第一部分 口罩相关国内外标准


国别

标准号

中文题名

英文题名


中国

GB  2626-2006

呼吸防护用品 自吸过滤式防颗粒物呼吸器

Respiratory  protective equipment. Non-powered air-purifying particle respirator

GB  2626-2019

呼吸防护 自吸过滤式防颗粒物呼吸器

GB/T  18664-2002

呼吸防护用品的选择、使用与维护

Selection,use  and maintenance of respiratory protective equipment

GB  19083-2010

医用防护口罩技术要求

Technical  requirements for protective face mask for medical use

GB/T  23465-2009

呼吸防护用品 实用性能评价

GB/T  32610-2016

日常防护型口罩技术规范

Technical  specification of daily protective mask

YY  0469-2011

医用外科口罩

Surgical  mask

YY/T  0691-2008

传染性病原体防护装备 医用面罩抗合成血穿透性试验方法(固定体积、水平注射)

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

YY/T  0866-2011

医用防护口罩总泄漏率测试方法

Total  inward leakage determination method of protective face mask for medical use

YY/T  0969-2013

一次性使用医用口罩

Single-use  medical face mask

YY/T  1497-2016

医用防护口罩材料病毒过滤效率评价测试方法 Phi-X174噬菌体测试方法

Evaluation  test method for the viral filtration efficiency (VFE)of medical protective  face mask materials. Test method using Phi-X174 bacteriophage

DB  50/ 107-2003

医用纱布口罩

DB  62/T 518-1998

一次性使用无纺布系列医疗卫生用品

DB  65/T 2028-2003

医用脱脂纱布口罩

Medical  purified ganuze mask

CNS  14258-1998

呼吸防護具之選擇、使用及維護方法

Guidance  for seclection use and maintenance of respiratory protective devices

CNS  14755-2003

拋弃式防尘口罩

Disposable  dust respirators

CNS  14756-2003

附加活性碳拋弃式防尘口罩

Disposable  dust respirators with activated - carbon

CNS  14774-2018

醫用面(口)罩

Medical  face masks

CNS  14775-2003

醫用面罩材料細菌過濾效率試驗法─使用金黃色葡萄球菌生物氣霧

Method  of test for evaluating the bacterial filtration efficiency (BFE) of  medical face mask materials, using a  biological aerosol of staphylococcus aureus

CNS  14776-2003

醫用面罩對合成血液穿透阻力的試驗法─以已知速度定量的水平噴灑

Method  of test for resistance of medical face masks to penetration by synthetic  blood (horizontal projection of fixed volume at a known velocity)

CNS  14777-2003

醫用面罩空氣交換壓力之試驗法

Method  of test for air exchange pressure of medical face mask

CNS  16076-2018

呼吸防護裝置-全面罩-要求、試驗、標示

Respiratory  protective devices. Full face masks. Requirements, testing, marking

国际

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,水平注射)

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

欧洲

EN  136-1998+AC-2003

呼吸保护装置 全面罩 要求、测试和标记

Respiratory  protective devices. Full face masks. Requirements,testing,marking

EN  140-1998+AC-1999

呼吸保护装置 半面罩和1/4面罩式 要求、测试和标记

Respiratory  protective devices. Half masks and quarter masks.  Requirements,testing,marking

EN  143-2000

呼吸保护装置 - 粒子滤波 - 要求、测试、标识

Respiratory  protective devices. Particle filters. Requirements,testing,marking Including  corrigenda July 2002 and March 2005;Including Amendment A1:June 2006

EN  149-2001

呼吸防护装置.颗粒防护用过滤半面罩.要求、检验和标记

Respiratory  protective devices - Filtering half masks to protect against particles -  Requirements testing marking

EN  149-2001+A1-2009

呼吸保护装置 颗粒防护用过滤半遮罩  要求、测试和标记

Respiratory  protective devices. Filtering half masks to protect against particles.  Requirements,testing,marking

EN  529-2005

呼吸保护器  选择、使用、维护和保养建议  指导性文件

Respiratory  protective devices. Recommendations for selection,use,care and maintenance.  Guidance document Supersedes CR 529:1993

EN  12942-1998+A2-2008

呼吸保护装置 全面罩、半面罩或1/4面罩式动力过滤装置 要求、测试和标记

Respiratory  protective devices. Power assisted filtering devices incorporating full face  masks,half masks or quarter masks. Requirements,testing,marking

EN  14387-2004+A1-2008

呼吸保护装置 气体过滤器和组合过滤器  要求、测试和标记

Respiratory  protective devices. Gas filter(s) and combined filter(s).  Requirements,testing,marking

EN  14683-2019+AC-2019

医用口罩 要求和试验方法

Medical  face masks - Requirements and test methods

美国

ASTM  F1862/F1862M-2017

医用口罩抗人工合成血渗透的标准试验方法(已知速度下固定体积的水平投影)

Standard  Test Method for Resistance of Medical Face Masks to Penetration by Synthetic  Blood (Horizontal Projection of Fixed Volume at a Known Velocity)

ASTM  F2100-2019

医用口罩材料性能标准规范

Standard  Specification for Performance of Materials Used in Medical Face Masks

ASTM  F2101-2019

用金黄色葡萄球菌生物气溶胶评价医用口罩材料的细菌过滤效率(BFE)的标准试验方法

Standard  Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of  Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus  aureus

ASTM  F2299/F2299M-2003(2017)

用乳胶球测定医用口罩材料被微粒渗透的初始效率的标准试验方法

Standard  Test Method for Determining the Initial Efficiency of Materials Used in  Medical Face Masks to Penetration by Particulates Using Latex Spheres

CFR  42-84-1995解释指南

NIOSH颗粒物防护口罩的选择和使用指南

NIOSH  Guide to the Selection and Use of Particulate Respirators

英国

BS  EN 136-1998

呼吸保护装置.全面罩.要求、试验、标记

Respiratory  protective devices. Full face masks. Requirements,testing,marking

BS  EN 140-1999

呼吸保护装置 半口罩和四分之一口罩  要求、试验、标记

Respiratory  protective devices. Half masks and quarter masks.  Requirements,testing,marking

BS  EN 143-2000

呼吸防护装置 微粒过滤器 要求、测试、标记

Respiratory  protective devices. Particle filters. Requirements,testing,marking

BS  EN 149-2001+A1-2009

呼吸保护装置 可防微粒的过滤式半面罩  要求、试验、标记

Respiratory  protective devices. Filtering half masks to protect against particles.  Requirements, testing, marking

BS  EN 529-2005

呼吸保护装置 选择、使用、保养和维护的建议  指导文档

Respiratory  protective devices. Recommendations for selection,use,care and maintenance.  Guidance document

BS  EN 14387-2004+A1-2008

呼吸防护装置 气体过滤器和组合过滤器  要求、试验、标志

Respiratory  protective devices. Gas filter(s) and combined filter(s). Requirements,  testing, marking

BS  EN 14683-2019

医用口罩 要求和试验方法

Medical  face masks. Requirements and test methods

德国

DIN  EN 136-1998

呼吸保护器.全面罩.要求、检验、标志

Respiratory  protective devices. Fullface masks. Requirements, testing, marking; German  version EN136:1997

DIN  EN 140-1998

呼吸保护器.半面和四分之一面罩.要求、检验、标记

Respiratory  protective devices. Half masks and quarter-masks. Requirements, testing,  marking; German version EN140:1998

DIN  EN 149-2009

呼吸保护装置 过滤半面罩以防止颗粒物  要求,测试,标记;

Respiratory  protective devices. Filtering half masks to protect against particles.  Requirements, testing, marking; German version EN149:2001+A1:2009

DIN  EN 529-2006

呼吸保护器  选择、使用、维护和保养建议  指导性文件

Respiratory  protective devices. Recommendations for selection, use, care and maintenance.  Guidance document; German version EN529:2005

DIN  EN 14683-2019

医用口罩 要求和试验方法

Medical  face masks - Requirements and test methods; German version EN  14683:2019+AC:2019

法国

NF  S76-014-2009

呼吸保护装置.颗粒防护用过滤式半面罩.要求、试验、标记

Respiratory  protective devices - Filtering half masks to protect against particles -  Requirements, testing, marking

NF  S76-034-1998

呼吸保护装置与防护罩或防护面具结合的带动力粒子过滤装置.要求,试验, 标志

Respiratory  protective devices. Powered filtering devices incorporating a helmet or a  hood. Requirements, testing, marking.

NF  S97-166-2014

医用口罩 要求和试验方法

Medical  face masks - Requirements and test methods

NF  EN 140-1998

呼吸保护装置.1/2 和1/4 防毒面具.要求,试验和标志

Respiratory  protective   devices  -  Half   masks  and  quarter   masks  -  Requirements,  testing,   marking

NF  EN 12941-1998

呼吸保护装置与防护罩或防护面具结合的带动力粒子过滤装置.要求,试验, 标志

Respiratory  protective   devices.  Powered  filtering   devices  incorporating  a   helmet  or  a   hood.  Requirements,  testing,   marking.

澳大利亚

AS/NZS  1715-2009

呼吸保护设备的选择 使用和维护

Selection,  Use And Maintenance Of Respiratory Protective Equipment

AS/NZS  1716-2012

呼吸防护设备

Respiratory  protective devices

日本

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,水平注射)

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

JIS  T8150-2006

呼吸防护器具的选择、使用及保管办法

Guidance  for selection, use and maintenance of respiratory protective devices

JIS  T8159-2006

呼吸防护面具漏泄率试验方法

Leakage  rate testing method for respiratory protective devices

韩国

KS  M 6673-2008

防尘口罩

Dust  respirators

KS  K ISO 22609-2018

抗传染病防护服 医用口罩 合成血液抗渗透的试验方法(确定容量,水平注射)

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

越南

TCVN  8389-1-2010

医用口罩. 第1部分: 普通医用口罩

Medical  face mask. Part 1: Normal medical face mask.

TCVN  8389-2-2010

医疗口罩. 第2部分: 防细菌医用口罩

Medical  face mask. Part 2: Medical face mask preventing bacteria.

TCVN  8389-3-2010

医用口罩. 第3部分: 防有毒化学物质医用口罩

Medical  face mask. Part 3: Medical face mask preventing of toxic chemicals

其他国家

DS/ISO  22609-2005

防病毒衣物. 医用口罩. 合成血液渗透性测试方法(确定容量,水平注射)

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

GOST  12.4.166-2018

职业安全标准体系 呼吸保护装置  面具 一般规范

Occupational  Safety Standards System. Respiratory Protective Devices. Facepiece. General  Specifications

GOST  12.4.285-2015

职业安全标准体系 呼吸保护装置  防微粒过滤半面罩 一般规范

Occupational  safety standards system. Respiratory protective devices. Filter self-rescuer.  General technical requirements. Test methods

GOST  12.4.294-2015

职业安全标准体系 呼吸保护装置  面罩 一般规范

Occupational  safety standards system. Respiratory protective devices. Filtering half masks  to protect against particles. General specifications

GOST  R 58396-2019

医疗口罩 要求和测试方法

Medical  Face Masks. Requirements And Test Methods

AS/NZS  1715-2009

呼吸保护设备的选择 使用和维护

Selection,  Use And Maintenance Of Respiratory Protective Equipment

AS/NZS  1716-2012

呼吸防护设备

Respiratory  protective devices

SANS  1866-1-2018

医疗设备 第1部分 医用口罩

Medical  devices Part 1: Medical face masks

SANS  50136-1998

呼吸保护装置. 全面罩. 要求、测试、标记

Respiratory  Protective Devices. Full Face Masks. Requirements, Testing, Marking

SANS  50140-1998

呼吸保护装置. 半面罩和四分之一面罩. 要求、测试、标记

Respiratory  Protective Devices. Half Masks And Quarter Masks. Requirements, Testing,  Marking

SS  548-2009

选择、使用和维修呼吸保护装置

Code  of practice for selection, use and maintenance of respiratory protective  devices

ABNT  NBR 13694-1996

呼吸保护装置 半面罩和四分之一面罩  规范

Respiratory  protective devices. Half masks and quarter masks. Specification

ABNT  NBR 13695-1996

呼吸保护装置 全面罩 规范

Respiratory  protective devices. Full face masks. Specification

ABNT  NBR 13698-2011

呼吸保护装置 颗粒过滤半面罩

Respiratory  protective devices. Filtering half mask to protect against particles

IS  14166-1994

呼吸防护装置:全面罩

Respiratory  protective devices : Full face masks

IS  14746-1999

呼吸防护装置-半面罩和四分之一面罩

Respiratory  Protective Devices - Half Masks And Quarter Masks

IS  9473-2002

呼吸防护装置-防止颗粒的过滤半面罩

Respiratory  Protective Devices - Filtering Half Masks to Protect Against Particles

UNI  EN 14683-2019

医用口罩 要求和试验方法

Medical  face masks - Requirements and test methods

IS  9623-2008

呼吸防护装置的选择、使用和维护-规程

Selection,  use and maintenance of respiratory protective devices - Code of practice

UNE  EN 14683-2014

医用口罩 要求和试验方法

Medical  Face Masks - Requirements And Test Methods




第二部分  消毒剂相关国内外标准


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)



第三部份 手套相关国内外标准


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