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口罩、手套、消毒劑、護(hù)目鏡、防護(hù)服等國內(nèi)外標(biāo)準(zhǔn)
發(fā)表時(shí)間:2020-08-03 15:30:22

當(dāng)前,一場防控新型冠狀病毒肺炎的全民阻擊戰(zhàn)已經(jīng)打響,全國上下眾志成城,共克時(shí)艱。本文將口罩、消毒劑、手套、護(hù)目鏡、防護(hù)服等防護(hù)產(chǎn)品相關(guān)國內(nèi)外標(biāo)準(zhǔn)進(jìn)行整理匯編,供參考。篇幅較長,建議收藏。



第一部分 口罩相關(guān)國內(nèi)外標(biāo)準(zhǔn)


國別

標(biāo)準(zhǔn)號(hào)

中文題名

英文題名


中國

GB 2626-2006

呼吸防護(hù)用品 自吸過濾式防顆粒物呼吸器

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

GB2626-2019

呼吸防護(hù) 自吸過濾式防顆粒物呼吸器


GB/T18664-2002

呼吸防護(hù)用品的選擇、使用與維護(hù)

Selection,use   and maintenance of respiratory protective equipment

GB19083-2010

醫(yī)用防護(hù)口罩技術(shù)要求

Technical   requirements for protective face mask for medical use

GB/T23465-2009

呼吸防護(hù)用品 實(shí)用性能評價(jià)


GB/T32610-2016

日常防護(hù)型口罩技術(shù)規(guī)范

Technical   specification of daily protective mask

YY0469-2011

醫(yī)用外科口罩

Surgical   mask

YY/T0691-2008

傳染性病原體防護(hù)裝備 醫(yī)用面罩抗合成血穿透性試驗(yàn)方法(固定體積、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/T0866-2011

醫(yī)用防護(hù)口罩總泄漏率測試方法

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

YY/T0969-2013

一次性使用醫(yī)用口罩

Single-use   medical face mask

YY/T1497-2016

醫(yī)用防護(hù)口罩材料病毒過濾效率評價(jià)測試方法 Phi-X174噬菌體測試方法

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

DB50/107-2003

醫(yī)用紗布口罩


DB62/T518-1998

一次性使用無紡布系列醫(yī)療衛(wèi)生用品


DB65/T2028-2003

醫(yī)用脫脂紗布口罩

Medical   purified ganuze mask

CNS14258-1998

呼吸防護(hù)具之選擇、使用及維護(hù)方法

Guidance   for seclection use and maintenance of respiratory protective devices

CNS14755-2003

拋棄式防塵口罩

Disposable   dust respirators

CNS14756-2003

附加活性碳拋棄式防塵口罩

Disposable   dust respirators with activated - carbon

CNS14774-2018

醫(yī)用面(口)罩

Medical   face masks

CNS14775-2003

醫(yī)用面罩材料細(xì)菌過濾效率試驗(yàn)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

CNS14776-2003

醫(yī)用面罩對合成血液穿透阻力的試驗(yàn)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)

CNS14777-2003

醫(yī)用面罩空氣交換壓力之試驗(yàn)法

Method   of test for air exchange pressure of medical face mask

CNS16076-2018

呼吸防護(hù)裝置-全面罩-要求、試驗(yàn)、標(biāo)示

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

國際

ISO22609-2004

傳染試劑防護(hù)服.醫(yī)療面罩.防人造血滲透的試驗(yàn)方法(固定容積,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)

歐洲

EN136-1998+AC-2003

呼吸保護(hù)裝置 全面罩 要求、測試和標(biāo)記

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

EN140-1998+AC-1999

呼吸保護(hù)裝置 半面罩和1/4面罩式 要求、測試和標(biāo)記

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

EN143-2000

呼吸保護(hù)裝置 - 粒子濾波 - 要求、測試、標(biāo)識(shí)

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

EN149-2001

呼吸防護(hù)裝置.顆粒防護(hù)用過濾半面罩.要求、檢驗(yàn)和標(biāo)記

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

EN149-2001+A1-2009

呼吸保護(hù)裝置 顆粒防護(hù)用過濾半遮罩   要求、測試和標(biāo)記

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

EN529-2005

呼吸保護(hù)器   選擇、使用、維護(hù)和保養(yǎng)建議   指導(dǎo)性文件

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

EN12942-1998+A2-2008

呼吸保護(hù)裝置 全面罩、半面罩或1/4面罩式動(dòng)力過濾裝置 要求、測試和標(biāo)記

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

EN14387-2004+A1-2008

呼吸保護(hù)裝置 氣體過濾器和組合過濾器   要求、測試和標(biāo)記

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

EN14683-2019+AC-2019

醫(yī)用口罩 要求和試驗(yàn)方法

Medical   face masks - Requirements and test methods

美國

ASTMF1862/F1862M-2017

醫(yī)用口罩抗人工合成血滲透的標(biāo)準(zhǔn)試驗(yàn)方法(已知速度下固定體積的水平投影)

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

ASTMF2100-2019

醫(yī)用口罩材料性能標(biāo)準(zhǔn)規(guī)范

Standard   Specification for Performance of Materials Used in Medical Face Masks

ASTMF2101-2019

用金黃色葡萄球菌生物氣溶膠評價(jià)醫(yī)用口罩材料的細(xì)菌過濾效率(BFE)的標(biāo)準(zhǔn)試驗(yàn)方法

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

ASTMF2299/F2299M-2003(2017)

用乳膠球測定醫(yī)用口罩材料被微粒滲透的初始效率的標(biāo)準(zhǔn)試驗(yàn)方法

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

CFR42-84-1995解釋指南

NIOSH顆粒物防護(hù)口罩的選擇和使用指南

NIOSH   Guide to the Selection and Use of Particulate Respirators

英國

BSEN 136-1998

呼吸保護(hù)裝置.全面罩.要求、試驗(yàn)、標(biāo)記

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

BSEN 140-1999

呼吸保護(hù)裝置 半口罩和四分之一口罩   要求、試驗(yàn)、標(biāo)記

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

BSEN 143-2000

呼吸防護(hù)裝置 微粒過濾器 要求、測試、標(biāo)記

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

BS   EN 149-2001+A1-2009

呼吸保護(hù)裝置 可防微粒的過濾式半面罩   要求、試驗(yàn)、標(biāo)記

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

BS   EN 529-2005

呼吸保護(hù)裝置 選擇、使用、保養(yǎng)和維護(hù)的建議   指導(dǎo)文檔

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

BS   EN 14387-2004+A1-2008

呼吸防護(hù)裝置 氣體過濾器和組合過濾器   要求、試驗(yàn)、標(biāo)志

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

BS   EN 14683-2019

醫(yī)用口罩 要求和試驗(yàn)方法

Medical   face masks. Requirements and test methods

德國

DIN   EN 136-1998

呼吸保護(hù)器.全面罩.要求、檢驗(yàn)、標(biāo)志

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

DIN   EN 140-1998

呼吸保護(hù)器.半面和四分之一面罩.要求、檢驗(yàn)、標(biāo)記

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

DIN   EN 149-2009

呼吸保護(hù)裝置 過濾半面罩以防止顆粒物   要求,測試,標(biāo)記;

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

DIN   EN 529-2006

呼吸保護(hù)器   選擇、使用、維護(hù)和保養(yǎng)建議   指導(dǎo)性文件

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

DIN   EN 14683-2019

醫(yī)用口罩 要求和試驗(yàn)方法

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

法國

NF   S76-014-2009

呼吸保護(hù)裝置.顆粒防護(hù)用過濾式半面罩.要求、試驗(yàn)、標(biāo)記

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

NF   S76-034-1998

呼吸保護(hù)裝置與防護(hù)罩或防護(hù)面具結(jié)合的帶動(dòng)力粒子過濾裝置.要求,試驗(yàn), 標(biāo)志

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

NF   S97-166-2014

醫(yī)用口罩 要求和試驗(yàn)方法

Medical   face masks - Requirements and test methods

NF   EN 140-1998

呼吸保護(hù)裝置.1/2 和1/4 防毒面具.要求,試驗(yàn)和標(biāo)志

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

NF   EN 12941-1998

呼吸保護(hù)裝置與防護(hù)罩或防護(hù)面具結(jié)合的帶動(dòng)力粒子過濾裝置.要求,試驗(yàn), 標(biāo)志

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

澳大利亞

AS/NZS   1715-2009

呼吸保護(hù)設(shè)備的選擇 使用和維護(hù)

Selection,   Use And Maintenance Of Respiratory Protective Equipment

AS/NZS   1716-2012

呼吸防護(hù)設(shè)備

Respiratory   protective devices

日本

JIS   T8062-2010

預(yù)防傳染性病原體的防護(hù)服.面罩.防止人造血漿滲透的試驗(yàn)方法(確定容量,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

呼吸防護(hù)器具的選擇、使用及保管辦法

Guidance   for selection, use and maintenance of respiratory protective devices

JIS   T8159-2006

呼吸防護(hù)面具漏泄率試驗(yàn)方法

Leakage   rate testing method for respiratory protective devices

韓國

KS   M 6673-2008

防塵口罩

Dust   respirators

KS   K ISO 22609-2018

抗傳染病防護(hù)服 醫(yī)用口罩 合成血液抗?jié)B透的試驗(yàn)方法(確定容量,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

醫(yī)用口罩. 第1部分: 普通醫(yī)用口罩

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

TCVN   8389-2-2010

醫(yī)療口罩. 第2部分: 防細(xì)菌醫(yī)用口罩

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

TCVN   8389-3-2010

醫(yī)用口罩. 第3部分: 防有毒化學(xué)物質(zhì)醫(yī)用口罩

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

其他國家

DS/ISO   22609-2005

防病毒衣物. 醫(yī)用口罩. 合成血液滲透性測試方法(確定容量,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

職業(yè)安全標(biāo)準(zhǔn)體系 呼吸保護(hù)裝置   面具 一般規(guī)范

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

GOST   12.4.285-2015

職業(yè)安全標(biāo)準(zhǔn)體系 呼吸保護(hù)裝置   防微粒過濾半面罩 一般規(guī)范

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

GOST   12.4.294-2015

職業(yè)安全標(biāo)準(zhǔn)體系 呼吸保護(hù)裝置   面罩 一般規(guī)范

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

GOST   R 58396-2019

醫(yī)療口罩 要求和測試方法

Medical   Face Masks. Requirements And Test Methods

AS/NZS   1715-2009

呼吸保護(hù)設(shè)備的選擇 使用和維護(hù)

Selection,   Use And Maintenance Of Respiratory Protective Equipment

AS/NZS   1716-2012

呼吸防護(hù)設(shè)備

Respiratory   protective devices

SANS   1866-1-2018

醫(yī)療設(shè)備 第1部分 醫(yī)用口罩

Medical   devices Part 1: Medical face masks

SANS   50136-1998

呼吸保護(hù)裝置. 全面罩. 要求、測試、標(biāo)記

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

SANS   50140-1998

呼吸保護(hù)裝置. 半面罩和四分之一面罩. 要求、測試、標(biāo)記

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

SS   548-2009

選擇、使用和維修呼吸保護(hù)裝置

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

ABNT   NBR 13694-1996

呼吸保護(hù)裝置 半面罩和四分之一面罩   規(guī)范

Respiratory   protective devices. Half masks and quarter masks. Specification

ABNT   NBR 13695-1996

呼吸保護(hù)裝置 全面罩 規(guī)范

Respiratory   protective devices. Full face masks. Specification

ABNT   NBR 13698-2011

呼吸保護(hù)裝置 顆粒過濾半面罩

Respiratory   protective devices. Filtering half mask to protect against particles

IS   14166-1994

呼吸防護(hù)裝置:全面罩

Respiratory   protective devices : Full face masks

IS   14746-1999

呼吸防護(hù)裝置-半面罩和四分之一面罩

Respiratory   Protective Devices - Half Masks And Quarter Masks

IS   9473-2002

呼吸防護(hù)裝置-防止顆粒的過濾半面罩

Respiratory   Protective Devices - Filtering Half Masks to Protect Against Particles

UNI   EN 14683-2019

醫(yī)用口罩 要求和試驗(yàn)方法

Medical   face masks - Requirements and test methods

IS   9623-2008

呼吸防護(hù)裝置的選擇、使用和維護(hù)-規(guī)程

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

UNE   EN 14683-2014

醫(yī)用口罩 要求和試驗(yàn)方法

Medical   Face Masks - Requirements And Test Methods


第二部分   消毒劑相關(guān)國內(nèi)外標(biāo)準(zhǔn)


類別

標(biāo)準(zhǔn)號(hào)

中文題名

英文題名
























中國

GB/T 10666-2019

次氯酸鈣(漂粉精)

Calcium hypochlorite

GB 16383-2014

醫(yī)療衛(wèi)生用品輻射滅菌消毒質(zhì)量控制

Quality control for radiation   sterilization of medical and hygienical products

GB 18280-2000

醫(yī)療保健產(chǎn)品滅菌   確認(rèn)和常規(guī)控制要求 輻射滅菌

Sterilization of health care   products--Requirement for validation and routine control--Radiation   sterilization

GB/T 19104-2008

過氧乙酸溶液

Peracetic acid solution

GB/T 19106-2013

次氯酸鈉

Sodium hypochlorite

GB 19193-2015

疫源地消毒總則

General principle on disinfection for   infectious focus

GB/T 19633-2005

最終滅菌醫(yī)療器械的包裝

Packaging for terminally sterilized   medical devices

GB/T 20468-2006

臨床實(shí)驗(yàn)室定量測定室內(nèi)質(zhì)量控制指南

Guideline for internal quality   control for quantitative measurements in clinical laboratory

GB/T 20469-2006

臨床實(shí)驗(yàn)室設(shè)計(jì)總則

General guideline of the clinical   laboratory design

GB/T 20470-2006

臨床實(shí)驗(yàn)室室間質(zhì)量評價(jià)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

二氧化氯消毒劑衛(wèi)生標(biāo)準(zhǔn)

Hygienic standard for chlorine   dioxide disinfectant

GB/T 26367-2010

胍類消毒劑衛(wèi)生標(biāo)準(zhǔn)

Hygienic standard for biguanides   disinfectants

GB/T 26368-2010

含碘消毒劑衛(wèi)生標(biāo)準(zhǔn)

Hygienic standard for iodine   disinfectants

GB/T 26369-2010

季銨鹽類消毒劑衛(wèi)生標(biāo)準(zhǔn)

Hygienic standard for quaternary   ammonium disinfectant

GB/T 26370-2010

含溴消毒劑衛(wèi)生標(biāo)準(zhǔn)

Hygienic standard for disinfectants   with bromine

GB/T 26371-2010

過氧化物類消毒劑衛(wèi)生標(biāo)準(zhǔn)

Hygienic standard for peroxide   disinfectants

GB/T 26372-2010

戊二醛消毒劑衛(wèi)生標(biāo)準(zhǔn)

Hygienic standard for glutaraldehyde   disinfectant

GB/T 26373-2010

乙醇消毒劑衛(wèi)生標(biāo)準(zhǔn)

Hygienic standard for alcohol   disinfectants

GB/T 27947-2011

酚類消毒劑衛(wèi)生要求

Hygienic requirements for phenol   disinfectant

GB 27948-2011

空氣消毒劑衛(wèi)生要求

Hygienic requirements for air   disinfectant

GB/T 27949-2011

醫(yī)療器械消毒劑衛(wèi)生要求

Hygienic requirements for medical   items disinfection

GB 27950-2011

手消毒劑衛(wèi)生要求

Hygienic requirements for hand   antiseptic agents

GB 27951-2011

皮膚消毒劑衛(wèi)生要求

Hygiene requirements for skin   disinfectant

GB 27952-2011

普通物體表面消毒劑的衛(wèi)生要求

Hygienic requirements for surface   disinfectants

GB 27953-2011

疫源地消毒劑衛(wèi)生要求

Hygienic requirements of disinfectant   for infectious focus

GB 27954-2011

黏膜消毒劑通用要求

General standard for disinfectant of   mucous membrane

GB 27955-2011

過氧化氫氣體等離子體低溫滅菌裝置的通用要求

General requirements for   low-temperature hydrogen peroxide gas plasma sterilizer

GB 28232-2011

臭氧發(fā)生器安全與衛(wèi)生標(biāo)準(zhǔn)

Safety and sanitation standard for   ozone generator

GB 28233-2011

次氯酸鈉發(fā)生器安全與衛(wèi)生標(biāo)準(zhǔn)

Safety and hygienic standard for   disinfection by sodium hypochlorite generator

GB 28234-2011

酸性氧化電位水生成器安全與衛(wèi)生標(biāo)準(zhǔn)

Safety and sanitation standard for   acidic electrolyzed-oxidizing water generator

GB 28235-2011

紫外線空氣消毒器安全與衛(wèi)生標(biāo)準(zhǔn)

Safety and sanitary standard for   ultraviolet appliance for air disinfection

GB 28931-2012

二氧化氯消毒劑發(fā)生器安全與衛(wèi)生標(biāo)準(zhǔn)

Safety and sanitation standard for   chlorine dioxide disinfectant generator

GB/T 30224-2013

剛地弓形蟲試驗(yàn)臨床應(yīng)用

Clinical use of tests for Toxoplasma   gondii

GB 30689-2014

內(nèi)鏡自動(dòng)清洗消毒機(jī)衛(wèi)生要求

Hygienic requirements for   washer-disinfectors employing chemical disinfection for thermolabile endoscopes

GB/T 30690-2014

小型壓力蒸汽滅菌器滅菌效果監(jiān)測方法和評價(jià)要求

Monitoring requirements and   evaluation of sterilization effect of small steam sterilizer

GB/T 33417-2016

過氧化氫氣體滅菌生物指示物檢驗(yàn)方法

Test method of biological indicator   for hydrogen peroxide vapour sterilization processes

GB/T 33418-2016

環(huán)氧乙烷滅菌化學(xué)指示物檢驗(yàn)方法

Test method of chemical indicator for   ethylene oxide sterilization processes

GB/T 33419-2016

環(huán)氧乙烷滅菌生物指示物檢驗(yàn)方法

Test method of biological indicator   for ethylene oxide sterilization processes

GB/T 33420-2016

壓力蒸汽滅菌生物指示物檢驗(yàn)方法

Evaluation standard of biological for   moist heat sterilization processes

GB/T 36758-2018

含氯消毒劑衛(wèi)生要求

Hygienic requirements for   disinfectants with chlorine

YY/T 0215-2016

醫(yī)用臭氧消毒設(shè)備

Ozone disinfector for medical purpose

YY 0970-2013

含動(dòng)物源材料的一次性使用醫(yī)療器械的滅菌液體滅菌劑滅菌的確認(rèn)與常規(guī)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

消毒劑殺滅分枝桿菌實(shí)驗(yàn)評價(jià)要求

Requirements of mycobactericidal   evaluation for disinfectant in laboratory

WS/T 466-2014

消毒專業(yè)名詞術(shù)語

Disinfection professional terms

WS/T 496-2017

臨床實(shí)驗(yàn)室質(zhì)量指標(biāo)

Quality indicators in clinical   laboratories

WS/T 497-2017

侵襲性真菌病臨床實(shí)驗(yàn)室診斷操作指南

Performance guideline for clinical laboratory   diagnosis of invasive fungal diseases

WS/T 498-2017

細(xì)菌性腹瀉臨床實(shí)驗(yàn)室診斷操作指南

Performance guideline for clinical   laboratory diagnosis of bacterial diarrhea

WS/T 508-2016

醫(yī)院醫(yī)用織物洗滌消毒技術(shù)規(guī)范

Regulation for washing and   disinfection technique of medical textiles in healthcare facilities

WS/T 514-2017

臨床檢驗(yàn)方法檢出能力的確立和驗(yàn)證

Establishment and verification of   detection capability for clinical laboratory measurement procedures

WS 628-2018

消毒產(chǎn)品衛(wèi)生安全評價(jià)技術(shù)要求


WS/T 646-2019

過碳酸鈉消毒劑衛(wèi)生要求


WS/T 648-2019

空氣消毒機(jī)通用衛(wèi)生要求


GA/T 933-2011

生物樣品中氟乙酸根離子的氣相色譜和氣相色譜-質(zhì)譜聯(lián)用檢驗(yàn)方法

GC and GC-MS examination methods for   monofluorocetate anion in biological samples

GA/T 934-2011

生物樣品中次烏頭堿、烏頭堿、中烏頭堿的液相色譜-串聯(lián)質(zhì)譜檢驗(yàn)方法


SN/T 1823-2006

醫(yī)學(xué)媒介生物衛(wèi)生處理常用藥物及處理方法

Common drugs and methods of sanitary   treatment for medical vectors

SN/T 2064-2008

國際直達(dá)列車突發(fā)公共衛(wèi)生事件處理規(guī)程

Codes for the rapid response to the   public health emergency occurred in international trains

SN/T 2069-2008

國際旅行衛(wèi)生保健中心 質(zhì)量管理標(biāo)準(zhǔn)及評價(jià)

Quanlity management criterion and   evaluation of international travel healthcare centre

SN/T 4387-2015

進(jìn)出口一次性使用衛(wèi)生用品檢驗(yàn)規(guī)程

Rules for inspection of disposable   sanitary products for import and export

DB11/ 116-1999

送餐企業(yè)衛(wèi)生規(guī)范


DB65/T 2176-2004

高原地區(qū)醫(yī)療機(jī)構(gòu)消毒滅菌工作規(guī)程

Rules of Disinfecting Sterilization   in Medical Institute on Plateau

DB65/T 2203-2005

海拔2000m以上地區(qū)壓力蒸汽滅菌效果評價(jià)方法與標(biāo)準(zhǔn)

Methods and Standards to Evaluting   the Efficacy of High.pressure Steam Sterilization at Altitude Above 2000m

DB13/T 491-2003

有害生物防制服務(wù)質(zhì)量要求


DB31/ 405-2008

公共場所空調(diào)通風(fēng)系統(tǒng)運(yùn)行衛(wèi)生要求


DB31/ 358-2006

驅(qū)避劑衛(wèi)生安全要求


DB31/ 354-2005

消毒劑生產(chǎn)環(huán)境衛(wèi)生要求


DB31/ 486-2010

獻(xiàn)血屋(點(diǎn))安全衛(wèi)生要求

Requirements for Fixed Collection   Sites

DB31/T 794-2014

老年護(hù)理院分級(jí)護(hù)理要求

Requirments of grading nursing in   Geriatric Nursing Hospital

DB34/T 1352-2011

住宿業(yè)衛(wèi)生服務(wù)規(guī)范

Hygienic Service Specification for   Lodging Industry

DB44/T 951-2011

水產(chǎn)品加工過程臭氧及過氧化氫使用準(zhǔn)則

Guidelines for the use of ozone and   hydrogen peroxide in fishery products

CNS 5937-1980

滅菌盤(消毒盤)

Sterilizing Trays

CNS 14622-1-2002

保健產(chǎn)品之滅菌─生物指示劑─第一部份:通則

Sterilization of health care   products-biological indicators-part 1:General

CNS 14622-2-2002

保健產(chǎn)品之滅菌─生物指示劑─第二部分:使用環(huán)氧乙烷滅菌的生物指示劑

Sterilization of health care   products-biological indicators-part 2:Biological indicators for ethylene oxide sterilization

CNS 14622-3-2002

保健產(chǎn)品之滅菌─生物指示劑─第三部分:用于濕熱滅菌的生物指示劑

Sterilization of health care   products-biological indicators-part 3:Biological indicators for moist heat sterilization

CNS 14623-1-2002

保健產(chǎn)品之滅菌─化學(xué)指示劑─第一部分:一般規(guī)定

Sterilization of health care   products-chemical indicators-Part 1:General requirements

CNS 14708-2002

醫(yī)療器材-環(huán)氧乙烷滅菌確效與例行管制

Medical decice-validation and routine   control of ethylene oxide strilization

CNS 14709-2002

保健產(chǎn)品之滅菌-輻射滅菌確效與例行管制規(guī)定

Sterilization of health care   products-requirements for validation and routine control-radiation   sterliization


































國際

ISO 6579 CORR 1-2004

食品和動(dòng)物飼料的微生物學(xué).沙門氏菌屬檢測的水平法.技術(shù)勘誤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. 化學(xué)指示物. 通用要求

Sterilization of health care products   — Chemical indicators — Part 1: General requirements

ISO 11140-3-2007

衛(wèi)生保健品的滅菌.化學(xué)指示劑.第3部分:布維-狄克(Bowie and Dick-type)蒸汽穿透試驗(yàn)用2級(jí)指示劑體系

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

衛(wèi)生保健品的滅菌.化學(xué)指示劑.第4部分:蒸汽穿透檢測布維-狄(Bowie and Dick)形式試驗(yàn)的2級(jí)指示劑

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

衛(wèi)生保健品的滅菌.化學(xué)指示劑.第5部分:布維-狄克形式(Bowie and Dick-type)除氣試驗(yàn)的2級(jí)指示劑

Sterilization of health care products   - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type   air removal tests

ISO 11607-1:2019

最終滅菌醫(yī)療器械的包裝. 第1部分:材料、無菌屏障系統(tǒng)和包裝系統(tǒng)的要求

Packaging for terminally sterilized   medical devices — Part 1: Requirements for materials, sterile barrier systems   and packaging systems

ISO 13408-1-2008

醫(yī)療保健產(chǎn)品的無菌加工.第1部分:一般要求

Aseptic processing of health care   products - Part 1: General requirements

ISO 13408-2-2018

醫(yī)療保健產(chǎn)品的無菌加工.第2部分:除菌過濾

Aseptic processing of health care   products - Part 2: Sterilizing filtration

ISO 13408-3-2006

衛(wèi)生保健產(chǎn)品的無菌工藝.第3部分:凍干法

Aseptic processing of health care   products - Part 3: Lyophilization

ISO 13408-6-2005

保健產(chǎn)品的無菌加工.第6部分:隔離器系統(tǒng)

Aseptic processing of health care   products - Part 6: Isolator systems

ISO 18472:2018

保健品消毒. 化學(xué)指示物. 試驗(yàn)設(shè)備

Sterilization of health care products   — Biological and chemical indicators — Test equipment

CIE 155-2003

紫外線空氣消毒法

ULTRAVIOLET AIR DISINFECTION (G)







歐洲

EN 1499-2013

化學(xué)消毒劑和防腐劑.消毒洗手液.檢驗(yàn)方法和要求(第2階段/2級(jí))

Chemical Disinfectants and   Antiseptics - Hygienic Handwash - Test Method and Requirements (Phase 2/Step   2)

EN 1811:2011+A1:2015

從插入人體穿孔部分和與皮膚直接和長期接觸的物品的所有柱組件中釋放鎳的參考試驗(yàn)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






















美國

ANSI/AAMI/ISO 13408-2-2003

醫(yī)療保健產(chǎn)品的無菌加工.第2部分:過濾

Aseptic Processing of health care   products - Part 2: Filtration

ANSI/AAMI/ISO 13408-3-2006

衛(wèi)生保健產(chǎn)品的無菌工藝.第3部分:凍干法

Aseptic Processing of health care   products - Part 3: Lyophilization

ANSI/AAMI/ISO 13408-4-2005

保健產(chǎn)品的無菌加工.第4部分:就地清洗技術(shù)

Aseptic Processing of health care   products - Part 4: Clean-in-place technologies

ANSI/AAMI/ISO 13408-5-2006

保健產(chǎn)品的無菌加工.第5部分:現(xiàn)場消毒

Aseptic Processing of health care   products - Part 5: Sterilization in place

ANSI/AAMI/ISO 13408-6-2005

保健產(chǎn)品的無菌加工.第6部分:隔離器系統(tǒng)

Aseptic Processing of health care   products - Part 6: Isolator systems

ANSI/AAMI/ISO 13408-6/A1-2013

保健產(chǎn)品的防腐處理.第6部分:隔離器.修改件1

Aseptic processing of health care   products - Part 6: Isolator systems - Amendment 1

ANSI/AAMI/ISO 13408-7-2012

保健產(chǎn)品的無菌加工.第7部分:非典型醫(yī)療設(shè)備和組合產(chǎn)品用替換加工

Aseptic processing of health care   products - Part 7: Alternative processes for atypical medical devices and   combination products

ANSI/AAMI ST79/A 3.1-2012

衛(wèi)生醫(yī)療設(shè)施蒸汽滅菌法和無菌保證綜合指南

Comprehensive guide to steam   sterilization and sterility assurance in health care facilities

ANSI/AAMI ST79/A 3.3-2012

衛(wèi)生醫(yī)療設(shè)施蒸汽滅菌法和無菌保證綜合指南

Comprehensive guide to steam   sterilization and sterility assurance in health care facilities

ANSI/AAMI ST79/A 3.4-2012

衛(wèi)生醫(yī)療設(shè)施蒸汽滅菌法和無菌保證綜合指南

Comprehensive guide to steam   sterilization and sterility assurance in health care facilities

ANSI/AAMI ST79/A 3.6-2012

衛(wèi)生醫(yī)療設(shè)施蒸汽滅菌法和無菌保證綜合指南

Comprehensive guide to steam   sterilization and sterility assurance in health care facilities

ANSI/AAMI ST79/A 3.7-2012

衛(wèi)生醫(yī)療設(shè)施蒸汽滅菌法和無菌保證綜合指南

Comprehensive guide to steam   sterilization and sterility assurance in health care facilities

ANSI/American Society of Sanitary   Engineering SERIES 12000-2018

所有建筑系統(tǒng)感染控制風(fēng)險(xiǎn)評估專業(yè)資格標(biāo)準(zhǔn)

Professional Qualifications Standard   for Infection Control Risk Assessment for All Building Systems

ANSI/ASTM E2553-2007

自動(dòng)通用衛(wèi)生保健識(shí)別系統(tǒng)實(shí)施用指南

Standard Guide for Implementation of   a Voluntary Universal Healthcare Identification System

ANSI/MEDBIQ PP.10.1-2008

衛(wèi)生保健專業(yè)簡介

Healthcare Professional Profile

ANSI/NSF 49(i14)-2008

II級(jí)(層流)生物安全室

Class II (laminar flow) biosafety   cabinetry

ANSI/NSF 49(i15r2)-2008

生物安全柜:設(shè)計(jì),制作,性能和行業(yè)認(rèn)證

Biosafety Cabinetry: Design,   Construction, Performance, and Field Certification

ANSI/NSF 49(i27)-2011

生物安全柜:設(shè)計(jì),制作,性能和行業(yè)認(rèn)證

Biosafety Cabinetry: Design,   Construction, Performance and Field Certification

ANSI/NSF 49(i42)-2011

生物安全柜:設(shè)計(jì),制作,性能和行業(yè)認(rèn)證

Biosafety Cabinetry: Design,   Construction, Performance and Field Certification

ANSI/NSF 49(i43)-2011

生物安全廚柜:設(shè)計(jì),建造,性能和實(shí)地認(rèn)證

Biosafety Cabinetry: Design,   Construction, Performance and Field Certification

ASHRAE QC-06-066-2006

在飛機(jī)艙實(shí)體模擬的空降疾病傳播的示蹤研究

Tracer Study of Airborne Disease   Transmission in an Aircraft Canin Mock-Up

CFR 42-70.1-2017

公共衛(wèi)生.第70部分:州際隔離.第70.1節(jié):一般定義.

Public health. Part 70: Interstate   quarantine. Section 70.1: General definitions.

CFR 42-70.5-2017

公共衛(wèi)生.第70部分:州際隔離.第70.5節(jié):與聯(lián)邦隔離、隔離或有條件釋放令下的旅行者有關(guān)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

公共衛(wèi)生.第70部分:州際隔離.第70.6節(jié):逮捕和拘留患有可隔離傳染病的人.

Public health. Part 70: Interstate   quarantine. Section 70.6: Apprehension and detention of persons with   quarantinable communicable diseases.

CFR 42-70.10-2017

公共衛(wèi)生.第70部分:州際隔離.第70.10節(jié):公共衛(wèi)生預(yù)防措施,以發(fā)現(xiàn)傳染病.

Public health. Part 70: Interstate   quarantine. Section 70.10: Public health prevention measures to detect communicable   disease.

CFR 42-70.11-2017

公共衛(wèi)生.第70部分:州際隔離.第70.11節(jié):航空公司經(jīng)營的飛機(jī)上死亡或生病的報(bào)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

公共衛(wèi)生.第70部分:州際隔離.第70.12節(jié):體檢.

Public health. Part 70: Interstate   quarantine. Section 70.12: Medical examinations.

CFR 42-70.13-2017

公共衛(wèi)生.第70部分:州際隔離.第70.13節(jié):支付護(hù)理和治療費(fèi)用.

Public health. Part 70: Interstate   quarantine. Section 70.13: Payment for care and treatment.

CFR 42-70.14-2017

公共衛(wèi)生.第70部分:州際隔離.第70.14節(jié):有關(guān)發(fā)出聯(lián)邦檢疫、隔離或有條件釋放令的要求.

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

公共衛(wèi)生.第70部分:州際隔離.第70.15節(jié):強(qiáng)制重新評估用于隔離、隔離或條件釋放的聯(lián)邦訂單.

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

公共衛(wèi)生.第70部分:州際隔離.第70.16節(jié):對聯(lián)邦隔離令、隔離令或有條件釋放令的醫(yī)學(xué)審查.

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

公共衛(wèi)生.第70部分:州際隔離.第70.17節(jié):與聯(lián)邦檢疫、隔離或有條件釋放有關(guān)的行政記錄.

Public health. Part 70: Interstate   quarantine. Section 70.17: Administrative records relating to Federal   quarantine, isolation, or conditional release.

CFR 42-405.373-2017

公共衛(wèi)生.第405部分:老年人和殘疾人聯(lián)邦醫(yī)療保險(xiǎn).第C子部分:暫停付款,追回多付款項(xiàng),償還獎(jiǎng)學(xué)金和貸款.第405.37節(jié):程序用于抵銷或收回的定金.

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

公共衛(wèi)生.第405部分:老年人和殘疾人聯(lián)邦醫(yī)療保險(xiǎn).第X子部分:農(nóng)村衛(wèi)生診所和聯(lián)邦合格醫(yī)療中心服務(wù).第405.2413節(jié):與醫(yī)生服務(wù)有關(guān)的服務(wù)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

公共衛(wèi)生.第405部分:老年人和殘疾人聯(lián)邦醫(yī)療保險(xiǎn).第X子部分:農(nóng)村衛(wèi)生診所和聯(lián)邦合格醫(yī)療中心服務(wù).第405.2415節(jié):服務(wù)事故和直接監(jiān)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

公共衛(wèi)生.第410部分:補(bǔ)充醫(yī)療保險(xiǎn)福利.第 B子部分:醫(yī)療和其他衛(wèi)生服務(wù).第410.26節(jié):向醫(yī)生提供的服務(wù)和用品事件:條件.

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

公共衛(wèi)生.第410部分:補(bǔ)充醫(yī)療保險(xiǎn)福利.第 B子部分:醫(yī)療和其他衛(wèi)生服務(wù).第410.79節(jié):醫(yī)療保健糖尿病預(yù)防方案擴(kuò)大模式:覆蓋條件.

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

公共衛(wèi)生.第411部分:醫(yī)療保險(xiǎn)除外和醫(yī)療保險(xiǎn)支付的限制.第 J子部分:提供指定保健服務(wù)的醫(yī)生和實(shí)體之間的財(cái)務(wù)關(guān)系.第411.357 節(jié):與賠償安排有關(guān)的禁止轉(zhuǎn)介的例外情況.

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

公共衛(wèi)生.第411部分:醫(yī)療保險(xiǎn)除外和醫(yī)療保險(xiǎn)支付的限制.第 J子部分:提供指定保健服務(wù)的醫(yī)生和實(shí)體之間的財(cái)務(wù)關(guān)系.第411.372 節(jié):提交請求的程序.

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

公共衛(wèi)生.第414部分:支付b部分醫(yī)療和其他衛(wèi)生服務(wù)費(fèi)用.第B子部分:醫(yī)生和其他從業(yè)人員.第411.372 節(jié):相對價(jià)值單位(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

公共衛(wèi)生.第414部分:支付b部分醫(yī)療和其他衛(wèi)生服務(wù)費(fèi)用.第B子部分:醫(yī)生和其他從業(yè)人員.第414.90節(jié):醫(yī)師質(zhì)量報(bào)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

公共衛(wèi)生.第414部分:支付b部分醫(yī)療和其他衛(wèi)生服務(wù)費(fèi)用.第B子部分:醫(yī)生和其他從業(yè)人員.第414.94節(jié):先進(jìn)診斷成像服務(wù)的適當(dāng)使用標(biāo)準(zhǔn).

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

保健產(chǎn)品的無菌加工.第6部分:隔離器系統(tǒng)

Aseptic Processing of health care   products - Part 6: Isolator systems

ANSI/AAMI/ISO 13408-7-2012

保健產(chǎn)品的無菌加工.第7部分:非典型醫(yī)療設(shè)備和組合產(chǎn)品用替換加工

Aseptic processing of health care   products - Part 7: Alternative processes for atypical medical devices and   combination products

ASTM E1327-2007

利用手指甲區(qū)域評估抗菌洗手液配方的標(biāo)準(zhǔn)試驗(yàn)方法

Standard Test Method for Evaluation   of Antimicrobial Handwash Formulations by Utilizing Fingernail Regions

ASTM E1714-2000

通用保健識(shí)別符(UHTD)特性的標(biāo)準(zhǔn)指南

Standard Guide for Properties of a   Universal Healthcare Identifier (UHID)

ASTM E1891-2010a

測定抗菌劑抗選定微生物的生存曲線和計(jì)算D值及濃度系數(shù)的標(biāo)準(zhǔn)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

可控區(qū)域和清潔室的清潔和維修的標(biāo)準(zhǔn)實(shí)施規(guī)程

Standard Practice for Cleaning and   Maintaining Controlled Areas and Clean Rooms

ASTM E2720-2010

當(dāng)表層沾有人體病原性病毒時(shí)用于評估透氣材料凈化程序效能的標(biāo)準(zhǔn)試驗(yàn)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

評定遭到含有人類致病性病毒的飛沫攻擊時(shí)表面凈化程序效能的標(biāo)準(zhǔn)試驗(yàn)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 化驗(yàn)測試消毒劑對綠膿桿菌(Pseudomonas aeruginosa)生物膜功效的標(biāo)準(zhǔn)試驗(yàn)方法

Standard Test Method for Testing   Disinfectant Efficacy against Pseudomonas aeruginosa Biofilm using the MBEC   Assay

ASTM E3058-2016

手消毒劑殺傷活性測定方法

Standard Test Method for Determining   the Residual Kill Activity of Hand Antiseptic Formulations

ASTM F1114-2006

商業(yè)用的熱消毒筒,槽和架式水驅(qū)動(dòng)旋轉(zhuǎn)噴射器皿站

Standard Specification for Heat   Sanitizing Commercial Pot, Pan, and Utensil Station Rack Type Water-Driven   Rotary Spray













英國

BS 3970-1-1990

醫(yī)療制品用滅菌消毒設(shè)備.第1部分:一般要求規(guī)范

Sterilizing and disinfecting   equipment for medical products. Specification for general requirements

BS 3970-2-1991

醫(yī)療制品用滅菌消毒設(shè)備.第2部分:裝含水液體的密封硬質(zhì)容器用蒸汽消毒器規(guī)范

Sterilizing and disinfecting   equipment for medical products. Specification for steam sterilizers for   aqueous fluids in sealed rigid containers

BS 6256-1989

醫(yī)用蒸汽消毒紙袋、紙盒和紙筒用紙規(guī)范

Specification for paper for steam   sterilization paper bags, pouches and reels for medical use

BS CWA 15793-2011

實(shí)驗(yàn)室生物危害管理

Laboratory biorisk management

BS CWA 16833-2014

整體管理棕色地帶更新的術(shù)語表   (GoT-HOMBRE)

Glossary of Terms for Holistic   Management of Brownfield Regeneration (GoT-HOMBRE)

BS DD CEN ISO/TS 17665-2-2009

保健產(chǎn)品的消毒.潮熱.ISO 17665-1應(yīng)用指南

Sterilization of health care products   - Moist heat - Guidance on the application of ISO 17665-1

BS EN 13549-2001

清潔服務(wù).質(zhì)量度量系統(tǒng)的基本要求和推薦方法

Cleaning services - Basic   requirements and recommendations for quality measuring systems

BS EN ISO 11137-3-2007

衛(wèi)生保健產(chǎn)品的滅菌.輻射.劑量測定方面的指南

Sterilization of health care products   - Radiation - Guidance on dosimetric aspects

BS EN ISO 11140-3-2009

保健品滅菌.化學(xué)指示劑.蒸汽滲透布維-狄(Bowie和Dick)型試驗(yàn)2級(jí)指示劑系統(tǒng)

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

保健產(chǎn)品的消毒.化學(xué)指示劑.選擇、使用和結(jié)果說明用指南

Sterilization of health care products   - Chemical indicators - Guidance for selection, use and interpretation of   results

BS ISO 11140-5-2007

衛(wèi)生保健品滅菌.化學(xué)指示劑.布維-狄(Bowie和Dick)型除氣試驗(yàn)用2級(jí)指示劑

Sterilization of health care products   - Chemical indicators - Class 2 indicators for Bowie and Dick-type air   removal tests

BS ISO 21527-1-2008

食品和動(dòng)物飼料的微生物學(xué).酵母和霉菌的計(jì)數(shù)用水平方法.水活性大于0.95的產(chǎn)品用菌落計(jì)數(shù)技術(shù)

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

醫(yī)院清潔服務(wù)的規(guī)劃, 應(yīng)用, 測量以及審查規(guī)格

Specification for the planning,   application, measurement and review of cleanliness services in hospitals

德國

DIN 58949-2-2014

消毒。蒸汽消毒儀 第二部分:要求 德語和英語文本

Disinfection. Steam disinfection   apparatus. Part2: Requirements; Text in German and English

DIN 58949-3-2012

消毒 蒸汽消毒裝置 第三部分:效率測試

Disinfection. Steam disinfection   apparatus. Part3: Efficiency testing

DIN 58949-4-2014

消毒。蒸汽消毒儀 第4部分:功效測試的生物指標(biāo)

Disinfection. Steam   disinfection-apparatus. Part4: Biological indicators for efficacy tests

DIN 58949-6-2015

消毒。蒸汽消毒儀 第六部分:蒸汽消毒設(shè)備的運(yùn)行,其安裝要求及其供應(yīng)來源

Disinfection. Steam disinfection   apparatus. Part6: Operation of steam disinfection apparatus, their   requirements for the installation and their supply sources

DIN EN 285-2016

滅菌。蒸汽滅菌器。大型消毒器

Sterilization. Steam sterilizers.   Large sterilizers; German version EN285:2015

DIN V ENV 12612-1997

醫(yī)療信息技術(shù).衛(wèi)生行業(yè)行政管理信息交換報(bào)文

Medical informatics - Messages for   the exchange of healthcare administrative information; English version ENV   12612:1997







法國

NF S98-101-2-2008

衛(wèi)生保健品的消毒.環(huán)氧乙烷.第2部分:ISO 11135-1應(yīng)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

食品和動(dòng)物飼料的微生物學(xué).酵母和霉菌的計(jì)數(shù)的水平方法.第1部分:水活性大于0.95的產(chǎn)品用菌落計(jì)數(shù)技術(shù)

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過濾器的試驗(yàn)方法

Test method of HEPA filters for   microbiological use

JIS T7328-2005

醫(yī)用甲醛氣消毒器

Formaldehyde gas disinfecters for   medical use



韓國

KS P 6115-2006

醫(yī)用氧化乙烯氣體消毒器

Ethylene oxide gas sterilizers for   medical use

KS P 6116-2006

醫(yī)用氧化乙烯氣體消毒器(小型)

Ethylene oxide gas sterilizers for   medical use(Small size)






















其他國家

CAN/CSA-ISO 13958-2011

主要用于血液分析和相關(guān)治療(第一版)

Concentrés pour   hémodialyse et thérapies apparentées (Première édition)

CAN/CSA-Z22870-2007

重點(diǎn)護(hù)理即時(shí)檢驗(yàn)(POCT). 質(zhì)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

評價(jià)預(yù)防感染和控制感染的新材料和技術(shù)(第一版)

Evaluating emerging materials and   technologies for infection prevention and control (First Edition)

GOST 10385-2014

魚類綜合飼養(yǎng)人員. 通用規(guī)格

Combined feeding staffs for fishes.   General specifications

GOST 32375-2013

人類危險(xiǎn)化學(xué)品檢測. 皮膚過敏

Testing of chemicals of human hazard.   Skin sensitisation

GOST R 56677-2015

人身防范工程手段. 編碼, 標(biāo)識(shí)和標(biāo)記. 通用要求

Means of physical protection   engineering. Coding, identification and marking. General requirements

AS/NZS 3896-2008

水.包括嗜肺軍團(tuán)菌的在內(nèi)的軍團(tuán)菌的檢查

Waters—Examination for Legionella

spp. including Legionella pneumophila

SNZ PAS 8170-2005

初級(jí)衛(wèi)生保健實(shí)踐管理系統(tǒng)

PRIMARY HEALTHCARE PRACTICE   MANAGEMENT SYSTEMS

SANS 1780-2018

一般用途過氧化氫和過氧乙酸產(chǎn)品的殺菌效果

Bactericidal efficacy of peroxide and   peracetic acid based products for general use.

UL 2783 BULLETIN-2015

UL安全標(biāo)準(zhǔn) 即時(shí)性手消毒產(chǎn)品的可持續(xù)性

Ul Standard For Safety Sustainability   Of Instant Hand Antiseptic Products (Comments Due: March 16, 2015)


第三部份 手套相關(guān)國內(nèi)外標(biāo)準(zhǔn)


國別

標(biāo)準(zhǔn)號(hào)

中文題名

英文題名











中國

GB   7543-2006

一次性使用滅菌橡膠外科手套

Single-use   sterile rubber surgical gloves

GB   10213-2006

一次性使用醫(yī)用橡膠檢查手套

Single-use   medical rubber examination gloves

GB/T   21869-2008

醫(yī)用手套表面殘余粉末的測定

Medical   gloves.Determination of removable surface powder

GB/T   21870-2008

天然膠乳醫(yī)用手套水抽提蛋白質(zhì)的測定. 改進(jìn)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醫(yī)用檢查手套

Single-use   medical poly (vinyl chloride) examination gloves

GB   24788-2009

醫(yī)用手套表面殘余粉末、水抽提蛋白質(zhì)限量

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

YY/T   0616.1-2016

一次性使用醫(yī)用手套.第1部分: 生物學(xué)評價(jià)要求與試驗(yàn)

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

YY/T   0616.2-2016

一次性使用醫(yī)用手套 第2部分: 測定貨架壽命的要求和試驗(yàn)

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

YY/T   0616.3-2018

一次性使用醫(yī)用手套 第3部分: 用倉貯中的成品手套確定實(shí)際時(shí)間失效日期的方法

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

一次性使用醫(yī)用手套 第4部分: 抗穿刺試驗(yàn)方法

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

YY/T   0616.5-2019

一次性使用醫(yī)用手套 第5部分: 抗化學(xué)品滲透 持續(xù)接觸試驗(yàn)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(shù)用橡膠手套

Surgical   rubber gloves

CNS   12837-1991

一般醫(yī)療用聚氯乙烯手套

Polyvinyl   Chloride Medical Gloves

CNS   12838-1991

一般醫(yī)療用聚氯乙烯手套檢驗(yàn)法

Method   of Test for Polyvinyl Chloride Medical Gloves









國際

ISO   11193-1-2008

一次性醫(yī)用檢驗(yàn)手套. 第1部分: 橡膠乳膠或膠液制手套規(guī)范

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

ISO   11193-1 AMD 1-2012

一次性醫(yī)用檢驗(yàn)手套. 第1部分: 橡膠乳膠或膠液制手套規(guī)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

一次性醫(yī)用檢查手套. 第2部分: 聚乙烯(氯乙烯)制手套規(guī)范

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

ISO   12243-2003

醫(yī)用天然膠乳手套   用改性格雷法測量可水萃取的蛋白質(zhì)

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

ISO   21171-2006

醫(yī)療專用手套.可移動(dòng)表面粉末的測定

Medical   gloves - Determination of removable surface powder










歐洲 

EN   455-1-2000

一次性醫(yī)用手套. 第1部分: 無孔試驗(yàn)和要求

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

EN   455-2-2015

一次性醫(yī)用手套. 第2部分: 物理性能要求和試驗(yàn)

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

EN   455-3-2015

一次性醫(yī)用手套 第3部分:生物評定要求和試驗(yàn)

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

EN   455-4-2009

一次性醫(yī)用手套. 第4部分: 保質(zhì)期測定要求和檢驗(yàn)

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

CEN/TR   16953-2017

一次性醫(yī)用手套. 選擇指南

Medical   gloves for single use - Guidance for selection

EN   ISO 21171-2006

醫(yī)療專用手套.可移動(dòng)表面粉末的測定 ISO 21171-2006

Medical   gloves Determination of removable surface powder



















美國

ASTM   D3578-2019

橡膠檢驗(yàn)手套標(biāo)準(zhǔn)規(guī)范

Standard   Specification for Rubber Examination Gloves

ASTM   D5151-2006(2015)

檢測醫(yī)用手套漏孔的標(biāo)準(zhǔn)試驗(yàn)方法

Standard   Test Method for Detection of Holes in Medical Gloves

ASTM   D5250-2019

醫(yī)用聚氯乙烯手套的標(biāo)準(zhǔn)規(guī)范

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

ASTM   D6124-2006(2017)

醫(yī)用手套殘余粉末的標(biāo)準(zhǔn)試驗(yàn)方法

Standard   Test Method for Residual Powder on Medical Gloves

ASTM   D6319-2000a(2005)

醫(yī)用腈橡膠檢驗(yàn)手套的標(biāo)準(zhǔn)規(guī)范

Standard   Specification for Nitrile Examination Gloves for Medical Application

ASTM   D6319-2010

醫(yī)用腈類檢驗(yàn)手套的標(biāo)準(zhǔn)規(guī)范

Standard   Specification for Nitrile Examination Gloves for Medical Application

ASTM   D6319-2019

醫(yī)用腈檢驗(yàn)手套規(guī)格

Standard   Specification for Nitrile Examination Gloves for Medical Application

ASTM   D6355-1998(2003)

醫(yī)用手套人重復(fù)損害修補(bǔ)試驗(yàn)的標(biāo)準(zhǔn)試驗(yàn)方法

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

ASTM   D6977-2019

醫(yī)療檢查用氯丁橡膠手套的標(biāo)準(zhǔn)規(guī)格

Standard   Specification for Polychloroprene Examination Gloves for Medical Application

ASTM   D6978-2005(2019)

醫(yī)用手套對化療藥物滲透阻力的評價(jià)的標(biāo)準(zhǔn)操作規(guī)程

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

ASTM   D7102-2010

測定無菌醫(yī)用手套上的內(nèi)毒素的標(biāo)準(zhǔn)指南

Standard   Guide for Determination of Endotoxin on Sterile Medical Gloves

ASTM   D7103-2018

醫(yī)用手套評定的標(biāo)準(zhǔn)指南

Standard   Guide for Assessment of Medical Gloves

ASTM   D7160-2016

醫(yī)用手套有效期測定的標(biāo)準(zhǔn)實(shí)施規(guī)程

Standard   Practice for Determination of Expiration Dating for Medical Gloves

ASTM   D7161-2016

測定典型倉庫條件下存放的成熟醫(yī)用手套實(shí)時(shí)有效期的標(biāo)準(zhǔn)實(shí)施規(guī)程

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

ASTM   D7907-2014

測定醫(yī)用檢查手套表面殺菌作用的標(biāo)準(zhǔn)試驗(yàn)方法

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

ANSI/ADA   102-1998

牙醫(yī)用無菌丁二烯手套

Non-Sterile   Nitrile Gloves for Dentistry

ANSI/ADA   103-2001

牙醫(yī)用無菌增塑聚氯乙烯手套

Non-Sterile   Polyvinyl Chloride Gloves for Dentistry














英國

BS   EN 455-1-2000

一次性醫(yī)用手套 無孔要求和測試

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

BS   EN 455-2-2015

一次性醫(yī)用手套.物理性質(zhì)的要求和測定

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

BS   EN 455-3-2015

一次性醫(yī)用手套 第3部分:生物評定要求和試驗(yàn)

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

BS   EN 455-4-2009

一次性醫(yī)用手套.第4部分: 測定貨架壽命的試驗(yàn)和要求

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

BS   EN ISO 21171-2006

醫(yī)療專用手套.可移動(dòng)表面粉末的測定

Medical   gloves - Determination of removable surface powder

BS   ISO 12243-2003+A1-2012

醫(yī)用天然膠乳手套   用改良的半細(xì)胞法測定水可萃取蛋白質(zhì)

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

BS   PD CEN/TR 16953-2017

一次性醫(yī)用手套. 選擇指南

Medical   gloves for single use. Guidance for selection














德國

DIN   58133-2008

醫(yī)療壓縮襪

Medical   compression hosiery

DIN   EN 455-1-2001

一次性醫(yī)用手套. 第1部分:密封性要求和檢驗(yàn)

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

一次性醫(yī)用手套. 第2部分:物理特性用要求和試驗(yàn).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

一次性醫(yī)用手套. 第3部分:生物評定要求和試驗(yàn);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

醫(yī)用手套一次性使用 第4部分:保質(zhì)期確定的要求和測試;

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

DIN   EN ISO 21171-2006

醫(yī)療專用手套. 可移動(dòng)表面粉末的測定 (ISO 21171-2006)

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

法國

NF   S97-004-2006

醫(yī)療專用手套. 可移動(dòng)表面粉末的測定

Medical   gloves - Determination of removable surface powder.





泰國

TIS   1056.1-2013

一次性醫(yī)用檢查手套. 第1部分: 橡膠乳膠或橡膠溶液制手套規(guī)范

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

TIS   1056-2005

一次性醫(yī)用檢查手套. 第1部分: 橡膠乳膠或橡膠溶液制手套規(guī)范

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





越南

TCVN   6343-1-2007

一次性醫(yī)用檢查手套. 第1部分: 橡膠膠乳或膠液制手套規(guī)范

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

TCVN   6343-2-2007

一次性醫(yī)用檢查手套. 第2部分: 聚乙烯(氯乙烯)制手套規(guī)范

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




























其他國家

GOST   EN 455-1-2014

一次性醫(yī)用手套. 第1部分. 緊密性的測定方法

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

GOST   EN 455-2-2014

一次性醫(yī)用手套. 第2部分. 物理特性的測定方法

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

GOST   R 52239-2004

一次性醫(yī)療檢查手套. 第1部分: 橡膠乳膠或橡膠膠漿制手套規(guī)范

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

GOST   R 57397-2017

醫(yī)療檢查用橡膠手套. 技術(shù)要求

Rubber   examination medical gloves. Technical requirements

GOST   R 57402-2017

醫(yī)用手套. 使用期限的測定

Medical   gloves. Determination of expiration dating

GOST   R 57403-2017

醫(yī)用聚氯乙稀手套. 技術(shù)要求

Poly(vinyl   chloride) medical gloves. Technical requirements

GOST   R 57404-2017

醫(yī)用手套. 質(zhì)量評估指南

Medical   gloves. Quality assessment guide

SANS   11193-1-2010

一次性使用醫(yī)用檢查手套 第1部分:橡膠膠乳或橡膠溶液制成的手套規(guī)范

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

SANS   15190-2016

醫(yī)用手套 安全要求

Medical   laboratories - Requirements for safety

LST   EN 455-1-2001

一次性醫(yī)用手套. 第1部分:孔自由度試驗(yàn)和要求

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

LST   EN 455-2-2015

一次性醫(yī)用手套. 第2部分: 物理特性的要求和檢驗(yàn)

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

LST   EN 455-3-2015

一次性醫(yī)用手套. 第3部分: 生物評價(jià)的要求和試驗(yàn)

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

LST   EN ISO 21171-2006

醫(yī)用手套表面殘余粉末的測定(ISO 21171-2006)

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

SNI   ISO 11193.1-2010

一次性醫(yī)用檢驗(yàn)手套. 第1部分:用橡膠乳和膠液制成的手套規(guī)范

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

SNI   ISO 11193.2-2010

一次性醫(yī)用檢查手套. 第2部分: 聚氯乙烯制成的手套規(guī)格

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

STN   EN 455-1-2002

一次性醫(yī)用手套. 第1部分: 指孔間自由度的要求和試驗(yàn)

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

STN   EN 455-2-2015

一次性醫(yī)用手套. 第2部分: 物理特性的要求和檢驗(yàn)

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

STN   EN 455-4-2009

一次性醫(yī)用手套. 第4部分: 測定貨架壽命的要求和試驗(yàn)

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

ABNT   NBR ISO 11193-1-2009/Amd 1-2015

一次性醫(yī)用檢驗(yàn)手套。第1部分:用膠乳或膠水制成的手套規(guī)范


ABNT   NBR ISO 11193-1-2015

一次性醫(yī)用檢驗(yàn)手套

Single-use   medical examination gloves

ABNT   NBR ISO 11193-2-2013

一次性使用的醫(yī)療檢查手套 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

一次性使用醫(yī)用手套第3部分:生物學(xué)評價(jià)要求和測試

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

DS/EN   ISO 21171-2006

醫(yī)用手套可移動(dòng)表面粉末的測定

Medical   gloves - Determination of removable surface powder


第四部分 防護(hù)服相關(guān)國內(nèi)外標(biāo)準(zhǔn)


國別

標(biāo)準(zhǔn)號(hào)

中文題名

英文題名

中國

GB   19082-2009

醫(yī)用一次性防護(hù)服技術(shù)要求

Technical   requirements for single-use protective clothing for medical use

GB/T   20097-2006

防護(hù)服一般要求

Protective   clothing - General requirements

YY   0318-2000

醫(yī)用診斷X射線輻射防護(hù)器具.第3部分:防護(hù)服和性腺防護(hù)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、醫(yī)護(hù)人員和器械用手術(shù)單、手術(shù)衣和潔凈服   第1部分:制衣廠、處理廠和產(chǎn)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、醫(yī)護(hù)人員和器械用手術(shù)單、手術(shù)衣和潔凈服   第2部分:性能要求和試驗(yàn)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、醫(yī)護(hù)人員和器械用手術(shù)單、手術(shù)衣和潔凈服   第4部分:干態(tài)落絮試驗(yàn)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、醫(yī)護(hù)人員和器械用手術(shù)單、手術(shù)衣和潔凈服   第5部分:阻干態(tài)微生物穿透試驗(yàn)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、醫(yī)護(hù)人員和器械用手術(shù)單、手術(shù)衣和潔凈服   第6部分:阻濕態(tài)微生物穿透試驗(yàn)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、醫(yī)護(hù)人員和器械用手術(shù)單、手術(shù)衣和潔凈服   第7部分:潔凈度-微生物試驗(yàn)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、醫(yī)護(hù)人員和器械用手術(shù)單、手術(shù)衣和潔凈服   第8部分:產(chǎn)品專用要求

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

YY/T   0689-2008

血液和體液防護(hù)裝備.防護(hù)服材料抗血液傳播病原體穿透性能測試.Phi-X174噬菌體試驗(yàn)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

液態(tài)化學(xué)品防護(hù)裝備.防護(hù)服材料抗加壓液體穿透性能測試方法

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

YY/T   0700-2008

血液和體液防護(hù)裝備.防護(hù)服材料抗血液和體液穿透性能測試.合成血試驗(yàn)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

血液和體液防護(hù)裝備.防護(hù)服材料抗血液和體液穿透性能測試.合成血試驗(yàn)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

醫(yī)用防護(hù)服的選用評估指南

Guideline   for evaluation of selection and use of medical protective clothing

YY/T   1499-2016

醫(yī)用防護(hù)服的液體阻隔性能和分級(jí)

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

YY/T   1632-2018

醫(yī)用防護(hù)服材料的阻水性:沖擊穿透測試方法

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

國際

ISO   16603-2004

防止接觸血液和體液的防護(hù)服.防護(hù)服材料防止血液和體液滲透性的測定.使用人造血液的試驗(yàn)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

防止接觸血液和體液的防護(hù)服.防護(hù)服材料防止血液病原滲透性的測定.使用Phi-X 174噬菌體的試驗(yàn)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

傳染試劑防護(hù)服.醫(yī)療面罩.防人造血滲透的試驗(yàn)方法(固定容積,水平噴射)

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

防傳感病病原體的防護(hù)服   防干微生物侵入能力的試驗(yàn)方法

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

歐洲

EN   14126-2003

防護(hù)服.防傳病毒防護(hù)服的性能要求和試驗(yàn)方法.合并勘誤表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

防護(hù)服 抗感染防護(hù)服的性能要求和試驗(yàn)方法

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

EN   ISO 22612-2005

防傳感病病原體的防護(hù)服   防干微生物侵入能力的試驗(yàn)方法

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

EN   61331-3-2014

醫(yī)用診斷x射線輻射防護(hù)器具. 第3部分: 防護(hù)服, 護(hù)目鏡和患者防護(hù)罩

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

美國

AAMI   PB70-2012

FDA認(rèn)可的用于衛(wèi)生保健設(shè)施的防護(hù)服和防護(hù)單的液體阻隔性能及分類

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

ANSI/PB70-2012

旨在用于醫(yī)療保健設(shè)施的防護(hù)服和防護(hù)層的液體屏障性能和分類(FDA認(rèn)可)

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

ANSI/AAMI   PB70-2012

醫(yī)療保健設(shè)施中使用的防護(hù)服和防護(hù)布的液體阻擋層性能和分類

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

ANSI/NFPA   1999-2008

急救醫(yī)療手術(shù)用防護(hù)服的標(biāo)準(zhǔn)

Standard   on Protective Clothing for Emergency Medical Operations

ASTM   F903-2018

防護(hù)服用材料耐液體滲透性的試驗(yàn)方法

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

ASTM   F1670/F1670M-2017a

防護(hù)服材料對合成血液滲透的阻力的標(biāo)準(zhǔn)試驗(yàn)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噬菌體滲透作為試驗(yàn)系統(tǒng)的血源性病原體對防護(hù)服使用的抗?jié)B透材料用標(biāo)準(zhǔn)試驗(yàn)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

防護(hù)服材料耐皮下注射針頭剌破性試驗(yàn)方法

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

ASTM   F3050-2017

個(gè)人防護(hù)服及設(shè)備合格評定指南

Standard   Guide for Conformity Assessment of Personal Protective Clothing and Equipment

NFPA   1999-2018

緊急醫(yī)療服務(wù)用防護(hù)服和服裝標(biāo)準(zhǔn)

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

英國

BS   EN 14325-2018

化學(xué)藥品防護(hù)服 化學(xué)防護(hù)服裝材料、縫合線、聯(lián)結(jié)和組合的試驗(yàn)方法和性能分類

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

BS   EN 61331-3-2014

防醫(yī)療診斷用X射線的防護(hù)裝置. 防護(hù)服, 護(hù)目鏡和患者防護(hù)罩

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

BS   EN ISO 13688-2013

防護(hù)服 通用要求

Protective   clothing. General requirements

BS   EN ISO 22612-2005

傳染介質(zhì)防護(hù)服.防干微生物滲入的試驗(yàn)方法

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

BS   ISO 16603-2004

防止接觸血液和體液的防護(hù)服.防護(hù)服材料防止血液和體液滲透性的測定.使用人造血液的試驗(yàn)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

德國

DIN   EN 61331-3-2016

防醫(yī)療診斷用X射線的防護(hù)裝置.第3部分:防護(hù)服,護(hù)目鏡和患者防護(hù)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

防傳感病病原體的防護(hù)服   防干微生物侵入能力的試驗(yàn)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

血液和體液接觸的防護(hù)用服裝.血液和體液滲透防護(hù)服裝材料

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

防止接觸血液和體液的防護(hù)服   測定防護(hù)服材料對血源性病原體滲透的抵抗力 使用Phi-X174噬菌體的測試方法

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

預(yù)防傳染性病原體的防護(hù)服.面罩.防止人造血漿滲透的試驗(yàn)方法(確定容量,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

醫(yī)療診斷用X射線防護(hù)裝置. 第3部分: 防護(hù)服, 護(hù)目鏡和患者防護(hù)罩

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

韓國

KS   K ISO 22609-2012

傳染試劑防護(hù)服.醫(yī)療面罩.防人造血滲透的試驗(yàn)方法(固定容積、水平噴射)

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

其他國家

DS/EN   61331-3-1999

防止診斷醫(yī)療X射線輻射的保護(hù)裝置 - 第3部分:生殖器防護(hù)服和保護(hù)裝置

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

GOST   R 57493-2017

醫(yī)療器械. 放射科材料防護(hù)服. 政府采購技術(shù)要求

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

GOST   R 57503-2017

醫(yī)療器械. 放射科患者防護(hù)服. 政府采購技術(shù)要求

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

ABNT   NBR IEC 61331-3-2004

防護(hù)服和性腺防護(hù)裝置-對診斷醫(yī)用X射線防護(hù)裝置第3部分

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

LST   EN 61331-3-2014

醫(yī)用診斷x射線輻射防護(hù)器具. 第3部分: 防護(hù)服, 護(hù)目鏡和患者防護(hù)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

傳染試劑防護(hù)服.醫(yī)療面罩.防人造血滲透的試驗(yàn)方法(固定容積,水平噴射)

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

醫(yī)用診斷X射線輻射防護(hù)器具. 第3部分: 防護(hù)服和性腺防護(hù)器具

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

STN   EN 61331-3-2015

醫(yī)用診斷X射線輻射防護(hù)器具. 第3部分: 防護(hù)服, 護(hù)目鏡和患者防護(hù)罩

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

IS   16545-2016

防止接觸血液和體液的衣服-血傳播致病菌對防護(hù)服材料滲透性的測定-Phi-X174噬菌體試驗(yàn)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

防止接觸血液和體液的衣服-血液和體液滲透性測定防護(hù)服材料的滲透性-合成血液的試驗(yàn)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


第五部分 護(hù)目鏡相關(guān)國內(nèi)外標(biāo)準(zhǔn)


國別

標(biāo)準(zhǔn)號(hào)

中文題名

英文題名

中國

GB   14866-2006

個(gè)人用眼護(hù)具技術(shù)要求

The   specifications for personal eye-protectors





國際

ISO   4849-1981

個(gè)人用護(hù)目鏡 技術(shù)要求

Personal   eye-protectors. Specifications first edition

ISO   12609-1-2013

第1部分: 產(chǎn)品規(guī)范. 防護(hù)人體和動(dòng)物用強(qiáng)光源用于化妝品和醫(yī)療用途的護(hù)目鏡. 第1部分: 產(chǎn)品規(guī)范

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

歐洲

EN   166-2001

個(gè)人眼睛保護(hù) - 規(guī)格

Personal   Eye-Protection. Specifications



英國

BS   EN 61331-3-2014

防醫(yī)療診斷用X射線的防護(hù)裝置. 防護(hù)服, 護(hù)目鏡和患者防護(hù)罩

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





德國

DIN   EN 61331-3-2016

防醫(yī)療診斷用X射線的防護(hù)裝置.第3部分:防護(hù)服,護(hù)目鏡和患者防護(hù)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



法國

NF   C74-228-3-2015

防醫(yī)療診斷用X射線的防護(hù)裝置. 第3部分: 防護(hù)服, 護(hù)目鏡和患者防護(hù)罩

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


日本

JIS   T8147-2016

個(gè)人眼睛防護(hù)

Personal   eye protectors




韓國

KS   G ISO 12609-1-2014

第1部分:產(chǎn)品規(guī)范。防護(hù)人體和動(dòng)物用強(qiáng)光源用于化妝品和醫(yī)療用途的護(hù)目鏡。第1部分:產(chǎn)品規(guī)范

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






其他國家

LST   EN 61331-3-2014

醫(yī)用診斷x射線輻射防護(hù)器具. 第3部分: 防護(hù)服, 護(hù)目鏡和患者防護(hù)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

醫(yī)用診斷X射線輻射防護(hù)器具. 第3部分: 防護(hù)服, 護(hù)目鏡和患者防護(hù)罩

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