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標(biāo)準(zhǔn)號(hào)

中文題名

英文題名

中國(guó)

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(guò)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(cè)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(píng)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(guò)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(guò)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(cè)方法和評(píng)價(jià)要求

Monitoring requirements and evaluation of sterilization effect of small steam sterilizer

GB/T 33417-2016

過(guò)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(píng)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(yǔ)

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(píng)價(jià)技術(shù)要求

WS/T 646-2019

過(guò)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(guó)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(guó)際旅行衛(wèi)生保健中心 質(zhì)量管理標(biāo)準(zhǔn)及評(píng)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(píng)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(chǎng)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(guò)程臭氧及過(guò)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(guó)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(cè)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(cè)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(wú)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(wú)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(wú)菌加工.第2部分:除菌過(guò)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(wú)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(wú)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(zhǎng)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(guó)

ANSI/AAMI/ISO 13408-2-2003

醫(yī)療保健產(chǎn)品的無(wú)菌加工.第2部分:過(guò)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(wú)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(wú)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(wú)菌加工.第5部分:現(xiàn)場(chǎng)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(wú)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(wú)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(wú)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(wú)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(wú)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(wú)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(wú)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(píng)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(jiǎn)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(yíng)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(píng)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(duì)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(qǐng)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(duì)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(wú)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(wú)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(píng)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(cè)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(píng)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(píng)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(cè)試消毒劑對(duì)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(cè)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(guó)

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(yǔ)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(cè)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(shuō)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(cè)量以及審查規(guī)格

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

德國(guó)

DIN 58949-2-2014

消毒、蒸汽消毒儀

第二部分：要求 德語(yǔ)和英語(yǔ)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(cè)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(cè)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(lái)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(guó)

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(guò)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(guó)

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(guó)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(píng)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(cè). 皮膚過(guò)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(guò)氧化氫和過(guò)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)

國(guó)別

標(biāo)準(zhǔn)號(hào)

中文題名

英文題名

中國(guó)

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(cè)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(cè)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(píng)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(cè)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(cāng)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(guó)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(cè)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(cè)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(wú)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(píng)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(cè)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(cè)定 ISO 21171-2006

Medical gloves Determination of removable surface powder

美國(guó)

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(cè)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(duì)化療藥物滲透阻力的評(píng)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(cè)定無(wú)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(píng)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(cè)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(cè)定典型倉(cāng)庫(kù)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(cè)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(wú)菌丁二烯手套

Non-Sterile Nitrile Gloves for Dentistry

ANSI/ADA 103-2001

牙醫(yī)用無(wú)菌增塑聚氯乙烯手套

Non-Sterile Polyvinyl Chloride Gloves for Dentistry

英國(guó)

BS EN 455-1-2000

一次性醫(yī)用手套 無(wú)孔要求和測(cè)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(cè)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(píng)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(cè)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(cè)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(cè)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(guó)

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(píng)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(cè)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(cè)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(guó)

NF S97-004-2006

醫(yī)療專用手套. 可移動(dòng)表面粉末的測(cè)定

Medical gloves - Determination of removable surface powder.

泰國(guó)

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(guó)家

GOST EN 455-1-2014

一次性醫(yī)用手套

第1部分. 緊密性的測(cè)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(cè)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(cè)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(píng)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(píng)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(cè)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 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(cè)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(píng)價(jià)要求和測(cè)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(cè)定

Medical gloves - Determination of removable surface powder

國(guó)別

標(biāo)準(zhǔn)號(hào)

中文題名

英文題名

中國(guó)

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(cè)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(cè)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(cè)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(cè)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(píng)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(cè)試方法

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

國(guó)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(cè)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(cè)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(guó)

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(duì)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(duì)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(píng)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(guó)

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(cè)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(guó)

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(cè)定防護(hù)服材料對(duì)血源性病原體滲透的抵抗力 使用Phi-X174噬菌體的測(cè)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(guó)

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(guó)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(gòu)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(gòu)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(duì)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(duì)防護(hù)服材料滲透性的測(cè)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(cè)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

國(guó)別

標(biāo)準(zhǔn)號(hào)

中文題名

英文題名

中國(guó)

GB 14866-2006

個(gè)人用眼護(hù)具 技術(shù)要求

The specifications for personal eye-protectors

國(guó)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(guó)

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(guó)

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(guó)

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(guó)

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(guó)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-Part3:Protectiveclothing,eyewear and protective patient shields