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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量控制

Quality control for radiation sterilization of medical and hygienical products

GB 18280-2000

醫(yī)療保健產品滅菌   確認和常規(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

臨床實驗室定量測定室內質量控制指南

Guideline for internal quality control for quantitative measurements in clinical laboratory

GB/T 20469-2006

臨床實驗室設計總則

General guideline of the clinical laboratory design

GB/T 20470-2006

臨床實驗室室間質量評價要求

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)生標準

Hygienic standard for chlorine dioxide disinfectant

GB/T 26367-2010

胍類消毒劑衛(wèi)生標準

Hygienic standard for biguanides disinfectants

GB/T 26368-2010

含碘消毒劑衛(wèi)生標準

Hygienic standard for iodine disinfectants

GB/T 26369-2010

季銨鹽類消毒劑衛(wèi)生標準

Hygienic standard for quaternary ammonium disinfectant

GB/T 26370-2010

含溴消毒劑衛(wèi)生標準

Hygienic standard for disinfectants with bromine

GB/T 26371-2010

過氧化物類消毒劑衛(wèi)生標準

Hygienic standard for peroxide disinfectants

GB/T 26372-2010

戊二醛消毒劑衛(wèi)生標準

Hygienic standard for glutaraldehyde disinfectant

GB/T 26373-2010

乙醇消毒劑衛(wèi)生標準

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)生標準

Safety and sanitation standard for ozone generator

GB 28233-2011

次氯酸鈉發(fā)生器安全與衛(wèi)生標準

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)生標準

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)生標準

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)生標準

Safety and sanitation standard for chlorine dioxide disinfectant generator

GB/T 30224-2013

剛地弓形蟲試驗臨床應用

Clinical use of tests for Toxoplasma gondii

GB 30689-2014

內鏡自動清洗消毒機衛(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)氧乙烷滅菌化學指示物檢驗方法

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)用臭氧消毒設備

Ozone disinfector for medical purpose

YY 0970-2013

含動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驗評價要求

Requirements of mycobactericidal evaluation for disinfectant in laboratory

WS/T 466-2014

消毒專業(yè)名詞術語

Disinfection professional terms

WS/T 496-2017

臨床實驗室質量指標

Quality indicators in clinical laboratories

WS/T 497-2017

侵襲性真菌病臨床實驗室診斷操作指南

Performance guideline for clinical laboratory diagnosis of invasive fungal diseases

WS/T 498-2017

細菌性腹瀉臨床實驗室診斷操作指南

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規(guī)范

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

WS/T 514-2017

臨床檢驗方法檢出能力的確立和驗證

Establishment and verification of detection capability for clinical laboratory measurement procedures

WS 628-2018

消毒產品衛(wèi)生安全評價技術要求

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-質譜聯用檢驗方法

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-串聯質譜檢驗方法

SN/T 1823-2006

醫(yī)學媒介生物衛(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 質量管理標準及評價

Quanlity management criterion and evaluation of international travel healthcare centre

SN/T 4387-2015

進出口一次性使用衛(wèi)生用品檢驗規(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)療機構消毒滅菌工作規(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方法與標準

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

DB13/T 491-2003

有害生物防制服務質量要求

DB31/ 405-2008

公共場所空調通風系統(tǒng)運行衛(wèi)生要求

DB31/ 358-2006

驅避劑衛(wèi)生安全要求

DB31/ 354-2005

消毒劑生產環(huán)境衛(wèi)生要求

DB31/ 486-2010

獻血屋(點)安全衛(wèi)生要求

Requirements for Fixed Collection Sites

DB31/T 794-2014

老年護理院分級護理要求

Requirments of grading nursing in Geriatric Nursing Hospital

DB34/T 1352-2011

住宿業(yè)衛(wèi)生服務規(guī)范

Hygienic Service Specification for Lodging Industry

DB44/T 951-2011

水產品加工過程臭氧及過氧化氫使用準則

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

保健產品之滅菌─化學指示劑─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

食品和動物飼料的微生物學.沙門氏菌屬檢測的水平法.技術勘誤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.化學指示劑.第3部分:布維-狄克(Bowie and Dick-type)蒸汽穿透試驗用2級指示劑體系

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.化學指示劑.第4部分:蒸汽穿透檢測布維-狄(Bowie and Dick)形式試驗的2級指示劑

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.化學指示劑.第5部分:布維-狄克形式(Bowie and Dick-type)除氣試驗的2級指示劑

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. 化學指示物. 試驗設備

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

化學消毒劑和防腐劑.消毒洗手液.檢驗方法和要求(第2階段/2級)

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

保健產品的無菌加工.第4部分:就地清洗技術

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

ANSI/AAMI/ISO 13408-5-2006

保健產品的無菌加工.第5部分:現場消毒

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

ANSI/AAMI/ISO 13408-6-2005

保健產品的無菌加工.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

保健產品的無菌加工.第7部分:非典型醫(yī)療設備和組合產品用替換加工

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)感染控制風險評估專業(yè)資格標準

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

ANSI/ASTM E2553-2007

自動通用衛(wèi)生保健識別系統(tǒng)實施用指南

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(層流)生物安全室

Class II (laminar flow) biosafety cabinetry

ANSI/NSF 49(i15r2)-2008

生物安全柜:設計,制作,性能和行業(yè)認證

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

ANSI/NSF 49(i27)-2011

生物安全柜:設計,制作,性能和行業(yè)認證

Biosafety Cabinetry: Design, Construction, Performance and Field Certification

ANSI/NSF 49(i42)-2011

生物安全柜:設計,制作,性能和行業(yè)認證

Biosafety Cabinetry: Design, Construction, Performance and Field Certification

ANSI/NSF 49(i43)-2011

生物安全廚柜:設計,建造,性能和實地認證

Biosafety Cabinetry: Design, Construction, Performance and Field Certification

ASHRAE QC-06-066-2006

在飛機艙實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)：與聯邦隔離、隔離或有條件釋放令下的旅行者有關的要求.

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)生預防措施，以發(fā)現傳染病.

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)：航空公司經營的飛機上死亡或生病的報告.

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)：支付護理和治療費用.

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)：有關發(fā)出聯邦檢疫、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)：強制重新評估用于隔離、隔離或條件釋放的聯邦訂單.

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)：對聯邦隔離令、隔離令或有條件釋放令的醫(yī)學審查.

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)：與聯邦檢疫、隔離或有條件釋放有關的行政記錄.

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：老年人和殘疾人聯邦醫(yī)療保險.第C子部分：暫停付款，追回多付款項，償還獎學金和貸款.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：老年人和殘疾人聯邦醫(yī)療保險.第X子部分：農村衛(wèi)生診所和聯邦合格醫(yī)療中心服務.第405.2413節(jié)：與醫(yī)生服務有關的服務和用品.

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：老年人和殘疾人聯邦醫(yī)療保險.第X子部分：農村衛(wèi)生診所和聯邦合格醫(yī)療中心服務.第405.2415節(jié)：服務事故和直接監(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：補充醫(yī)療保險福利.第 B子部分：醫(yī)療和其他衛(wèi)生服務.第410.26節(jié)：向醫(yī)生提供的服務和用品事件：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：補充醫(yī)療保險福利.第 B子部分：醫(yī)療和其他衛(wèi)生服務.第410.79節(jié)：醫(yī)療保健糖尿病預防方案擴大模式：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)療保險除外和醫(yī)療保險支付的限制.第 J子部分：提供指定保健服務的醫(yī)生和實體之間的財務關系.第411.357 節(jié)：與賠償安排有關的禁止轉介的例外情況.

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)療保險除外和醫(yī)療保險支付的限制.第 J子部分：提供指定保健服務的醫(yī)生和實體之間的財務關系.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)生服務費用.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)生服務費用.第B子部分：醫(yī)生和其他從業(yè)人員.第414.90節(jié)：醫(yī)師質量報告制度.

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)生服務費用第B子部分：醫(yī)生和其他從業(yè)人員第414.94節(jié)：先進診斷成像服務的適當使用標準

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

保健產品的無菌加工

第7部分:非典型醫(yī)療設備和組合產品用替換加工

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準試驗方法

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

ASTM E1714-2000

通用保健識別符(UHTD)特性的標準指南

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算D值及濃度系數的標準指南

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準實施規(guī)程

Standard Practice for Cleaning and Maintaining Controlled Areas and Clean Rooms

ASTM E2720-2010

當表層沾有人體病原性病毒時用于評估透氣材料凈化程序效能的標準試驗方法

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表面凈化程序效能的標準試驗方法

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 化驗測試消毒劑對綠膿桿菌(Pseudomonas aeruginosa)生物膜功效的標準試驗方法

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,槽和架式水驅動旋轉噴射器皿站

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備 

第2部分:裝含水液體的密封硬質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

實驗室生物危害管理

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

保健產品的消毒.潮熱.ISO 17665-1應用指南

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

BS EN 13549-2001

清潔服務.質量度量系統(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.化學指示劑.蒸汽滲透布維-狄(Bowie和Dick)型試驗2級指示劑系統(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

保健產品的消毒.化學指示劑.選擇、使用和結果說明用指南

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.化學指示劑.布維-狄(Bowie和Dick)型除氣試驗用2級指示劑

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

BS ISO 21527-1-2008

食品和動物飼料的微生物學.酵母和霉菌的計數用水平方法.水活性大于0.95的產品用菌落計數技術

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)院清潔服務的規(guī)劃，應用， 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

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：蒸汽消毒設備的運行，其安裝要求及其供應來源

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.衛(wèi)生行業(yè)行政管理信息交換報文

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

食品和動物飼料的微生物學.酵母和霉菌的計數的水平方法.

第1部分:水活性大于0.95的產品用菌落計數技術

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治療(第一版)

Concentrés pour hémodialyse et thérapies apparentées (Première édition)

CAN/CSA-Z22870-2007

重點護理即時檢驗(POCT). 質量和能力的要求(第一版)

Point-of-care testing (POCT) - Requirements for quality and competence (First Edition)

CSA EXP06-2015

評價預防感染和控制感染的新材料和技術(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

人類危險化學品檢測. 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, 標識和標記. 通用要求

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

AS/NZS 3896-2008

水.包括嗜肺軍團菌的在內的軍團菌的檢查

Waters—Examination for Legionella spp. including Legionella pneumophila

SNZ PAS 8170-2005

初級衛(wèi)生保健實踐管理系統(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安全標準 即時性手消毒產品的可持續(xù)性

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

國別

標準號

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的測定. 改進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: 生物學評價要求與試驗

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

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際時間失效日期的方法

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: 抗化學品滲透 持續(xù)接觸試驗方法

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

CNS 12543-1997

外科手術用橡膠手套

Surgical rubber gloves

CNS 12837-1991

一般醫(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法

Method of Test for Polyvinyl Chloride Medical Gloves

國際

ISO 11193-1-2008

一次性醫(yī)用檢驗手套. 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

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

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

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: 保質期測定要求和檢驗

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

橡膠檢驗手套標準規(guī)范

Standard Specification for Rubber Examination Gloves

ASTM D5151-2006(2015)

檢測醫(yī)用手套漏孔的標準試驗方法

Standard Test Method for Detection of Holes in Medical Gloves

ASTM D5250-2019

醫(yī)用聚氯乙烯手套的標準規(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準試驗方法

Standard Test Method for Residual Powder on Medical Gloves

ASTM D6319-2000a(2005)

醫(yī)用腈橡膠檢驗手套的標準規(guī)范

Standard Specification for Nitrile Examination Gloves for Medical Application

ASTM D6319-2010

醫(yī)用腈類檢驗手套的標準規(guī)范

Standard   Specification for Nitrile Examination Gloves for Medical Application

ASTM D6319-2019

醫(yī)用腈檢驗手套規(guī)格

Standard Specification for Nitrile Examination Gloves for Medical Application

ASTM D6355-1998(2003)

醫(yī)用手套人重復損害修補試驗的標準試驗方法

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準規(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的標準操作規(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)用手套上的內毒素的標準指南

Standard   Guide for Determination of Endotoxin on Sterile Medical Gloves

ASTM D7103-2018

醫(yī)用手套評定的標準指南

Standard Guide for Assessment of Medical Gloves

ASTM D7160-2016

醫(yī)用手套有效期測定的標準實施規(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)用手套實時有效期的標準實施規(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準試驗方法

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

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   

用改良的半細胞法測定水可萃取蛋白質

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

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.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;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. 技術要求

Poly(vinyl chloride) medical gloves. Technical requirements

GOST R 57404-2017

醫(yī)用手套. 質量評估指南

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

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: 生物評價的要求和試驗

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

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

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: 測定貨架壽命的要求和試驗

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:生物學評價要求和測試

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

DS/EN ISO 21171-2006

醫(yī)用手套可移動表面粉末的測定

Medical gloves - Determination of removable surface powder

國別

標準號

中文題名

英文題名

中國

GB 19082-2009

醫(yī)用一次性防護服技術要求

Technical requirements for single-use protective clothing for medical use

GB/T 20097-2006

防護服一般要求

Protective clothing - General requirements

YY 0318-2000

醫(yī)用診斷X射線輻射防護器具.第3部分:防護服和性腺防護器具

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)護人員和器械用手術單、手術衣和潔凈服   

第1部分:制衣廠、處理廠和產品的通用要求

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)護人員和器械用手術單、手術衣和潔凈服   

第2部分：性能要求和試驗方法

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)護人員和器械用手術單、手術衣和潔凈服   

第4部分：干態(tài)落絮試驗方法

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)護人員和器械用手術單、手術衣和潔凈服   

第5部分:阻干態(tài)微生物穿透試驗方法

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)護人員和器械用手術單、手術衣和潔凈服   

第6部分:阻濕態(tài)微生物穿透試驗方法

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)護人員和器械用手術單、手術衣和潔凈服   

第7部分:潔凈度-微生物試驗方法

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)護人員和器械用手術單、手術衣和潔凈服   

第8部分：產品專用要求

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

YY/T 0689-2008

血液和體液防護裝備.防護服材料抗血液傳播病原體穿透性能測試.Phi-X174噬菌體試驗方法   

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)化學品防護裝備.防護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

血液和體液防護裝備.防護服材料抗血液和體液穿透性能測試.合成血試驗方法

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

血液和體液防護裝備.防護服材料抗血液和體液穿透性能測試.合成血試驗方法

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)用防護服的液體阻隔性能和分級

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

YY/T 1632-2018

醫(yī)用防護服材料的阻水性: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服.防護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服.防護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

傳染試劑防護服.醫(yī)療面罩.防人造血滲透的試驗方法(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服   

防干微生物侵入能力的試驗方法

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

歐洲

EN 14126-2003

防護服.防傳病毒防護服的性能要求和試驗方法.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

防護服 抗感染防護服的性能要求和試驗方法

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服   

防干微生物侵入能力的試驗方法

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射線輻射防護器具.第3部分: 防護服, 護目鏡和患者防護罩

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

美國

AAMI PB70-2012

FDA認可的用于衛(wèi)生保健設施的防護服和防護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)療保健設施的防護服和防護層的液體屏障性能和分類（FDA認可）

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)療保健設施中使用的防護服和防護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)療手術用防護服的標準

Standard on Protective Clothing for Emergency Medical Operations

ASTM F903-2018

防護服用材料耐液體滲透性的試驗方法

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

ASTM F1670/F1670M-2017a

防護服材料對合成血液滲透的阻力的標準試驗方法

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系統(tǒng)的血源性病原體對防護服使用的抗?jié)B透材料用標準試驗方法

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

防護服材料耐皮下注射針頭剌破性試驗方法

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

ASTM F3050-2017

個人防護服及設備合格評定指南

Standard Guide for Conformity Assessment of Personal Protective Clothing and Equipment

NFPA 1999-2018

緊急醫(yī)療服務用防護服和服裝標準

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

英國

BS EN 14325-2018

化學藥品防護服 化學防護服裝材料、縫合線、聯結和組合的試驗方法和性能分類

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射線的防護裝置. 防護服, 護目鏡和患者防護罩

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

BS EN ISO 13688-2013

防護服 通用要求

Protective clothing. General requirements

BS EN ISO 22612-2005

傳染介質防護服.防干微生物滲入的試驗方法

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服.防護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射線的防護裝置.第3部分:防護服,護目鏡和患者防護罩(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服   

防干微生物侵入能力的試驗方法

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用服裝.血液和體液滲透防護服裝材料

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服

測定防護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

預防傳染性病原體的防護服.面罩.防止人造血漿滲透的試驗方法（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射線防護裝置. 第3部分: 防護服, 護目鏡和患者防護罩

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

韓國

KS K ISO 22609-2012

傳染試劑防護服.醫(yī)療面罩.防人造血滲透的試驗方法(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射線輻射的保護裝置 - 第3部分:生殖器防護服和保護裝置

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. 放射科材料防護服. 政府采購技術要求

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

GOST R 57503-2017

醫(yī)療器械. 放射科患者防護服. 政府采購技術要求

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

ABNT NBR IEC 61331-3-2004

防護服和性腺防護裝置-對診斷醫(yī)用X射線防護裝置第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射線輻射防護器具. 第3部分: 防護服, 護目鏡和患者防護罩(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

傳染試劑防護服.醫(yī)療面罩.防人造血滲透的試驗方法(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射線輻射防護器具. 第3部分: 防護服和性腺防護器具

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射線輻射防護器具. 第3部分: 防護服, 護目鏡和患者防護罩

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服材料滲透性的測定-Phi-X174噬菌體試驗方法

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服材料的滲透性-合成血液的試驗方法

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

國別

標準號

中文題名

英文題名

中國

GB 14866-2006

個人用眼護具 技術要求

The specifications for personal eye-protectors

國際

ISO 4849-1981

個人用護目鏡 技術要求

Personal eye-protectors. Specifications first edition

ISO 12609-1-2013

第1部分: 產品規(guī)范. 防護人體和動物用強光源用于化妝品和醫(yī)療用途的護目鏡. 第1部分: 產品規(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

個人眼睛保護 - 規(guī)格

Personal Eye-Protection. Specifications

英國

BS EN 61331-3-2014

防醫(yī)療診斷用X射線的防護裝置. 防護服, 護目鏡和患者防護罩

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射線的防護裝置.第3部分:防護服,護目鏡和患者防護罩(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射線的防護裝置. 第3部分: 防護服, 護目鏡和患者防護罩

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

日本

JIS T8147-2016

個人眼睛防護

Personal eye protectors

韓國

KS G ISO 12609-1-2014

第1部分:產品規(guī)范。防護人體和動物用強光源用于化妝品和醫(yī)療用途的護目鏡。第1部分:產品規(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射線輻射防護器具. 第3部分: 防護服, 護目鏡和患者防護罩(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射線輻射防護器具. 第3部分: 防護服, 護目鏡和患者防護罩

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