防护服出口欧盟需要什么认证标准?

防护服是用来隔离病菌、有害超细粉尘、酸碱溶液、盐溶液,保持环境清洁。防护服的主要作用是保护人体不受外界环境的侵害,同时也减少甚至消除自身对产品和环境的影响。受疫情的影响,海外对于防护服的需求在逐渐增长,市场前景非常乐观。但是企业想要出口产品到海外市场,需要有一定的认证标准,下面小编就来带大家看下防护服出口海外都需要哪些认证标题,尤其是出口欧盟需要什么认证标准?

国别

标准号

中文题名

英文题名

国际

ISO    16603-2004

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

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

ISO    16604-2004

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

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

ISO    22609-2004

传染试剂防护服.医疗面罩.防人造血渗透的试验方法(固定容积,水平喷射)

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

ISO    22612-2005

防传感病病原体的防护服  防干微生物侵入能力的试验方法

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

欧洲

EN    14126-2003

防护服.防传病毒防护服的性能要求和试验方法.合并勘误表2004年9月

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

EN    14126-2003+AC-2004

防护服 抗感染防护服的性能要求和试验方法

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

EN  ISO   22612-2005

防传感病病原体的防护服  防干微生物侵入能力的试验方法

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

EN    61331-3-2014

医用诊断x射线辐射防护器具. 第3部分: 防护服, 护目镜和患者防护罩

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

美国

AAMI    PB70-2012

FDA认可的用于卫生保健设施的防护服和防护单的液体阻隔性能及分类

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

ANSI/PB70-2012

旨在用于医疗保健设施的防护服和防护层的液体屏障性能和分类(FDA认可)

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

ANSI/AAMI    PB70-2012

医疗保健设施中使用的防护服和防护布的液体阻挡层性能和分类

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

ANSI/NFPA    1999-2008

急救医疗手术用防护服的标准

Standard  on   Protective Clothing for Emergency Medical Operations

ASTM    F903-2018

防护服用材料耐液体渗透性的试验方法

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

ASTM    F1670/F1670M-2017a

防护服材料对合成血液渗透的阻力的标准试验方法

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

ASTM    F1671/F1671M-2013

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

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

ASTM    F2878-2019

防护服材料耐皮下注射针头剌破性试验方法

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

ASTM    F3050-2017

个人防护服及设备合格评定指南

Standard    Guide for Conformity Assessment of Personal Protective Clothing and   Equipment

NFPA    1999-2018

紧急医疗服务用防护服和服装标准

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

英国

BS  EN   14325-2018

化学药品防护服 化学防护服装材料、缝合线、联结和组合的试验方法和性能分类

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

BS  EN   61331-3-2014

防医疗诊断用X射线的防护装置. 防护服, 护目镜和患者防护罩

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

BS  EN ISO   13688-2013

防护服 通用要求

Protective    clothing. General requirements

BS  EN ISO   22612-2005

传染介质防护服.防干微生物渗入的试验方法

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

BS  ISO   16603-2004

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

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

德国

DIN  EN   61331-3-2016

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

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

DIN  EN ISO   22612-2005

防传感病病原体的防护服  防干微生物侵入能力的试验方法

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

日本

JIS    T8060-2015

血液和体液接触的防护用服装.血液和体液渗透防护服装材料

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

JIS    T8061-2015

防止接触血液和体液的防护服  测定防护服材料对血源性病原体渗透的抵抗力 使用Phi-X174噬菌体的测试方法

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

JIS  T8062-2010

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

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

JIS    T61331-3-2016

医疗诊断用X射线防护装置. 第3部分: 防护服, 护目镜和患者防护罩

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

韩国

KS  K ISO   22609-2012

传染试剂防护服.医疗面罩.防人造血渗透的试验方法(固定容积、水平喷射)

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

其他国家

DS/EN    61331-3-1999

防止诊断医疗X射线辐射的保护装置 - 第3部分:生殖器防护服和保护装置

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

GOST  R   57493-2017

医疗器械.   放射科材料防护服. 政府采购技术要求

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

GOST  R   57503-2017

医疗器械.   放射科患者防护服. 政府采购技术要求

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

ABNT  NBR IEC   61331-3-2004

防护服和性腺防护装置-对诊断医用X射线防护装置第3部分

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

LST  EN   61331-3-2014

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

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

UAE.S/GSO    ISO 22609-2010

传染试剂防护服.医疗面罩.防人造血渗透的试验方法(固定容积,水平喷射)

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

STN  EN   61331-3-2001

医用诊断X射线辐射防护器具. 第3部分: 防护服和性腺防护器具

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

STN  EN   61331-3-2015

医用诊断X射线辐射防护器具. 第3部分: 防护服, 护目镜和患者防护罩

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

IS    16545-2016

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

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

IS    16546-2016

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

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

 【海外顾问帮】是协助国内企业和个人跨境发展的一站式服务中心,协同全球专家顾问,坚持透明服务,打破跨境壁垒,为防护服出口欧盟提供一站式服务,详情请咨询官方电话:400-106-2206。

医疗产品CE认证

医疗产品CE认证

推荐指数:
项目简介:医疗器械CE认证,MDD,MDR,ISO 13485质量管理体系,欧盟授权代表 查看详情>>

直连专家

免责声明:本网站所提供的信息仅供参考之用,并不代表本网赞同其观点,也不代表本网对其真实性负责。图片版权归原作者所有,如有侵权请联系我们,我们立刻删除。如有关于作品内容、版权或其它问题请于作品发表后的30日内与本站联系,本网将迅速给您回应并做相关处理。


抱团交流:想及时跟进跨境产品资质认证及工商财税新政,我们建立了交流群,扫描以下二维码进行交流。

资质认证交流群

工商财税交流群

目前有1000+企业已关注加入我们

咨询秘书
您好,欢迎来到海外顾问帮!
欧盟EPR注册、德国WEEE、西班牙包装法、欧盟能效、欧代、欧盟检测认证、亚马逊气候友好认证-碳中和、OEKO、GRS、FSC、GOTS…欢迎向我咨询!

扫码添加客服

咨询时间:9:00 — 19:00