CERTIFICATION
Mask
US
ASTM F2100
NIOSH for N95(PPE)
EU
EN 14683
ISO 10993 – BIOCOMPATIBILITY
EN149 for N95(PPE)
Gown
US
Surgical gown or protective gown
ASTM F2407-06
AAMI ANSI PB70:2012
ASTM F1671 /F1671M-13
ASTM F1670 /F1670M-17
AAMI ANSI ST65:2008/(R)2018
EU
Surgical Gown
EN13795
Protective Gown for different types
EN 14126: 2003+AC: 2004
EN 943-1:2015 (PPE)
EN 14605:2005+A1:2009 (PPE)
EN ISO 13982-1:2004+A1:2010 (PPE)
EN 13034:2005+A1:2009 (PPE)
Glove
US (depends on which material used for glove)
ASTM D3578-05 (Reapproved 2015) - Standard Specification for Rubber Examination Gloves
ASTM D6978-05 (Reapproved 2019) - Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
ASTM D5151-06 (Reapproved 2015) - Standard Test Method for Detection of Holes in Medical Gloves
ASTM D7103-06 (Reapproved 2013) - Standard Guide for Assessment of Medical Gloves
ASTM D6124-06 (Reapproved 2017) - Standard Test Method for Residual Powder on Medical Gloves
ASTM D5250-06 (Reapproved 2015) - Standard Specification for Poly(vinyl chloride) Gloves for Medical Application
ASTM D7907-14 (Reapproved 2019) - Standard Test Methods for Determination of Bactericidal Efficacy on the Surface of Medical Examination Gloves
ASTM D7160-16 - Standard Practice for Determination of Expiration Dating for Medical Gloves
ASTM D5151-19 - Standard Test Method for Detection of Holes in Medical Gloves
ASTM D6977-04 (Reapproved 2016) - Standard Specification for Polychloroprene Examination Gloves for Medical Application
ASTM D6319-10 (Reapproved 2015) - Standard Specification for Nitrile Examination Gloves for Medical Application
ASTM D7866-14 - Standard Specification for Radiation Attenuating Protective Gloves
ASTM D6355-07 (Reapproved 2017) - Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves
ASTM D6499-18 - Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products
EU
EN374
EN455 Part 1 to 4
Goggles or Face shield
US
ANSI/ISEA Z87.1-2015 (including clause 7.2.4 Protection against droplets and splashes of liquids)
EU
EN166(PPE)
Thermometer
US
ANSI/AAMI ES60601-1:2005/(R)2012, (IEC 60601-1:2005, MOD)
ANSI/AAMI/IEC 60601-1-2:2014
ANSI/AAMI HA60601-1-11:2015 (IEC 60601-1-11:2015, MOD)
ASTM E1965-98 (Reapproved 2016)
FCC
CA Prop 65 if applicable
EU
EN 60601-1:2006+A12:2014
EN 60601-1-2:2015
EN 60601-1-11:2015
EN ISO 80601-2-56:2017
EMC
REACH chemical Tests
ROHs
WEEE
CERTIFICATION SERVICES
Stay In Touch & Follow Us!
Contact Us
Fax: +86 592 5219 230
Phone: +86 592 5219 260
Email: service@tts-global.net
Wechat: +86 13599922343
Copyright © 2019, Testing Technology Service Ltd All rights Reserved 闽ICP备10202026号-1