PPE TEST PARAMETERS AVAILABLE WITH FGT CPS
FOR FAST SERVICES ADDITIONAL CHARGES WILL BE APPLICABLE: 24 HR SERVICE-2 x normal charges
48 HR SERVICE-1.5 x normal charges
PPE:
We at FgT CPS have all testing facilities for following protective items as per (EU) 2016/425 on personal protective equipment (PPE).
PROTECTIVE CLOTHING FOR USE AGAINST SOLID PARTICULATES: BS EN ISO13982-1:2004 CHEMICAL PROTECTIVE CLOTHING GENERAL REQUIREMENTS: EN 14325:2004 REQUIREMENTS FOR CLOTHING THAT GIVES LIMITED PROTECTION AGAINST LIQUID CHEMICALS (TYPE 6 CLOTHING): EN 13034:2005 SURGICAL DRAPES & GOWNS: EN 13795: 2011 CLASSIFICATION OF BARRIER PERFORMANCE OF SURGICAL GOWNS, OTHER PROTECTIVE APPAREL, SURGICAL DRAPES AND DRAPE: ANSI/AAMI PB 70:12 DISPOSABLE PROTECTIVE GLOVES UNDER EU PPE REGULATION 2016/425: EN ISO 21420-2020 PROTECTIVE GLOVES AGAINST THERMAL RISKS.EN 407 PROTECTIVE GLOVES AGAINST DANGEROUS CHEMICALS AND MICRO-ORGANISMS: EN ISO 374-1-2016 MEDICAL GLOVES FOR SINGLE USE: EN 455-1-2020+A1-22 PROTECTIVE GLOVES AGAINST MECHANICAL RISKS EN 388-2016+A1-2018 PVC GLOVES FOR MEDICAL APPLICATION: ASTM D 5250-2020 NITRILE EXAM GLOVES FOR MEDICAL APPLICATION: ASTM D 6319-2019 MEDICAL FACE MASK- EN 14683-2019 PROTECTIVE MASK RESPIRATORY-EN 149-2001+A1-2009 PROTECTIVE MASK RESPIRATORY-EN 149-2001+A1-2009 SAFETY FOOTWEAR-ISO 20345 PERSONAL PROTECTIVE FOOTWEAR-ISO 20346 OCCUPATIONAL FOOTWEAR-ISO 20347 INDUSTRIAL SAFTEY HELMET-IS 2925, EN 397 EN 50365 – Insulating helmets for use on low voltage installations EN 12492 – Helmets for mountaineers EN 1078 – Cycling helmet SAFETY EYEWEAR DIN EN 166 — Personal eye protection DIN EN 167 — Optical test methods DIN EN 168 — non-optical test methods DIN EN 170 — Ultraviolet filters DIN EN 171 — Infrared filters DIN EN 172 — Sun glare filters for industrial use DIN EN 207 — Laser eye protectors Eye protector —IS 5983-part 1and 2 Eye protector—IS 7524 Part 1 and 2 Eye and face protection —IS 7524-part 3 Eye and face protection— IS 8521-part 1 Eye and face protection —IS8521 part 2 Eye and face protection —ANSI/SEA/Z87.1.
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PROTECTIVE CLOTHING FOR USE AGAINST SOLID PARTICULATES (TYPE 5 CLOTHING): BS EN ISO 13982-1: 2004 Sr. N TEST PARAMETERS TEST STANDARD SAMPLE REQUIRE TAT/NORMAL SERVICE 1 Abrasion Resistance EN 530 2 Flex Cracking EN ISO 7854-Method B 3 Trapezoidal tear resistance EN ISO 9073-4/ ASTM D5733 4 Puncture Resistance EN 863 5 Resistance to ignition EN 13274-4 6 Seams, joins and assemblages (Applicable only for garment) EN ISO 13935-2 7 Inward leakage of aerosols & solid particles (Only for Garment) ISO 13982-2 8 Visor ISO 13982-1
(CHEMICAL PROTECTIVE CLOTHING GENERAL REQUIREMENTS): EN 14325:2004 Sr. N TEST PARAMETERS TEST STANDARD SAMPLE REQUIRE TAT/NORMAL SERVICE 1 Abrasion Resistance EN 530 up to 10000 rubs 2 Trapezoidal Test Strength EN ISO 9073-4 3 Tensile Strength EN ISO 13934-1 4 Puncture resistance EN 863 5 Flex Cracking EN ISO 7854-METHOD B Up to 25000 cycles Up to 50000
REQUIREMENTS FOR CLOTHING THAT GIVES LIMITED PROTECTION AGAINST LIQUID CHEMICALS (TYPE 6 CLOTHING): EN 13034:2005 Sr. N TEST PARAMETERS TEST STANDARD SAMPLE REQUIRE TAT/NORMAL SERVICE 1 Abrasion Resistance EN 530 up to 10000 rubs 2 Trapezoidal Test Strength EN ISO 9073-4 3 Tensile strength EN ISO 13934-1 4 Puncture resistance EN 863 5 Repellency of Liquid EN ISO 6530 6 Resistance to penetration by liquids EN ISO 6530 7 Resistance to ignition EN 13274-4
SURGICAL DRAPES & GOWNS: EN 13795: 2011 Sr. N TEST PARAMETERS TEST STANDARD SAMPLE REQUIRE TAT/NORMAL SERVICE 1 Resistance to microbial penetration (Dry) ENISO 22612 2 Resistance to microbial penetration (Wet) ENISO 22610 3 Cleanliness-microbial or bioburden ENISO 11737-1 4 Cleanliness-particulate matter ENISO 9073-10 5 Resistance to liquid penetration EN 20811 6 Bursting strength (Dry) ENISO 13938-1 7 Bursting strength (Wet) ENISO 13938-1 8 Tensile strength (Dry) EN 29073-3 9 Tensile strength (Wet) EN 29073-3
CLASSIFICATION OF BARRIER PERFORMANCE OF SURGICAL GOWNS, OTHER PROTECTIVE APPAREL, SURGICAL DRAPES AND DRAPE: ANSI/AAMI PB 70:12 Sr. N TEST PARAMETERS TEST STANDARD SAMPLE REQUIRE TAT/NORMAL SERVICE 1 Impact Penetration AATCC 42 2 Hydrostatic Pressure AATCC 127 3 Synthetic Blood Penetration Test (for surgical drapes) ASTM F1670- Surrogate Blood 4 Viral Penetration Test (for surgical and isolation gowns) ASTM F1671- Bacteriophage
DISPOSABLE PROTECTIVE GLOVES UNDER EU PPE REGULATION 2016/425: EN ISO 21420-2020 Sr. N TEST PARAMETERS TEST STANDARD SAMPLE REQUIRE TAT/NORMAL SERVICE 1 General Requirements: 4.1-Glove Design & Construction EN ISO 21420-2020 2 EN 1811-2023 ISO 14362-1- 2017/ISO17234-1-2020 EN 16778-2016 ISO 4045- ISO/TS 16190-2013 3 4.3Cleaning IF APPLICABLE EN ISO 21420-2020 4 4.4 Additional Properties Electrostatic Properties EN 16350 OR EN 1149-1, EN 1149-2 & EN 1149-3 5 5.1comfort & Efficiency-Sizing & Measurement of Gloves EN ISO 21420-2020 6 5.2 Dexterity EN ISO 21420-2020 7 5.3.1 Breathability-WVT EN ISO 21420-2020 8 5.3.1Breathability-WVA EN ISO 21420-2020 9 Glove Labelling EN ISO 21420-2020 10 Instruction For Use EN ISO 21420-2020 PROTECTIVE GLOVES AGAINST THERMAL RISKS.EN 407 (FIRST IT SHOULD MEET EN ISO 21420) Sr. N TEST PARAMETERS TEST STANDARD SAMPLE REQUIRE TAT/NORMAL SERVICE 1 Abrasion Resistance EN 388-2016+A1-2018 2 Tear Resistance EN 388-2016+A1-2018 3 Burning Behavior ISO 15025-2016- method A 4 Contact Heat EN ISO 12127-1-2015 5 Convective Heat ISO 9151-2016 6 Radiant Heat EN ISO 6942 -2022-Method B 7 Small drops of molten metal splash ISO 9150.1988 8 Large quantities of molten metal splash ISO 9185-1990
DISPOSABLE PROTECTIVE GLOVES UNDER EU PPE REGULATION 2016/425. PROTECTIVE GLOVES AGAINST DANGEROUS CHEMICALS AND MICRO-ORGANISMS: EN ISO 374-1-2016, EU DIRECTIVE 89/686/EEC CAT III Sr. N TEST PARAMETERS TEST STANDARD SAMPLE REQUIRE TAT/NORMAL SERVICE 1 Penetration of Chemicals EN 374-2-2014 2 Degradation with chemical contact EN 374-4-2013 3 Permeation to chemicals EN 374-3(withdrawn)/ EN 16523-1-2015 4 Microorganisms Protection against Viruses REACH ANNEX-VI, SVHC, CARCINOGENIC, ALLERGIC, APEO, FORMALDE HYDE, PHTHALATE, VOC EN 374-5-2016 ISO 16604-Procedure B
DISPOSAL MEDICAL GLOVES. MEDICAL DEVICE REGULATION EU DIRECTIVE 93/42/EEC, CLASS I, MEDICAL GLOVES FOR SINGLE USE: EN 455-1-2020+A1-22 Sr. N TEST PARAMETERS TEST STANDARD SAMPLE REQUIRE TAT/NORMAL SERVICE 1 Freedom from Holes EN 455-1-20+A1-22 2 Dimension EN 455-2-2015 3 Tensile Strength After aging & before aging EN 455-2-2015 4 Biological evaluation EN 455-3-2023 5 End toxin contamination of sterile gloves EN 455-3-2023 6 Powder Residue-Powder free gloved EN 455-3-2023 7 Powder amount-powdered gloves EN 455-3-2023 8 Leachable proteins in natural rubber latex EN 455-3-2023 9 Shelf-Life determination EN 455-4-2023
PROTECTIVE GLOVES AGAINST MECHANICAL RISKS EN 388 -2016+A1-2018 Sr. N TEST PARAMETERS TEST STANDARD SAMPLE REQUIRE TAT/NORMAL SERVICE 1 Abrasion Resistance EN 388-2016+A1-2018 2 Blade Cut Resistance EN 388-2016+A1-2018 3 Tear strength EN 388-2016+A1-2018 4 Puncture Resistance EN 388-2016+A1-2018 5 Cut Resistance TDM test EN ISO 13997-TDM 6 Impact Protection EN 13594
PVC GLOVES FOR MEDICAL APPLICATION: ASTM D 5250-2020 Sr. N TEST PARAMETERS TEST STANDARD SAMPLE REQUIRE TAT/NORMAL SERVICE 1 Freedom from holes ASTM D 5151 2 Dimension ASTM D 5151 3 Tensile strength (after aging & before aging) ASTM D 412 DIE C 4 Powder Residue-Powder free gloved ASTM D 6124 5 Powder amount-powdered gloves ASTM D 6124
NITRILE EXAM GLOVES FOR MEDICAL APPLICATION: ASTM D 6319-2019 Sr. N TEST PARAMETERS TEST STANDARD SAMPLE REQUIRE TAT/NORMAL SERVICE 1 Freedom from holes ASTM D 5151 2 Dimension ASTM D 5151 3 Tensile strength (after aging & before aging) ASTM D 412 DIE C 4 Powder Residue-Powder free gloved ASTM D 6124 5 Powder amount-powdered gloves ASTM D 6124 EXTRA TEST FOR GLOVES 1 Resistance of Medical Gloves to Permeation by Chemotherapy Drugs ASTM D 6978-05-2019 2 Resistance of Protective Clothing to Penetration by Blood-Borne Pathogens- Using Phi-X174 Bacteriophage ASTM F 1671-2022 3 Test Method for Protective Clothing Material Resistance to Puncture ASTM F 1342-05-2022
MEDICAL DEVICES DIRECTIVE 93/42/EEC and MEDICAL DEVICE REGULATION EU 2017/745– MEDICAL FACE MASK- EN 14683-2019 Sr. N TEST PARAMETERS TEST STANDARD SAMPLE REQUIRE TAT/NORMAL SERVICE 1 BFE% (Speed28.3 LPM)-Annex B EN 14683-2019 2 Differential Pressure or Breathability (H2O/Cm2 or Pa/Cm2 , {Speed 8 LPM)-ANNEX C EN 14683-2019-Annex C 3 Sub-Micron PFE% (0.1 Micron%) EN 14683-2019 Splash Resistance/Synthetic Blood Resistance, mmHg ISO 22609:2004 4 Flame Spread NR 5 Microbial Cleanliness (Cfu/G) EN ISO 11737-1:2018 6 Biocompatibility – EN ISO 10993- 1:2009
MEDICAL FACE MASK- ASTM F 2100 Sr. N TEST PARAMETERS TEST STANDARD SAMPLE REQUIRE TAT/NORMAL SERVICE 1 BFE% (Speed28.3 LPM)-Annex B ASTM MF 2101 2 Differential Pressure or Breathability (H2O/Cm2 or Pa/Cm2 , {Speed 8 LPM)-ANNEX C EN 14683-2019-Annex C 3 Sub-Micron PFE% (0.1 Micron%) ASTM F 2299 Splash Resistance/Synthetic Blood Resistance, mmHg ASTM F 1862 4 Flame Spread 16CFR PART 10 5 Microbial Cleanliness (Cfu/G) NR 6 Biocompatibility Biocompatibility for medical masks under EUA Cytotoxicity test is required sensitization and irritation must be addressed via memo*after EUA all three tests are required for killing 510(K) filling.
EN 14683 ASTM F 2100 TYPE I TYPE II TYPE III LEVEL 1 LEVEL 2 LEVEL 3 BFE >95% >98% >98% >95% >98% >98% BREATHABILITY <40 pa/cm2 <40 pa/cm2 <60 pa/cm2 <5H2 O cm2 <6H2 O cm2 <6H2 O cm2 PFE NR NR NR >95 >98 >98 BLOOD RESISTANCE NR NR 120 80 120 160 FLAME SPREAD NR NR NR CLASS 1 CLASS 1 CLASS 1 MICROBIAL <30 <30 <30 NR NR NR IS 16289-2014 TYPE I TYPE II TYPE III BFE >95% >98% >98% BREATHABILITY 29.4 29.4 49.0 PFE NR NR 98 BLOOD RESISTANCE NR NR 120
PROTECTIVE MASK RESPIRATORY-EN 149-2001+A1-2009 Sr. N TEST PARAMETERS TEST STANDARD SAMPLE REQUIRE TAT/NORMAL SERVICE 1 Visual inspection EN 149-2001+A1-2009 2 Material EN 149-2001+A1-2009 3 Cleaning and disinfecting EN 149-2001+A1-2009 4 Practical performance EN 149-2001+A1-2009 5 Total inward leakage EN 149-2001+A1-2009 6 Penetration of filter material EN 149-2001+A1-2009 7 Compatibility with skin EN 149-2001+A1-2009 8 Flammability EN 149-2001+A1-2009 9 Carbon dioxide content of the inhalation air EN 149-2001+A1-2009 10 Head harness EN 149-2001+A1-2009 11 Field of vision EN 149-2001+A1-2009 12 Exhalation valves EN 149-2001+A1-2009 13 Breathing resistance EN 149-2001+A1-2009 14 Clogging EN 149-2001+A1-2009 15 Demountable parts EN 149-2001+A1-2009
