Testing Services for the paper, nonwovens, packaging, and consumer products industries.

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Medical Devices and Personal Protective Equipment (PPE)

Nonwovens have become critical to the medical industry. Low cost, disposability, and the ability to customize the material for its intended use are just some of the reasons for their wide acceptance. Significant factors in the selection of surgical drapes, surgical and isolation gowns, and face masks include barrier protection, breathability, comfort, drapeability, and durability.

Versatile Nonwoven Materials Testing

With a high demand for Personal Protective Equipment (PPE) comes an increase in need for testing. Industry standards have been developed to assess PPE such as surgical gowns, isolation gowns, and face masks. For example, ASTM F2100 covers the minimum performance requirements for materials used in the construction of medical face masks. ASTM F2407 and ASTM F3352 cover the requirements for the performance, documentation, and labeling of surgical and isolation gowns used in healthcare facilities.

The ANSI/AAMI PB70 standard has established a system to classify gowns based on their liquid barrier performance. Based on industry standard methods, this classification system assists manufacturers with device labeling and healthcare professionals with selecting appropriate PPE. AATCC 42 evaluates a material’s ability to resist water penetration, while AATCC 127 evaluates its resistance to water under hydrostatic pressure. Additionally, ASTM F 1670 evaluates a gown’s ability to resist penetration by synthetic blood.

There are several other key tests relating to PPE performance properties. For example, Water Vapor Transmission Rate (ASTM D6701) relates to wearer comfort or breathability, while Blood Penetration (ASTM F 1862 and ASTM F1670) relates to a product’s barrier protection capabilities. Physical tests such as Tensile Strength (ASTM D5034), Tear Resistance (ASTM D5733), and Seam Strength (ASTM D 1683) also prove useful and are referenced in ASTM F2407 and ASTM F3352 for surgical and isolation gowns.

Wound Care

Bandages and skin substitutes such as artificial skin help promote wound healing. SGS-IPS Testing can help support your testing needs for wound care.

SGS-IPS Testing has extensive experience in Medical Device and PPE Testing, offering standards in AATCC, ASTM, CFR, ISO, TAPPI, WSP, and internal methodology.

Whether developing a new product, assessing the competition, or responding to consumer complaints, SGS-IPS Testing can help you answer your critical questions about Medical Device and PPE Testing.

Please contact our customer service team at (920) 749-3040 Ext. 1 or Appleton.CustomerService@sgs.com.

Test Methods Applicable to Medical Devices and PPE

TitleMethod Number
Water Resistance: Impact Penetration TestAATCC 42
Water Resistance: Hydrostatic Pressure TestAATCC 127
Tearing Strength of Fabric by Trapezoid ProcedureASTM D 5587
Tearing Strength of Nonwoven Fabrics by the Trapezoid ProcedureASTM D 5733
Failure in Sewn Seams of Woven Apparel FabricsASTM D 1683
Test methods for Nonwovens - Part 10: Lint and other particles generation in the dry state.ISO 9073-10
MOCON Water Vapor Transmission RateASTM D 6701
Colorfastness to Crocking: Crockmeter MethodAATCC 8
Air Permeability of Textile FabricsASTM D 737
Tearing Strength of Fabrics by Falling-Pendulum (Elmendorf-Type) ApparatusASTM D1424
Mass Per Unit Area (Weight) of FabricASTM D 3776
Busting Strength of Textile Fabrics - Diaphragm Bursting Strength Tester MethodASTM D 3786
Bursting Strength of Textiles - Constant-Rate-of-Traverse (CRT) Ball Burst TestASTM D3787
Abrasion Resistance of Textile Fabrics (Rotary Platform, Double-Head Method)ASTM D3884
Total Energy Impact of Plastic Films by Dart DropASTM D4272
Breaking Strength and Elongation of Textile Fabrics (Grab Test)ASTM D 5034
Breaking Force and Elongation of Textile Fabrics (Strip Method)ASTM D 5035
Bursting Strength of Fabrics Constant Rate of Extension (CRE) Ball Burst TestASTM D 6797
Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum MethodASTM D 1922
Resistance of Materials Used in Protective Clothing to Penetration by Synthetic BloodASTM F 1670
Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)ASTM F1862
Detecting Seal Leaks on Porous Medical Packaging by Dye PenetrationASTM F1929
Standard Specification for Isolation Gowns Intended for Use in Healthcare FacilitiesASTM F3352
Standard Specification for Performance of Materials Used in Medical Face MasksASTM F 2100
Standard Specification for Surgical Gowns Intended for use in Healthcare FacilitiesASTM F 2407
Laboratory Test Method for 16 CFR Part 1610: Standard for Flammability of Clothing Textiles Laboratory Test ManualCFR 1610
Absorption, Time and Rewet - Three Insults (Specimen cut from Whole Product)IPS Method
Absorption, Time and Rewet - Single Insult (Specimen cut from Whole Product)IPS Method
Absorption, Time - Liquid Strike - Through, Repeated (Specimen cut from Whole Product)IPS Method
Absorption, Time - Liquid Strike - Through (Specimen cut from Whole Product)IPS Method
Absorption, Capacity - 4" x 4" Specimen (Tissue and Thin Absorbent Products)IPS Method
Textile Test Methods - Textile Fabrics - Determination of Resistance to Water Penetration - Hydrostatic Pressure TestISO 811:1981
Textiles - Test methods for nonwovens - Part 3: Determination of tensile strength and elongationISO 9073-3
Test Methods for nonwovens - Part 6: AbsorptionISO 9073-6
Textiles - Determination of the Permeability of Fabrics to AirISO 9237
Abrasion Resistance of Nonwoven Fabrics Using a Nonwoven Modified Martindale Abrasion Test MethodWSP 20.5
Electro Static Decay of Nonwoven FabricsWSP 40.2
Air Permeability of Nonwoven MaterialsWSP 70.1
Water Resistance (Hydrostatic Pressure)NWSP 80.6
Water Penetration (Spray Impact Test)NWSP 80.3
Liquid Strike-Through TimeNWSP 70.3
Water Vapor Transmission RateASTM E 96
Handle-O-Meter StiffnessNWSP 090.3
Pneumatic BurstNWSP 090.3
Alcohol RepellencyNWSP 080.8
Absorption PropertiesNWSP 010.1
Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilitiesAAMI/AMSI PB70

Don’t see the test method you need or not sure which one is for you? Please call our Customer Service department at 920-749-3040, ext 1.