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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.
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.
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.
|Water Resistance: Impact Penetration Test||AATCC 42|
|Water Resistance: Hydrostatic Pressure Test||AATCC 127|
|Tearing Strength of Fabric by Trapezoid Procedure||ASTM D 5587|
|Tearing Strength of Nonwoven Fabrics by the Trapezoid Procedure||ASTM D 5733|
|Failure in Sewn Seams of Woven Apparel Fabrics||ASTM D 1683|
|Test methods for Nonwovens - Part 10: Lint and other particles generation in the dry state.||ISO 9073-10|
|MOCON Water Vapor Transmission Rate||ASTM D 6701|
|Colorfastness to Crocking: Crockmeter Method||AATCC 8|
|Air Permeability of Textile Fabrics||ASTM D 737|
|Tearing Strength of Fabrics by Falling-Pendulum (Elmendorf-Type) Apparatus||ASTM D1424|
|Mass Per Unit Area (Weight) of Fabric||ASTM D 3776|
|Busting Strength of Textile Fabrics - Diaphragm Bursting Strength Tester Method||ASTM D 3786|
|Bursting Strength of Textiles - Constant-Rate-of-Traverse (CRT) Ball Burst Test||ASTM D3787|
|Abrasion Resistance of Textile Fabrics (Rotary Platform, Double-Head Method)||ASTM D3884|
|Total Energy Impact of Plastic Films by Dart Drop||ASTM 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 Test||ASTM D 6797|
|Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method||ASTM D 1922|
|Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood||ASTM 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 Penetration||ASTM F1929|
|Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities||ASTM F3352|
|Standard Specification for Performance of Materials Used in Medical Face Masks||ASTM F 2100|
|Standard Specification for Surgical Gowns Intended for use in Healthcare Facilities||ASTM F 2407|
|Laboratory Test Method for 16 CFR Part 1610: Standard for Flammability of Clothing Textiles Laboratory Test Manual||CFR 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 Test||ISO 811:1981|
|Textiles - Test methods for nonwovens - Part 3: Determination of tensile strength and elongation||ISO 9073-3|
|Test Methods for nonwovens - Part 6: Absorption||ISO 9073-6|
|Textiles - Determination of the Permeability of Fabrics to Air||ISO 9237|
|Abrasion Resistance of Nonwoven Fabrics Using a Nonwoven Modified Martindale Abrasion Test Method||WSP 20.5|
|Electro Static Decay of Nonwoven Fabrics||WSP 40.2|
|Air Permeability of Nonwoven Materials||WSP 70.1|
|Water Resistance (Hydrostatic Pressure)||NWSP 80.6|
|Water Penetration (Spray Impact Test)||NWSP 80.3|
|Liquid Strike-Through Time||NWSP 70.3|
|Water Vapor Transmission Rate||ASTM E 96|
|Handle-O-Meter Stiffness||NWSP 090.3|
|Pneumatic Burst||NWSP 090.3|
|Alcohol Repellency||NWSP 080.8|
|Absorption Properties||NWSP 010.1|
|Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities||AAMI/AMSI PB70|
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