Facial Protection. ASTM - Halyard Health · 2014. 6. 20. · ASTM F2100-11 KC100 Masks† ASTM...
6
Face the facts: Facial protection and what ASTM means to you † . Facial Protection. ASTM
Transcript of Facial Protection. ASTM - Halyard Health · 2014. 6. 20. · ASTM F2100-11 KC100 Masks† ASTM...
Face the facts:Facial protection and what ASTM means to you†.
Facial Protection. ASTM
What are the primary purposesfor wearing masks in thehealthcare setting?Masks have 3 primary purposes.1 They are:
Why do I need a fl uid-resistant mask?
If your mask is not fl uid-resistant, you are not adequately protected when performing procedures such as endotracheal suctioning, bronchoscopy, and invasive surgery that generate splashes or sprays of blood, body fl uids, secretions, or excretions. Wearing a fl uid-resistant mask helps to protect the wearer from mucosal contact
and inhalation of these potentially infectious splashes and sprays.1
Worn by healthcare Worn by healthcare Worn by healthcare personnel to protect personnel to protect personnel to protect them from contact them from contact them from contact with infectious with infectious with infectious splashes and sprays.splashes and sprays.splashes and sprays.
Worn by healthcare Worn by healthcare Worn by healthcare personnel to personnel to personnel to protect patients protect patients protect patients from exposure from exposure from exposure to infectious to infectious to infectious agents carried in a agents carried in a agents carried in a healthcare worker’s healthcare worker’s healthcare worker’s mouth or nose; andmouth or nose; andmouth or nose; and
Worn by patients Worn by patients Worn by patients to limit potential to limit potential to limit potential dissemination dissemination dissemination of infectious of infectious of infectious respiratory respiratory respiratory secretions from the secretions from the secretions from the patient to others patient to others patient to others (protect others).(protect others).(protect others).
1 2 3
2Level
2FLUID RESISTANT PROTECTION
LOW MODERATE HIGH
Level
1Level
3
What is ASTM?ASTM International (www.astm.org) is one of the world’s largest standards developing organizations. ASTM has classified face masks on levels 1, 2 and 3; levels determined by the test results of material performance categories covering Bacterial Filtration Efficiency (BFE) and Submicron Particle Filtration Efficiency (PFE), Fluid Resistance, Delta P/Differential Pressure and Flammability.
Why are the performance characteristics tested using criteria specified by ASTM F2100-11 important?
• BFE and PFE:Describe mask performance for bacteria filtration efficiency (BFE) and particle filtration efficiency (PFE). The higher the percentage, the more the mask prevents the passage of bacteria or particles.2
• Fluid Resistance:Face masks are challenged with synthetic blood at various levels of pressure (80, 120, 160mm Hg). The higher the pressure withstood, the greater the fluid spray and splash resistance.
• Delta P/Differential Pressure:Measures the effort it takes to force air through the mask material... the lower the Delta P, the more breathable and comfortable the mask.
• Flammability:The mask material is subjected to flame. The rate at which the material burns determines the level of flammability.
How do the ASTM standards fit with EN Norms?The relevant EN Norms for facial protection include EN14683. This standard classifies facial protection using Bacterial Filtration Efficiency, Breathing Resistance (Pa) and Splash Resistance above 120mmHg. ASTM uses additional properties to classify fluid protection such as three levels of Splash Resistance (80mmHg, 120mmHg and 160mmHg), Particle Filtration Efficiency and Flammability.
KIMBERLY-CLARK* ASTM face masks are designed to meet industry standards and regulations, including EN14683. Some masks in the facial protection range designed for specific clinical applications meet EN 149:2001.
EN14683EU
Standard Class
Bacterial Filtration Efficiency
Breathing Resistance
(Pa)
Splash Resistance
(mmHg)
Type I 95% < 29.4 NA
Type IR 95% < 49.0 > 120
Type II 98% < 29.4 NA
Type IIR 98% < 49.0 > 120
KC100 masks exceed the EN14683 Type I standard class for bacterial filtration efficiency.KC200 masks comply with the requirements of Type IIR masks as defined by EN 14683. KC300 masks exceed the requirements of Type IIR masks as defined by EN 14683.
LEVEL 1 LEVEL 2 LEVEL 3
Test Method
Test Description
ASTM F2100-11
KC100 Masks†
ASTM F2100-11
KC200 Masks†
ASTM F2100-11
KC300 Masks†
ASTM F1862 Fluid Resistance with synthetic blood, in mm Hg 80 mm Hg 80 mm Hg 120 mm Hg 120 mm Hg 160 mm Hg 160 mm Hg
MIL-M-36954C Delta P Differential pressure, mm H2O/cm2 <4.0 mm H2O 2.7 <5.0 mm H2O 3.7 <5.0 mm H2O 3.0
ASTM F2101 Bacterial Filtration Efficiency (BFE), % ≥ 95% 99.9% ≥ 98% 99.9% ≥ 98% 99.8%
ASTM F2299 Submicron Particle Filtration (PFE) @ 0.1 μ, % ≥ 95% 98.8% ≥ 98% 99.1% ≥ 98% 98.9%
16 CFR Part 1610 Flammability Class 1 Class 1 Class 1 Class 1 Class 1 Class 1
† Based on the calculated median
2Level
2FLUID RESISTANT PROTECTION
LOW MODERATE HIGH
Level
1Level
3
(01) 2 06 80651 47147 9
Easy-to-read type identifi es ASTM F2100 11 Level 3 protection and EN Norm information.
Regulation-compliant icon displays important information – level 3 protection.
How do I know if my currentface mask is providingadequate protection?The pack tells you everything you need to know. The new ASTM F2100-11 standard requires a graphic display on the packaging stating the mask performance level.The pack also provides EN Norm information.
Easy to read ASTM graphics show the classification for fluid resistance at a glance:
Sources/References:
1. Siegel JD, Rhinehart E, Jackson M, Chiarello L. 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Health Care Settings. Am. J. Infect. Control. Dec 2007;35(10 Suppl 2):S65-164.
2. ASTM International. Standard Specification for Performance of Materials Used in Medical Face Masks. Vol ASTM F2100-11.
West Conshohocken, PA: ASTM International; 2011.†Kathleen Stoessel, RN, BSN, MS, Senior Manager, Clinical Education and Accreditation, Kimberly-Clark Health Care
*Registered Trademark or Trademark of Kimberly-Clark Worldwide, The COLOR ORANGE and COLOR PURPLE are Registered Trademarks of KCWW.
COLOR GREY is a Trademark of KCWW. Inc. ©2014 KCWW. All rights reserved.HC352/00-UK
Comfortable Fluid Resistance and Splash Protection
∆P < 5mmH20ASTM F1852 ≥ 160mmHg Flammability: Class 1 BFE ≥ 98%
1 2 3Level
1FLUID-RESISTANT PROTECTION
LOW MODERATE HIGH
1 2 3Level
2FLUID-RESISTANT PROTECTION
LOW MODERATE HIGH
1 2Level
3FLUID-RESISTANT PROTECTION
LOW MODERATE HIGH
High-Fluid Risks Need High-Level Fluidshield *
Protection
∆P < 5mmH20ASTM F1852 ≥ 160mmHg Flammability: Class 1 BFE ≥ 98%
1 2 3Level
1FLUID-RESISTANT PROTECTION
LOW MODERATE HIGH
1 2 3Level
2FLUID-RESISTANT PROTECTION
LOW MODERATE HIGH
1 2Level
3FLUID-RESISTANT PROTECTION
LOW MODERATE HIGH
Softness and Breathability for Comfortable Fluid Protection
∆P < 5mmH20ASTM F1852 ≥ 160mmHg Flammability: Class 1 BFE ≥ 98%
1 2 3Level
1FLUID-RESISTANT PROTECTION
LOW MODERATE HIGH
1 2 3Level
2FLUID-RESISTANT PROTECTION
LOW MODERATE HIGH
1 2Level
3FLUID-RESISTANT PROTECTION
LOW MODERATE HIGH
THE KIMBERLY-CLARK ADVANTAGE*
www.kchealthcare.co.uk
Knowledge networK* Clinical EducationKnowledgeable Customer SupportExpert Sales ForceTools & Best PracticesClinical ResearchCommitment to ExcellenceFor more information, please send an email to [email protected] or visit:
