ISO 22609 Certification (Medical Face Mask)
ISO 22609 Certification describes a lab test technique for estimating the obstruction of medical face masks to infiltration by a sprinkle of synthetic-blood.
ISO 22609 Certification primarily addresses the exhibition of materials or certain material developments utilized in medical face mask. The test technique doesn’t address the exhibition of the medical face mask design, development, interfaces or different variables which may influence the general security offered by the medical face mask and its activity, (for example, filtration productivity and weight drop).
ISO 22609:2004 doesn’t assess the presentation of medical face covers as an assurance against defilement by means of airborne introduction pathways or in the anticipation of the entrance of personalized body liquids stored on the medical face mask.
ISO 22609 Certification was set up by Technical Committee ISO/TC 94, Personal health & Safety — Protective attire and hardware, Subcommittee SC 13, Protective garments. It depends on ASTM F1862-00a.
Introduction of ISO 22609 Certification :
Workers, fundamentally those in the health care profession, associated with treating and thinking about people harmed or wiped out, can be presented to natural fluids fit for transmitting malady. These illnesses, which might be brought about by an assortment of microorganisms, can present critical dangers to life and health. This is particularly valid for blood-borne infections (Virus) that cause hepatitis [Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV)] and (AIDS) [Human Immunodeficiency Virus (HIV)]. Since building controls can’t wipe out every single imaginable introduction, consideration is set on decreasing the capability of direct skin contact using defensive dress that opposes infiltration. This test strategy was created for positioning the engineered blood infiltration obstruction execution of medical face mask in a way speaking to real use as might happen when the face mask is reached by a high speed stream of blood from a punctured injury.
The test technique is planned to assess the security of the medicinal services provider face from presentation to blood and body liquids. It is utilized to assess the obstruction of medical face mask to entrance by manufactured blood under high-speed fluid contact with the medical face mask surface of a fixed volume over a moderately brief timeframe (0 s to 2,5 s). medical face mask “pass/come up short” conclusions depend on visual discovery of manufactured blood penetration.
NOTE 1 Medical face masks are planned to oppose fluid infiltration from the splatter or sprinkling of blood, body liquids, and other conceivably irresistible materials. Numerous elements can influence the wetting and entrance qualities of body liquids, for example, surface strain; consistency; and extremity of the liquid, just as the structure and relative hydrophilicity or hydrophobicity of the materials. The surface pressure run for blood and body liquids (barring spit) is around 0,042 N/m to 0,060 N/m. To help reproduce the wetting attributes of blood and body liquids, the surface pressure of the engineered blood is acclimated to rough the lower end of this surface strain run. The subsequent surface pressure of the manufactured blood is (0,042 ± 0,002) N/m.
NOTE 2 During a medical technique, a blood vessel can be punctured bringing about a high-speed stream of blood affecting a defensive medical face mask. The effect speed relies upon a few factors, the most significant being the pulse of the patient. A subsequent factor is the good ways from the cut. The speed of bigger punctures drops in light of the fact that the weight in the vein drops rapidly. Since just little punctures cause high-speed streams, huge punctures were not used to show the scope of blood-splatter speeds considered right now. Besides, this test strategy depends on the presumption that the clinical face veil will be in nearness to the cut territory. This test technique is thusly founded on the effect speed of a surge of liquid that compares to the objective circulatory strain.
NOTE 3 The mean human blood presure by and large changes over a scope of around 10,6 kPa to 16,0 kPa (80 mm Hg to 120 mm Hg). Right now, medical face covers are tried at stream speeds comparing to 10,6 kPa, 16,0 kPa, and 21,3 kPa (80 mm Hg, 120 mm Hg, and 160 mm Hg, separately). This test technique allows the utilization of other non-standard test pressures, stream speeds, liquid volumes, and example directions for assessing clinical face cover entrance obstruction reliable with explicit applications.
This International Standard doesn’t have any significant bearing to all structures or states of blood-borne pathogen presentation. Clients of the test technique should audit modes for face introduction and evaluate the fittingness of this test strategy for their particular application.
This International Standard essentially addresses the exhibition of materials or certain material developments utilized in medical face mask . This test strategy doesn’t address the presentation of the medical face mask design, development, interfaces or different components which may influence the general security offered by the medical face mask and its activity, (for example, filtration effectiveness and weight drop).
This test method does not address breathability of the medical-face mask materials or any other properties affecting the ease of breathing through the medical face mask. This test method evaluates medical face masks as an item of protective clothing. This test method does not evaluate the performance of medical face cover as protection against contamination via airborne exposure pathways or in the prevention of the penetration of aerosolized body fluids deposited on the medical face mask.
NOTE 4 Users of this test strategy ought to understand that specific tradeoffs exist between improved obstruction of medical face mask to infiltration by engineered blood and in pressure drop across veil materials which is a pointer of the breathability of the face mask. When all is said in done, expanding manufactured blood infiltration obstruction for medical face mask brings about expanding pressure drop or decreased breathability for clinical face covers of a similar plan and attack of the individual wearer.
NOTE 5 This test technique assesses clinical face mask as a thing of defensive attire and doesn’t assess medical face mask as respirators. On the off chance that respiratory assurance for the wearer is required, an endorsed respirator ought to be utilized. This test strategy can be utilized to assess the opposition of a respirator to entrance by manufactured blood, whenever justified.
This International Standard portrays a lab test technique for estimating the obstruction of clinical face veils to entrance by a sprinkle of synthetic blood.
This International Standard principally addresses the exhibition of materials or certain material developments utilized in medical face mask . This test strategy doesn’t address the exhibition of the medical face mask plan, development, interfaces or different elements which may influence the general security offered by the medical face mask and its activity, (for example, filtration productivity and weight drop).
This test technique doesn’t assess the presentation of medical face mask as an insurance against pollution by means of airborne introduction pathways or in the avoidance of the entrance of aerosolized body liquids stored on the clinical face cover.
2 Normative references
The accompanying referenced reports are basic for the utilization of this archive. For dated references, just the version refered to applies. For undated references, the most recent version of the referenced archive (counting any corrections) applies.
- ISO 304, Surface dynamic operators — Determination of surface strain by drawing up fluid films (Layer).
- ISO 2859-1, Sampling methodology for investigation by properties — Part 1: Sampling plans listed by acknowledgment quality cutoff (AQL) lot-by-lot inspection
3 Terms and definitions
For the reasons for this document, the accompanying terms and definitions apply.
Aerosolized Body Liquids
body liquids which have been scattered into air as extremely little fluid droplets
Airborne Presentation Pathways
inward breath courses of presentation to the medical face mask wearer
Note 1 to Entry: Inhalation routes of presentation do exclude floods of blood or body liquid that might be ousted from an injury.
Any infectious emitted or discharged bacterium, infection, or other sickness prompting microorganism conveyed in blood or other body liquids
Any fluid created (discharged or discharged) by the body
Note 1 to section: For the reason for this International Standard, body liquids incorporate those fluids possibly tainted with blood-borne pathogens, including, yet not constrained to, blood, semen, vaginal emissions, cerebrospinal liquid, synovial liquid and peritoneal liquid, amniotic liquid, spit in dental methods, and anyone liquid that is unmistakably polluted with blood, and all body liquids in circumstances where it is troublesome or difficult to separate between body liquids.
Fluid which is utilized to go about as a model for human body liquids
Medical Face MAsk
Thing of defensive apparel intended to ensure parts of the wearer’s face, including in any event the mucous layer territories of the wearer’s nose and mouth, from contact with blood and other body liquids during clinical methodology
stream of particles or fluids through terminations, permeable materials, creases and gaps or different blemishes in a defensive attire material
Note 1 to passage: In this International Standard, the infiltration fluid is manufactured blood.
Any material or mix of materials utilized in a thing of garments to separate pieces of the body from contact with a potential risk
Note 1 to section: For the reason for this International Standard, the potential peril of contact with blood or other body liquids is reenacted.
blend of amaranth color, surfactant, thickening operator, inorganic salts and refined water having a surface strain illustrative of blood and some other body fluids
Note 1 to section: The synthetic blood right now doesn’t recreate the entirety of the attributes of blood or body liquids. For instance, this manufactured blood doesn’t reenact extremity (wetting attributes), coagulation, or substance of cell matter.