Workshop Face Masks Standards

Transcription

1 Workshop Face Masks Standards European Standard 1. EN (Surgical masks - Requirements and test methods) Introduction: The transmission of infective agents during surgical procedures in operating theatres and other medical settings can occur in several ways. Sources are e.g. noses and mouths of the surgical team. The main intended use of surgical masks is to protect the patients from infective agents from the noses and mouths of the staff and, in certain situations, to protect the wearer against splashes of potentially contaminated liquids. Scope: This European Standard specifies construction and performance requirements, and test methods for surgical masks intended to limit the transmission of infective agents from staff to patients and (in certain situations vice-versa) during surgical procedures in operating theatres and other medical settings with similar requirements. This European Standard is not applicable to masks intended exclusively for the personal protection of staff. Classification: Surgical masks specified in this standard are classified into two types according to bacterial filtration efficiency and differential pressure. Moreover each type is class-divided according to whether or not the masks are splash resistant. Performance requirements for surgical masks: Test Type I Type IR Type II Type IIR Bacterial Filtration Efficiency (BFE), (%) Differential pressure (mm water /cm² ) < 3 < 5 <3 <5 Splash Resistance pressure (mm Hg) Not required 120 Not required 120 NOTE: Type IR and Type IIR are splash resistant types. 1 / 6

2 Labelling and information have to be supplied: Annex 1 13 of the Medical Devices Directive (93/42/EEC) specifies the information that has to be specified on the packaging in which the surgical mask is supplied. The following information shall be supplied: a) The number of this European Standard. b) The type of mask (as indicated in Table). 2. EN 149 (European Standards for disposable filtering half masks) Scope: This European Standard specifies construction and performance requirements, and test methods for Filtering Face Piece Respirators to protect against solid or liquid aerosols, or oil based particulates. Classification: EN 149 divide particulate protection into the following categories: FFP1 FFP2 FFP3 Performance requirements for filtering half masks: Requirements Type Penetration of filter media Breathing resistance (mbar) Sodium chloride 95 l/min Paraffin oil 95 l/min Inhalation Exhalation 30 l/min 95 l/min 160 l/min FFP1 20% 20% 0,6 2,1 3 FFP2 6% 6% 0,7 2,4 3 FFP3 1% 1% / 6

3 Labelling and information have to be supplied: The following information shall be supplied: a) Identification of the manufacturer or responsible supplier. b) Protection class: FFP1, FFP2 or FFP3. c) Number of the standard and year of publication (EN 149:2001) d) Shelf-life e) Recommended storage conditions. f) Instructions for use shall be given with every smallest commercial package. g) Identification number of the body which has made the EC-type examination. Which case? Which mask? Overview of the requirements: Personal Protective Equipment Directive Filtering Face Piece (EN149) Filtering efficiency Sodium chloride Personal Protective Equipment US Norm N95 Filtering efficiency Sodium chloride Medical Devices Directive Surgical mask (EN 14683) Bacterial filtration efficiency (staphylococcus aureus) Filtering efficiency Paraffin oil - - Total inward leakage Total inward leakage - Breathing resistance Breathing resistance Breathing resistance Rebreathed CO Fluid penetration No bacterial filtration efficiency No bacterial filtration efficiency No filtering efficiency against paraffin oil Most requirements of EN149 not tested Inhalation protection is not considered 3 / 6

4 Surgical masks are not Personal Protective Equipment. Normal surgical masks are not certified as protective against airborne diseases. Surgical masks are not designed for use as particulate filter respirators and do not provide as much protection as a respirator. Surgical masks do not prevent leakage around the edge of the mask when the user inhales. About 60% - 90% particulates pass at the edge of the mask. Devices should comply with the Directive(s) that covers the principle intended purpose of the device. 1. Protecting the patient Medical Devices Directive 2. Protecting the wearer Personal Protective Equipment Directive 3. Medical Devices Directive: in certain situations, to protect the wearer against splashes Use DACH-High-Risk-Mask for medical personal protection. DACH-High-Risk-Mask is accredited in reference to EN149:2001 FFP3, especially for medical use & approved according to US standard NIOSH N95. DACH-High-Risk-Mask has very high filtration efficiency (99,47%) and small breathing resistance (even smaller than an FFP1 respirator). Test results EN 149 Requirements DACH-High-Risk-Mask FFP3 FFP1 FFP2 Penetration of filter media (Sodium chloride) 20% 6% 1% 0,53% Breathing resistance (mbar) Inhalation (30 l/min) 0,6 0,7 1 0,26 Inhalation (95 l/min) 2,1 2,4 3 0,88 Exhalation (160 l/min) ,37 DACH-High-Risk-Mask is test winner in Germany. 4 / 6

5 How to use the respirator You must wear the respirator correctly! You will not be protected if you don't wear your respirator correctly. Follow the manufacturer's instructions. Check before use: Inspect the respirator if there are any deficiencies. Check the face-piece for cuts, tears, frays or loss of elasticity Check for damaged or missing hardware Check the elasticity of the headbands Don the respirator 1. Cup the respirator in your hand with the nosepiece on your fingertips. Slightly bend the nose piece to form a gentle curve. 2. Position the respirator over your nose and mouth with the nosepiece up. Pull the bottom strap over your head and position it around neck below your ears. 3. Pull the top strap over your head so that it rests high on the back of your head. 4. Using two hands, mould the nosepiece to the shape of your nose. Press the nose piece tightly on your nose. 5. Adjust the respirator tightly on your face. Nothing (beards, head coverings, etc.) passes between the skin and the respirator's sealing edge. The respirator cannot be used with beards, facial hair, or other conditions that prevent a good seal between the face and the edge of the respirator. Remove the respirator when Significant increase in the breathing resistence The respirator collapses due to excess moisture The employee senses (smells/tastes) break through The respirator is visibly soiled or damaged The respirator no longer fits to the user s face When leaving the patient s room (followed by hand hygiene) 5 / 6

6 Extras: European Directive 89/686/EEC (the PPE Directive) eliminate barriers to trade within Europe, while safeguarding health and safety - essential health and safety requirements for different types of PPE. Category 1 - 'Simple design' PPE Self-certified by manufacturer Category 2 - 'Intermediate design' PPE Type-tested and assessed by Notified Body Category 3 - 'Complex design' PPE Type-tested and assessed by Notified Body Conformity to EU Standard Continuous control of production PPE should not be used or placed on the (EU) market unless it conforms to the PPE Directive. Medical Devices Directive Class I non-invasive devices Self-certified by manufacturer Class II - surgically invasive devices Self-certified by manufacturer Limited quality assurance Class III medicinal product Type-tested and assessed by Notified Body Full quality assurance 6 / 6