Workshop Face Masks Standards
European Standard
1. EN 14683 (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), (%) ≥ 95 ≥ 95 ≥ 98 ≥ 98 Differential pressure (mm water /cm² ) < 3 < 5 <3 <5 Splash Resistance pressure (mm Hg) Not required ≥ 120 Not required ≥ 120
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
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)
Personal Protective Equipment US Norm N95
Medical Devices Directive Surgical mask (EN 14683)
Filtering efficiency – Sodium chloride
Filtering efficiency – Sodium chloride
Bacterial filtration efficiency (staphylococcus aureus)
Filtering efficiency – Paraffin oil - -
Total inward leakage Total inward leakage -
Breathing resistance Breathing resistance Breathing resistance
Rebreathed CO2 -- --
-- -- 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
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).
EN 149 Requirements
Test results DACH-High-Risk-Mask FFP1 FFP2
FFP3 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) 3 3 3 1,37
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
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
