AS 4381:2015
Level 1
Purpose
Level 1
Level 2
Level 2
Level 3
Level 3
Level 1 barrier
medical face
Level 2 barrier
medical
Level 3 barrier
medical
mask materials
are evaluated
face mask
materials are
face mask
materials are
for resistance to
penetration
evaluated for
resistance to
evaluated for
resistance to
by synthetic
blood, bacterial
penetration by
synthetic
penetration by
synthetic
filtration
efficiency and
differential
blood, bacterial
filtration
blood, bacterial
filtration
efficiency and
differential
efficiency and
differential
pressure, as
specified below.
pressure, as
specified
APPLICATIONS:
For use in
below.
pressure, as
specified below.
APPLICATIONS:
For general
purpose medical
procedures,
where the
wearer is not at
risk
of blood or
bodily fluid
splash
or to protect staff
and/or the
emergency
departments,
dentistry,
changing
dressings
on small or
healing wounds
where minimal
blood droplet
APPLICATIONS:
For all
surgical
procedures,
major trauma
first aid or in
any area where
the health
care worker is at
risk of
N95
N95
P2
Reduces
wearer’s
exposure
to
particles
including
small
particle
aerosols
and large
droplets
(only
non-oil
aerosols)
P2
patient from
droplet exposure
exposure may
possibly occur
blood or bodily
fluid splash
to
microorganisms
(e.g. patient
(e.g. endoscopy
procedures)
(e.g.
orthopaedic,
cardiovascular
procedures)
with upper
respiratory tract
infection visits
GP)
>95%
Bacterial
Filtration
>98%
>98%
ASTM
F2101-14
or
EN
14683:2014
Differential
Pressure
<4.0
<5.0
<5.0
EN
14683:2014
Pentration
Resistance
80 mmHg
120 mmHg
160 mmHg
ASTM
F1862 /
F1862M-13
or ISO
22609
Testing
Qualitative
fit testing
Qualitative fit testing is a pass/fail test based on the wearer’s subjective
assessment of any leakage from the face seal region, by sensing the
introduction of a test agent. These tests are suitable for half masks. They are
not suitable for full face masks.
Examples of qualitative fit testing methods are:

method based on bitter- or sweet-tasting aerosol;

Quantitative
fit testing
method based on odour compounds.
Quantitative fit testing provides a numerical measure of the fit, called a fit factor.
These tests give an objective measure of face fit. They require specialised
equipment and are more complicated to carry out than qualitative methods.
Quantitative methods are suitable for full face masks (but can also be used for
half masks).
Examples of quantitative fit testing methods are:
laboratory test chamber;
portable fit test devices, such as a particle counting device.
PROPERTIES
Characteristics
P2 RESPIRATORS
N95 RESPIRATORS
N95 respirator, respiratory protection device,
particulate respirator
P2 respirator, respiratory protection device,
particulate respirator






Raised dome or duckbill
4–5 layers (outer polypropylene, central
layers electret [charged polypropylene])
Filtration through mechanical impaction and
electrostatic capture
Designed to provide a good facial fit to
minimise aerosol contamination of the
mucous membranes of the nose and mouth
P2 particulate filtering respirators/ masks


Raised dome or duckbill
4–5 layers (outer polypropylene, central
layers electret [charged polypropylene])
Filtration through mechanical impaction and
electrostatic capture
• Designed to provide a good facial fit to
minimise aerosol contamination of the
mucous membranes of the nose and mouth
NIOSH classified N95 particulate filtering

Sealing


must have a filter efficiency of at least 94%
when tested with Sodium Chloride aerosol at
a flow rate of 95 litres/minute.
Under the EN system, aerosol testing is
similar to Standard AS/ NZS 1716: 2012, but
have additional filter efficiency testing with
paraffin oil aerosol that must also meet the
minimum 94% filter efficiency to be classified
as P2. The particle size of this aerosol has a
mass median diameter of 0.3 to 0.6 microns
with a range of particles in the 0.02 to 2
micron size range.
Ties at crown and bottom of head, pliable
metal nose bridge
Fit testing and fit checking required
respirators/ masks must have a filter
efficiency of at least 95% when tested with
Sodium Chloride aerosol at a flow rate of 85
litres/minute. N95 respirator masks can only
be used for oil free aerosols. The particle size
of this aerosol ~0.3 micron.


Ties at crown and bottom of head, pliable
metal nose bridge
Fit testing and fit checking required
Australian Standards

Standard AS/NZS 1715: 2009 Standard
AS/NZS 1716: 2012

Set by the US NIOSH classification (NIOSH
Guidelines – Procedure No. TEB-APR-STP0059)
Intended Use

Routine care of patients on airborne
precautions
High-risk procedures such as bronchoscopy
when the patient’s infectious status is
unknown
Procedures that involve aerosolisation of
particles that may contain specific known
pathogens

Routine care of patients on airborne
precautions
High-risk procedures such as bronchoscopy
when the patient’s infectious status is
unknown
Procedures that involve aerosolisation of
particles that may contain specific known
pathogens
Care must be taken if placing respirators on
patients and must suit clinical need (i.e. if the
patient has chronic obstructive airways
disease [COAD] or is in respiratory distress,
the respirator will exacerbate symptoms).



Notes




Care must be taken if placing respirators on
patients and must suit clinical need (i.e. if the
patient has chronic obstructive airways
disease [COAD] or is in respiratory distress,
the respirator will exacerbate symptoms).


Fit-testing
measures the effectiveness of the
seal between the



respirator and the wearer’s face. It is
required for all
tight-fitting respirators

Filter
efficiency
at least
94%
Testing
substance
Sodium
Chloride
Aerosol
Aerosol flow
rate
95 litres
per
minute
Aerosol
particle size
0.3 to
0.6
microns
Eyewear
AS/NZS 1337.1:2010 – Personal eye protection
The aim of this Standard is to assist in the provision of safe, efficient and comfortable vision in the occupational situation, including consideration of
the need for protection against sunglare and optical radiation in the natural environment.
AS/NZS 1337.1:2010 specifies minimum requirements for non-prescription eye and face protectors and associated oculars. They are designed to
provide protection for the eyes and faces of persons against common occupational hazards such as flying particles and fragments, dusts, splashing
materials and molten metals, harmful gases, vapours and aerosols. Requirements for optical qualities and low, medium, high and very high impact
resistance are given and appendices describing appropriate test methods are included in this Standard.
All uvex eyewear is approved under the standard AS/NZS 1337.1:2010. All AS/NZS 1337.1:2010 approved eyewear requires the relevant lens
markings to show that the product is approved to standards.
Marking in accordance with AS/NZS 1337.1:2010
Marking on frame and arms
Marking on lens
MARKING
HAZARD
APPLICATION FOR
C or 3
splash proof
goggles, eye shields and face shields
D or 4
dust proof
goggles
G or 5
gas tight
goggles
M or 9
molten metal and hot solids
face shields only
EYE AND FACE PROTECTOR TYPE
LOW IMPACT 13 M/S
MEDIUM IMPACT 45 M/S
wide vision spectacle
x
x
goggle
x
x
eye shield
x
x
face shield
x
x
All eye protection is tested to be capable of withstanding impact from a specified weight ball without cracking, detaching or dislodging, breaking or
coming into contact with the eye or the head. AS/NZS test requirements categorise impact resistance into four categories: Low Impact, Medium
Impact, High Impact, Very High Impact.
Appropriate Frame
– the frame meets minimum lens dimension requirements of AS/NZS 1337.
–
Low impact sufficient to cover 2 ellipses 42mm wide and 32mm high centered on a 64mm pupil distance (PD).
–
Medium impact sufficient to cover 2 ellipses 42mm wide x 35mm high. Additionally, protection from side impact is mandatory. Where this is
achieved by the use of side shields, these must be permanently attached (for example, riveted on or moulded with the side rather than screwed on).
1. Appropriate lens material and thickness
Any material that meets the performance requirements of the standard may be used for low to medium impact protection, with the
exception of untempered or high index (including chemically tempered) glass, which should not be used as the front-most or the rearmost element in any eye protection.
Appropriate Fitting
With the availability of thermoplastic materials such as polycarbonate, lens fracture under impact is rarely an issue. The problem of a lens being
dislodged from the frame is a more common problem. A lens must be held securely and should not be able to be dislodged under impact but
shall not be held so tightly that the surfaces are distorted.
Labelling and assuring compliance
Prescription eye protectors shall have a manufacturer’s name or logo on the frame and lenses. This has the dual affect of allowing the
user to identify the manufacturer in the event of product failure and also allows the manufacturer what is not their product or when their
product has been altered for instance reglazed frames).
–
Lenses must be appropriately marked
–
There are three levels of compliance
1. Certification using the Standards Mark – the Standards Mark is the highest level of assurance in which manufacturers are
supervised and audited. The exact requirements to be involved in such a scheme are not part of the Standard but are
negotiated with a compliance authority such as SAI Global or BSI Benchmark.
2. Self-Certification with third party systems certification and third party testing – The extent of necessary system certification and
third party testing is not set down in the standard but might become an issue in a court case.
3. Self-Certification using internal procedures and checks only- Self-certification is not precluded in the standard but it would be
difficult to justify in the event of litigation.
Updated ANSI safety eyewear standards include the following key features:

For the basic impact tests, lenses are tested separately (not mounted in a frame). For the high impact classification, the
frame and lenses are tested together as a unit.
Non-prescription lenses used for high impact testing are considered to be structurally weaker than prescription lenses made of the same material; the
prescription lenses are generally thicker.
Thinner prescription safety lenses are now allowed, if they meet the high impact testing requirements. (Previously, all prescription safety lenses had to have a
minimum thickness of 3 mm, making them significantly thicker and heavier than regular eyeglass lenses.)
Safety lenses now have two classifications of performance: basic impact and high impact.


The "drop ball" test determines the basic impact safety classification for lenses. In this test, a one-inch diameter steel ball is
dropped onto the lens from a height of 50 inches. To pass, the lens must not crack, chip or break. All glass safety lenses
must undergo this test. For plastic safety lenses, however, only a statistical sample of a large batch of lenses needs to be
tested.
In high impact testing, a high velocity test is performed by shooting a quarter-inch diameter steel ball at the lens at a speed
of 150 feet per second. To pass, the lens must not crack, chip or break, and it must not become dislodged from the lens
holder.