UGANDA STANDARD Non-medical face mask - Specification - World Trade Organization
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UGANDA STANDARD
US 2552
First Edition
2020-05-12
Non-medical face mask — Specification
! Reference number
US 2252: 2020
© UNBS 2020US 2252: 2020
Compliance with this standard does not, of itself confer immunity from legal obligations
A Uganda Standard does not purport to include all necessary provisions of a contract. Users are
responsible for its correct application
© UNBS 2020
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilised in any
form or by any means, electronic or mechanical, including photocopying and microfilm, without prior written
permission from UNBS.
Requests for permission to reproduce this document should be addressed to
The Executive Director
Uganda National Bureau of Standards
P.O. Box 6329
Kampala
Uganda
Tel: +256 417 333 250/1/2
Fax: +256 414 286 123
E-mail: info@unbs.go.ug
Web: www.unbs.go.ug
i! © UNBS 2020 – All rights reservedUS 2252:2020
Contents Page
Foreword ...........................................................................................................................................................iii
Introduction .......................................................................................................................................................iv
1 Scope ............................................................................................................................................................... 1
2 Normative references .....................................................................................................................................1
3 Terms and definitions .....................................................................................................................................1
4 Requirements.................................................................................................................................................. 2
4.1 Materials .......................................................................................................................................................2
4.1.1 Types of materials .................................................................................................................................... 2
4.1.2 Compatibility with skin ............................................................................................................................2
4.1.3 Flammability ..............................................................................................................................................2
4.1.4 Cleaning and disinfecting reusable masks ............................................................................................ 2
4.2 Design........................................................................................................................................................... 2
4.3 Presentation and components ...................................................................................................................3
4.3.1 General ...................................................................................................................................................... 3
4.3.2 Head harness ............................................................................................................................................3
4.3.3 Other components.................................................................................................................................... 3
4.4 Practical performance .................................................................................................................................3
4.4.1 General ...................................................................................................................................................... 3
4.4.2 Resistance of temperature ...................................................................................................................... 3
4.4.3 Other specific requirements ....................................................................................................................3
5 Packaging ........................................................................................................................................................4
6 Labelling .......................................................................................................................................................... 4
7 Sampling .........................................................................................................................................................4
Annex A (informative) Recommended fabrics for non-medical face masks ................................................5
Annex B (normative) Test methods for non-medical masks ......................................................................... 6
B.1 Visual inspection......................................................................................................................................... 6
B.2 Practical performance test .........................................................................................................................6
B.2.1 Procedure ................................................................................................................................................. 6
B.2.2 Wearing test ..............................................................................................................................................6
B.2.3 Results ...................................................................................................................................................... 6
B.3 Resistance to temperature .........................................................................................................................6
Bibliography .......................................................................................................................................................7
© UNBS 2020 – All rights reserved ii!US 2252: 2020
Foreword
Uganda National Bureau of Standards (UNBS) is a parastatal under the Ministry of Trade, Industry and
Cooperatives (MTIC) established under Cap 327, of the Laws of Uganda, as amended. UNBS is mandated to
co-ordinate the elaboration of standards and is
(a) a member of International Organisation for Standardisation (ISO) and
(b) a contact point for the WHO/FAO Codex Alimentarius Commission on Food Standards, and
(c) the National Enquiry Point on the World Trade Organisation (WTO) Agreement on Technical Barriers to
Trade (TBT).
The work of preparing Uganda Standards is carried out through Technical Committees. A Technical Committee
is established to deliberate on standards in a given field or area and consists of key stakeholders including
government, academia, consumer groups, private sector and other interested parties.
Draft Uganda Standards adopted by the Technical Committee are widely circulated to stakeholders and the
general public for comments. The committee reviews the comments before recommending the draft standards
for approval and declaration as Uganda Standards by the National Standards Council.
The committee responsible for this document is Technical Committee UNBS/TC 14, Medical devices.
! iii © UNBS 2020 – All rights reservedUS 2252:2020
Introduction
Respiratory diseases caused by infective agents such as bacteria, fungi or viruses are common. Two main
routes of transmission are respiratory droplets and contact. Respiratory droplets are generated when an
infected person coughs or sneezes. Any person who is in close contact with someone who has respiratory
symptoms (coughing, sneezing) is at risk of being exposed to potentially infective respiratory droplets.
Droplets may also land on surfaces where the virus could remain viable; thus, the immediate environment of
an infected individual can serve as a source of transmission (contact transmission). Some of the diseases are
transmitted through respiratory droplets and contact with symptomatic, pre-symptomatic, and asymptomatic
people infected with infecting agents.
The use of non-medical face masks has a potential to reduce the emission of infectious agents from
symptomatic, pre-symptomatic, and asymptomatic persons. The mask can also reduce the risk of contracting
of infection by people who are not infected through reducing contact and possible inhalation of infectious
droplets.
Use of the non-medical face masks is envisaged for example for a person when visiting busy, closed spaces,
such as grocery stores, shopping centres, markets and or walking around busy roads or places; when using
public transport; and for certain workplaces and professions that involve physical proximity to many other
people (such as members of the police force, cashiers – if not behind a glass or other partition) and when
teleworking is not possible This device can contribute to the protection of a whole group wearing this barrier
mask.
There are many products marketed as “face masks” that offer a range of protection against potential health
hazards. Face masks may be classified into medical face masks and non-medical face masks. Medical face
masks and respirators are intended for a medical purpose, including for use by health care professionals.
Non-medical face masks are not intended for a medical purpose and are not medical devices.
Non-medical masks may be made from home or commercially made available. They may be made from a
variety of materials including paper or cloth. These types of masks may not be effective in blocking virus
particles that may be transmitted by coughing, sneezing or certain medical procedures. They do not provide
complete protection from virus particles because of a potential loose fit and the materials used. They are not
tested to standards of medical practice and the materials are not the same as used in surgical masks or
respirators. The edges are not designed to form a seal around the nose and mouth.
Wearing of masks constitutes a protective barrier to prevent emission of infecting agents from the wearer to
other person, to protect against possible penetration of infecting agents into the user’s mouth and nose area
or from a nearby person. It is also intended to protect the eyes, nose and mouth against any contact with the
hands.
Wearing of masks may make it difficult to breathe and can prevent you from getting the required amount of
oxygen needed by your body. It is restricted to short periods and one mask should not be worn for more than
6 hours. Face masks should not be put on children under the age of two (2) years, people who have trouble
breathing, people who are unconscious, or people who are unable to remove the mask on their own.
Non-medical face masks and other face covers made of textiles have the advantage that they can be
produced easily; they are washable and reusable.
This standard is intended to provide requirements for commercial non-medical face masks for use in
communities and other places where medical face masks may not be appropriate either due to shortage or
cost. The standards will enable testing of non-medical masks to minimum performance specifications.
© UNBS 2020 – All rights reserved !ivUS 2252: 2020
Non-medical masks — Specification
1 Scope
This Uganda Standard specifies the requirements, sampling and test methods for the non-medical face masks
intended to reduce the risk of general transmission of the infectious agent.
It covers non-medical face masks and other face covers made of textiles intended for single use (disposable)
or for multiple use that may be washed, disinfected and reused.
It does not cover respiratory protective devices such as medical face masks, filtering face masks and
breathing apparatus.
NOTE 1 Standards for medical face masks are available.
NOTE 2 Guidance for users of non-medical masks is available.
2 Normative references
The following referenced documents referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 2859-1, Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by
acceptance quality limit (AQL) for lot-by-lot inspection
US ISO 6940, Textile fabrics — Burning behaviour — Determination of ease of ignition of vertically oriented
specimens
US ISO 11737-1, Sterilization of health care products — Microbiological methods — Part 1: Determination of a
population of microorganisms on products
US ISO 16900-2, Respiratory protective devices — Methods of test and test equipment — Part 2:
Determination of breathing resistance
US ISO 16900-3, Respiratory protective devices — Methods of test and test equipment — Part 3:
Determination of particle filter penetration
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply. ISO and IEC maintain
terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at http://www.iso.org/obp
3.1
head harness
means of holding a barrier mask in place on the head
3.2
face blank
main body of a face mask that is functional and to which other components are attached
3.3
nose clamp
piece of metal or other material fixed on the face mask which help hold the mask in place around the nose
3.4
respirator
personal protective device to protect the user from inhalation of hazardous atmosphere.
3.5
non-medical face mask
face mask or covering that protects the full face or parts of the face against contaminated atmosphere or
reduces the emission of droplets from the wearer to the atmosphere.
© UNBS 2020 – All rights reserved !13.6
half face mask
a mask which covers the nose and mouth and possibly the chin
3.7
full face mask
tight fitting face piece covering mouth, nose, eyes and chin.
3.8
filtering face mask
face piece entirely or substantially constructed of filter material used for purifying the air
3.9
breathing apparatus
apparatus which enables the wearer to breathe independently of the ambient atmosphere by supplying
breathable air from an uncontaminated source
3.10
breathing resistance
resistance of a barrier mask to the flow of air inhaled (inhalation resistance) or exhaled (exhalation resistance)
4 Requirements
4.1 Materials
4.1.1 Types of materials
Non-medical face masks may be made from variety of common cloth and other fabric materials which are
compatible and suitable for use (see Annex A for some of the recommended fabrics).
If the face mask is designed to be reusable, the manufacturer shall indicate so and declare a method for
cleaning, disinfecting and drying products.
4.1.2 Compatibility with skin
Materials that may come into contact with the wearer's skin shall not be known to have potential to cause
irritation or any health hazard or deleterious effect to the user.
4.1.3 Flammability
The material used shall not present a danger of fire for the wearer and shall not be of highly flammable fabric.
When tested in accordance with US ISO 6940, the face mask shall not continue to burn after removal from the
flame.
4.1.4 Cleaning and disinfecting reusable masks
The materials used in both the face masks including filters, if any, and the straps (elastic bands) shall be
compatible with the normal household laundry and disposal methods. The mask shall tolerate at least five (5)
full machine washing cycles without loss of barrier properties or degradation of the elastic bands. The full
wash cycle (wetting, washing, rinsing) shall be at least 30 min (laundry or other) with a wash temperature of
60 °C.
If the materials require specific cleaning, disinfecting or disposal methods the manufacturers shall declare
such methods. This shall be tested by cleaning or disinfecting the face masks as specified by the
manufacturer, and then returning to normal conditions of expected use. The face mask shall be compatible
with cleaning, disinfecting or disposal methods and shall not show appreciable discolouration or deformation.
EXAMPLE Cellulose-based materials are incompatible with hydrogen peroxide as hydrogen peroxide will degrade
cellulose.
The materials, the methods of cleaning or disinfecting and the residues remaining on the cleaned or
disinfected face masks shall not cause a health hazard or deleterious effect to the user.
4.2 Design
Face masks may be of a single layer or a multi-layer composite made of single or blended fabric, with or
without film and shall have head harness for holding it on the user’s head.
Face masks shall be designed so that air enters the face mask and passes directly to the nose and mouth
area of the face mask. The exhaled air shall flow directly to the ambient atmosphere or via the exhalation
valve(s) or by other appropriate means if applicable.
! 2 © UNBS 2020– All rights reservedUS 2252: 2020
Face masks shall have a mechanism to fix to the wearer such as head harness to tie it securely to the head or
ears to minimize any gaps between the face and the mask. The mechanism shall be adjustable, if needed, to
ensure nose and mouth are fully covered.
The mask shall fit snugly to the cheeks and there shall not be any gaps.
All design features shall be assessed by visual inspection.
4.3 Presentation and components
4.3.1 General
Face masks may be made as full face masks or half face masks as a single piece or as components such as
face blank, head harness, nose clamp and ear loops or ear bands. Face mask may be presented in different
shapes.
Unless integral with the full face mask or half face mask the components shall be replaceable.
Such components shall be visually inspected in accordance with to Annex B.1.
4.3.2 Head harness
The head harness shall be so designed that the face mask can be donned and removed easily, when visually
inspected.
The head harness shall be adjustable or self-adjusting and shall hold the face mask firmly and comfortably in
position, when tested according to Annex B.2.
4.3.3 Other components
All components shall function correctly in all orientations and shall be protected against dirt and mechanical
damage.
All de-mountable connections shall be readily connected and secured, where possible by hand. Any means of
sealing used shall be retained in position when the connection is disconnected during normal maintenance.
4.4 Practical performance
4.4.1 General
The complete device shall be acceptable to the wearer as determined by a person familiar with the intended
condition of use including wearing, walking and working. The method of test is in Annex B.2.
Face masks shall be free from sharp edges, portions or blurs that can injure the wearer.
Face masks shall be adjustable to fit closely over the nose, cheeks and chin of the wearer to ensure sufficient
sealing of the user’s face against the ambient atmosphere, when the user’s skin is dry or damp or when the
user moves his/her head.
4.4.2 Resistance of temperature
After storing the masks at specified temperature in accordance with Annex B.3 and then returning to room
temperature, the face mask shall not show appreciable deformation.
4.4.3 Other specific requirements
Face masks shall comply to the specific requirements in given Table 1 when tested in accordance with the test
methods specified therein.
© UNBS 2020 – All rights reserved !3Table 1 — Specific performance requirements for face masks
Test parameter Requirement Test method
Minimum filtering capacity %, min.:
US ISO 16900-3, Sodium chloride test
• Solid particle 70
method
• Liquid particle (droplet) 70
US ISO 16900-3, Paraffin oil test method
Breathing resistance, mbar, max.:
• Inhalation resistance 2.4 US ISO 16900-2
• Exhalation resistance 3.0
Tensile strength for head harness Remain intact Annex B.2.2
Microbial cleanliness, cfu/g, max. 100 US ISO 11737-1
5 Packaging
The masks shall be packaged in suitable packaging materials which shall protect the product from any
contamination and mechanical damage during transportation, handling and storage. Masks may be packaged
in unit packages and into bulk packs.
6 Labelling
Each package shall be legibly and indelibly marked with the following information:
a) name and physical address of the manufacturer, packer or distributor;
b) name of product as “non-medical face mask”, “barrier mask” or “fabric mask” or “cloth mask”;
c) lot identification number;
d) instructions for use;
e) for reusable mask, the word, “Reusable” followed by instruction for cleaning (number of washes,
washing and drying method);
f) precautions like “Not for medical use”; and
g) type of material/fabric used.
7 Sampling
Sampling of masks shall be done in accordance with ISO 2859-1.
! 4 © UNBS 2020– All rights reservedUS 2252: 2020
(informative)
Annex
Recommended fabrics A
for non-medical face masks
The fabric composition for common single layer and multi-layer masks are shown in Table A.1. The
composition may be determined in accordance with the relevant part of ISO 1833.
Table A.1 — Composition of common single layermasks
medical and multilayer fabrics suitable for use in non-
Type of mask Name Fibre composition
Single layer Chiffon 90 % polyester and 10 % spandex
Cotton 100 % cotton
Multi-layer Cotton quilt (2 layers of 120 TPI 90 % cotton, 5 % polyester, 5 % other
cotton and filling: ~0.5cm fibres)
Cotton/Flannel 100 % cotton layer and, 65 % cotton
and 35 % polyester layer
Chiffon (2 layers) 90 % polyester and 10 % spandex
Cotton/silk (no gap) 100 % cotton layer and 100 % silk
layer
Cotton/chiffon 100 % cotton layer and chiffon layer
Natural silk (4 layers) 100 % silk
Cotton (2 layers) 100 % cotton
Cotton/ polyester 65 % polyester and 35 % cotton
Polyester/ viscose 65 % polyester, 35 % viscose
Knitted polyamide /nonwoven 50 % polyamide and 50 % polyester
polyester joined by thermal bonding
Nonwoven polypropylene (2 layers) 100 % polypropylene
© UNBS 2020 – All rights reserved !5Test methods(normative)
Annex
for B
non-medical masks
B.1 Visual inspection
The visual inspection is carried out before the laboratory or practical performance tests.
B.2 Practical performance test
B.2.1 Procedure
AII tests shall be carried out by two test subjects at ambient temperature and the test temperature and
humidity shall be recorded. For the test, persons shall be selected who are familiar with using the face masks.
During the tests, a face mask shall be subjectively assessed by the wearer and after the test, comments on
the acceptability of the face mask shall be recorded.
B.2.2 Wearing test
The subjects wearing normal working clothes and wearing the face mask shall assess the acceptability of the
face mask. Record results as indicated in B.2.3.
The head harness shall not disintegrate or lose elastics properties when put on and removed five times
consecutively.
B.2.3 Results
For each of the tests- wearing, walking and work simulations record the acceptability of the following aspects
of face mask to the subject undertaking the test:
a) harness comfort;
b) security of fastenings and couplings;
c) accessibility of controls (if fitted);
d) clarity of vision of the wearer with mask; and
e) any other comments reported by the wearer on request.
B.3 Resistance to temperature
Two face masks shall be treated in the state as received. The face mask shall be exposed during successive
tests:
a) for 24 h to a dry atmosphere of 70 °C ± 3 °C; and
b) for 24 h to a temperature of −30 °C ± 3 °C.
! 6 © UNBS 2020– All rights reservedUS 2252: 2020
Bibliography
[1] IS 8347: 2008, Respiratory protective devices — Definitions, classification and nomenclature
[2] IS 14746: 1999, Indian Standard, respiratory protective devices — Half masks and quarter masks —
Specification of components
[3] IS 14166: 1994, (Indian Standard) Respirator y protective devices — Full-face masks — Specification
[4] AFROR SPEC S 76- 00: 2020, Barrier masks — Guide to minimum requirement methods of testing,
marking and use.
[5] Testing the efficacy of homemade masks by, Anna Davies, KatyAnne Thompson, Karthika Giri, George
Kafatos, Jimmy Walker and Allan Bennett, 2013, Disaster Medicine and Public Health Preparedness,
pp16
[6] Aerosol Filtration Efficiency of Common Fabrics Used in Respiratory Cloth Masks.
[7] WHO, 2020, Infection prevention and control during health care when COVID-19 is suspected: interim
guidance
[8] WHO, 2020, Advice on the use of masks in the context of COVID-19: interim guidance
[9] Samy Rengasamy, Benjamin Eimer and Ronald E. Shaffer, 2010. Simple Respiratory Protection —
Evaluation of the Filtration Performance of Cloth Masks and Common Fabric Materials Against 20–
1000 nm Size Particles. Ann. Occup. Hyg., Vol. 54, No. 7, pp. 789–798.
© UNBS 2020 – All rights reserved !7US 2252: 2020
Certification marking
Products that conform to Uganda standards may be marked with Uganda National Bureau of Standards
(UNBS) Certification Mark shown in the figure below.
The use of the UNBS Certification Mark is governed by the Standards Act, and the Regulations made
thereunder. This mark can be used only by those licensed under the certification mark scheme operated by
the Uganda National Bureau of Standards and in conjunction with the relevant Uganda Standard. The
presence of this mark on a product or in relation to a product is an assurance that the goods comply with the
requirements of that standard under a system of supervision, control and testing in accordance with the
certification mark scheme of the Uganda National Bureau of Standards. UNBS marked products are
continually checked by UNBS for conformity to that standard.
Further particulars of the terms and conditions of licensing may be obtained from the Director, Uganda
National Bureau of Standards.
!
© UNBS 2020 – All rights reserved !8US 2552: 2020
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