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ISBN 978-0-626-32368-4
SANS 1866-1:2018
Edition 1

SOUTH AFRICAN NATIONAL STANDARD

Medical devices

Part 1: Medical face masks

WARNING
This document references other
documents normatively.

Published by the South African Bureau of Standards

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SANS 1866-1:2018
Edition 1

Table of changes
Change No. Date Scope

Foreword
This South African standard was prepared by National Committee SABS/TC 1039, Medical devices,
in accordance with procedures of the South African Bureau of Standards, in compliance with
annex 3 of the WTO/TBT agreement.

This document was approved for publication in March 2018.

SANS 1866 consists of the following parts, under the general title Medical devices:

Part 1: Medical face masks.

Part 2: Medical respirators.

Compliance with this document cannot confer immunity from legal obligations.

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SANS 441:2018
Edition 1

Contents
Page

Foreword

1 Scope ...................................................................................................................................... 3

2 Normative references .............................................................................................................. 3

3 Terms and definitions.............................................................................................................. 4

4 Classification ........................................................................................................................... 5

5 Requirements .......................................................................................................................... 5
5.1 General requirements ................................................................................................... 5
5.2 Performance requirements .......................................................................................... 6

6 Testing requirements……………………………………………………………………………….. 6

7 Packaging and marking…………………………………………………………………………… . 7

8 Test report ............................................................................................................................... 7

Bibliography............................................................................................................................... 8

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SANS 1866-1:2018
Edition 1

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SANS 1866-1:2018
Edition 1

Medical devices

Part 1:
Medical face masks

1 Scope
1.1 This part of SANS 1866 covers the minimum performance requirements for materials used in
the construction of medical face masks, and is intended to limit the transmission of infective
agents in the healthcare environment.

1.2 This part of SANS 1866 provides classification of performance for a range of medical face
mask materials. Medical face mask performance classes are based on the barrier performance
properties of the medical face mask materials (such as fluid resistance, bacterial filtration efficiency,
and submicron filtration efficiency).

1.3 This part of SANS 1866 specifies the materials used in the construction of medical face masks
but not the material of the seal of the medical face mask against the wearer’s face or that of other
design features that determine the effectiveness of the mask in preventing particle or liquid
exposure to the wearer.

NOTE If respiratory protection is required, see 42 CFR-85 or SANS 50149 (or both).

2 Normative references
The following referenced documents, in whole or in part, are normatively referenced in this
document and are indispensable for its application. For dated references, only the edition
cited applies. For undated references, the latest edition of the referenced document (including any
amendments) applies. Information on currently valid national and international standards can
be obtained from the South African Bureau of Standards.

16 CFR-1610, Standard for the flammability of clothing textiles.

ASTM F1862, Standard test method for resistance of medical face masks to penetration by
synthetic blood (horizontal projection of fixed volume at a known velocity).

ASTM F2100, Standard specification for performance of materials used in medical face masks.

ASTM F2101, Standard test method for evaluating the bacterial filtration efficiency (BFE) of medical
face mask materials, using a biological aerosol of staphylococcus aureus.

EN 14683, Medical face masks – Requirements and test methods.

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SANS 1866-1:2018
Edition 1

SANS 15223-1/ISO 15223-1, Medical devices – Symbols to be used with medical device labels,
labelling and information to be supplied – Part 1: General requirements.

SANS 50149/EN 149, Respiratory protective devices – Filtering half masks to protect against
particles – Requirements, testing, marking.

3 Terms and definitions

For the purposes of this document, the following terms and definitions apply.

3.1
aerosol
suspension of solid, liquid, or solid and liquid particles that has a negligible falling velocity in a
gaseous medium

3.2
bacterial filtration efficiency
BFE
effectiveness of a medical face mask and respirator in capturing aerosol droplets that contain
bacteria

NOTE Transmission of blood-borne agents from patient to healthcare workers may occur in the event of
splashes.

3.3
body fluid
fluid produced, secreted, or excreted by the human body

NOTE Body fluids include liquids potentially infected with blood-borne pathogens, including, but not limited to,
blood, semen, vaginal secretions, cerebrospinal fluid, synovial fluid and peritoneal fluid, amniotic fluid, saliva in
dental procedures, and any body fluid that is visibly contaminated with blood, and all body fluids in situations
where it is difficult or impossible to differentiate between body fluids (see 29 CFR-1910.1030).

3.4
flammability
characteristics of a material that pertain to its relative ease of ignition and relative ability to
sustain combustion

3.5
healthcare
maintenance and restoration of health by the treatment and prevention of disease by trained and
licensed health professionals

3.6
healthcare environment
area used for the prevention, maintenance or restoration of health by trained and licensed health
professionals

3.7
infective agent
micro-organism that has been proven to cause infections in patients and members of the healthcare
team

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SANS 1886-1:2018
Edition 1

3.8
medical face mask
item of protective clothing designed to protect portions of the wearer’s face, including the mucous
membrane areas of the wearer’s nose and mouth, from contact with blood and other infective
agents

3.9
submicron particulate filtration efficiency
efficiency of the filter material in capturing aerosolized particles smaller than 1 µ, expressed as a
percentage of a known number of particles that does not pass the medical face mask at a
given flow rate

4 Classification

4.1 Medical face mask materials covered in this part of SANS 1866 shall be designated as one or
more of the following performance classes as based on the barrier performance properties of the
materials used in the medical face masks:

a) level 1 barrier medical face mask materials shall be evaluated for their ability to capture
submicron particles and their resistance to penetration by synthetic blood at the minimum
velocity specified in ASTM F1862;

b) level 2 barrier medical face mask materials shall be evaluated for their ability to capture
submicron particles and their resistance to penetration by synthetic blood at the middle velocity
specified in ASTM F1862; and

c) level 3 barrier medical face mask materials shall be evaluated for resistance to penetration by
synthetic blood at the maximum velocity specified in ASTM F1862.

4.2 General use medical face mask materials shall be evaluated for bacterial filtration efficiency
and differential pressure.

4.3 Submicron filtering medical face mask materials shall be evaluated for their ability to capture
submicron particles, for bacterial filtration efficiency and differential pressure. The medical face
masks that use submicron filtering materials do not provide respiratory protection to the wearer.

4.4 Fluid resistant medical face mask materials shall be evaluated for resistance to penetration
by synthetic blood, submicron particulate filtration, bacterial filtration efficiency, and differential
pressure.

5 Requirements

5.1 General requirements

5.1.1 Materials and construction

5.1.1.1 The medical face mask shall not disintegrate, split or tear during the intended use.

5.1.1.2 Any material from the filter media released by the airflow through the filter shall not
constitute a hazard or nuisance for the wearer.

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SANS 1866-1:2018
Edition 1

5.1.2 Design

The medical face mask shall have a means by which it can be fitted closely over the nose, mouth
and chin of the wearer, and that it fits closely at the sides.

5.2 Performance requirements

5.2.1 Bacterial filtration efficiency (BFE)

When tested in accordance with EN 14683 or ASTM F2101, the BFE of the medical face mask
shall conform to the minimum value given for the relevant type in table 1.

5.2.2 Breathability (different pressure)

When tested in accordance with EN 14683 or ASTM F2101, the differential pressure of the
medical face mask shall conform to the minimum value given for the relevant type in table 1.

NOTE Differential pressure is expressed in Pascal (Pa) or millimetres of water per square centimetre
(mmH2O); 1 Pa is equal to 9,806 times pressure expressed in mmH2O.

5.2.3 Submicron particulate filtration efficiency

When tested in accordance with ASTM F2100, the medical face mask shall conform to the
minimum value given for the relevant type in table 1.

5.2.4 Splash resistance

When tested in accordance with ASTM F1862, the resistance of the medical face mask to
penetration of liquid as a result of splashes shall conform to the minimum value given for the
relevant type in table 1.

5.2.5 Flammability

When tested in accordance with the flammability test in SANS 50149 and 16 CFR-1610, the
medical face mask shall not burn or continue to burn for more than 5 s after removal from the flame.

6 Testing requirements

6.1 All tests shall be carried out on finished products or samples cut from finished products.

6.2 Unless otherwise specified for a particular test, samples for testing shall be conditioned at
20 °C ± 2 °C and at the relative humidity for the time required to bring them into equilibrium with
the atmosphere.

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SANS 1886-1:2018
Edition 1

Table 1 — Performance requirements for the medical face masks

1 2 3 4
Characteristic Level 1 barrier Level 2 barrier Level 3 barrier
Bacterial filtration efficiency,
% ≥ 95 ≥ 98 ≥ 98
Differential pressure,
2 ˂ 4,0 ˂ 5,0 ˂ 5,0
mmH2O/cm
Submicron particulate
filtration efficiency at % ≥ 95 ≥ 98 ≥ 98
Resistance to penetration
by synthetic blood,
minimum pressure in mmHg 80 120 160
for pass result
Flame spread see 5.2.5 see 5.2.5 see 5.2.5

7 Packaging and marking

The packaging shall allow for ease of dispensing, and shall be marked with the following
information:

a) the description of the medical face mask as indicated in table 1;

b) the quantity in the packaging;

c) the manufacturer's name or trademark (or both);

d) the year of manufacture or the expiry date (or both);

e) a latex free warning;

f) a single use warning;

g) the lot number; and

h) pictograms in accordance with SANS 15223-1.

8 Test report
The following information shall be given in the test report:

a) the manufacturer’s name;

b) the product or style name;

c) the product lot; and

d) a graphic representation or a summary table of results that indicates the performance level and
its technical requirements in accordance with table 1.

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SANS 1866-1:2018
Edition 1

Bibliography
29 CFR-1910.1030, Bloodborne pathogens.

42 CFR-84, Approval of respiratory protective devices.

42 CFR-85, Requests for health hazard evaluations.

EN 13274-7, Respiratory protective devices – Methods of test – Part 7: Determination of particle

filter penetration.

SANS 9001/ISO 9001, Quality management systems – Requirements.

SANS 13485/ISO 13485, Medical devices – Quality management systems – Requirements for
regulatory purposes.

SANS 14971/ISO 14971, Medical devices – Application of risk management to medical devices.

SANS 50132/EN 132, Respiratory protective devices – Definitions of terms and pictograms.

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