Protective Face Mask Testing and Certification

Blue Virus Cell

Face masks are only as good as their testing and certification.

From public transport to intensive care units, personal protective equipment (PPE) has never been more important. Protecting people from COVID-19 is the number one priority for individuals, business, organizations and governments. Face masks are now compulsory in many settings.

Our testing and certification services verify your product's effectiveness and compliance to those regulations relevant to your destination market.

ONE STOP SHOP

Providing a one stop shop, our global network of PPE experts and accredited laboratories can ensure the compliance of face masks and PPE products with testing and certification requirements, help with technical files and coordinate with Notified Bodies for EC type examinations.

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Medical Masks

Also known as surgical and procedure masks, medical face masks protect the wearer’s face from contact with blood and other bodily fluids. They may be worn by medical staff, patients and others to reduce the risk of spreading infections.

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Respirators

Commonly known as a filtering face piece, or a half mask, respirators have a tight facial fit and provide the wearer with protection against the inhalation of hazardous atmospheres and are very efficient for the filtration of airborne particles.

LEARn MORE ABOUT REGULATORY REQUIREMENTS

Reusable Fabric Masks

Reusable fabric masks provide the wearer with basic protection in their everyday life.

LEARN MORE ABOUT REGULATORY REQUIREMENTS

Medical Masks

Medical face masks, also known as surgical or procedure masks, protect the wearer’s face - including the mucous membrane areas of the wearer’s nose and mouth - from contact with blood and other body fluids during medical procedures.

REQUIREMENTS

The intended use environment and market country dictate the applicable requirements. The main intended use of medical face masks is to protect patients from infective agents and, in certain circumstances to protect the wearer against splashes of potentially contaminated liquids.

Medical face masks are considered as medical devices and regulated by national medical device regulations. Regulations will define the legal obligations, to ensure that medical face masks provide the minimum level of protection against intended risks. Specific requirements by classification are cited in the referenced performance standards.

Evaluation areas include (but not limited to):

  • Registration and approval
  • Classification designations
  • Marking and labeling
  • Particulate Filtration Efficiency (PFE)
  • Bacterial Filtration Efficiency (BFE)
  • Differential pressure (breathability)
  • Blood penetration resistance
  • Flammability
  • Microbial cleanliness/li>
  • Biocompatibility

COUNTRY-SPECIFIC REGULATIONS

Country Classification Primary regulation Performance standard
Australia Level 1, Level 2, Level 3 Therapeutic Goods (Medical Devices) Regulations 2002 AS 4381:2015
Brazil - Resolution RDC 185/2001 ABNT NBR 15052:2004
Canada Level 1, Level 2, Level 3 SOR/98-282 ASTM F2100-19
China Single-use Medical Face Mask Regulations for the Supervision and Administration of Medical Devices YY/T 0969-2013
Surgical Mask YY 0469-2011
EU Type I, Type II, Type IIR Directive 93/42/EEC EN 14683-2019+AC:2019
United States Level 1, Level 2, Level 3 21 CFR Subchapter H ASTM F2100-19

MARKING

United States

Classified as Class 2 medical device, in the US medical masks must meet the labeling requirements of the relevant regulations.

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EU

Classified as either a Class 1 or Class 2 medical device, medical masks destined for the EU market must meet the labeling requirements of the corresponding standards.

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Respirators

Designed to provide the wearer with respiratory protection against inhalation of a hazardous atmosphere respirators are designed for the very efficient filtration of airborne particles.

There are many different types and classifications of respirators, which vary depending on the user's facial coverage and the intended hazardous atmosphere.

Commonly known as a filtering facepiece or half mask, respirators are those masks whose edges are designed to form a seal around the user’s nose and mouth. This tight facial fit is the one primary differences between respirators and surgical masks that are not intended to provide respirator protection.

Examples of these type of respirators include:

  • United States and Canada: N95
  • China: KN95, KP95
  • EU: FFP2/FFP3
  • Australia: P2/P3
  • Brazil: FFP2/FFP3

REQUIREMENTS

The intended use environment and market country dictate the applicable requirements.

Respirators are generally used in commercial environments, with most intended for use in construction and other industrial type jobs that expose workers to dust and small particles. Some respirators are intended for use in a health care setting, when respiratory and fluid resistance is required.

Due to their primary commercial use, respirator regulations are the jurisdiction of the country’s workplace safety agency. Regulations define the legal obligations to ensure that respirators provide the minimum level of protection against intended risks. Specific requirements by classification will be contained within regulation or cited in referenced performance standards.

Evaluation areas include (but not limited to):

  • Certification and Approval
  • Classification Designations
  • Marking and Labeling
  • Particle Filtration Efficiency
  • Breathing Resistance
  • Leakage
  • Flammability

COUNTRY-SPECIFIC REGULATIONS

Country Classification Primary regulation Performance standard
Australia P3, P2, P1 AS/NZS 1715:2009 AS/NZS 1716:2012
Brazil PFF3, PFF2, PFF1 Fundacentro CDU 614.894 ABNT/NBR 13698:2011
Canada N95, N99, N100
R95, R99, R100
P95, P99, P100		 - -
Surgical N95 - -
China N90, N95, N100
P90, P95, P100		 GB/T 18664—2002 GB 2626-2019
Level l, Level ll, Level lll NMPA GB 19083-2010
EU FFP3, FFP2, FFP1 (EU) 2016/425
EN 529:2005		 EN 149:2001+A1:2009
United States N95, N99, N100
R95, R99, R100
P95, P99, P100		 OSHA 29 CFR1910.134 NIOSH: 42 CFR 84
Surgical N95 OSHA: 29 CFR 1910.134
FDA: 21 CFR 878.4040		 NIOSH: 42 CFR 84
ASTM F2100

COVID-19 REGULATORY UPDATES & ADVICE

During the COVID-19 pandmic, regulators around the world are updating and reviewing their standard respirator approval processes. A selection of the updates, by country, are listed below.

Australia

Brazil

Canada

EU

United Kingdom

United States

NOTE: information on these links changes frequently due to the fluid situation.

MARKING

United States

The National Institute for Occupational Safety and Health (NIOSH) specifies minimum approval requirements for respiratory protective devices in Title 42 Code of Federal Regulations (CFR) Part 84.

NIOSH approval labels are described in 42CFR84 (§84.33), and the information they provide, and their locations differ depending on the respirator type. These labels are referred to as “entire” or “abbreviated” (§84.33[e]). However, these labels do not identify the approved respirator’s complete configuration of components.

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European Union

Particle filtering half masks complying with the European standard must display a rnage of informaiton on the product itself and on its packaging.

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Reusable Fabric Masks

As more individuals turn to reusable face masks, most often ‘do-it-yourself’ (DIY) made from fabric, countries have begun to develop regulations, standards and guidelines to ensure their proficiency.

As a fabric mask is directly in contact with skin for potentially long periods of time, relevant restricted substance and biocompatibility testing are highly encouraged. Also, the ear loops have to be securely attached to a reusable mask for the duration of its expected lifetime.

Relevant performance testing for fabric face masks include:

Barrier performance

Breathing resistance

Functional testing

Colorfastness testing

Ear loop attachment strength

Restricted substances

Of all the specifications, ‘barrier performance’ is the most crucial when it comes to reusable fabric masks. Most locations have adopted particulate filtration efficiency (PFE) as the major barrier performance, while bacterial filtration efficiency (BFE) is specified in Spain and Portugal.

Summarized below are the barrier performance regulations/standards/guidelines in some markets:

Country Type of specification Regional regulation/ standard/guidelines Barrier performance Test method Requirement
France Regulation French Cross Ministries Note (NOTE d’INFORMATION du 29 mars 2020 Mise a jour le 26 avril) Mandatory requirement in France PFE Dissolved gas analysis (DGA) method Annex 2 or equivalent Particles size: 3 microns:
> 90% for UNS Class I
> 70% for UNS Class II
Guidelines AFNOR Spec S76-001 v1.1 PFE DGA method Annex 2 or equivalent 3 microns particles:
> 90% for UNS Class I
> 70% for UNS Class II
Spain National standard UNE 0065 BFE EN 14683:2019 + AC: 2019 Clause B ≥ 90%
Portugal Portugal specifications Masks intended for use under COVID-19 technical specifications 1 PFE EN 13274-7:2019 Level 2: ≥ 90%
Level 3: ≥ 70%
BFE EN 14683:2019+AC:2019 Annex B Level 2: ≥ 90%
Level 3: ≥ 70%
China Association standard T/CSTM 00387-2020 PFE GB/T 38413-2019 PM 2.5 daily reusable protective mask
As received: ≥ 95%
After care: ≥ 90%

General daily reusable protective mask:
As received: ≥ 90%
After care: ≥ 85%
Switzerland Recommendation by task force Swiss National COVID-19 Science Task Force PFE Particle size: 1μm ≥ 70%
Germany Recommendation BfArM recommendations - - Attention on marking and labeling issue
United States Recommendation by industry General Purpose Woven Face Coverings – Guidance and Considerations PFE ASTM F2299 or technical equivalent, with modified micron size 3 micron particles >= 70% filtration efficiency as minimal
United Kingdom Recommendation BSI guide to masks and face coverings for use in the UK during the COVID-19 pandemic PFE EN 13274-7:2019 Requirement to be determined by the Cabinet Office/Department for Business, Energy and Industrial Strategy (BEIS)
Belgium National Standard NBN/DTD S 65-001:2020 PFE EN 13274-7:2019 ≥ 70%
BFE EN 14683:2019+AC:2019 Annex B ≥ 70%

SGS offers testing and consultation services for interested parties on fabric masks to test if the product performance satisfies relevant regional specifications and requirements, and shares information on export/import procedures.

Our network is capable of providing mask testing and consultation services in the following locations:

  • Hong Kong, China
  • Shanghai, China
  • Cestas, France
  • Fairfield, USA
  • Grasslake, USA

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SGS Next Normal Solutions

Next Normal Solutions

The COVID-19 pandemic is unprecedented in the modern era, posing unforeseen challenges to business continuity. At SGS, we are working hard to meet those challenges and support international efforts to beat COVID-19.

Our experts are responding to the challenges our clients face with innovative solutions to help operations now, to ensure business continuity for the duration of the pandemic, and to support the recovery and evolution through each phase of the ‘next normal’.

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