Technical specifications of personal

protective equipment for COVID-19

IN T E RIM GUIDA NC E
13 NO V E MBE R 2020
Technical specifications of personal
protective equipment for COVID-19
IN T E RIM GUIDA NC E
13 NO V E MBE R 2020

WHO reference number: WHO/2019-nCoV/PPE_specifications/2020.1

© World Health Organization 2020. Some rights reserved. This work is available under the CC BY-NC-SA 3.0 IGO licence.
Contents
Acknowledgements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv

Abbreviations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v

1. Methodology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

2. Context and considerations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

3. Regulatory approvals and certifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

4. Technical specifications for procurement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Selected further reading. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Annex 1. Tables of standards and values: respirators; medical face masks; isolation and surgical
gowns; medical examination gloves (non-sterile); surgical gloves (sterile) (not exhaustive). . . . . . . . . 9

Annex 2. Checklists: respirators; medical face masks; isolation and surgical

gowns; medical examination gloves (non-sterile); surgical gloves (sterile).. . . . . . . . . . . . . . . . . . . . . . 12

Contents iii
 Acknowledgements
We are grateful to World Health Organization (WHO) consultants Ying Ling Lin and Erol Ozbakir, for drafting the
technical specifications and the standards and checklists.

Input is acknowledged from the following members of the Technical Advisory Group of Experts on Personal
Protective Equipment (TAG PPE), specifically group 1 on standards, technical specifications and quality assurance:
Faisal Al Shehri, Razan Asally, Ehab Atia, Patricia Ching, Nagwa Hasanin, Emilio Hornsey, Ayse Ayzit Kilinc, Selcen
Kilinc-Balci, Melissa Leavitt, Claudio Meirovich, John McGhie, Alison Syrett, Nasri Yussuf. All members of TAG PPE
provided Conflict of Interest declarations, which were reviewed by WHO and no conflicts of interest were found.

Revision, technical input and alignment to WHO guidelines and guidance was received from the following WHO
staff (including from the Pan American Health Organization, South-East Asia Region, European Region and Eastern
Mediterranean Region): April Baller, Antoine Delaitre, Murilo Freitas, Bruce Gordon, Tifenn Humbert, Agnes Kijo,
Alexandre Lemgruber, Fernanda Lessa, Ismail Mohamed, Houda Langar, Madison Moon, Adriana Velazquez.

The project was coordinated by Adriana Velazquez, Lead for Medical Devices and In Vitro Diagnostics, Policy,
Norms and Standards, Medicines and Health Products, World Health Organization, Geneva, Switzerland.

Special thanks to copyeditor Vivien Stone (Etchingham, United Kingdom of Great Britain and Northern Ireland).

iv COVID-19 Technical specifications for personal protective equipment — Interim guidance

Abbreviations
AQL acceptance quality limit
CE Conformité Européenne
CFU colony forming unit
EU European Union
FDA Food and Drug Administration (USA)
FSC free sales certificate
IB barrier index
ILAC International Laboratory Accreditation Cooperation
IPC infection prevention and control
ISO International Organization for Standardization
NIOSH National Institute for Occupational Safety and Health (USA)
NMPA National Medical Products Administration (China)
OSHA Occupational Safety and Health Administration (USA)
PPE personal protective equipment
RQL rejectable quality limit
TAG PPE Technical Advisory Group of Experts on Personal Protective Equipment
WHO World Health Organization

Abbreviations v
1. Methodology
Each personal protective equipment (PPE) item listed is considered a priority medical device for COVID-19
(1). The technical specifications define the minimum requirements for the product to ensure good quality,
safety and efficacy. The methods used to develop the following technical specifications involved review of the
infection prevention and control (IPC) COVID-19 guidelines, review of PPE products available in the market, and
PPE products approved by stringent regulatory agencies, and analysis of international, regional and country
standards on PPE. The four COVID-19 guidelines analysed were: Rational use of personal protective equipment
for coronavirus disease (COVID-19) and considerations during severe shortage (2), Advice on the use of masks in
the context of COVID-19 – in the community, during home care, and in health care settings (3), COVID-19 advice
for the public: when and how to use masks (4), Analysis of the PPE required to perform the clinical management
of COVID-19 patients (5), and the Disease commodity package for novel coronavirus (6).

The specifications were reviewed by members of the Technical Advisory Group of experts on Personal Protective
Equipment (TAG PPE), who also provided technical input; and by WHO staff and consultants from WHO regional
offices. All experts and consultants provided Conflict of Interest declarations and no conflicts were found.

1. Methodology 1
 2. Context and considerations
The present publication defines the basic technical characteristics of PPE. The decision as to the appropriate
clinical use of each of these devices is reserved to medical staff and according to IPC guidance.

2 COVID-19 Technical specifications for personal protective equipment — Interim guidance

3. Regulatory approvals and
certifications
For all the PPE and related IPC supplies the following regulatory approvals and certifications apply.

It should be noted that in some economic regions, some PPE is considered a medical device and therefore the
relevant regulations are to be followed. In other regions, some PPE may be considered an industrial protection
garment and not tagged for medical use.

Due to limited manufacturing capacity some products might come from other economic regions or might
have “emergency use authorizations” from regulatory agencies. Therefore, the requirements listed below might
apply only to the COVID-19 period and may be updated; otherwise, they will be valid for up to 2 years following
publication.

Naming Names, synonym

General technical See Section 4 for technical specifications for PPE specific for COVID-19.
requirements
Primary packaging Labelling on the primary packaging needs to include:
Name and/or trademark of the manufacturer.
Model or product reference.
Information for particular storage conditions (temperature, pressure, light, humidity).
Quality management Certified quality management system for medical devices (e.g. ISO 13485) and
system from the application of risk management to medical devices (e.g. ISO 14971), if applicable.
manufacturer, for the General quality management (e.g. ISO 9001) (for non-medical devices).
PPE types European Union (EU) Module C2 or D conformity to type certificate (Category III CE certified PPE only).
Regulatory approval/ Free sales certificate (FSC) of medical device and related IPC products.
certification Certificate for exportation of medical device and related IPC products, provided by the authority in
manufacturing country (in case of imported goods).
National local regulatory approval (of recipient country, as applicable).
Proof of regulatory compliance, as appropriate, per the product’s risk classification
(e.g. Europe: Conformité Européenne [CE] certification and declaration of conformity and/or EU type
examination certificate as applicable, e.g. PPE cat. III for respirators; USA: Food and Drug Administration [FDA]
approval or emergency use authorization; China: National Medical Products Administration [NMPA] listed).
Ability for purchaser to check authenticity directly with the issuing regulatory authority (e.g. online database of
active licences).
Category I PPE, may accept self-declaration with declaration of conformity (COVID-19 context).
Authorized representative must be identified and document expiration date supplied (valid until).
Test reports Official test reports (all pages, in English) must either originate from accredited test labs, whereby the
accreditation authority is preferably a member of International Laboratory Accreditation Cooperation (ILAC), or
from an EU notified body. Accredited facilities should be ISO 17025 certified.
Test reports should clearly indicate the accredited laboratory name and accreditation (for regulator or procurer,
to be able to check authenticity of test reports).
Test standard must be within the scope of the accreditation of the laboratory.
CE certificates (EU type examination certificates) for category III PPE should mention the notified body name/
number.
Instructions for authentication of test report(s) and certificates should be provided.
Ability for purchaser to check authenticity directly with the accredited test laboratory (e.g. online uploading of
test report and automatic version check, or emailing test facility).

3. Regulatory approvals and certifications 3

 4. Technical specifications for
procurement
Item Characteristics Performance standards (or alternative
equivalent standard)
Gloves, medical Gloves, examination, nitrile (preferable), latex, EN 455
examination (non- polychloroprene or PVC, powder-free, non-sterile (e.g. ASTM D6319, D3578, D5250, or D6977
sterile) minimum 230 mm total length). Minimum thickness EN 374, optional additional
0.05 mm. Sizes S, M, L. Or alternative equivalent set of standards
Gloves, surgical (sterile) Gloves, surgical, nitrile (preferable), latex, polyisoprene or EN 455
polychloroprene, sterile, powder-free, single use. ASTM D3577
Gloves should have long cuffs, reaching well above the wrist, Sterility:
ideally to mid-forearm. Minimum thickness 0.10 mm. Sizes United States Pharmacopeia
ranging 5.0–9.0. EN ISO 11607
Or alternative equivalent set of standards

Goggles, glasses Good seal with the skin of the face, flexible PVC frame to EN 166
protective easily fit with all face contours with even pressure, enclose ANSI/ISEA Z87.1
eyes and the surrounding areas, accommodate wearers Or alternative equivalent set of standards
with prescription glasses, clear plastic lens with fog- and
scratch-resistant treatments. Adjustable band to secure
firmly so as not to become loose during clinical activity.
Indirect venting to avoid fogging. May be reusable (provided
appropriate arrangements for decontamination are in place)
or disposable.
Face shield Made of clear plastic and providing good visibility to both EN 166 (if reusable)
the wearer and the patient. Adjustable band to attach firmly ANSI/ISEA Z87.1 (if reusable)
around the head and fit snuggly against the forehead, fog Or alternative equivalent set of standards
resistant (preferable). Completely cover the sides and length
of the face. May be reusable (made of robust material which
can be cleaned and disinfected) or disposable.
Fit test kit To evaluate effectiveness of seal for tight fitting respiratory OSHA 29 CFR 1910.134 Appendix A
protection devices.
Particulate respirator Good particle filtration (minimum 94% or 95%), good Fluid resistant respirator:
breathability with design that does not collapse against the • Minimum NIOSH approved (42 CFR Part 84)
mouth (e.g. duckbill, cup-shaped). May be tested for fluid and FDA cleared “surgical N95”
resistance (NIOSH/FDA surgical N95, EN 149 FFP2+Type IIR, • EN 149, minimum “FFP2“ and EN 14683 Type
GB 19083 Grade/Level 1). IIR
• GB 19083, minimum “Grade/Level 1”
• Or alternative equivalent standard

Non-fluid resistant respirator:

• Minimum NIOSH approved “N95” according to
42 CFR Part 84
• EN 149, minimum “FFP2”
• GB 2626, minimum “KN95”
• Or alternative equivalent standard

4 COVID-19 Technical specifications for personal protective equipment — Interim guidance

Item Characteristics Performance standards (or alternative
equivalent standard)
Mask, medical for Medical mask, good breathability, internal and external Fluid resistant masks (surgical masks):
health care worker faces should be clearly identified, 98% droplet filtration, • EN 14683 Type IIR
preferably fluid resistance. • ASTM F2100 Level 1, 2 or 3
• YY 0469, with at least 98% bacterial droplet
filtration
• Or alternative equivalent standard

Non-fluid resistant mask:

• EN 14683 Type II
• YY/T 0969, with at least 98% bacterial
droplet filtration
• Or alternative equivalent standard
Mask, medical for Medical mask, good breathability, internal and external faces EN 14683 Type I
patient should be clearly identified. YY 0469 or YY/T 0969, if bacterial droplet
filtration is below 98%
Or alternative equivalent standard
Scrubs, tops Tunic/tops, woven, scrubs, reusable or single use, short  
sleeved (tunic/tops), worn underneath the coveralls or gown.
Scrubs, pants Trouser/pants, woven, scrubs, reusable or single use, worn  
underneath the coveralls or gown.
Apron, heavy duty Straight apron with bib. EN ISO 13688
Fabric: 100% polyester with PVC coating, or 100% PVC, or EN 14126 and partial protection (EN 13034 or
100% rubber, or 100% reusable and biodegradable material, EN 14605)
or other fluid-resistant coated material. ASTM F903 for bleach, sodium hypochlorite
Waterproof, sewn strap for neck and back fastening or EN 343 for waterproofing and breathability
single-material cut film. Or alternative equivalent set of standards
Minimum basis weight: 300 g/m2.
Thickness: 200–300 µm, optional. If biodegradable:
Covering size: 70–90 cm (width) x 120–150 cm (height). • EN 13432
Reusable (provided appropriate arrangements for • ASTM D6400
decontamination are in place) or biodegradable.
Apron, disposable Single-use straight sleeveless protective apron, for use in Product performance testing if biodegradable
health care settings. • EN 13432
Seamless liquid proof and stain resistant. • ASTM D6400
Comfortable to wear, apron has back- and neck-band strips • Or alternative equivalent set of standards
attached (4 in total).
Both back- and neck-band can be adjusted/fastened.
Colour: white.
Material: polyethylene (PE) or biodegradable or compostable
material.
Size: 85 x 145 cm (w x l) (± 15%).
Thickness: not less than: 50 µm.
Can resist water and disinfectant (ethanol 70% and chlorine
solution 0.05% or 500 ppm).
Gown, isolation Single use, disposable, made of non-woven material, length AAMI PB70 (Level 1–3) and ASTM F3352
mid-calf. Sizes S, M, L, XL. EN 13034 - Type PB [6] (stitched gown), with
May also be reusable, woven, length mid-calf. Sizes S, M, L, minimum hydrostatic head of 50 cmH2O
XL. Critical zones may be more fluid resistant than non- AAMI PB70 Level 4 and ASTM F3352 or
critical zones. Reusable gowns should meet the minimum ISO 16604 Class 5
performance requirements after maximum suggested Or alternative equivalent set of standards
laundering cycles.

4. Technical specifications for procurement 5

 Item Characteristics Performance standards (or alternative
equivalent standard)
Gown, surgical Single use, disposable, non-woven material, length mid- AAMI PB70 and ASTM F2407
calf, sterile or non-sterile. Critical zones may be more fluid EN 13795
resistant than non-critical zones. Or EN 13034 - Type PB [6] (stitched gown), with
Single use, woven material, length mid-calf, sterilizable. minimum hydrostatic head of 50 cmH2O
Critical zones may be more fluid resistant than non-critical YY/T 0506 or alternative equivalent set of
zones. standards
Reusable gowns should meet the minimum performance EN 556, if sterile, or alternative equivalent set
requirements after maximum suggested laundering cycles. of standards
Alcohol-based hand rub Bottle 100 mL and 500 mL, at least 80% ethanol or 75% ASTM E2755
isopropyl alcohol (v/v). EN 1500
Or alternative equivalent set of standards
Optional: ASTM E1115 or ASTM E1174
Biohazard bag Disposable autoclavable bag for biohazard waste. Puncture resistant meets ASTM D1709 (dart
Material: high density polyethylene (HDPE) or polypropylene impact test)
(PP). Tear resistant meets ASTM D1922 or ISO 6383-2
Colour: red or yellow. Temperature resistance test at 121°C
Autoclave ability (temperature resistant up to 121 °C).
Printed with a sterilization patch that darkens when subject
to steam.
Puncture, tear and leak resistant.
Leak proof flat bottom seal.
Black imprint “Biohazard” and tri-sickle logo according
U+2623 on one side.
Capacity: approximately 20 L or 50 L.
Thickness: minimum 0.038 mm (1.5 mil).
Sizes: width (45 cm), length (50 cm) (± 10%); width
(60 cm), length (82 cm) (± 10%).
Safety box Safety box for needles/syringes, 5 L capacity, cardboard for Biohazard label as per WHO PQS E010/011
incineration, box of 25.
Soap Liquid (preferred), powder and bar.
Gloves, cleaning Glove should have long cuffs, reaching well above the wrist, EN 388
ideally to mid-forearm. Minimum 280 mm total length. ANSI 105
Sizes: S, M, L. Reusable. Heavy duty gloves. High cracking, EN 374-1, EN 374-2 (at least Level 2)
puncture- and abrasion-resistant. Powder free, seamless, EN 374-4 and EN 374-5
and entirely waterproof. Made of nitrile, synthetic rubber EN 420 + A1
(no latex). Knit inner lining facilitates slide-in and removal. Or alternative equivalent set of standards
Cleanable with water and disinfectant (resisting both
ethanol solutions 70% and chlorine solutions 0.05% or
500 ppm). Material thickness, at level of the fingers, not
less than: 0.38 mm. Length not less than: 30 cm. Supply
co-packed as one left/right pair.
Hand drying tissue 50–100 m roll.
Chlorine NaDCC, granules, 1 kg, 65–70% + measurement spoon.

6 COVID-19 Technical specifications for personal protective equipment — Interim guidance

References
1. WHO. List of priority medical devices for COVID-19 case management. Geneva: World Health Organization;
9 April 2020 (https://www.who.int/publications/m/item/list-of-priority-medical-devices-for-covid-19-case-
management, accessed 30 October 2020).

2. WHO. Rational use of personal protective equipment for coronavirus disease (COVID-19) and considerations
during severe shortages: interim guidance. Geneva: World Health Organization; 6 April 2020 (https://www.
who.int/publications/i/item/rational-use-of-personal-protective-equipment-for-coronavirus-disease-(covid-
19)-and-considerations-during-severe-shortages, accessed 30 October 2020).

3. WHO. Advice on the use of masks in the context of COVID-19: interim guidance; 5 June 2020 (https://www.who.
int/publications/i/item/advice-on-the-use-of-masks-in-the-community-during-home-care-and-in-healthcare-
settings-in-the-context-of-the-novel-coronavirus-(2019-ncov)-outbreak, accessed 30 October 2020).

4. WHO. Coronavirus disease (COVID-19) advice for the public: when and how to use masks; 20 October 2020
[website]. Geneva: World Health Organization; 2020 (https://www.who.int/emergencies/diseases/novel-
coronavirus-2019/advice-for-public/when-and-how-to-use-masks, accessed 30 October, 2020).

5. WHO. Clinical management of COVID-19: interim guidance; 27 May 2020 (https://www.who.int/publications/i/

item/clinical-management-of-covid-19, accessed 30 October 2020).

6. WHO. Disease commodity package for novel coronavirus. Geneva: World Health Organization; 11 January 2020
(https://www.who.int/publications/i/item/disease-commodity-package-for-novel-coronavirus, accessed 30
October 2020).

References 7
 Selected further reading
AAMI (2020). AAMI offers free standards and resources to help fight coronavirus. Arlington (VA): Association for
the Advancement of Medical Instrumentation (https://www.aami.org/detail-pages/press-release/aami-offers-
free-standards-and-resources-to-help-fight-coronavirus, accessed 12 August 2020).

ASTM (2020). ASTM standards & COVID-19. West Conshohocken (PA): ASTM International (https://www.astm.org/
COVID-19, accessed 12 August 2020).

BSI (2020). Personal protective equipment: COVID-19 response. London: British Standards Institution (https://
www.bsigroup.com/en-GB/topics/novel-coronavirus-covid-19/medical-devices-ppe/, accessed 12 August 2020).

CDC (2020). Strategies for optimizing the supply of N95 respirators: crisis/alternate strategies. 28 June 2020.
Atlanta (GA): Centers for Disease Control and Prevention (https://www.cdc.gov/coronavirus/2019-ncov/hcp/
respirators-strategy/index.html, accessed 12 August 2020).

EU (2020). Commission recommendation (EU) 2020/403 of 13 March 2020. Luxembourg: Publications Office of
the European Union (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32020H0403, accessed 12
August 2020).

ISO (2020). COVID-19 freely available ISO standards. Geneva: International Organization for Standardization
(https://www.iso.org/covid19, accessed 12 August 2020).

PAHO (2020). Technical and regulatory aspects of the extended use, reuse, and reprocessing of respirators
during shortages, 10 June 2020. Washington (DC): Pan American Health Organization (https://iris.paho.org/
handle/10665.2/52431, accessed 12 August 2020).

Standardization Administration of China (various dates). Beijing, China. Translated Chinese standards: ftp://ftp.
cencenelec.eu/EN/COVID19/ENGTranslationsOfChineseStandards_Q4.1.zip

WHO (2020). Priority Medical Devices for COVID-19 [website]. Geneva: World Health Organization (https://www.
who.int/medical_devices/priority/COVID-19/en/, accessed 17 August 2020).

WHO (2020). Technical Specification for Medical Devices [website]. Geneva: World Health Organization (https://
www.who.int/medical_devices/management_use/mde_tech_spec/en/, accessed 18 May 2020).

8 COVID-19 Technical specifications for personal protective equipment — Interim guidance

Annex 1.
Tables of standards and values: respirators;
medical face masks; isolation and surgical gowns;
medical examination gloves (non-sterile); surgical
gloves (sterile) (not exhaustive)

Respirators
Europe (EN 149) USA (NIOSH CFR PART 84) China (GB 2626) China (GB 19083)
Filtration (NaCl) ≥ 94% (FFP2) ≥ 95% (N95) ≥ 95% (KN95) ≥ 95% (Grade 1)
Filtration (paraffin oil) ≥ 94% (FFP2) N/A N/A N/A
Breathing resistance ≤ 70 Pa (@ 30 L/min) ≤ 343 Pa (@ 85 L/min) ≤ 350 Pa (@ 85 L/min) ≤ 343 Pa (@ 85 L/min)
(inhalation) ≤ 240 Pa (@ 95 L/min)
≤ 500 Pa (clogging)
Breathing resistance ≤ 300 Pa (@160 L/min) ≤ 245 Pa (@ 85 L/min) ≤ 250 Pa (@ 85 L/min)
(exhalation)
Fit Tested with 10 human Fit testing upon arrival 10 participants, see below Fit factor of 100, with
participants, see below according to OSHA, not 8 subjects
required by NIOSH
Total inward leakage ≤ 8% leakage N/A ≤ 8% leakage
(arithmetic mean) (arithmetic
mean)
CO2 of inhalation air ≤ 1% N/A ≤ 1%
Synthetic blood If type IIR, 120 mmHg If surgical N95, None If surgical N95,
penetration (≥ 29/32 passing masks 120 mmHg 120 mmHg (5 masks)
(≥ 29/32 passing masks)

Medical face masks

Europe (EN 14683) US (ASTM F2100) China (YY 0469) China (YY 0969)
Filtration (BFE) ≥ 95% (Type I) ≥ 95% (Level 1) ≥ 95% (ASTM F2101) ≥ 95% (ASTM F2101)
≥ 98% (Type II, IIR) ≥ 98% (Level 2, 3)
Filtration (PFE) N/A ≥ 95% (Level 1) N/A N/A
≥ 98% (Level 2, 3)
Pressure drop (Pa/cm2) < 40 (Type I, II) < 49 Pa or 5 mm H2O/cm2 < 49 < 49
< 60 (Type IIR) (Level 1)
< 58.8 Pa or 6 mm
H2O/cm2 (Level 2, 3)
Synthetic blood 120 mmHg (ISO 22609) 80 mmHg or 10.7 kPa 120 mmHg or 16 kPa N/A
penetration (kPa) 16 kPa (Type IIR) (Level 1)
120 mmHg or 16 kPa
(Level 2)
160 mmHg or 21.4 kPa
(Level 3)
Microbial cleanliness ≤ 30 N/A ≤ 100 ≤ 100
(CFU/g)

Annex 1: Tables of standards and values: respirators; medical face masks; isolation and surgical gowns; medical examination gloves (non-sterile);
9
surgical gloves (sterile) (not exhaustive)
 Isolation and surgical gowns
Europe (EN 13795) US (AAMI PB70, ASTM F3352, China (YY T/0506)
ASTM F2407)
Water resistance < 4.5 g (AAMI Level 1)
(impact penetration) ≤ 1.0 g (AAMI Level 2, 3)
(AQL 4%, RQL = 20%
Water resistance ≥ 20 cmH2O (critical area, standard ≥ 20 cm (AAMI Level 2) ≥ 20 cmH2O (critical area, standard
(hydrostatic pressure) performance) ≥ 50 cm (AAMI Level 3) performance)
≥ 100 cmH2O (critical area, high (AQL 4%, RQL = 20% ≥ 100 cmH2O (critical area, high
performance) performance)
≥ 10 cmH2O (less critical area, ≥ 10 cmH2O (less critical area,
standard and high performance) standard and high performance)
Viral penetration Pass (AQL 4%, RQL = 20% (AAMI
Level 4)
Resistance to wet ≤ 2.8 IB (critical areas, standard ≤ 2.8 IB (critical areas, standard
bacterial penetration performance) performance)
≤ 6.0 IB (critical areas, high ≤ 6.0 IB (critical areas, high
performance) performance)
Resistance to dry ≤ 300 CFU (less critical areas, ≤ 300 CFU (less critical areas,
microbial penetration standard and high performance) standard and high performance)
Cleanliness microbial ≤ 300 CFU (all areas, standard and ≤ 300 CFU (all areas, standard and
high performance) high performance)
Bursting strength (dry) ≥ 40 kPa (all areas, standard and ≥ 40 kPa (all areas, standard and
high performance) high performance)
Bursting strength ≥ 40 kPa (critical areas, standard ≥ 40 kPa (critical areas, standard
(wet) and high performance) and high performance)
Tensile strength (dry) ≥ 20 N (all areas, standard and ≥ 30 N ≥ 20 N (all areas, standard and
high performance) high performance)
Tensile strength (wet) ≥ 20 N (critical areas, standard and ≥ 20 N (critical areas, standard and
high performance) high performance)
Other criteria to Optional: China (GB 38462) gown standard,
consider • water vapour transmission rate in effect October 2020
(ASTM D6701)
• evaporative resistance (ASTM
F1868, Part B)

Medical examination gloves (non-sterile)

Europe (EN 455) US (ASTM material specific)
EN 455-1, EN 455-2, EN 455-3, EN 455-4 D6319, D3578, D5250, D6977
Freedom from holes AQL < 1.5 (ISO 2859) AQL < 2.5 (ISO 2859)
Force at break (N)/ AQL N/A AQL < 4.0 (ISO 2859)
tensile strength (MPa) Nitrile > 6.0 N Nitrile > 14 MPa
(after ageing) Latex (natural) > 6.0 N Latex (natural) > 14 MPa
Polyisoprene > 6.0 N Polychloroprene > 14 MPa
Polychloroprene > 6.0 N PVC > 11 MPa
PVC, PE > 3.6 N
Powder residue < 2.0 mg < 2.0 mg
content
Aqueous soluble <10 μg per g of glove < 200 µg/dm2
protein content
Extractable antigenic <10 μg per g of glove < 10 µg/dm2
protein content

10 COVID-19 Technical specifications for personal protective equipment — Interim guidance

Surgical gloves (sterile)
Europe (EN 455) US (ASTM material specific)
EN 455-1, EN 455-2, EN 455-3, EN 455-4 D3577
Freedom from holes AQL < 1.5 (ISO 2859) AQL < 1.5 (ISO 2859)
Force at break (N)/ AQL N/A AQL < 4.0 (ISO 2859)
tensile strength (MPa) All materials > 9.0 N Type 1 latex (natural) > 18 MPa
(after ageing) Type 2 polyisoprene, polychloroprene, nitrile > 12 MPa
Powder residue < 2.0 mg < 2.0 mg
content
Aqueous soluble < 10 μg per g of glove < 200 µg/dm2
protein content
Extractable antigenic < 10 μg per g of glove < 10 µg/dm2
protein content
Sterility ASTM refers to United States Pharmacopeia pass/fail
EN 455 refers to EN ISO 11607

Annex 1: Tables of standards and values: respirators; medical face masks; isolation and surgical gowns; medical examination gloves (non-sterile);
11
surgical gloves (sterile) (not exhaustive)
12
Annex 2.
Checklists: respirators; medical face masks; isolation and surgical gowns;
medical examination gloves (non-sterile); surgical gloves (sterile)
Technical compliance to relevant performance standards for respirators (face filtering)
Supplier:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Manufacturer:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Model:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Standard test title Reference standard Minimum acceptable Compliant Claimed performance (class, Year/version of standard Reference document (pdf)

COVID-19 Technical specifications for personal protective equipment — Interim guidance

performance level Yes No type or measured)
Test report origin
ILAC accredited lab ISO 17025 Compliant
National notifying body ISO 17025 Compliant
Local, non-accredited ISO 17025 Compliant
Whole respirator performance
Europe respirators EN 149 FFP2
EN 149 FFP3
United States respirators NIOSH N95
NIOSH N99
NIOSH N100
NIOSH Surgical N95
Republic of Korea respirators KMOEL - 1st
2017-64 Class
 Standard test title Reference standard Minimum acceptable Compliant Claimed performance (class, Year/version of standard Reference document (pdf)
performance level Yes No type or measured)
China respirators GB2626 KN95
GB 19083 Grade 1
Australia respirators AS/NZA 1716 P2
Japan respirators JMHLW - Notification 214 DS
Physical performance/characteristics
Filter penetration of NaCl dry EN 149, Clause 7.9.2 < 6% (FFP2)
aerosol (at 95 L/min air flow) < 1% (FFP3)
Filter penetration of paraffin EN 149, Clause 7.9.2 < 6% (FFP2)
aerosol (at 95 L/min air flow) < 1% (FFP3)
Filter penetration of NaCl dry Filters > 94% of NaCl < 6%
aerosol (at 30 L/min air flow) particles of 2.5 μm
Filter penetration of NaCl dry NIOSH 42 CFR 84 (N95) > 95% particle removal
aerosol (at 85 L/min air flow) efficiency
GB 19083 > 95% particle removal
(Grade 1) efficiency
Total inward leakage (TIL) EN 149 Clause 7.9.1 < 11 %, FFP2
< 8%, mean
EN 149 Clause 7.9.1 < 5%, FFP3 2% (mean)
CO2 in inhalation air EN 149 Clause 7.12 < 1%
Synthetic blood penetration ASTM F1862 80 mmHg
(Surgical N95) 120 mmHg
160 mmHg
Synthetic blood penetration ISO 22609 120 mmHg
(FFP2 with fluid resistance)
Synthetic blood penetration GB 19083 80 mmHg
Synthetic blood penetration GB 19083 Need test reference
(Grade 1), reference (YY/T
0691-2008)

Annex 2: Checklists: respirators; medical face masks; isolation and surgical gowns; medical examination gloves (non-sterile); surgical gloves (sterile)
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14
Standard test title Reference standard Minimum acceptable Compliant Claimed performance (class, Year/version of standard Reference document (pdf)
performance level Yes No type or measured)
Flammability 16 CFR Part 1610 Class 1
EN 149, Clause 7.11 < 5 seconds
GB 19083, 4.10 < 5 seconds
Compatibility with skin EN 149, Clause 7.10 —
GB 19083, 4.11 Max. score of 1
Shelf life    5 years
Comfort characteristics
Breathing resistance EN 149, Clause 7.16 Max. 0.7 mbar (FFP2)
(inhalation) @ 30 L/min 70 Pa
Max. 1.0 mbar (FFP3)
100 Pa
Breathing resistance EN 149, Clause 7.16 Max 2.4 mbar (FFP2)
(inhalation) @ 95 L/min 240 Pa
Max 3.0 mbar (FFP3)

COVID-19 Technical specifications for personal protective equipment — Interim guidance

300 Pa
Breathing resistance EN 149, Clause 7.16 Max 3.0 mbar (FFP2 and
(exhalation) @ 160 L/min FFP3)
300 Pa
Breathing resistance EN 149, Clause 7.17.2.2 Max 4 mbar, after clogging
(inhalation/exhalation) @ (FFP2)
95 L/min
Breathing resistance Surgical N95 Max 3.5 mbar
(inhalation) @ 85 L/min 350 Pa
GB 19083 343.2 Pa
Breathing resistance Surgical N95 Max 2.5 mbar
(exhalation) @ 85 L/min 250 Pa
Breathing resistance Korea 1st Class ≤ 70 Pa (at 30 L/min)
(inhalation) @ 30 L/min (KMOEL - 2017-64) ≤ 240 Pa (at 95 L/min)
Breathing resistance Korea 1st Class ≤ 300 Pa
(exhalation) @ 160 L/min (KMOEL - 2017-64)
 Standard test title Reference standard Minimum acceptable Compliant Claimed performance (class, Year/version of standard Reference document (pdf)
performance level Yes No type or measured)
Breathing resistance GB2626, KN95 Max 350 Pa
(inhalation) @ 85 L/min
Breathing resistance GB2626, KN95 Max 210 Pa
(exhalation) @ 85 L/min
Quality compliance
General quality ISO 9001 Compliance
management system
Medical device quality ISO 13485 Compliance
management
Sampling procedures for ISO 2859 Compliance
inspection by attribute
Regulatory compliance
Establishment licence US FDA database Active
Listed as an acceptable NIOSH Active listing
respirator
Listed as a non-NIOSH US FDA emergency use Active listing
acceptable respirator authorization
Medical device licence US FDA database Active

Medical devices active Health Canada (MDALL) Active

licence listing
CE/EC certification PPE Regulation 2016/425 Compliance
MHRA UK Compliance
KOSHA Korea KMOEL - 2017-64 Compliance
Manufacturers allowed to National Medical Products Active licence/permit
export Administration
Manufacturers cleared for National Medical Products Active licence/permit
local sale Administration

Annex 2: Checklists: respirators; medical face masks; isolation and surgical gowns; medical examination gloves (non-sterile); surgical gloves (sterile)
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16
Technical compliance to relevant performance standards for medical face mask
Supplier:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Manufacturer:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Model:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Standard test title Reference standard Minimum acceptable Compliant Claimed performance (class, Year/version of standard Reference document (pdf)
performance level Yes No type or measured)
Test report origin
ILAC accredited lab ISO 17025 Compliant
National notifying body ISO 17025 Compliant
Local, non-accredited ISO 17025 Compliant
Whole mask performance

COVID-19 Technical specifications for personal protective equipment — Interim guidance

Materials used in medical ASTM F2100 Level 1
face masks ASTM F2100 Level 2
ASTM F2100 Level 3
Requirements and test EN 14683 Type I
methods for medical face EN 14683 Type II
masks
EN 14683 Type IIR
Surgical mask (fluid YY 0469 Compliant
resistant)
Single-use medical face YY/T 0969 Compliant
mask
Physical performance/characteristics
Droplet filtration efficiency ASTM F2101 95% AQL 4%, RQL = 20%
(3.0 μm particle size) ASTM F2101 98% AQL 4%, RQL = 20%
Droplet filtration efficiency YY 0469 95% AQL 4%, RQL = 20%
(3.0 μm particle size) YY 0469 80 mmHg AQL 4%, RQL =
20%
 Standard test title Reference standard Minimum acceptable Compliant Claimed performance (class, Year/version of standard Reference document (pdf)
performance level Yes No type or measured)
Droplet filtration efficiency YY/T 0969 120 mmHg AQL 4%, RQL =
(3.0 μm particle size) 20%
YY 0469 160 mmHg AQL 4%, RQL =
20%
Filtration efficiency (0.1 μm ASTM F2299 Class 1 AQL 4%, RQL = 20%
particle size)
Synthetic blood penetration ASTM F1862 95% AQL 4%, RQL = 20%
98% AQL 4%, RQL = 20%
95% AQL 4%, RQL = 20%
Flammability 16 CFR Part 1610 80 mmHg AQL 4%, RQL =
20%
Biocompatibility —
Number of layers — Minimum 3
Basis weight ASTM D3776 —
Shelf life 5 years
Comfort characteristics
Differential pressure MIL-M-36945C 4.4.1.1.1 < 3.0 mmH2O/cm2,
Method 1 29.4 Pa/cm2
or < 4.0 mmH2O/cm2,
EN14683 39.2 Pa/cm2 
< 5.0 mmH2O/cm2,
49.0 Pa/cm2
Quality compliance
General quality ISO 9001 Compliant
management system
Medical device quality ISO 13485 Compliant
management
Sampling procedures for ISO 2859 Compliant
inspection by attribute, post
shipment

Annex 2: Checklists: respirators; medical face masks; isolation and surgical gowns; medical examination gloves (non-sterile); surgical gloves (sterile)
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18
Standard test title Reference standard Minimum acceptable Compliant Claimed performance (class, Year/version of standard Reference document (pdf)
performance level Yes No type or measured)
Regulatory clearance
EU PPE Regulation 2016/425 Valid, issued < 5 years
EN MD Directive 93/42/EEC Valid, issued < 5 years
US FDA 510(k) Valid, issued < 5 years
NMPA, export clearance Valid, issued < 5 years
NMPA, internal use Valid, issued < 5 years

COVID-19 Technical specifications for personal protective equipment — Interim guidance

 Technical compliance to relevant performance standards for isolation and surgical gowns
Supplier:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Manufacturer:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Model:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Standard test title Reference standard Minimum acceptable Compliant Claimed performance (class, Year/version of standard Reference document (pdf)
performance level Yes No type or measured)
Test report origin
ILAC accredited lab ISO 17025 Compliant
National notifying body ISO 17025 Compliant
Local, non-accredited ISO 17025 Compliant
Whole gown performance, surgical
Liquid barrier performance AAMI PB70 Level 1
Liquid barrier performance AAMI PB70 Level 2
Liquid barrier performance AAMI PB70 Level 3
Liquid barrier performance AAMI PB70 Level 4
Surgical clothing and drapes EN 13795 Standard performance
Surgical clothing and drapes EN 13795 High performance
Protective clothing against EN 13034 Compliant Hydrostatic head pressure:
liquid chemicals cmH2O
Surgical gowns YY/T 0506 Compliant
Sterilization of medical EN 556 Compliant (sterile)
devices
Whole gown performance, isolation
Isolation gowns ASTM F3352 Compliant
Protective clothing against EN 13034 Compliant
liquid chemicals

Annex 2: Checklists: respirators; medical face masks; isolation and surgical gowns; medical examination gloves (non-sterile); surgical gloves (sterile)
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20
Standard test title Reference standard Minimum acceptable Compliant Claimed performance (class, Year/version of standard Reference document (pdf)
performance level Yes No type or measured)
Material performance
Water resistance (impact AATCC 42 < 4.5 g (AAMI Level 1) AQL
penetration) 4%, RQL = 20%
≤ 1.0 g (AAMI Level 2) AQL
4%, RQL = 20%
Water resistance (hydrostatic AATCC 127 ≥ 20 cm (AAMI Level 2) AQL
pressure) 4%, RQL = 20%
≥ 20 cm (AAMI Level 3) AQL
4%, RQL = 20%
Viral penetration ASTM F1671 Pass (AQL 4%, RQL = 20%
(AAMI Level 4)
Clothing for protection ISO 16604 Class 5
against contact with blood
and body fluids
Resistance to wet bacterial ISO 22610 ≥ 2.8 IB (critical area,

COVID-19 Technical specifications for personal protective equipment — Interim guidance

penetration standard performance)
≥ 6.0 IB (critical area,
standard performance)
Resistance to dry microbial ISO 22612 ≤ 300 CFU
penetration
Cleanliness microbial/ EN ISO 11737-1 ≤ 300 CFU/100 cm2
bioburden
Particle release EN ISO 9073-10 ≤ 4.0 log10 (lint count)
Liquid penetration EN ISO 811 ≥ 20 cmH2O (critical area,
standard performance)
≥ 10 cmH2O (less critical
area, standard performance)
≥ 100 cmH2O (critical area,
high performance)
≥ 10 cmH2O (less critical
area, high performance)
 Standard test title Reference standard Minimum acceptable Compliant Claimed performance (class, Year/version of standard Reference document (pdf)
performance level Yes No type or measured)
Physical performance/characteristics
Seam type  N/A Stitched, welded, taped

Bursting strength (wet) EN ISO 13938-1 ≥ 40 kPa (critical area)

Tensile strength (dry) EN 29073-3 ≥ 20 N (critical and less
critical areas)
Tensile strength (wet) EN 29073-3 ≥ 20 N (critical area)

Basis weigh ASTM D3776 —

Shelf life 5 years
Quality compliance
General quality ISO 9001 Compliant
management system
Medical device quality ISO 13485 Compliant
management

Sampling procedures for ISO 2859 Compliant

inspection by attribute, post
shipment
Regulatory clearance 
EU PPE Regulation 2016/425 Valid, issued < 5 years
EN MD Directive 93/42/EEC Valid, issued < 5 years
US FDA 510(k) Valid, issued < 5 years
NMPA, export clearance Valid, issued < 5 years
NMPA, internal use Valid, issued < 5 years
Other: Valid, issued < 5 years

Annex 2: Checklists: respirators; medical face masks; isolation and surgical gowns; medical examination gloves (non-sterile); surgical gloves (sterile)
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22
Technical compliance to relevant performance standards for medical examination gloves (non-sterile)
Supplier:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Manufacturer:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Model:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Standard test title Reference standard Minimum acceptable Compliant Claimed performance (class, Year/version of standard Reference document (pdf)
performance level Yes No type or measured)
Test report origin
ILAC accredited lab ISO 17025 Compliant
National notifying body ISO 17025 Compliant
Local, non-accredited ISO 17025 Compliant
Whole glove performance

COVID-19 Technical specifications for personal protective equipment — Interim guidance

Standard specification for ASTM D6319 Compliant
nitrile examination gloves
for medical application
Terminology and EN ISO 374-1 Type A
performance requirements Type B
for chemical risks
Type C
Determination of resistance EN ISO 374-2 Compliant
to penetration
Determination of resistance EN ISO 374-4 Compliant
to degradation by chemicals
Terminology and EN ISO 374-5 Compliant
performance requirements
for micro-organisms risks
Medical gloves for single EN 455-1 Compliant
use – Part 1: Requirements
and testing for freedom from
holes
 Standard test title Reference standard Minimum acceptable Compliant Claimed performance (class, Year/version of standard Reference document (pdf)
performance level Yes No type or measured)
Medical gloves for single EN 455-2 Compliant
use – Part 2: Requirements
and testing for physical
properties
Medical gloves for single EN 455-3 Compliant
use – Part 3: Requirements
and testing for biological
evaluation
Medical gloves for single EN 455-4 Compliant
use – Part 4: Requirements
and testing for shelf life
determination
Penetration/freedom from holes
Water test ASTM D6319 AQL < 2.5, G1
(ASTM D5151)
Water tightness test EN 455-1 AQL < 1.5
Water leak/air leak test EN ISO 374-2 Level 3 AQL < 0.65, G1
(ISO 2895) Level 2 AQL < 1.50, G1
Level 1 AQL < 4.50, S4
Material strength characteristics
Tensile strength (before ASTM D6319 > 14 MPa AQL < 4.0, S2
ageing)
Tensile strength (after > 14 MPa AQL < 4.0, S2
ageing)
Elongation (before ageing) > 500% AQL < 4.0, S2
Elongation (after ageing) > 400% AQL < 4.0, S2
Breaking force (before EN 455-2 > 6.0 N
ageing)
Breaking force (after ageing) > 6.0 N

Annex 2: Checklists: respirators; medical face masks; isolation and surgical gowns; medical examination gloves (non-sterile); surgical gloves (sterile)
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24
Standard test title Reference standard Minimum acceptable Compliant Claimed performance (class, Year/version of standard Reference document (pdf)
performance level Yes No type or measured)
Powder residue
Powder free ASTM D6319 < 2.0 mg (N = 5)
Powder free EN 455-3 < 2.0 mg
Size
Thickness ASTM D6319 Finger > 0.05 mm AQL <
4.0, S2
Palm > 0.05 mm AQL <
4.0, S2
EN 455 N/A
Length EN 455-2 ≥ 240 mm
(all sizes)
ASTM D6319 ≥ 220 mm AQL < 4.0, S2
(xs, s and 6–7)
ASTM D6319 ≥ 230 mm AQL < 4.0, S2

COVID-19 Technical specifications for personal protective equipment — Interim guidance

(uni, m, l and 7.5–9)
Chemical resistance
Penetration resistance to ASTM F1671 Compliant
viral
Permeation by continuous ASTM F739 Compliant
contact
Permeation by intermittent ASTM F1383 Compliant
contact
Human repeat insult patch ASTM D6355 Compliant
testing – allergens
Resistance to chemotherapy ASTM D6978 Compliant
drugs
Primary skin irritation ISO 10993 Compliant
Skin sensitization ISO 10993 Compliant
 Standard test title Reference standard Minimum acceptable Compliant Claimed performance (class, Year/version of standard Reference document (pdf)
performance level Yes No type or measured)
Other
Shelf life   5 years
Quality compliance
General quality ISO 9001 Compliant
management system
Medical device quality ISO 13485 Compliant
management
Sampling procedures for ISO 2859 Compliant
inspection by attribute, post
shipment
Regulatory clearance
EU PPE Regulation 2016/425 Valid, issued < 5 years
EN MD Directive 93/42/EEC Valid, issued < 5 years
US FDA 510(k) Valid, issued < 5 years
NMPA, export Valid, issued < 5 years
NMPA, internal Valid, issued < 5 years

Annex 2: Checklists: respirators; medical face masks; isolation and surgical gowns; medical examination gloves (non-sterile); surgical gloves (sterile)
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26
Technical compliance to relevant performance standards for surgical gloves (sterile)
Supplier:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Manufacturer:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Full product description:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Model name:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Size:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Standard test title Reference standard Minimum acceptable Compliant Claimed performance (class, Year/version of standard Reference document (pdf)
performance level Yes No type or measured)
Test report origin
ILAC accredited lab ISO 17025 Compliant
National notifying body ISO 17025 Compliant
Local, non-accredited ISO 17025 Compliant
Whole glove performance

COVID-19 Technical specifications for personal protective equipment — Interim guidance

Standard specification for ASTM D3577 Type 1 (natural)
rubber examination gloves
Type 2 (synthetic)
Terminology and EN ISO 374-1 Type A
performance requirements Type B
for chemical risks
Type C
Determination of resistance EN ISO 374-2 Compliant
to penetration
Determination of resistance EN ISO 374-4 Compliant
to degradation by chemicals
Terminology and EN ISO 374-5 Compliant
performance requirements
for micro-organisms risks
Medical gloves for single EN 455-1 Compliant
use – Part 1: Requirements
and testing for freedom from
holes
 Standard test title Reference standard Minimum acceptable Compliant Claimed performance (class, Year/version of standard Reference document (pdf)
performance level Yes No type or measured)
Medical gloves for single EN 455-2 Compliant
use – Part 2: Requirements
and testing for physical
properties
Medical gloves for single EN 455-3 Compliant
use – Part 3: Requirements
and testing for biological
evaluation
Medical gloves for single EN 455-4 Compliant
use – Part 4: Requirements
and testing for shelf life
determination
Penetration/freedom from holes
Water test ASTM D3577 AQL < 1.5

Water tightness test EN 455-1 AQL < 1.5

Water leak/air leak test EN ISO 374-2 Level 3 AQL < 0.65
(ISO 2895) Level 2 AQL < 1.50
Level 1 AQL < 4.50
Material strength characteristics
Tensile strength (before ASTM D3577 Compliant
ageing) (Type 1)
Ultimate elongation (before Compliant
ageing)
Stress at 500% elongation Compliant
(before ageing)
Tensile strength (after Compliant
ageing)
Ultimate elongation (after Compliant
ageing)

Annex 2: Checklists: respirators; medical face masks; isolation and surgical gowns; medical examination gloves (non-sterile); surgical gloves (sterile)
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28
Standard test title Reference standard Minimum acceptable Compliant Claimed performance (class, Year/version of standard Reference document (pdf)
performance level Yes No type or measured)
Tensile strength (before ASTM D3577 Compliant
ageing) (Type 2)
Ultimate elongation (before Compliant
ageing)
Stress at 500% elongation Compliant
(before ageing)
Tensile strength (after Compliant
ageing)
Ultimate elongation (after Compliant
ageing)
Breaking force (before EN 455-2 Compliant
ageing)
Breaking force (after ageing) Compliant
Powder residue

COVID-19 Technical specifications for personal protective equipment — Interim guidance

Powder free ASTM D3577 < 2.0 mg (N = 5)
Powder free EN 455-3 <2.0 mg
Protein content for allergies
Aqueous soluble protein ASTM D3577 < 200 µg/dm2 (N = 3)
content EN 455-3 < 10 μg protein per g of
glove
Extractable antigenic protein ASTM D3577 < 10 µg/dm2 (N = 1)
content
Size
Thickness/length/width ASTM D3577 Compliant
Compliant
Compliant
EN 455 Compliant
 Standard test title Reference standard Minimum acceptable Compliant Claimed performance (class, Year/version of standard Reference document (pdf)
performance level Yes No type or measured)
Chemical resistance
Penetration resistance to ASTM F1671 Compliant
viral
Permeation by continuous ASTM F739 Compliant
contact
Permeation by intermittent ASTM F1383 Compliant
contact
Human repeat insult patch ASTM D6355 Compliant
testing – allergens
Resistance to chemotherapy ASTM D6978 Compliant
drugs
Primary skin irritation ISO 10993 Compliant
Skin sensitization ISO 10993 Compliant
Sterility test
Latest edition of United ASTM D3577 Compliant
States Pharmacopeia
Sterile barrier integrity EN ISO 11607 Compliant
Other
Shelf life  5 years
Quality compliance
General quality ISO 9001 Compliant
management system
Medical device quality ISO 13485 Compliant
management
Sampling procedures for ISO 2859 Compliant
inspection by attribute, post
shipment

Annex 2: Checklists: respirators; medical face masks; isolation and surgical gowns; medical examination gloves (non-sterile); surgical gloves (sterile)
29
30
Standard test title Reference standard Minimum acceptable Compliant Claimed performance (class, Year/version of standard Reference document (pdf)
performance level Yes No type or measured)
Regulatory clearance
EU PPE Regulation 2016/425 Valid, issued < 5 years
EN MD Directive 93/42/EEC Valid, issued < 5 years
US FDA 510(k) Valid, issued < 5 years
NMPA, export Valid, issued < 5 years
NMPA, internal Valid, issued < 5 years

COVID-19 Technical specifications for personal protective equipment — Interim guidance

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Switzerland
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