Protective Face Masks, GB 2626-2019 and EN 149: 2001 + A1: 2009, Standards Comparison

Protective face masks are classified as PPE in the EU and are subject to the requirements of Regulation (EU) 2016/425 and performance tests according to EN 149:2001+A1:2009. The Chinese counterpart is GB 2626-2019, but it is not equivalent to EN 149: 2001 + A1: 20019, so what is the difference between the two? Here I will explain the scope of application, basic requirements, and testing items of the standard.

 Comparison of differences between GB 2626-2019 and EN 149: 2001 + A1:2009 

1 Comparative scope of application

GB 2626-2019	EN 149: 2001+A1: 2009
For half and full face masks	Only for half face masks

2 Appearance requirements

GB 2626-2019	EN 149: 2001+A1: 2009
Parts should not be dislodged, damaged or deformed after temperature and humidity pre-treatment and mechanical strength pre-treatment, and also include identification and information from the manufacturer.	Signage and information provided by the manufacturer.

3 Filtration efficiency

GB 2626-2019	EN 149: 2001+A1: 2009
Can be detected by sodium chloride particulate matter cargo oily particulate matter, divided into three grades, 90% (KN90/KP90), 95% (KN95/KP95), 99.97% (KN100/KP100)	It can be detected by sodium chloride particles or oily particles in three grades, 80% (FFP1), 94% (FFP2), 99% (FFP3).

4 Leakage

GB 2626-2019, divided into disposable face mask, replaceable half face mask, and full face mask.

Leakage of disposable face mask

Media level	Evaluate the TIL for each action, with at least 46 of the 50 actions meeting the TIL requirements.	valuate the overall TIL of the person, with at least 8 out of 10 subjects having an overall TIL that meets the requirements
KN90 / KP90	＜13%	＜10%
KN95 / KP95	＜11%	＜8%
KN100 / KP100	＜5%	＜2%

Leakage of replaceable half face mask: To assess the IL for each action, at least 46 out of 50 actions had an IL <5%; to assess the overall IL for each individual, at least 8 out of 10 subjects had an overall IL <2%.

Leakage of full face mask: Assess the IL for per action, IL per action <0.05%

EN 149: 2001+A1: 2009, there is only a requirement for a half mask, no requirement for a replaceable full mask and no requirement for a full mask.

For particle filtering half masks fitted in accordance with the manufacturer’s information, at least 46 out of the 50 individual exercise results (i.e. 10 subjects x 5 exercises) for total inward leakage shall be not greater than

25% for FFP1, 11% for FFP2, 5% for FFP3,

and, in addition, at least 8 out of the 10 individual wearer arithmetic means for the total inward leakage shall be not greater than

22% for FFP1, 8% for FFP2, 2% for FFP3.

FFP2 and KN95/KP95 requirements are consistent, FFP3 and KN100/KP100 requirements are consistent. But the FFP1 is a bit more lenient than the KN90/KP90 requirements.

5 Breathing resistance

GB 2626-2019, the ventilation volume is set to (85±1)L/min, different face mask types have different requirements and the test results are in Pa.

Face mask types	Inhalation resistance			Exhale resistance
	KN90/KP90	KN95/KP95	KN100/KP100
disposable face mask, non-exhalation valve	≤170	≤210	≤250	Same resistance as inhalation
Disposable face mask, with exhalation valve	≤210	≤250	≤300	≤150
Replaceable half face mask and full face mask, including filter elements	≤250	≤300	≤350

EN 149: 2001+A1: 2009, tested using different ventilation volumes (expiratory corresponding to 30L/min and 95L/min, exhaled corresponding to 160L/min) with results in mbar and 1mbar = 100Pa.

Classification	Maximum permitted resistance (mbar)
	inhalation		exhalation
	30L/min	95L/min	160L/min
FFP1	0.6	2.1	3.0
FFP2	0.7	2.4	3.0
FFP3	1.0	3.0	3.0

6 Air tightness of breathing valve

GB 2626-2019	EN 149: 2001+A1: 2009
Detect only half of the mask, each respirator’s exhalation leak gas flow should not be greater than 30L/min; if the mask has multiple exhalation valves, each exhalation valve should meet the leak gas flow should be evenly divided.	No requirements

7 Breathing valve secrecy device

GB 2626-2019	EN 149: 2001+A1: 2009
Disposable mask with 10N axial pull for 10s. Replaceable mask with 50N axial pull for 10s.	10N axial pull for 10s

8 Clogging

GB 2626-2019	EN 149: 2001+A1: 2009
Average ≤ 1%	Inhalation of carbon dioxide in the clogging must not exceed 1% of the average (by volume)

9 Field of vision

GB 2626-2019, divided into half face mask and full face mask

field of vision	Face masks types
	Half face mask	Full face mask
		large-eyed window	double-eye window
Vision of below	≥35°	≥35°	≥35°
General vision	not applicable	≥70%	≥65%
binocular vision	≥65%	≥55%	≥24%

EN 149: 2001+A1: 2009, subjective evaluation in practical performance tests, no specific quantitative indicators.

10 Headbands

GB 2626-2019, the three types of face masks correspond to different tensions (10N, 50N, 150N) and last for 10S and should not slip or break.

Face mask type	Disposable face mask	Replaceable face mask	Full face mask
Tensile strength	10N for 10S	50N for 10S	150N for 10S

EN 149: 2001+A1: 2009, subjective evaluation in practical performance tests, no specific quantitative indicators.

11 Axial tension to be applied to the connecting parts

GB 2626-2019, the interchangeable half face mask shall bear an axial pull force of 50N for 10s, and the full mask shall bear an axial pull force of 250N for 10s. there are no specific pull requirements in EN 149: 2001+A1: 2009.

Other ancillary performance requirements

Performance	GB 2626-2019	EN 149: 2001+A1: 2009
Airtightness	For full face mask only, the pressure change in each full face mask within 60S is ≤100Pa.	No requirements
Flammability	Individual parts exposed to the flame should continue to burn for no longer than 5S after the flame has been removed.	Parts must not burn or burn continuously for more than 5S after removal from the flame
Cleaning and disinfection	If the product claims that the filter element can be cleaned or disinfected for repeated use, the following information shall be provided: 1 The specific characteristics and extent of the applicable particulate matter. 2 The maximum number of times the filter element can be cleaned or disinfected. 3 The method for determining whether the filter element continues to be effective after cleaning or disinfection and when it is replaced.	If the particle filter half face mask is designed to be reusable, the acting material should be able to withstand the cleaning/disinfectant and related procedures specified by the manufacturer.
Practical performance	In accordance with 5.5 of GB/T 23465-2009, the test is carried out by the subject for fast walking, bending walking, continuous walking, jogging, etc., and provides subjective evaluation of the comfort level, safety, visual field, and other indicators of the face mask.	Tests, including walking and work simulation tests, were conducted by two subjects (persons familiar with the use of such equipment) to evaluate indicators such as the comfort of the headband, the safety of fasteners, and the field of view.
Product Identification	The logo on the product must contain the following information. 1 Name, trademark or other identifiable manufacturer or supplier 2 Model and number (if applicable) 3 This standard number, the filter element should be marked with the filter media level, using this standard number and filter element level combination, such as GB 2626-2019 KN95. The logo on the package must contain the following information. 1 Name, trademark or other identifiable manufacturer or supplier 2 Mask type, model and number (if applicable) 3 This standard number, the filter element should be marked with the level, the level is marked with this standard number and filter element level combination, such as GB 2626-2019 KN95 4 Applicable licensing or certification information 5 Date of production (at least months and years) or production lot number, storage life (at least years) 6 “See the words “Information provided by the manufacturer 7 Manufacturer’s recommended storage conditions (including at least temperature and humidity)

From the above comparison, it can be seen that there are certain similarities between the EU personal protective face mask testing standard EN 149:2001+A1:2009 and the domestic standard GB 2626-2019 in terms of testing items and index requirements, such as clogging, flammability, cleaning and disinfection, practical performance, and product marking. But because GB 2626 applies to three types of face masks, there will be more items tested overall than EN 149. And in some indicators, such as particulate matter filtration efficiency, GB 2626 has even higher requirements than EN 149 (for FFP1).

Also, if you want to know the difference between protective masks KN95 and N95, check out this article: How to Distinguish Between KN95 and N95 Masks.