Do you know the medical face masks you wear every day? Analysis of 8 medical mask styles and standards in 6 major countries! (Part 2)

Do you know the medical face masks you wear every day? Analysis of 8 medical mask styles and standards in 6 major countries! (Part 2)

After knowing the 8 styles of medical masks in the previous article (part 1), we will introduce you the standards and regulations of medical masks in various countries, followed by the analysis of the license number of medical equipment – using Taiwan’s as example, so you can have a deeper understanding of the specifications of medical masks!

Note: Masks without filtration effects (such as: general cotton/gauze masks, activated carbon masks) are not included in the content of this article, because they can only prevent dust or air pollution particles, and do not belong to the category of medical masks.

Standards & Regulations of Medical Mask

When purchasing finished masks, you should check whether there are information such as BFE, PFE, or even VFE shown on the packaging. These labels represent the filtration efficiency of the mask tested by a reliable 3rd party laboratory. The higher the value is, the better filtration ability it has. Most of the standards refer to the filtration rate test standard of the American Society for Testing and Materials International (ASTM), and the three filtration rates – BFE, PFE, and VFE are introduced as follows:

(1) BFE (Bacterial Filtration Efficiency): The ability to filter microbial particles.

The test was conducted by using approximately 3.0 μm S.aureus aerosols, passing through the filter layer at a flow rate of 28.3 LPM (liters per minute).

μm: Micrometer

(2) PFE (Particle Filtration Efficiency): The ability to filter sub-micron particles.

Method A (Latex Spheres Method): The test was conducted by using approximately 0.1μm polystyrene latex sphere (PSL), passing through the filter layer at a flow rate of 28.3 LPM (liters per minute).
Method B (Salt Spray Method): The test was conducted by using approximately 0.075μm (CMD) of sodium chloride particles (NaCl), passing through the filter layer at a flow rate of 85 LPM (liters per minute).

Particle size conversion: 0.075 (or 0.1)μm [CMD] = 0.26 (or 0.3)μm [MMD]。

CMD = Count Median Diameter
MMD = Mass Median Diameter
PM2.5 means 2.5μm [MMD]

(3) VFE (Virus Filtration Efficiency): The ability to filter viral particles.

The test was conducted by using approximately 3.0 μm nebulized Phi-X174 (ΦX174) virus and Escherichia coli aerosols, passing through the filter layer at a flow rate of 28.3 LPM (liters per minute).

 

Comparison of filtration test methods for different filtration standards < Comparison of filtration test methods for different filtration standards >
Credit: https://cfr.umn.edu/covid-19/maskrespirator-evaluation-methods/filtration-test-standard>

Many countries have enacted their own regulations for the filtration rates and levels of medical masks, and we have chosen some often-mentioned countries (Taiwan, the United States, Europe, China, Japan, and South Korea) to be introduced in the following.

Note: As the laws and regulations of every country will be continuously updated with time and requirements, all of the following standards in this article refer to the latest version of the current laws and regulations published before March 2022 by each country.

 

Standards and Regulations of Medical Mask in Taiwan: CNS14774(T5017)

<Standards and Regulations of Medical Mask in Taiwan > CNS14774(T5017)

Medical face mask is a type of medical equipment, and under Article 3 of the “Regulations Governing the Classification of Medical Devices” promulgated by the Ministry of Health and Welfare in Taiwan, medical devices are classified into the following classes according to their risk level:

Class I: Low Risk

Class II: Medium Risk

Class III: High Risk

The risk here refers to the invasiveness to our human body. The invasiveness of the Class I medical devices to the human body is the lowest among the three levels, such as general medical masks (excluding surgical masks), cotton swabs, gauze, band-aid, etc.  And in the annex to Article 3 – “Medical Device Classification”, medical masks belong to “I.4040 Medical Apparel – devices that are intended to be worn by operating room personnel during surgical procedures to protect both the patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material”. In this category, except for surgical gowns and masks worn during surgery, which are classified as Class II, other products including general medical masks belong to the Class I.

Note: Sometimes you will see the words “Medical Class I ” or “Medical Glass II ” shown on the mask packaging, and it may mislead consumers that medical masks are divided into two more different levels, which is wrong. “Medical Class II refers to the surgical masks that belong to Class II in the annex to Article 3-I.4040 Medical Apparel- classification, and “Medical Class I ” refers to other general medical masks that are not surgical masks. It does not mean that there are more levels divided for medical masks.

The national standard implemented in Taiwan is abbreviated as CNS (the full name is National Standards of the Republic of China). In this standard, the performance and specifications of medical face mask must comply with CNS14774 (T5017)- Medical face masks, and the requirements are listed below:

1. General Medical Masks: Class I Medical Device:

(1) Bacterial Filtration Efficiency (BFE) ≧95% (Test standard CNS 14775)
(2) Differential pressure (ΔP, respiratory impedance) ≦5 mmH2O/cm2 (Test standard CNS 14777)

2. Surgical masks: Class II Medical Device, which is further divided into three levels – Level 1, 2, and 3.

Taking “Level 1” surgical masks as an example, the required standards are:

(1) Bacterial Filtration Efficiency (BFE) ≧95% (Test standard CNS 14775)
(2) Sub-Micron Particulate Filtration Efficiency (PFE)
        ≧95% – Method A (Latex Ball Method) (Test Standard ASTM F2299-03)
Or   ≧80% – Method B (Salt Spray/Fog Method) (Test Standard 8.2 of CNS 14755)
(Note: For Level 2 and 3, only Method A can be adopted)
(3) Differential Pressure (ΔP, breathing impedance) ≦4 mmH2O/cm2 (Test Standard CNS 14777)
(4) Synthetic Blood Penetration Resistance (minimum passing pressure): 80 mmHg (Test Standard CNS 14776)
(5) Flammability (Flame Resistance) Class 1: ≧3.5 seconds or Non-Flammable (Test Standard CNS 10285 C method)

Compared with general medical masks, surgical masks include 3 more test standards: Sub-Micron Particulate Filtration Efficiency (PFE), Synthetic Blood Penetration Resistance, and Flammability. It is because that comparing to ordinary people, medical personnel may face much higher risk during the surgery, such as blood splashing or contacting highly infectious pathogenic particles, which make it necessary to ask for higher protection standard of surgical masks.

For standards of surgical masks Level 2 & 3, and surgical D2 dustproof, please refer to the < Standards and Regulations of Medical Mask in Taiwan > chart shown below.

Note: Regarding medical masks that are marked or declared to have the same or more efficacy than “N95 masks” in the market in Taiwan, according to the regulation, in addition to complying with the CNS14774 standard, for Sub-Micron Particulate Filtration Efficiency (PFE) and Differential Pressure (ΔP, breathing impedance), the requirements are changed to follow CNS14755 (Z2125) by reaching D2 level (equivalent or above) of “Surgical Dust Respirator/Face Mask” standard (that is, PFE needs to be ≧95% (by salt spray/fog method), inspiratory impedance ≦350Pa, and exhalation Impedance≤250Pa. Please refer to the last column of the chart as follows).

< CNS14774(T5017)-2018 Standards and Regulations of Medical Mask in Taiwan >
Credit: http://tiua.instruments.org.tw/archive/file/1080712002.pdf
Conversion: 1 mmH2O/cm2 = 9.81 Pa/cm2 ;1 Pa/cm2 = 0.102 mmH2O/cm2

Reminder: Since September 2020, The “Double Stamp” regulation has been implemented in Taiwan. All domestic flat medical and surgical masks must comply with Double Stamp standard, that is, the masks must show two stenciled words: “MD” (MD= Medical Device) and “Made In Taiwan” on the surface clearly. Masks without “MD” & “Made In Taiwan” are not allowed to be sold in Taiwan, which helps consumers to determine whether the masks purchased are legitimate or not.

Standards and Regulations of Medical Mask in the United States: ASTM F2100、NIOSH 42 CFR Part 84、ASTM F3502

< Standards and Regulations of Medical Mask in the United States > ASTM F2100、NIOSH 42 CFR Part 84、ASTM F3502

The standard of medical masks in the United States is promulgated by American Society for Testing and Materials (ASTM). The masks can only be called Medical masks according to ASTM F2100, and this standard divide medical masks into 3 levels: Level 1, 2, and 3. Medical masks belong to Class II of medical devices in the United States, and all medical masks sold in the American market must meet the ASTM F2100 standard before they can be legally launched.

However, the most mentioned N95 masks are not under the jurisdiction of ASTM, but under 42 CFR Part 84 – the standard of filter respirators classification issued by National Institute for Occupational Safety and Health (NIOSH). 42 CFR Part 84 includes three series: N, R, and P, which represent different resistance to oily particles, and each series is further divided into three levels according to the lowest filtration rate. Details will be given below in the section of N95 masks, NIOSH 42 CFR Part 84.

During the COVID-19 pandemic, in response to the sharp rise in the demand of not only medical masks and N95 masks, but also non-medical masks, for the first time, ASTM added a new regulation for general protective masks: ASTM F3502 so as to provide guidance on purchasing and manufacturing non-medical masks for general public and mask manufacturers.

All three standards are introduced as follows:

1. Medical Mask, Takin ASTM F2100 Level 1 as an example:

(1) Bacterial Filtration Efficiency(BFE) ≧ 95% (Test Standard ASTM F2101)
(2)
Sub-Micron Particulate Filtration Efficiency(PFE) ≧ 95% (Test Standard ASTM F2299)
(3)
Differential Pressure (ΔP, breathing impedance) < 5 mmH2O/cm2 (Test Standard EN 14683)
(4) Synthetic Blood Penetration Resistance (minimum passing pressure): 80 mmHg (Test Standard F1862)
(5) Flammability (Flame Resistance) Class 1:
3.5 seconds or Non-Flammable (Test Standard 16 CFR Part 1610)

ASTM Level 1 is similar to Taiwan’s surgical face mask Level 1 (which belong to the s Class II Medical Device), and the difference between these two is only the pressure difference: ASTM Level 1 requires <5 mmH2O/cm2, while CNS14774 still needs ≦4 mmH2O/cm2.

Note: Originally, ASTM F2100 requires: Level 1 <4 mmH2O/cm2, Level 2, 3 <5 mmH2O/cm2 for pressure difference of medical masks. However, it has been updated as shown in the following table.

For standards of ASTM-F2100 Level 2、3 face masks, please refer to the chart < Standards and Regulations of Medical Mask in the United States > shown below.

< ASTM F2100-19e1 Standards and Regulations of Medical Mask in the United States >< ASTM F2100-19e1 Standards and Regulations of Medical Mask in the United States >
Credit: https://www.astm.org/f2100-19e01.html

2. N95 masks, NIOSH 42 CFR Part 84:

N95 is one of the American respirator classifications certified by NIOSH, and its 42 CFR Part 84 is divided into three series:

(1) N-series: stands for Not resistant to Oil, which can filter non-oily particles, but has no resistance to oily particles.
Test Method: Using 0.3 µm diameter [MMD] sodium chloride (NaCl) aerosols, gravimetrically loaded with particles up to 200 mg for detection through a mask/respirator.

(2) R-series: stands for Resistant to Oil, which can filter non-oily and oily particles, but the effective time for filtering oily particles is limited to 8 hours.
Test Method: Using 0.3 µm diameter [MMD] dioctyl phthalate (DOP) aerosols, gravimetrically loaded with particles up to 200 mg for detection through a mask/respirator.

(3) P-series: stands for Oil Proof, which can filter non-oily and oily particles, and there is no limit to the effective time of filtering oily particles.
Test Method: Using 0.3 µm diameter [MMD] dioctyl phthalate (DOP) aerosols, gravimetrically loaded with particles up to 200 mg for detection through a mask/respirator.

Test particle size conversion: 0.075 (or 0.1) μm [CMD] = 0.26 (or 0.3) μm [MMD].
CMD = Count Median Diameter.
MMD = Mass Median Diameter.

Each of the series above is further divided into 3 levels according to the minimum filter rate:

(1) 95%: Minimum filtration efficiency ≥95%
(2) 99%: Minimum filtration efficiency ≥99%
(3) 99.7% (100%): Minimum filtration efficiency ≥99.7%

In this standard, N95 belongs to the lowest level requirement in the N series, but the filtration efficiency has reached the medical care level. Therefore, the public is urged to reserve the N95 masks for medical care personnel. Moreover, considering the wearing comfort and price, N95 mask is not a good choice for daily use.

For complete 3 series x 3 filtration rate = 9 Levels in total, please see the table below.

NIOSH 42 CFR Part 84-1995 Standards and Regulations of Filter Respirators in the United States< NIOSH 42 CFR Part 84-1995 Standards and Regulations of Filter Respirators in the United States >
Credit: https://www.cdc.gov/niosh/npptl/topics/respirators/pt84abs2.html

Reminder: Masks that have obtained NIOSH N95 certification must be marked with the words “NIOSH” and “N95” on the surface!

If you want to check whether the purchased N95 masks are NIOSH certified, you can go to the following website and check according to the English name of the manufacturer! Check the website (US CDC website):
https://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/N95list1sect3.html

3. Ordinary protective masks, ASTM F3502(*2021 New Standard):

In February 2021, in response to the needs of masks during COVID-19 pandemic, ASTM issued a new standard: ASTM 3502 for protective masks. ASTM 3502 is the first standards formulated for general protective masks, and the following two factors can be judged separately. The packaging of masks should be marked with the levels respectively (so a total of 4 combinations of level can be produced):

(1) Sub-Micron Particulate Filtration Efficiency (PFE)
   Level 1: ≧20% Level 2: ≧50%
(2) Breathing Impedance
   Level 1: Inhalation≦15 mmH2O/cm2Level 2: Inhalation≦5 mmH2O/cm2

ASTM F3502-2021 Standards and Regulations of Protective Masks in the United StatesASTM F3502-2021 Standards and Regulations of Protective Masks in the United States-Packing<ASTM F3502-2021 Standards and Regulations of Protective Masks in the United States >
Credit: https://www.astm.org/f3502-21.html

 

Standards and Regulations of Medical Mask in EU (European Union): EN 14683EN 149

< Standards and Regulations of Medical Mask in EU (European Union) > EN 14683、EN 149

According to the new version of the EU Medical Device Regulation (MDR) 2017/745 (effective on May 25, 2017, and officially implemented on May 26, 2021), the classification of medical masks in the EU belongs to Class I medical devices. The EU medical mask standard is EN 14683, which divides medical masks into three levels: Type I, II, and IIR (Type IIR = II+R, R stands for Resistance, that is, with anti-splash ability).

In addition, EN149 is applicable to FFP respirator, which belongs to PPE (Personal Protective Equipment), and it is also divided into three levels: FFP1, FFP2, FFP3. Among them, the filtration efficiency of FFP1 is 80%, FFP2 is 94% (around the same level as the US N95 mask), and the FFP3 is 99% (around the same level as the US N99 mask).

Whether it is a medical mask or an FFP respirator, before they are circulated and sold in the EU market, it is necessary to be embossed with CE Mark on the surface, and it can be divided into two forms:

[A] CE certificate issued by authorized notified body is needed. The product should show a CE Mark + 4-digit code of the agency [provided by the European Commission, issuing a list of authorized notified bodies (Notified Body, NB)]:
(1) Sterile
Medical Masks
(2) FFP3 Level Masks

[B] CE certificate is not required, but enterprises need to submit CE Declaration of Conformity and related documents to obtain European Commission registration. There still is CE Mark on the product, but there is no 4-digit code of the agency:
(1) Non-Sterile
Medical Masks
(2) FFP1 & FFP2 Level Masks

The two mask standards mentioned above (EN 14683 for medical masks and EN149 for FFP respirator) are introduced separately as follows:

1. Medical Mask, Taking “EN 14683 Type I” as an example:

(1) Bacterial Filtration Efficiency (BFE)≧95%
(2)
Differential Pressure (ΔP, breathing impedance) <40 Pa/cm2 (approximately = 4.08 mmH2O/cm2
(3) Bacteria Count (Microbial Load)≦30 cfu/g (colony-forming unit per gram)

The medical masks certified by the EU standard are not required to possess Sub-Micron Particulate Filtration Efficiency (PFE), instead, the restriction on the bacterial count is required to regulate the hygienic conditions of the masks themselves. Among EN 14683, only Type IIR EN is required to possess the ability to prevent penetration/splash of synthetic blood, while Type I and II are not required.

※Please refer to the following table for the complete all levels of EU medical mask.

EN 14683: 2019 Standards and Regulations of Medical Mask in the EU<EN 14683: 2019 Standards and Regulations of Medical Mask in the EU >
Credit: http://www.nobelcert.com/DataFiles/FreeUpload/BS%20EN%2014683-2019.pdf
Conversion: 1 mmH2O/cm2 = 9.81 Pa/cm2 ;1 Pa/cm2 = 0.102 mmH2O/cm2
Conversion: 1 mm Hg = 0.133 kPa ; 1 kPa=7.51mm Hg

2. Respirator Mask,EN 149:

EN149 is the regulation for FFP protective masks/respirator masks, FFP=Filtering Face Pieces, which is divided into three levels according to the filtering efficiency of masks:

(1) FFP1: Minimum Filtration Efficiency ≥80%
(2) FFP2: Minimum Filtration Efficiency ≥
94%
(3) FFP3: Minimum Filtration Efficiency ≥
99%

Test method: Filtration Efficiency was measured using sodium chloride (NaCl) with a diameter of 0.6 µm [MMD] and dioctyl phthalate (DOP) with a diameter of 0.4 µm [MMD].

It can be seen that FFP uses two kinds of particles with different properties in the test method, so the FFP mask has both protection against oily and non-oily particles, and has a protective effect on harmful substances in an industrial environment.

In addition, according to the number of times the mask is used, “NR” or “R” can be added after the Level, representing as:

NR, Not Re-usable: Single use only.
R, Re-usable: reusable.

※For the complete specifications of FFP protective masks/respirators in the EU, please see the following table.

EN 149:2001+A1:2009 Standards and Regulations of Filter Respirators in the EU

< EN 149:2001+A1:2009 Standards and Regulations of Filter Respirators in the EU >
Credit: https://en.wikipedia.org/wiki/FFP_standards#cite_note-inrs-6

 

Standards and Regulations of Medical Mask in China: GB 19083GB 2626

< Standards and Regulations of Medical Mask in China> GB 19083、GB 2626

At present, the latest version of China’s standard for medical masks is GB 19083-2010, which divides medical masks into three levels as follows:

(1) Level 1: PFE95%
(2) Level 2: PFE99%
(3) Level 3: PFE99.97%

However, the commonly heard “KN95 mask” is not under this standard, but belongs to: GB 2626-2019Respiratory protection – Non-powered air-purifying particle respirator” standard, which is introduced as follows:

1. Medical Mask, Taking “ GB 19083-2010 Level 1” as an example:

(1) Sub-Micron Particulate Filtration Efficiency (PFE)≧ 95%
(2) Inspiratory Impedance≦ 343.2 Pa/cm2 (=35 mmH2O/cm2
) (Gas flow: 85L/min)
(3) Synthetic Blood Penetration Resistance (minimum passing pressure): 80 mmHg
(4) Flammability (Flame Resistance): The material used should not be flammable. Continued ignition time 5 seconds
(5) Surface Moisture Resistance: Class 3 – only small unconnected areas are wetted
(GB/T 4745—1997)
(6) Microbiological indicators: (GB 15979—2002)


(7) Skin irritation: The primary stimulus score for the mask material ≦ 1 (Test Method: GB/T 16886.10-2005)
(8) Conformity: The mask should be designed to provide a good fit with a total fit factor of the mask should notbe less than 100 (Test Method: Select 10 subjects, wear a mask according to the instruction manual, perform 6 prescribed movements, and test according to the methods specified in Appendix B. At least 8 subjects should meet the total fitness factor requirement.)

The test method of PFE is to use sodium chloride particles (NaCl) of about 0.075μm (CMD) to pass through the filter layer at a flow rate of 85 LPM (liters per minute) for testing, which belongs to the salt spray method and is aimed at the filtration of non-oily particles. The national standard GB 19083 has no requirements for the Bacterial Filtration Efficiency (BFE) of medical masks. Bacterial Filtration Efficiency (BFE) is required for YY 0469, another standard for surgical masks, and it is needed to be ≥95%, with PFE ≥30%, Pressure Difference ≤49 Pa/cm2 (=5 mmH2O/cm2)

Conversion: 1 mmH2O/cm2 = 9.81 Pa/cm2 ;1 Pa/cm2 = 0.102 mmH2O/cm2

<GB 19083-2010 Standards and Regulations of Medical Mask in China>
Credit: http://openstd.samr.gov.cn/bzgk/gb/newGbInfo?hcno=1738BD9CCF76E55F81A5B0E9ED4D4EFA


2. KN95
Protective Mask/Respirator,GB 2626-2019:

At present, the latest version of the standard is GB 2626-2019, officially implemented on July 1, 2021. The standard includes two categories of KN and KP, and each category is divided into 3 levels, and there are more distinctions according to the mask category as follows:

KN: only suitable for filtering non-oily particles
KP: suitable for filtering oily and non-oily particles

Taking the KN95+disposable+no exhalation valve mask as an example, the passing criteria are:
(1) Sub-Micron Particulate Filtration Efficiency (PFE) ≧95% (by NaCl particles)
(2) Inspiratory/Expiratory impedance≦210 Pa/cm2 (=21.42 mmH2O/cm2) (Gas flow: 85L/min)

Conversion: 1 mmH2O/cm2 = 9.81 Pa/cm2 ;1 Pa/cm2 = 0.102 mmH2O/cm2

The PFE of KN95 for non-oily particulate needs to be no less than 95%, and the KN95 mask that has passed the test must be clearly embossed with the words “GB2626-2019 KN95” to qualify as genuine KN95; and KN95 is also often used as a substitute for N95.

※For the complete specifications of KN/KP protective masks and respirators, please see the following table.

<GB 2626-2019 Standards and Regulations of Filter Respirators in China >
Credit: http://openstd.samr.gov.cn/bzgk/gb/newGbInfo?hcno=16D8935B45AD7AE40228801B7FADFC6C

 

Standards and Regulations of Medical Mask in Japan: JIS T 9001、JIS T 9002、JMHLW-Notification 214-2018

< Standards and Regulations of Medical Mask in Japan> JIS T 9001、JIS T 9002、JMHLW-Notification 214-2018

Comparing to other countries, the Japanese government was late in setting official standards for medical masks. Before the standard was implemented, manufacturers were asked to conduct independent tests on their own and then show the relevant test results on the outer packaging, which makes consumers feel insecure about the quality, therefore, choosing the manufactures who are members of “National Mask Industry Association” is the best choice for them. Manufactures with membership are allowed to print certification mark of National Mask Industry Association on the packaging, which also led to a group of manufacturers rushing to join the guild, resulting in the chaos of competitive application, and even forcing the association announced to stop accepting the application of joining the guild for a while. In order to give consumers the reference for purchasing and protect their rights and interests, finally the official Japanese Standards Association (JSA) formulated the official Japanese Industrial Standards (JIS) for masks in June 2021, which are divided into the following two categories:

JIS T 9001: Performance requirements and test methods of medical face masks and non-medical face masks. – Including masks used by people engaged in general medical care, nursing, etc. and general consumers.

JIS T 9002: Performance requirements and test methods of filtering facepiece respirators for infection control at medical use. – Masks for healthcare workers who care for infections and perform surgeries.

1. Medical Mask, Taking ” JIS T 9001:2021 Class 1” as an example:

(1) Bacterial Filtration Efficiency (BFE) ≧95%
(2) Sub-Micron Particulate Filtration Efficiency (PFE)≧95%
(3) Viral Filtration Efficiency (VFE)≧95%
(4) Differential Pressure (ΔP, breathing impedance) < 60 Pa/cm2  (=6.12 mmH2O/cm2)
(5) Synthetic Blood Penetration Resistance (minimum passing pressure): 10.6 kPa (=120 mm Hg)
(6) Flammability (Flame Resistance) Class 1: ≧3.5 seconds or Non-Flammable
(7) Free Formaldehyde
≦75 μg/g
(8) Specific Azo Pigments≦30 μg/g
(9) Fluorescence test: no fluorescence

Conversion: 1 mmH2O/cm2 = 9.81 Pa/cm2 ;1 Pa/cm2 = 0.102 mmH2O/cm2

IST 9001 includes the requirements for masks used by general consumers and medical masks, while JIS T 9002 is mainly a more advanced surgical mask for surgery and infectious medical care. The general classification is as follows:

JIS T 9001(General): Pass at least one functional test in BFE, PFE, VFE, and pollen particles & differential pressure(ventilation) & safety and hygiene items (flammability, formaldehyde, azo, fluorescence).

JIS T 9001(Medical): In addition to all functions and specifications included in JIS T 9001(General) (except pollen particles), need to pass through Synthetic Blood Penetration Resistance Class I.

JIS T 9002(Surgical): In addition to all functions and specifications included in JIS T 9001(General) (except pollen particles), need to pass through Synthetic Blood Penetration Resistance ClassⅡ,Ⅲ.

It can be seen that although Japan’s regulations on medical masks were announced later than other countries/regions, it can be said that it is a one-time integration, which has unified the various doubts that consumers may have when purchasing masks during the pandemic, including all functional or safety and health aspects, so the standard items are more numerous and quite complete than other standards.

※For the complete JIS T 9001 mask specification, please see the following table.

<JIS T 9001:2021 Standards and Regulations of Medical Mask in the Japan>
Credit: http://www.labtesting.cn/jis_t_90019002.html

2. DS2 Masks, Taking ” JMHLW-Notification 214-2018 DS2” as an example:

In addition to the newly enforced medical mask regulation, in fact, Japan Ministry of Health Labor and Welfare (JMHLW) had already formulated national specifications for industrial dust masks before the pandemic. The updated mask specification is Notice No. 214-201 issued in 2018. This standard divides disposable masks into two categories: DS and DL. Each category is further divided into 3 levels according to filtration efficiency.

DS: It can filter non-oily particles, tested with sodium chloride (NaCl) aerosols.
DL: It can filter oily particles, tested with dioctyl phthalate (DOP) aerosols.

(1) Level 1: Minimum Filtration Efficiency ≧80%
(2) Level 2: Minimum Filtration Efficiency ≧95%
(3) Level 3: Minimum Filtration Efficiency ≧99%

Therefore, the most similar level of Japanese dust mask to N95 is “DS2“.
Besides, “D” stands for disposable, and If it is a reusable mouth/mask, it can be marked with “R” (re-usable), deriving to RS (1, 2, 3) and RL ( 1, 2, 3) series.

 

Standards and Regulations of Medical Mask in Korea: MFDS Notice No.2015-69、KMOEL Notice No. 2017-64

 < Standards and Regulations of Medical Mask in Korea> MFDS Notice No.2015-69、KMOEL Notice No. 2017-64

Medical masks (Sanitary Mask) in South Korean are managed under Notice No. 2015-69 issued by the Ministry of Food and Drug Safety (MFDS) of South Korea. According to the filtration efficiency, it is divided into three levels: KF80, KF94 and KF99 – KF means “Korean Filter”, followed by the number indicating its filtering efficiency:

KF80:Block approximately 80% of non-oily particles with 0.60 µm [MMD] in size, such as sodium chloride (NaCl).

KF94:Block approximately 94% of non-oily particles with 0.60 µm [MMD] in size, such as sodium chloride (NaCl) & oily particles with 0.40 µm [MMD] in size, such as dioctyl phthalate (DOP).

KF99:Block approximately 99% of non-oily particles with 0.60 µm [MMD] in size, such as sodium chloride (NaCl) & oily particles with 0.40 µm [MMD] in size, such as dioctyl phthalate (DOP).

1. Medical Mask, Taking ” MFDS Notice No.2015-69 KF94” as an example:

(1) Sub-Micron Particulate Filtration Efficiency (PFE)≧94% (Oily and non-oily particles; Test flow: 95 L/min)
(2) Differential Pressure (ΔP, breathing impedance) ≦7.2 mmH2O/cm2 (=68.67 Pa/cm2 Test flow:30 L/min)
(3) Leakage rate≦11% (KF80≦25%;KF99≦5%)

Conversion: 1 mmH2O/cm2 = 9.81 Pa/cm2 ;1 Pa/cm2 = 0.102 mmH2O/cm2

The KF series of medical masks have recently become a trend in the market due to their special appearance, with the strengthened tightness, and minimum leakage rate of masks is also regulated. Therefore, when people start worrying about the fit of the flat medical masks, it is no wonder that the public would prefer KF masks which include all aspects of filtration efficiency, breathing comfort and tightness. Basically, KF80 can only prevent air pollution particles and dust, and cannot block infectious germs, however KF94 and KF99 can meet the general requirements of medical masks that can prevent germs.

2. Protective Mask, Taking ” KMOEL Class 1” as an example:

Similarly, South Korea also has specifications for protective masks/facepieces of the same level as N95. The latest regulation is the “Personal Protective Equipment Safety Certification Notice No. 2017-64” announced by the Korea Ministry of Employment and Labor (KMOEL) in 2017, it is divided into three classes:

(1) Class 2: Minimum Filtration Efficiency ≥
80%
(2) Class 1: Minimum Filtration Efficiency ≥
94%
(3) Superior: Minimum Filtration Efficiency ≥
99%

All three classes can block both oily and non-oily particles, and the filtration efficiency of KMOEL-2017-64 Class 1 is ≥94%, of, which is the same level as N95 and FFP2.

 

**************************************************************

After introducing the mask standards above, we should already know that there is currently no an uniform mask regulation for all countries. Generally, ordinary consumers who are not on the front line of medical care should feel very hard to understand these various test methods and regulations mentioned in the mask regulations. It is difficult to analyze and understand all standards at once, but for medical professionals who are on the front line of protection and have practical requirements for the efficacy of masks to ensure their own safety, or people who are interested in in-depth comparisons, here are the Comparison Table of National Standard of Similar Grades to N95 masks for reference:


Note: P2 (AS/NZ 1716:2021) is the Australian and New Zealand standard, and PFF2 (ABNT/NBR 13.698.2011) is the Brazilian standard. These two are relatively rare in the Taiwan market. If you are interested in their specifications, please check the comparison table below.

< Comparison Table of National Standard of Similar Grades to N95 masks >

< Comparison Table of National Standard of Similar Grades to N95 masks >
Credit: https://www.hsa.ie/eng/Publications_and_Forms/Publications/Chemical_and_Hazardous_Substances/Respiratory%20Protective%20Equipment.pdf

 

To meet the standards, mask manufacturers need to carefully evaluate and control the type, quality, and weight of non-woven fabrics of each layer of the mask while producing masks. For consumers, choosing the trustworthy suppliers and ensuring that mask manufacturers have the legitimate license to manufacture/import/sell medical equipment are important, so as to ensure the efficacy such as filtration rate and pressure difference of the finished mask. At the end of the article, we will introduce you the official licenses issued by the Taiwan government of medical device.

 

The License Number of Medical Device in Taiwan

There is no doubt that even there are many fancy masks in the markets, the most important thing is still the efficacy. Due to the hygiene considerations, consumers cannot directly touch the masks inside the packaging, so the information disclosed on the packaging is the basis for everyone to check before purchasing. If there is a professional certification mark shown on it, consumers can be more secure and reassured. In Taiwan, medical masks are regulated by the Food and Drug Administration of the Ministry of Health and Welfare (for short: Food and Drug Administration), (Note: General/non-medical masks are regulated by the Bureau of Standards, Metrology and Inspection & Bureau of Foreign Trade, M.O.E.A.) and for approved suppliers of manufacturing/importing medical masks, a Medical Device Permit License will be issued, with a set of 6-code Registration Number – it is just like the official ID number of the product, all products to be sold in Taiwan, as long as they belong to the scope of medical devices, are mandatory to apply for the license. If the sellers do not apply for this license and then directly sell it on the shelves, it will violate Article 27 of the “Pharmaceutical Affairs Law” and would be imposed a fine of no less than NT$30,000 to no more than NT$2,000,000 (Article 92 of the Pharmaceutical Affairs Law). The public should pay attention to choose legitimate medical masks with a license number to protect ourselves. There are total 6 types of medical equipment licenses available on the market in Taiwan (2 types made in Taiwan + 4 types imported), which are introduced as follows:

  1. MOHW(DOH) Medical Device Manufacturing No. 000000 (衛部(署)醫器字第000000號)
    => Made in Taiwan and belong to Class II & Class III medical devices.
  2. MOHW(DOH) Medical Device Manufacturing-(1) No. 000000 (衛部(署)醫器製壹字第000000號)
    => Made in Taiwan and belong to Class I medical devices.
  3. MOHW(DOH) Medical Device Import No. 000000 (衛部(署)醫器字第000000號)
    => Imported and belong to Class II & Class III medical devices.
  4. MOHW(DOH) Medical Device Import-(1) No. 000000 (衛部(署)醫器輸壹字第000000號)
    => Imported and belong to Class I medical devices.
  5. MOHW(DOH) Medical Device China Import No. 000000 (衛部(署)醫器陸輸字第000000號)
    => Imported from China and belong to Class II & Class III medical devices.
  6. MOHW(DOH) Medical Device China Import-(1) No. 000000 (衛部(署)醫器陸輸壹字第000000號)
    => Imported from China and belong to Class I medical devices.

「Manufacturing製」、「Import輸」、「China Import陸輸」:
       Class II & Class III medical devices
「Manufacturing-(1)製壹」、「Import-(1)輸壹」、「China Import-(1)陸輸壹」:
       Class I medical devices
「Manufacturing製」: Made in Taiwan
「Import輸」: Imported from foreign countries (China excluded)
「China Import陸輸」: Imported from China

After understanding the meaning of the words mentioned on the license, it should be quite useful while purchasing next time and you will no longer feel confusing about these words. Hope this article will help everyone while purchasing masks or medical equipment and protect yourself and take care of others by choosing the guaranteed merchants!

 

 

Reference

https://www.textiletoday.com.bd/types-non-woven-fabrics-manufacturing-processes-applications/

https://www.coronavirus.kdheks.gov/DocumentCenter/View/1416/Understanding-ASTM-Levels-for-Facemasks-PDF—7-30-20

國家標準(CNS)網路服務系統 檢索 (cnsonline.com.tw)

https://www.nonwoven.org.tw/index.php?Act=0&SK=11293&MK=0&PK=5345

https://cfr.umn.edu/covid-19/maskrespirator-evaluation-methods/filtration-test-standard

http://tiua.instruments.org.tw/archive/file/1080712002.pdf

https://www.verywellhealth.com/kf94-masks-covid-5216618

https://law.moj.gov.tw/LawClass/LawAll.aspx?pcode=L0030120

https://law.moj.gov.tw/LawClass/LawGetFile.ashx?FileId=0000305316&lan=C

https://law.moj.gov.tw/LawClass/LawSingle.aspx?pcode=L0030001&flno=27

https://law.moj.gov.tw/LawClass/LawSingle.aspx?pcode=L0030001&flno=92

https://www.astm.org/f2100-19e01.html

https://www.cdc.gov/niosh/npptl/topics/respirators/pt84abs2.html

https://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/N95list1sect3.html

https://www.astm.org/f3502-21.html

https://makermask.org/new-astm-standard-for-face-coverings-astm-f3502/

http://www.nobelcert.com/DataFiles/FreeUpload/BS%20EN%2014683-2019.pdf

https://www.hsa.ie/eng/Publications_and_Forms/Publications/Chemical_and_Hazardous_Substances/Respiratory%20Protective%20Equipment.pdf

https://www.mhlw.go.jp/stf/newpage_19244.html

http://openstd.samr.gov.cn/bzgk/gb/newGbInfo?hcno=1738BD9CCF76E55F81A5B0E9ED4D4EFA

http://www.isrp.com.au/isrpcom/journal/ed_abstracts/abstract__myojo.htm

 

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