What are the 11 coverall testing methods? What does the CE mark stands for?

What are the CE testing methods and procedures for PPE coverall?

What are the 11 coverall testing methods?  In recent years, safety managers are more concerned if Personal Protective Equipment (PPE) wears the CE market.   CE mark has become a must, certified by law, especially for the PPE to be sold in Europe.

What does CE mark/certification mean for the PPE?

The CE mark ensures that the PPE product is compliant with relevant EU safety and quality requirements.   A CE mark is a symbol that must be affixed to many products before they can be sold on the European market. The mark indicates that a product:

  • Fulfills the requirements of relevant European product directives
  • Meets all the requirements of the relevant recognized European harmonized performance and safety standards
  • Is fit for its purpose and will not endanger lives or property

The presence of CE marking further indicates that appropriate technical documentation supporting the use of the mark is available and can be provided by the manufacturer, importer, or person responsible for placing the product on the EU market upon request.

According to European Commission, Regulation (EU) 2016/425 covers the design, manufacture, and marketing of PPE.  It defines legal obligations to ensure PPE on the EU internal market provides the highest level of protection against risks. The CE mark affixed to PPE will provide evidence of compliance which product applicable to EU legislation. It indicates risk categories of which PPE is intended to protect users, such as protective clothing that complies with Category III is appropriate to prevent death or irreversible health damages.

 

CE mark VS PPE performance

The technical performance of PPE is specified by European Norms, harmonized standards, or in a technical file when the harmonized standard does not exist. Very often you will find a reference to this European Norm as additional information on the product, the packaging, or other documentation.

 

CE Standard for protective clothing (EU)

The CE regulation further specifies the coveralls into 6 types of suits.

  • Type 1: Gas Tight Suits (EN 943 part 1)
    • Protects against liquid and gaseous chemicals.  More or less equivalent to US level A.
  • Type 2: Non-gas Tight Suits (EN 943 part 1)
    •  Protects against liquid and gaseous chemicals.  More or less equivalent to US level B.
  • Type 3: Liquid Tight Suits. (EN 14605)
    • Protects against liquid chemicals for a limited period.
  • Type 4: Spray Tight Suits (EN 14605)
    • Protects against liquid chemicals for a limited period.   More or less equivalent to US level C.
  • Type 5: Particulate suits (EN ISO 13982-1)
    • Protects against airborne dry particulates for a limited period.
  • Type 6: Reduced Spray Tight Suits (EN 13034)
    • Protects against a light spray of liquid chemicals. More or less equivalent to US level D.

 

The 11 coverall testing methods

To pass the testing standards, protective clothing/coveralls must meet or exceed minimum requirements of materials’ physical and chemical properties.

EN 943-1

Type 1 EN 943-1 Gas-tight suits

  • Type 1:
    • Type 1a:  Self-contained breathing apparatus wore on the inside.
    • Type 1b:Self-contained breathing apparatus worn on the outside.
    • Type 1c:Air supply via a compressed-air hose system.
EN 943-1

Type 2 EN 943-1 Non-gas-tight suits

  • Type 2:
    • Ventilated and positive pressure by air supply via a compressed-air hose system.
EN 14605

TYPE 3 EN 14605 Liquid Jet Suits

The principle of this type 3 EN463 test is to determine if there is leakage under a jet aqueous stream.  The test method is that a jet of water, containing a fluorescent or visible dye tracer is directed under controlled conditions at chemical protective clothing, which is worn by a test mannequin or human test subject.  Inspection of the inside surface of the protective clothing and outside surface of absorbent clothing worn underneath allows any points of inward leakage to be identified.

  • Before entering the test chamber, a series of movements, including climbing a ladder and crawling on the floor are performed to check the whole suit doesn’t split or tear.
  • The wearer then enters the chamber and stands on a rotating platform. (The platform turns at 360º/min)
  • A series of short jets of the water, at pressures of 3 Bar is then directed at the coverall.
  • There is a 1m gap between the jet nozzle and the test subject.
  • Pass or Fail Criteria (all 3 must pass!)
    1. If any penetration is greater than 3 times the total calibration stain area.
    2. The calibration stain area is 2.0cm²
    3. The test is repeated on 3 suits
      TYPE 3 EN 14605
EN 14605

TYPE 4 EN 14605 Liquid Jet Suits

The principle of this type 4 EN468 test method is to determine if there is leakage under an aqueous spray condition.   The test method includes an aqueous spray, containing a fluorescent or visible dye tracer is directed under controlled conditions at chemical protective clothing is worn by a test mannequin or human test subject.

  • Inspection of the inside surface of the protective clothing and outside surface of absorbent clothing worn underneath allows any points of inward leakage to be identified.
  • Before entering the test chamber, a series of movements, including climbing a ladder and crawling on the floor are performed to check the whole suit doesn’t split or tear.
  • The wearer then enters the chamber and stands on a rotating platform. (The platform turns at 360º/min) The suit is sprayed from all sides (saturated) by approx 4.5 liters of dyed water.
  • There is a 1m gap between the spray nozzles and the test subject.
  • Pass or Fail Criteria (all 3 must pass!)
    1. If any penetration is greater than 3 times the total calibration stain area.
    2. The calibration stain area is 2.0cm²
    3. The test is repeated on 3 suits

EN 14605

EN ISO 13982-1

Type 5: EN ISO 13982-1 Particulate Suits

Performance requirements for chemical protective clothing are to protect the full-body against airborne solid particulates (type 5 clothing).

Test requirements for seams, joins & assemblages of Type 5 protective clothing

  • Seams should be constructed to minimize or prevent penetration of solid particles through stitch holes or other components of a seam.
  • Seam strength is determined and classified by EN14325:2004, Clause 5.5 and must obtain at least Class 1 (>30N).

The test method specified in clause 5.5 is EN ISO 13935-2

EN ISO 13982-1

Testing for an inward leakage of aerosols & solid particles‒Type5 protective clothing

Test method of determination of inward leakage of aerosols of fine particles into suits.

  • This test is performed using “real people” and is designed to simulate everyday use. The garment is donned according to the manufacturersʼ instructions, including any protective equipment.
  • The manufacturersʼ instructions also have to specify whether or not the additional equipment
    is taped to the suit and how the taping should be done.
  • At least 5 test subjects are involved, each testing 2 suits. So at least 10 suits are
    tested.

 

Before entering the test chamber the test subject (real person) is asked to repeat the following sequence of movements 3 times at what is termed “normal working speed”
  1. Kneel on both knees, lean forward, and place both hands on the floor 45cm in front of the knees. Crawl forward on hands and knees over a distance of 3m and crawl backward again over the same distance.
  2. Stand with feet shoulder-width apart, arms at side. Raise arms until
    they are parallel to the floor in front of the body. Squat down as far as
    possible.
  3. Kneel on right knee, place the left foot on the floor with left knee bent 90º, left
    arm hanging loosely at side. Raise left arm fully overhead.

Once they have completed these movements the suit is inspected visually for tears or rips in the fabric, seams, closures, or connections to gloves, boots, or mask (if any). Any damage is mentioned in the test report, but the test would be discontinued if the damage was significant or hindered the test subjectsʼ movement. If this happens then the garment is deemed to have failed!

On entering the test chamber, the test subject is asked to perform various test exercises in sequence:
  1. standing still
  2. walking at 5 km/h
  3. continuous squatting at a frequency of five squats per minute, between standing up straight and knees completely bent, while keeping both hands during all squats on a grip at a height of 1m (+/-0.05m) above the standing surface.
  4. A 3 min rest is allowed (standing still) between the walking and squatting exercises.

Throughout the process, various measurements are taken on the concentration of particulates inside and outside of the suit. A calculation is then used to ascertain the inward leakage during each test and the total inward leakage of particles into the suit. The test agent used is Sodium chloride aerosol.

 

Type 5 chemical protective clothing has to meet the following requirements;

  • Inward leakage (IL ) ≤30% IL for 91.1% (or more) of all values measured
    (all exercises, all sampling positions all suits) 82 out of 90 measurements!
  • Total inward leakage (TILS)≤15% for 80% (or more) of all TILS values
EN 13034

TYPE 6 EN 13034 Reduced Spray Suits

Performance requirements for chemical protective clothing are to protect the full-body against liquids in the form of mist (type 6 clothing).   This standard sets out the general requirements for protective clothing.

Mist Testing Methods

  • This test is performed using “real people” and is designed to simulate everyday use. The garment is donned according to the manufacturersʼ instructions, including any protective equipment.
  • Three suits shall be tested after preconditioning by 5.1 (if applicable) and each test shall be made with a new preconditioned suit.
  • If more than one size of a chemical protective suit is manufactured, the test subject is asked to select the appropriate size according to the manufacturer’s information.
  • If more than one size of a chemical protective suit is manufactured, the test subject is asked to select the appropriate size according to the manufacturer’s information.

EN 14605

On entering the test chamber, the test subject is asked to perform various test exercises with 7 movements:

  1.  Movement 1: kneel on both knees, lean forward, and place both hands on the floor (45 ± 5) cm in front of the knees; crawl forward and backward on hands and knees for a distance of three meters in each direction.
  2. Movement 2: climb a vertical ladder at least four steps, rungs to be as encountered on a typical ladder.
  3. Movement 3: position hands at chest level, palms out; reach directly overhead, interlock thumbs, extend arms fully upwards.
  4. Movement 4: Kneel on the right knee, place the left foot on the floor with the left knee bent (90 ± 10)°; touch the thumb of the right hand to toe of the left shoe.
  5. Movement 5: extend arms fully in front of the body, lock thumbs together, twist upper body (90 ± 10)° left and right.
  6. Movement 6: stand with feet shoulder-width apart, arms at side; raise arms until they are parallel to the floor in front of the body; squat down as far as possible.
  7. Movement 7: kneel as in movement 4, left arm hanging loosely at side; raise arm fully overhead.

If the test subject is not able to perform the test due to the hindrance of the suit or if the test results in substantial damage to the suit, the suit will be considered to have failed.

The test method of EN 468 shall be modified as follows for low-level spray testing conditions:

  • The four hydraulic nozzles shall be hollow cone-type nozzles, with a spray angle of (75 ± 5)° at
    3 bar, each nozzle supplying liquid at a rate of (0,47 ± 0,05) l/min at 300 kPa pressure;
  • the liquid used shall be modified to have a surface tension of (52,5 ± 7,5). 10-3 N/m to form suitable spray droplets; calibration of the test apparatus shall also be carried out with test liquid at the same surface tension.

 

NOTE The low-level spray testing conditions result in about 10 % of the liquid loading onto the suit surface compared with the full level spray test of EN 468, as used for the testing of type 4 chemical protective clothing.

When tested by EN 468 using the modifications described above, all chemical protective suits shall pass the test, i.e. there shall be no penetration of any suit, i.e. the total stain area on the undergarment shall be less than or equal to three times the total calibrated stain area.

For suits that do not cover the entire body, the test report shall specify other components with which the suit was worn to achieve the mist test performance, e.g. an appropriate hood, gloves, boots, etc.

EN 14126

EN 14126 Against Biological Hazards

The European standard EN 14126 defines performance requirements for clothing materials to protect against infective agents. The test methods specified in this standard focus on the medium containing the microorganism; such as liquid, aerosol, or solid dust particle. Due to the heterogeneity of micro-organisms, the standard does not define performance criteria for specific types of microorganisms.

This is not a ‘stand-alone’ standard and needs to be combined with standards for Type 1, 2, 3, 4, 5, and/or 6 protective garments. 

Types 1, 2, and 5 protective garments are required to be of the ‘full body’ type.  Type 3, 4, and 6 protective garment standards include partial body ‘PB’ garments covering only a part of the body.

Protective suits made of EN 14126 compliant fabrics must also meet the whole suit requirements specified in the relevant chemical protective clothing “Type” standard.  They must be CE Certified as Category III and can be identified by the bio-hazard pictogram.

 

EN 14126:2003 comprises the following material tests conducted on garment fabrics:

  1. Screening pressure test: Resistance to penetration by blood and body fluids using synthetic blood – ISO 16603
  2. Resistance penetration by blood-borne pathogens using a bacteriophage (“virus” penetration simulation) – ISO 16604
  3. Resistance to penetration by biologically contaminated liquids (wet bacterial penetration) – ISO 22610
  4. Resistance to penetration by biologically contaminated liquid aerosols – ISO/DIS 22611
  5. Resistance to penetration by biologically contaminated solid particles (dry microbial penetration) – ISO 22612

 

EN 1149-5

EN 1149-5 Antistatic

This standard specifies requirements for clothing that conducts electricity. This clothing (combined with e.g. shoes that conduct electricity) forms part of a completely earthed system. The clothing prevents sparks and therefore explosions.

 

EN 1149 consists of the following parts:

  • EN1149-1: test methods for the measurement of surface resistance
  • EN1149-2: test methods for the measurement of the electrical resistance through a material (vertical resistance)
  • EN1149-3: test methods for the measurement of charge decay
  • EN1149-4: garment test method (standard currently under development)
  • EN1149-5: performance requirements.

 

Different tests

The fabric from which the clothing is made must be EN 1149-1, EN 1149-2, or EN 1149-3 compliant – or entire garments must be tested by EN 1149-4 (under development).

 

EN 1149-1: Protective clothing – Electrostatic properties, part 1

  • The fabric releases its electrostatic charge via conduction.
  • In the related test, the surface resistance is determined; it has to be ≤ 2,5 * 109 Ω.
  • Electricity can be conducted via homogeneous or heterogeneous material.
  • If the material is heterogeneous, static electricity has to be released via a grid of conductive fibers (metal/carbon) measuring max. 10 mm x 10 mm.

 

EN 1149-3: Protective clothing – Electrostatic properties, part 3

The fabric releases its electrostatic charge to the air (and not via conduction).

  • The standard contains a test method in which the amount of time it takes for a static electrical charge to dissipate is measured (Electrostatic Discharge of clothing): t50% < 4 s or S > 0.2.

The requirements set in this standard

  • Models must meet the requirements specified in EN 340
  • Materials that can carry an electric charge (metal buttons, etc.) must be covered on the outside
  • Non-conductive elements (reflective strips, emblems, etc.) are permitted, provided they are permanently attached. For example, a removable badge is not permitted
  • Clothing that complies with EN 1149-5 is in itself insufficient; the wearer must also wear shoes that conduct electricity
  • The outer material must always be in contact with the wearer’s skin. When designing, for example, winter clothing, the seam must therefore be in contact with the skin
  • If clothing meets the requirements for EN 1149-5, it must also meet the requirements for EN 531.
EN ISO 14116

EN ISO 14116 Flame Retardant Test

The EN ISO 11612 is established to protect people who are exposed to heat and flames.

FABRIC REQUIREMENTS ACCORDING TO EN ISO 11612

To meet the EN ISO 11612 standard, the protective fabric needs to pass at least two tests: the A test and at least one of the B, C, D or E test. Per test, the performance of the fabric is tested on:

  • Test A – flames spread
  • Test B – convective heat
  • Test C – radiant heat
  • Test D – E molten metal
  • Test F – contact heat

EN ISO 14116

The test results are classified into ‘performance levels’

Performance level 1 for example, indicates that the fabric provides the minimum protection to pass the test.

It is important to understand the different performance levels because they are related to the size of the risk impact. The three performance levels in the E test, for example, tell you something about the protection of different amounts of a molten iron splash: E1 stands for 60 to < 120-gram molten iron splash and E3 for >200 gram.

11612A (ISO 15025) – Flame Test

This test consists of applying a flame to a fabric sample for 10 seconds. To pass the test, the after flame & smolder times and formation of holes must be within the tolerances (set in the standard).  The application of a flame can take place in two ways:

  • in procedure A (leads to Class A1), the flame is applied horizontally (similarly to EN 470 and EN 531)
  • in procedure B (leads to Class A2), the flame is applied laterally.

11612B (ISO 9151) – Heat Transmission Test

Convective heat: determination of the heat transmission when exposed to flames. The sample is held above the flame and the rise in temperature on the top side of the sample is measured with a calorimeter. Subsequently, the length of time the sample can remain exposed before its temperature rises by 24 °C is determined.

  • B1: 4 < 10 seconds
  • B2: 10 < 20 seconds
  • B3: 21 seconds and longer

11612C (ISO 6942) – Radiant Heat Test

In this test, a fabric sample is exposed to radiant heat (infrared rays). The temperature on the reverse (unexposed) side of the sample is registered using a calorimeter. Subsequently, the length of time the sample can remain exposed before its temperature rises by 24 0C is measured. The test procedure is the same as EN ISO 11611, but the classification is different:

  • C1: 7 < 20 seconds
  • C2: 20 < 50 seconds
  • C3: 50 < 95 seconds
  • C4: 95 seconds and longer

11612D en E (ISO 9185) – Spatters of Molten Metal Test

This test is to determine the level of protection against spatters of molten metal. A membrane, similar properties to human skin, is attached to the reverse of the fabric sample. Subsequently, sequentially rising quantities of molten metal.  The quantity of molten metal which deforms the membrane is determined.

The classification for molten aluminum is:
  • D1: 100 < 200 grams
  • D2: 200 <350 grams
  • D3: 350 grams and more
The classification for molten iron is:
  • E1: 60 < 120 grams
  • E2: 120 < 200 grams
  • E3: 200 grams and more
11612F (ISO 12127) contact heat test

A new test supplementing 531): contact heat. The classification in this respect:

  • F1: 5 < 10 seconds
  • F2: 10 < 15 seconds
  • F3: 15 seconds and longer
DIN 32781

DIN 32781 Against Pesticides

  • The test standard covers requirements in chemical penetration, fabric strength, and ergonomics.
  • The certification includes EN 14786, which simulates liquid spray of drugs
  • Five different pesticides including U46-D-Fluid (BASF), Pirimor Granulat (Syngenta), Amistar(Syngenta), Bethnal Expert(Bayer), Folicur(Bayer) are tested to ensure protection against pesticides
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