Coverall regulation introduction 2019

1. Coverall Regulation Introduction
2019

2. Personal Protective Equipment
• Helmet
• Goggle
• Respirator
• Hearing
Protection
1
• Glove
• Clothing
• Shoe
• Falling
Protection
Chemical
Protective
Clothing

3. Gown v.s. Coverall
Isolation
Gown
Protective
Apparel
2

4. 3 ultitec-protection.com
Protection Purpose
General Purpose Cleanroom Purpose

5. Ergonomic Design
Wrist Elastic
3-piece hood
Zipper to Chin
Waist Elastic
Ample Crotch
Ankle Elastic

6. How to choose appropriate coverall
Protection Level
Correct Use
Particulate
Liquid
Gas
Risk Level

7. Coverall Segmentation
Level A
Level B
Level C
Level D
Category I
Category II
Category III
Type 1
Type 2
Type 3
Type 4
Type 5
Type 6

8. Type
1/2
Type 3
Type 4
Type 5 / 6
Category I
LOW
HIGH
Protective
Level
Against gases, aerosols, liquid and
solid chemicals
Against Minimal Risks
Against Normal Liquid Spray
& Dry Particles or Dusts
Against Pressurized Liquid Spray
Against Pressurized Liquid Jet
Gas Tight &
Non-Gas Tight
General
Protect
Limited
Spray Tight &
Particle Tight
Spray Tight
Liquid Tight
7
Segment in EU

9. Segment in US
等級 環境危害 建議配備
A
• 劇毒化學物質，其化學固體/液體/氣體
會立即傷害皮膚與呼吸道
• 含氧量低於19.5％
• 氣密式防護衣
• 正壓或循環呼吸系統
• 防化學手套與安全鞋
B
• 劇毒化學物質，其氣體不會立即傷害皮
膚與呼吸道，但會傷害皮膚
• 含氧量低於19.5％
• 液密式防護衣
• 正壓或循環呼吸系統
• 防化學手套與安全鞋
C
• 化學物質不會立即傷害皮膚與呼吸道 • 全身防護衣
• 全面或半面口罩
• 配戴防護手套
• 配戴安全鞋或是防護鞋套
D
• 無空氣污染、無飛濺、無浸泡、無吸入
或接觸的危害環境
• 視狀況配戴面部防護
• 視狀況配戴防護手套
美國只有為危險場域分級，建議配備
並沒有針對防護衣進行分級

10. Sagment EU vs US
美國分級
歐盟分級
等級 環境危害 建議配備
A • 劇毒化學物質，其化學液
體/氣體會傷害皮膚與呼吸
道
• 含氧量低於19.5％
• 氣密式防護衣
• 呼吸系統 Type 1 氣密防護服
B • 劇毒化學物質，其化學氣
體不會立即傷害皮膚與呼
吸道，但液體會傷害皮膚
• 含氧量低於19.5％
• 液密式防護衣
• 呼吸系統 Type 2 非氣密防護服
Type 3 防強力液體防護服
C • 化學物質不會立即傷害皮
膚與呼吸道
• 全身防護衣
• 全面或半面口
罩
Type 4 防噴霧防護服
Type 5 防乾燥粒子防護服
D • 其他環境 • 不需配戴面部
防護 Type 6 防輕型噴霧防護服
9

11. EU Regulation Funnel
EN ISO 13688:2013
Protective clothing. General requirements
EN 943-1/2
Type 1
EN 14605
Type 3
EN 14605
Type 4
EN ISO 13982-1
Type 5
EN 13034
Type 6
10
89/686/EEC & (EU) 2016 / 425
EN 14325:2018
Protective clothing against chemicals

12. Regulation Requirement
EN 943-1/2
Type 1
Protective clothing against dangerous solid, liquid and gaseous
chemicals, including liquid and solid aerosols. Performance
requirements for Type 1 (gas-tight) chemical protective suits
EN 14605
Type 3
Protective clothing against liquid chemicals. Performance requirements
for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections,
including items providing protection to parts of the body only.
EN 14605
Type 4
Protective clothing against liquid chemicals. Performance requirements
for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections,
including items providing protection to parts of the body only.
EN ISO 13982-1
Type 5
Protective clothing for use against solid particulates. Performance
requirements for chemical protective clothing providing protection to
the full body against airborne solid particulates (type 5 clothing)
EN 13034
Type 6
Protective clothing against liquid chemicals. Performance requirements
for chemical protective clothing offering limited protective performance
against liquid chemicals (Type 6)
11
Coverall Regulation & Test Requirements

13. ultitec-protection.com12
Coverall Regulation & Test Requirements
Type 3
EN14605:2005
+ A1:2009
• EN ISO 17491-3:
2008
• EN 14325:2018
Type 4
EN14605:2005
+ A1:2009
• EN ISO 17491-4:
2008
Method:B
• EN 14325:2018
Type 5
EN ISO 13982-1
:2004 + A1:2010
• EN 13982-2:
2004
• EN 14325:2018
Type 6
EN13034:2005
+ A1:2009
• EN ISO 17491-4:
2008
Method:A
• EN 14325:2018
Regulation
Whole suit
Test Method
Material
Test Method
EN 14325: 2018 Protective clothing against chemicals
Test methods and performance classification of chemical protective clothing
materials, seams, joins and assemblages

14. EN 17491-3 - Jet Test for Type 3
• Determination of resistance to penetration by a
jet of liquid
• The principle of this test method is that a jet of
water, containing a fluorescent or visible dye
tracer, is directed under controlled conditions
at chemical protective clothing worn by a
human test subject.
13

15. EN 17491-3 - Jet Test Method
• Part 1: Prior to 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.
• Part 2: Then enters the chamber:
stands on a rotating platform. (The
platform turns at 360º/min), ) A series
of short jets directed at the coverall.
By low surface tension of water 30-35
m N/m, at pressures 3 Bar. There is a
1m gap between the jet nozzle and
the test subject.14

16. EN 17491-3 - Jet Test Requirement
Pass or Fail Criteria:
If any penetration is greater
than 3 times the total
calibration stain area. It fails.
The calibration stain is the stain
area produced by 0.02 ml of the
test liquid.
The test is repeated on 3 suits –
and all 3 must pass!
15

17. EN 17491-4 - Spray Test for Type 4
• Determination of resistance to penetration by
spray
• The principle of this test method is that an
aqueous spray, containing a fluorescent or
visible dye tracer, is directed under controlled
conditions at chemical protective clothing worn
by a human test subject.
16

18. EN 17491-4 -Spray Test Method
• Part1: Prior to 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.
• Part 2: Then enters the chamber:
stands on a rotating platform. (The
platform turns at 360º/min) The suit is
sprayed from all sides (saturated) by
low surface tension of 30-35 m N/m,
approx. 4.5 litres of the dyed water at
pressures 3 Bar. There is a 1.5m gap
between the spray nozzles and the test
subject.
17

19. EN 17491-4 -Spray Test Requirement
Pass or Fail Criteria:
If any penetration is greater
than 3 times the total
calibration stain area. It fails.
The calibration stain is the
stain area produced by 0.02 ml
of the test liquid.
The test is repeated on 3
suits – and all 3 must pass!
18

20. EN 17491-4 Spray Test for Type 6
• As with Type 4 clothing, Type 6 suits must pass a “Spray
Test” in accordance with EN 17491-4: 2008
• Type 6 clothing is designed for garments which provide
resistance to light “reduced spray” by EN 17491-4
method:A.
• The modifications ensure that only about 40% of the
liquid sprayed is loaded onto the suit, compared to the
full level spray test of EN 17491-4 method: B for Type 4
clothing.
19

21. EN 17491-4 -Spray Test Method
• Part1: Prior to 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.
• Part 2: Then enters the chamber:
stands on a rotating platform. (The
platform turns at 360º/min) The suit is
sprayed from all sides (saturated) by
surface tension of 57 m N/m, approx.
1.9 litres (reduced spray) at pressures
3 Bar of the dyed water. There is a
1.5m gap between the spray nozzles
and the test subject.
20

22. EN 17491-4 -Spray Test Requirement
Pass or Fail Criteria:
If any penetration is greater
than 3 times the total
calibration stain area. It fails.
The calibration stain is the
stain area produced by 0.02 ml
of the test liquid.
The test is repeated on 3
suits – and all 3 must pass!
21

23. EN ISO 13982 – Dust Test for Type 5
Testing for inward leakage of aerosols & solid
particles
• EN ISO 13982-1:2004
Performance requirements for chemical
protective clothing providing protection to
the full body against airborne solid
particulates (type 5 clothing)
• EN ISO 13982-2:2004
Specifies a test method to determine the
barrier efficiency of chemical protective
clothing against aerosols of dry, fine dusts.
• This test is performed using “real people”
and is designed to simulate everyday use.
• At least 5 test subjects are involved, each
testing 2 suits. So at least 10 suits are
tested.
22

24. EN ISO 13982 – Dust Test for Type 5
23

25. EN ISO 13982-2 Test Method
• Part 1: Prior to 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 backwards 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 left foot on floor with left knee bent 90º,
left arm hanging loosely at side. Raise left arm fully overhead.
24

26. EN ISO 13982-2 Test Method
• Part 2: 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.
25

27. EN ISO 13982-2 Requirement
Part 2 Requirement:
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 (IL) and the total inward
leakage (TILS) of particles into the suit.
The test agent used is Sodium chloride aerosol.
26

28. EN ISO 13982-2 Requirement
IL 82/90
TILS 8/10
Reference from: IOM Test report No.: 602-00690(a)
27

29. EN ISO 13982-2 Requirement
28

30. EN 1073-2 Protection Radioactive
Contamination
• The EN 1073-2 standard was developed with the
nuclear industry in mind, but does not apply for the
protection against ionizing radiation.
• EN 1073-2 follows the same test method with Type 5 -
EN ISO 13982-2.
• The difference between EN 1073-2 and Type 5 is the
test requirement / criteria.
29

31. EN 1073-2 Requirement
One Activity (ILE)
All Activities (ILA)
Reference from: IOM Test report 602-00690(b)
30

32. EN 1073-2 Requirement
31

33. Performance
requirement
Description
ISO 16603: 2004 Resistance to penetration by blood and body fluids
ISO 16604: 2004 Resistance to penetration by blood borne pathogens-
Test method using Phi-X174 bacteriophage
ISO 22611: 2003 Resistance to penetration of biologically contaminated
aerosols (Staphylococcus aureus)
ISO/DIS 22612:
2005
Resistance to dry microbial penetration (Bacillus subtilis)
ISO 22610: 2006 Resistance to wet microbial penetration (Staphylococcus
aureus)
EN 14126 Protection against Biological
Hazards and Infective Agents
32

34. ISO 16603 & ISO 16604
• Penetration test using synthetic blood (ISO/FDIS 16603)
• The synthetic blood used contain mixture of cellulose,
colouring, buffer solution and stabilizing agents
• Resistance to penetration by viruses (ISO/FDIS 16604)
 same criteria as ISO 16603 but virus (Phi-X-174) instead
Class Exposure pressure [kPa]
6 20.0
5 14.0
4 7.0
3 3.5
2 1.75
1 0.0
33

35. ISO 22610
• Resistance to penetration by bacteria (ISO/DIS
22610)
• The test method is testing material’s resistance to
wet bacterial penetration by breakthrough times.
Class Bacterial penetration
6 > 75 min
5 > 60 min
4 > 45 min
3 > 30 min
2 > 15 min
1 < 15 min
34

36. ISO22611
• Resistance to penetration by biologically contaminated
aerosols (ISO/DIS 22611)
• An aerosol is sprayed onto both an unprotected
cellulose nitrate membrane and one covered with the
test material
Class
Penetration ratio without/with test
material [log]
3 > 5
2 > 2
1 > 1
35

37. ISO 22612
• Resistance to penetration by contaminated dust
(ISO/DIS 22612)
• Dose with contaminated (Bacillus Subtilis) talcum
powder on test materials, then shake it to count the
penetrated, then compare with non-contaminated.
Class
Penetration ratio without/with test
material [log]
3 > 5
2 > 2
1 > 1
36

38. DIN 32781 Protective clothing
Protective suits against pesticides
37
• DIN 32781 contain some tests and requirements,
regarding mechanical properties, comfort and
permeability to chemicals.
• Most important criteria as protection effect is
the degree of penetration. Atomizer test (EN
14786) is considered and need be under 5%.

39. DIN 32781 Test Method
Criteria Measurement Test Method Limit Value
Chemical Penetration Degree of penetration EN 14786 5%
Chemical Penetration Spray test EN 13034 pass
Mechanical Properties Tensile load strength EN ISO 13934-1 30 N
Mechanical Properties Tear resistance EN ISO 9073-4 10 N
Mechanical Properties Seam strength EN ISO 13935-2 30 N
Comfort Water Resistance EN 20811 200 cmH2O
Comfort
Water vapor volume
resistance
EN ISO 11092 20 m2*PA/W
38

40. DIN 32781 Requirement
• five selected chemical which are considered
representative due to formulation and their
usage in the market.
39
Trade name ZA-No. Formulation Active substance
U46-D- Fluid 0941-00 SL 2,4-D-DMA-Salt
Pirimor Granulat 2470-00 WG Pirimicarb
Amistar 5090-00 SC Azoxystrobin
Betanal Expert 4991-00 EC Phenmedipham
Folicur 4028-00 EW Tebuconazole

41. EN 1149-5 Material performance
and design requirements
• An electrostatic dissipating material must
meet at least one of the following
requirements:
• Half decay time < 4s or shielding factor S > 0.2
tested according to EN 1149-3
• Surface resistivity equal or less than
2.5 x 10
9
Ω according to the norm EN 1149-1
40

42. EN 1149-1 Surface resistivity
(test methods and requirements)
• Test method: the sample is placed on an insulating
base plate, then place the group of electrodes on
the sample, apply a continuous stream and
measure the resistance of the sample
• Requirements: the surface
resistivity must be less than
2.5 x 10
10
Ω
41

43. EN 1149-3 Test methods for
measurement of charge decay
• The test methods are applicable to all materials,
including homogeneous materials and heterogeneous
forms of fiber materials with conducting surface and / or
conductive fibers with conductive fiber core.
• Test method: The subject is tested to release its
electrostatic charge into the air, not through conduction
• Requirements: The shielding factor
should be greater than 0.2
and/or the half decay time
be less than 4 seconds.
42

44. EN 14325: 2018
Test Requirement of Materials
• EN14325: 2018 details the test methods & performance classification of
chemical protection clothing materials, seams, joins and assemblages.
Clause in EN 14325 Test Method Performance requirement
4.4 Abrasion Resistance EN 530 6 classes, At least meet class 1
4.5 Flex Cracking Resistance EN ISO 7854 6 classes, At least meet class 1
4.7 Trapezoidal Tear Resistance (MD & CD) EN ISO 9073-4 6 classes, At least meet class 1
4.9 Tensile Strength (MD & CD) EN ISO 13934-1 6 classes, At least meet class 1
4.10 Puncture Resistance EN863 6 classes, At least meet class 1
4.11 Resistance to permeation by liquids
EN374-3 or
EN ISO 6529
6 classes, At least meet class 1
4.12 Repellency to liquids EN 6530 3 classes, At least meet class 1
4.13 Resistance to penetration by liquids EN 6530 3 classes, At least meet class 1
4.14 Resistance to ignition EN 13274-4 must not continue to burn after 5 s
5.5 Seam Strength ISO 13935-2 6 classes, At least meet class 1
43

45. EN 14325: 2018
Test Requirement of Materials
• EN14325: 2004 details the test methods & performance classification of
chemical protection clothing materials, seams, joins and assemblages.
Clause in EN 14325 Classification according to EN 14325
4.4 Abrasion Resistance 6 Classes; 1 >10; 2 >100; 3 >500; 4 >1000; 5 >1500; 6 >2000
4.5 Flex Cracking Resistance 6 Classes; 1 >1000; 2>2500; 3 >5k; 4>15k; 5>40k; 6>100k
4.7 Trapezoidal Tear Resistance 6 Classes; 1 >10; 2 >20; 3 >40; 4 >60; 5 >100; 6 >150
4.9 Tensile Strength 6 Classes; 1 >30; 2 >60; 3 >100; 4 >250; 5 >500; 6 >1000
4.10 Puncture Resistance 6 Classes; 1 >5; 2 >10; 3 >50; 4 >100; 5 >150; 6 >250
4.11 Resistance to permeation by liquids 6 Classes; 1 >10; 2 >30; 3 >60; 4 >120; 5 >240; 6 >480
4.12 Repellency to liquids 3 classes; 1 >95%; 2>90%; 3>80%
4.13 Resistance to penetration by liquids 3 classes; 1 <1%; 2<5%; 3<10%
4.14 Resistance to ignition must not continue to burn after 5 s
5.5 Seam Strength 6 Classes; 1 >30; 2 >50; 3 >75; 4 >125; 5 >300; 6 >500
44

46. EN ISO 6530 Gutter Test
• Protection against liquid chemicals.
• The European standard EN ISO 6530 (often referred
to as the “Gutter Test”) measures Liquid Penetration
through a fabric and Liquid Repellency by a fabric.
• Liquid chemical penetration
is a physical process whereby
a liquid penetrates a fabric by
passing through pores or holes
in the fabric.
Repellency
Penetration
Fabric
45

47. EN ISO 6530 -Gutter Test Method
Test Method:
1. Placing the fabric to be tested in a gutter, inclined at 45º, which is lined
with an absorbent fabric as picture.
2. 10ml of the pre-determined liquid chemical (as Table B) is then poured in
within 10 seconds on to the top of the test fabric via a nozzle.
Repellency Index
Penetration Index
46

48. EN ISO 6530 -Gutter Test Requirement
Repellency Index
Class Repellency Index
3 > 95%
2 > 90%
1 > 80%
Penetration Index
Class Penetration Index
3 < 1%
2 < 5%
1 < 10%
• Test result:
Any liquid which penetrates the fabric
within 1 minute is expressed as a
percentage (%) of the original quantity
poured onto the fabric.
(For resistance to penetration by
liquids a performance level of at least
2 shall be obtained for at least one of
the chemicals listed in table)
• Test Result:
The volume of liquid collected in the
detector beaker (positioned at the
bottom of the gutter) is also expressed
as a percentage (%) of the original
quantity. This measures the repellence
of the fabric.
(For liquid repellence a performance
level of 3 shall be obtained for at least
one of the chemicals listed in table)
47

49. Q & A
Thank You