Directive 89/686/EEC concerning Personal Protective Equipment (PPE)
Directive 89/686/EEC harmonizes the terms for the marketing and distribution of Personal Protective Equipment within the European Union.
The CE marking shows the compliance with the Directive.
Standard EN 420
The standard specifies the general requirements and tests for the design and manufacturing of the gloves, resistance to water penetration, safety, comfort and efficiency features together with the information concerning the marking and supplementary information provided by the manufacturer applicable to all protection gloves.
The EN 388 standard provides the minimum requirements for the mechanical origin risks, due to contact with sharp objects, sharp or protruding simply. The legislation requires four types of test:
A. Abrasion resistance: evaluated as number of cycles required to completely consume the specimen. The results are shown as protection levels 1 to 4.
(Security Level 1: 100 cycles Security Level 2 – 500 cycles; Security level 3 – 2000 cycles; Security Level 4 – 8000 cycles).
B. Shear strength: evaluated as number of cycles required to cut the sample at constant speed. The results are shown as protection levels 1 to 5.
(Security Level 1 – N 1.2 cycles. Security Level 2 – N 2.5 cycles. Security level 3 – N 5 cycles. Security Level 4 – N 10 cycles. Security Level 5 – N 20 cycles).
C. Tear strength: indicates the force required to tear and tear the specimen. The results are shown as protection levels 1 to 4.
(Security Level 1-10 newtons; Protection level 2-25 newtons; Protection level 3-50 newtons; Protection level 4-75 newtons).
D. Resistance to perforation: indicates the force required to be applied to a tip of the standard size to pierce the specimen. The results are shown as protection levels 1 to 4.
(Security Level 1-20 newtons; Protection level 2-60 newtons; Protection Level 3-100 newtons; Protection Level 4-150 newtons).
The EN 374 standard specifies the requirements for gloves to protect the user against chemicals and / or microorganisms and is constituted of 3 parts:
EN 374-1: It defines the terminology and general requirements.
EN 374-2: Defines the resistance to penetration of the glove, which means the promotion, at non-molecular level of a chemical substance or a micro-organism through porous material, seams holes or other imperfections in the glove material.
The resistance to penetration of the glove is evaluated with the execution of 2 tests:
–the evidence of air leakage, which involves immersing a glove in water, apply pressure with air inside and check for a leak from any stream of air bubbles on the surface;
–the evidence of loss of water, which provides water to fill a glove and verify the presence of a leak from any of the outside appearance of water droplets.
It is believed that gloves that are resistant to penetration, in accordance with EN 374-2, constitute an effective barrier against microbiological hazards.
The resistance to penetration is also described in ISO 2859 standard, as the acceptable quality level (AQL), which represents the average number of acceptable defective gloves (for presence of holes) present in a production batch.
The lower the AQL, the higher the quality of the glove.
So that they can be certified as medical devices, gloves must have an AQL ≤1,5. The test that determines the AQL of a glove, consists in a test of water-tight, which provides that the gloves are hanging to a filling tube positioned vertically and are filled with about 1000 ml of water at a room temperature. The glove thus filled is visually checked for 2-3 min. and if it does not waste water is considered suitable.
They define 3 levels of AQL:
Level 1: the acceptable quality level (AQL) ≤0,65
Level 2: the acceptable quality level (AQL) ≤1,50
Level 3: the acceptable quality level (AQL) ≤4,00
EN 374 -3: The law defines the resistance of the glove to permeation, which means the promotion at the molecular level of non-gaseous chemicals. Permeation includes three processes: the absorption of the chemical in the contact surface (external) of the glove; the diffusion of the chemical through the glove material; the desorption of the chemical from the opposite (inside) surface of the glove. More simply, the currency permeation for each chemical compound absorption from the outside to the glove, but also the subsequent release from the glove to the hand of the operator.
The resistance of the glove to permeation is evaluated as a measure of the penetration time of the chemical through the glove material under laboratory conditions specifically described in the reference standard.
On the basis of the penetration times obtained, they define 6 performance levels of permeation.
PERFORMANCE REQUIREMENTS PERMEATION
|Measured breakthrough time (minutes)||Permeation level performance|