Consulting for Personal Protective Equipments – CE Marking (EU Regulation)

The first most important question which arises when we talk about EU regulation or CE Marking of N95 Face Mask (Particle Filtered Face Mask / Half Face Mask), Coverall, Aprons etc. is whether CE has to be applied under MDD 93/42/EC or PPE 2016/425??
The answer to it is they are Personal Protective Equipments and not Medical Devices so they have to be certified under “PPE 2016/425” regulation.

Protective Clothing (Coveralls, Aprons etc.)

Protective clothing will include clothing that covers or replaces personal clothing and is designed to protect against one or more hazards, with the definition given in the standards.

Protective clothing is designed to protect the wearer against various dangers and risks. For this reason, they are classified as personal protective equipment.

a. Standards Subject: TS EN 14126
b. Legislation Required: Personal Protective Equipment Regulation – Category 3
c.      Conformity Control Mechanism: Must bear the CE Mark with the 4 digit Notified body number

Protective clothing is subject to different standards against the risks and dangers in the protection target and classified accordingly. This classification table is shown below.

Table 1: Types of protective clothing and intended use

Table 2: Standards to which Protective Clothing types are subject

Protective Clothing Against Pathogenic Organisms;

As shown in Table 2, overalls or protective clothing in general are shown in 6 types in terms of suitability for use and additional standards are given. As can be seen from the table, a classification of protection against pathogenic organisms such as Corona Virus is not given here.

Protection against pathogenic organisms is defined as an additional feature for all types of protective clothing given above. Whether or not protective clothing has this feature is determined by EN 14126 standard. In other words, when a protective clothing of the above type meets the requirements of EN 14126 standard, it will provide protection against pathogenic organisms in various forms (at risk of liquid, solid, vapor, contact, etc.). As a result of such certification, it is stated that the product provides protection against biological risks by adding “–B” next to the type information in the form of Type XB.

If the protective suit has an electrostatic protection feature, additional requirements of EN 1149-5 standard are required.

Protective Aprons

Protective gowns can also be evaluated, including the types of protective clothing given above. Clothes such as gowns are defined as clothing that protects part of the body, as the body does not protect the entire body, and the Type selection should be accordingly. Attention should be paid to the type of risk intended for protection in the selection of Type of such products. For example, the Type 5 selection is not suitable for the apron, as Type 5 contains the whole body. If the clothing that protects part of the body as personal protective clothing is documented, “PB” should be added after the type information as labeling. For example, Type6 PB or Type 6-B PB.

In the evaluation of protective gowns, it is possible to consider compliance with EN 13795-1 (Surgical gowns and gowns) standard instead of the selection of these standards in gowns for patient protection. This standard is not covered by the Personal Protective Equipment Directive and is handled according to the Medical Devices Regulation.

There are two basic types of masks that our people can use in the Covid19 Pandemic process. These masks are Particle Filtered Face Masks and Medical Face Masks. There are many manufacturers who turn to mask production due to intense need. It is clear that producer initiatives should be supported in order to meet the needs. On the other hand, the suitability of these masks for their intended use is also of great importance. There are standards and regulations that these masks are subject to for their intended use.

Particle Filtered Face Masks (Also called N95 or Dust mask in public.)

EN149-trasnparent.png

a.      Standard Required: EN 149
b.      Legislation Required: Personal Protective Equipment Regulation – Category 3
c.      Conformity Control Mechanism: Must bear the CE Mark with the 4 digit Notified body number

Our company mobilized all its possibilities during this period when the need for personal protective equipment was vital and informs the manufacturers about the features that these products should bear and consumers In terms of providing suitable products to our people, it carries out the duties of reflection, with our cooperation with European laboratories, suitability control mechanisms have been created for Particle Filtered Masks Coveralls, Aprons and other PPE devices and is aimed to present the required functional masks to required people.

Please contact us for required testing & CE certification as per PPE 2016/425

MAVEN PROFCON SERVICES LLP.

CE – MDR / MDD / US FDA / MD-QMS / Trainings / Associated Services

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