PPE product categorisation changes

Three different categories are used to define PPE. They are determined according to risk levels, with I being the lowest and III the highest. There have been a number of changes to each of these, brought about as a result of the latest regulation changes.

PPE categories 

Three different categories are used to define PPE. They are determined according to risk levels, with I being the lowest and III the highest. There have been a number of changes to each of these, brought about as a result of the latest regulation changes.

Category I – Simple PPE

PPE Directive 89/686/EEC
New PPE Regulation (EU) 2016/425
Superficial mechanical action
Superficial mechanical injury
Minor impacts and lesions
Contact with hot surfaces <50 degrees Celsius
Contact with hot surfaces <50 degrees Celsius
Atmospheric conditions that are not of an extreme nature
Atmospheric conditions that are not exceptional
Exposure to sunlight (not observing the sun)
Sunlight (sunglasses)
Contact with cleaning materials, weak action or prolonged contact with water

Category II – Intermediate PPE

PPE Directive 89/686/EEC
New PPE Regulation (EU) 2016/425
Any PPE risks which aren’t covered in Categories I and III
Any PPE risks which aren’t covered in Categories I and III

Category III – Complex PPE

PPE Directive 89/686/EEC
New PPE Regulation (EU) 2016/425
Filtering respiratory devices
Substances and mixtures hazardous to health
Respiratory protective devices
Oxygen deficient atmospheres
PPE for a chemical attack or ionizing radiation
Harmful biological agents
High-temp environments of >100 degrees Celsius
Ionising radiation
Low-temp environment of <-50 degrees Celsius
High-air temperatures in environments >100 degrees Celsius
Fall arrest
Low-air temperatures in environments <-50 degrees Celsius
PPE to protect against electrical risks
Falling from a height or drowning
Electric shock and live working
Cuts by handheld chainsaws
High-pressure jets
Bullet wounds or knife stabs
Harmful noises

In summary, some of the biggest changes include:

PPE modules

In addition to the changes made to categories, a complete new structure has been introduced to define the directives within these sections. These are referred to as “modules”. Currently, there are four modules:

1) Module A (Annex IV) – Placing product on the market 

This applies to all Cat I PPE. It’s nothing more than a name change with this one, as it refers to the manufacturer’s self-declaration (as it always has).

2) Module B (Annex V) – Initial product approval

This module covers both Cat II and Cat III PPE. It has replaced the Article 10 process. This sees all PPE needing to receive an EU Type Examination. On completion:

3) Module C2 (Annex VII) - On-going surveillance through testing

This has replaced Article 11A. It relates to the ongoing testing of products throughout their lifecycle. This sees tests being carried out by the notified body at least once a year at random intervals.

If this check results in a problem, the notified body will inform the notifying authority – who will take measure to fix the faults.

4) Module D (Annex VIII) – On-going surveillance through factory auditing

This has replaced Article 11B. It requires the manufacturer to maintain a documented quality system. It’s the duty of the manufacturer to lodge an application for an assessment of quality with a single notified body of their choice. These will also be assessed once a year.