PPE categories describe the risks a product is intended to protect against. Category I covers specified minimal risks, Category III covers specified risks with potentially fatal or irreversible consequences, and Category II covers the remaining risks.
Category I: specified minimal risks
Examples include superficial mechanical injury, weak cleaning agents or prolonged water contact, surfaces no hotter than 50°C, ordinary sunlight exposure and non-extreme weather. The risk list is limited: a product is not Category I simply because it looks simple or costs little. The categories are outlined in the Turkish Ministry of Trade's PPE guide.
Categories II and III: the risk determines the route
Category II applies to risks outside Categories I and III. Category III examples include falls from height, oxygen deficiency, harmful biological agents, electric shock, drowning and harmful noise. A product name such as glove, mask or protective clothing does not establish its category: the claimed protection and intended use must be assessed. Refer to the official risk categories.
Which conformity assessment modules apply?
- Category I: Module A, with the manufacturer controlling production.
- Category II: Module B EU type-examination, followed by Module C conformity to the approved type.
- Category III, standard series-production route: Module B plus either Module C2 supervised product checks or Module D production quality assurance.
Modules B, C2 and D involve a notified body. Under the normal Category III route, the identification number of the body responsible for production surveillance follows the CE mark. Article 19 also contains a specific exception for a single unit made to fit an individual user. See Articles 17–19 in the European Commission's PPE guidance.
What should the manufacturer prepare?
Start with a precise description of the wearer, the task, the hazards and the protection claimed. Use the same model identification in drawings, test reports, labels and instructions. Before requesting a quotation, assemble a sample label and a list of product variants so that differences in materials or construction can be discussed.
For a borderline classification, document the reasoning against the regulation instead of choosing a category from a competitor's label. Review a proposed design or intended-use change before treating an earlier assessment as applicable.
Frequently asked questions
Does Category I mean that no compliance evidence is needed?
No. The manufacturer still needs the applicable technical documentation, declaration and conformity controls. Category I changes the assessment route; it does not remove the requirements.
Is a type-examination certificate sufficient for series-produced Category III PPE?
No. The standard route also includes production surveillance through Module C2 or Module D.
Official sources