PPE basics: do you understand PPE?

How do I know if I am dealing with PPE? What does CE mean? What is certification?

Here at EDELRID, we are frequently asked questions about our products and are often involved in various discussions with customers and consumers where it becomes obvious that the meaning, the relation and the works of product-related contexts like CE markings, UIAA markings, stated specified EN standards, certifications, and the like are not very well or not even at all understood. We would like to use these articles to help clarify things so that you are able take part in any PPE related discussions with confidence.

The underlying issue with climbing equipment

When someone produces and sells a product—any product—they naturally have to comply with all the relevant legal provisions within the jurisdiction in which the product is being produced and sold. As you can imagine, these provisions differ greatly depending on the country or product at hand, for example. However, one principle that all the applicable laws and obligations have in common is the intention that no-one will come to harm with the given product. However, there are also products whose intended use is to protect the user from certain hazards. This means that users may put themselves in dangerous situations where they rely on the functionality of these very products. This article naturally focuses on climbing equipment, but to give another example, think of medical products that protect users against diseases. Many regulatory frameworks therefore differentiate product groups according to the severity of the health consequences in the event of the failure of such a product and define differing strict requirements for the products and the quality assurance process that ensures that these can be met reliably and in the long term. This is also the case with our climbing equipment, which belongs to the group of personal protective equipment (PPE) against falls from a height. There are several legal frameworks for PPE worldwide but one of the most comprehensive, most stringently enforced, and therefore globally most recognized is that of the European Union, governed by European Regulation 2016/425 on personal protective equipment. The following definitions and explanations are derived from this framework.

PPE—Personal Protective Equipment

The first step in order to understand PPE is to give your undivided attention to the word “personal”. We are talking PPE if a product protects the user’s individual physical well-being from some kind of hazard. In this context, the product must be assigned to a single individual in order for it to be classed as PPE. A railing on a balcony, for example, prevents people from falling off unintentionally but is always there doing its job for anyone who happens to step on the balcony. This makes it a collective safety measure rather than a personal one—and therefore subject to different provisions.

Personal or collective safety measures to prevent people from falling off?

While it might now be clear how to determine if a given product can be regarded as “personal”, the question of whether we are truly dealing with a product classified as PPE might not always be so obvious.

Three carabiners but only one of them is truly PPE. How can you tell which?

Let’s take the above three carabiner models. The first one is unlikely to fall under any specific directive or regulation. The only legal requirements regarding this product will be found in the national product safety act. The last one is for heavy loads, explicitly excluding human loads, and falls under European Directive 2006/42 on machinery. And of course, the middle one is actually classified as PPE and has to comply with European Regulation 2016/425. So, who decides whether or not a product is truly PPE?

The answer might be surprising, but the key factor in the decision is the manufacturer’s stated purpose for the product. A product can basically be anything we want it to be! Of course, in order to legally market a product, what ultimately counts is that the manufacturer has to take responsibility for all the resulting obligations and consequences that result from the stated classification. So, if I want to market my key chain hanger carabiner as PPE I can do so as long as I comply with all the PPE-related obligations defined in EU 2016/425. Which in the end will not be possible nor worth the hassle. 

So, let’s say we now have a product that is rated as PPE. The next question now needs to be: Which category of PPE does it belong to? There are three categories into which products are organized according to the severity of the potential injuries they protect against. 

PPE protection categories

Depending on the stated product purpose and the resulting protection category, the manufacturer has to comply with different obligations and provisions in order to be able to legally market the product. Again, let’s look at an example.

Four pairs of glasses, four different protection categories. How do you know which is which?

These products are assigned to different protection categories based on their intended use. As we will see later, this means that the manufacturer has to fulfil a wide range of different requirements in order to market these glasses. But let’s look at them one at a time. The first pair might protect someone’s identity but are obviously not classed as PPE. The second pair, the sunglasses, will fall under protection category 1. The third pair are safety goggles according to EN 166 and fall under protection category 2. Finally, the fourth pair are radiation safety goggles and fall under protection category 3.

How can users determine what kind of product and protection category they have in their hands? Do they even need to know it at all? To a certain extent, this is certainly debatable but there will be widespread consensus that a clear distinction should at least be made for the highest protection category 3 as this is intended to protect against serious and permanent physical injury and users must be able to rely on this. To the user, the fact that this is guaranteed is symbolized by a famous product marking.

The CE mark

This is something that everyone probably knows or has seen before, whether on a carabiner, a climbing harness, or other everyday items like a mobile phone, sunglasses, or toothbrush packaging. This mysterious mark comprising the two unusually shaped capital letters C and E can be found almost everywhere: the CE mark.

The famous and so often misunderstood CE mark

But do you actually know what it means? And if it is on both my carabiner and my toothbrush, does this mean I am allowed to rappel on my toothbrush? The important answer first: please don’t rappel on your toothbrush (or on your mobile phone or sunglasses)!

A CE mark is first and foremost “only” a European thing. It simply signifies that the product at hand has been assessed as meeting the relevant European safety, health, and environmental protection requirements and can therefore be legally sold and traded within the European Economic Area (EEA). That is all, for a start. It assures manufacturers, but also retailers, that they can market and trade the specific product without hesitation—and assures consumers that the product meets a guaranteed level of health, safety, and environmental standards. Which standards and levels are affected depends on the intended use of the product as stated by the manufacturer and the resultant PPE category. Let’s take a look at an overview showing the required quality measurements and resultant markings and documentation for the three different categories.

What are the manufacturer’s responsibilities when marketing PPE?—It depends on the category…

At first glance, we can see that the higher the protection category, the greater the control efforts for the manufacturer. Admittedly, it makes complete sense to control products more strictly if their potential malfunction could lead to the most severe consequences. As we see, there are three levels of control starting with product documentation as the very basic measure for all PPE. Moving up to category 2, external product certification is added, requiring things like technical tests, a risk analysis, the confirmation of the user manual, etc. Finally, for the highest protection category 3, the production process is also monitored so as to do everything possible to minimize the risk of product failure. When all of these requirements are met and have been confirmed, the manufacturer can label the product with the CE mark and must publish a product-specific declaration of conformity affirming that the product complies with the PPE regulation.

So, in the case of products that fall under protection category 1, the manufacturer is solely responsible for compliance with the requirements defined in the PPE regulation. Whether these are met for the respective product is confirmed under the manufacturer’s own responsibility by means of a self‑declaration. However, should issues arise, it must of course be possible to prove this compliance to the relevant authorities.

For category 2 products, manufacturers need to go a step further and let an external authorized institute certify the product. This institute needs to be specified in the published declaration of conformity, making this information one way for you to identify a category 2 product. Under the PPE regulation, the product certification needs to be renewed every five years.

With regard to the highest protection category 3, in addition the production process needs to be monitored by an external body. Here, a manufacturer has two options for a given product. Either the final product can be monitored regularly or the production process in its entirety. In the former case, the product as a whole must be completely checked and re-tested externally at random times, but at least once a year. Having the entire production process monitored is definitely the more complex option, but offers the advantage that all products that result from it are considered to be monitored at the same time. If a product passes all of these steps it must be labelled with the CE mark followed by four digits identifying the notified body responsible for the monitoring process. This information can also then be found in the mandatory declaration of conformity provided.

Your take-aways

• Whether or not a product is classed as PPE primarily depends on its intended purpose declared by the manufacturer. 
• Depending on a product’s intended use, it falls within certain legal frameworks and jurisdictions (e.g. European directives/European Union regulations), the requirements of which must then be met. Ultimately, the manufacturer always bears the responsibility for this.
• For personal protective equipment, the corresponding European regulation EU 2016/425 differentiates between three different protective categories for products with a differing range of requirements to be met depending on the severity of the health hazards that the product claims to provide protection against.
• The CE mark signifies that a product has been assessed to meet the relevant European safety, health, and environmental protection requirements and can therefore be legally sold and traded within the European Economic Area (EEA). It does not automatically mean that the marked product is classified as PPE.
• The PPE protection category to which a product has been assigned can only really be indirectly deduced from the declaration of conformity, which must be published by the manufacturer. In it you should find:
  • For category 1: a self-declaration by the manufacturer that the product complies with the European PPE regulation. 
  • For category 2: a declaration about compliance with the European PPE regulation as well as with the relevant standards to which the product has been tested, and which external institute performed the tests.
  • For category 3: in addition to the category 2 content, a declaration indicating which external institute monitors and audits the production processes.

• In the case of category 3 PPE, the CE mark is followed by 4 digits indicating the external authorised body responsible for monitoring the production process required for this category. The body indicated by the number can be either determined from the declaration of conformity or looked up here: