STANDARDS FOR PROTECTIVE CLOTHING

WHAT IS A protective STANDARD?

There are some types of risk present in every workplace. Some may be minor, while others can have devastating consequences. To create a safe working environment, the risks must be identified and minimised. By law, the employer is obliged to provide employees with protective equipment against risks in the workplace that cannot be eliminated. Necessary equipment may, for example, be protective clothing, eye protection, gloves, helmets and footwear.

What equipment protects against which risks, and how does the manufacturer ensure that the protectionmeets the required level? The short answer is that there are statutory EU standards that the protective equipment must be certified against.  

There are a large number of different types of standards and for most people it can feel overwhelming to familiarise themselves with the regulations. This can ultimately lead to manufacturing companies aiming to meet more standards than necessary, which can restrict the design of the garment and the wearer.

We have created this page to simplify and summarise everything you need to know about standards and certifications for protective clothing.

Why do standards and certifications exist? 

The purpose of standards and certifications is to ensure that all personal protective equipment is manufactured correctly and in accordance with statutory requirements and specifications. When all manufacturers within the EU certify their protective clothing in a uniform way, garments from different suppliers can be easily compared. Imported protective clothing must also meet the same requirements. A certified garment provides assurance that workers within the EU are properly protected, thereby minimising the risk of injury.

As a manufacturer of protective clothing, we certify our garments against EU standards to ensure they provide the right level of protection in your workplace.

What is the difference between a standard and EN certification?  

It is important to understand the difference between a standard and certification. Put simply, a standard sets the minimum requirements for certain protective equipment, while a certification means that an independent third party has confirmed that a product meets the requirements of the relevant standard. 

Standard  

European legislation for personal protective equipment is governed by the PPE Regulation (more on this in the next chapter). Based on the regulation, standards specify the minimum requirements that must be met for protective clothing to provide protection against a specific risk.   

Certification  

Certification is the process by which a notified body reviews and confirms that the protective clothing meets the specified standards. When a protective garment has undergone and passed the certification process, the garment is issued with a certificate and must be CE marked, either in on the garment or on the packaging. The garment is then type-approved. As part of the certification process, an EU Declaration of Conformity must also be drawn up. 

Certification with the support of an independent third party is not required for all risk categories, but only for category II and category III garments. For category III garments, a production assessment carried out by a notified body is also required. Chapter 2 describes the risk categories in more detail. 

What is the PPE Regulation? 

The PPE Regulation was mentioned in the previous chapter, but what exactly is it?  

PPE is an abbreviation for Personal Protective Equipment which translates to "Personlig skyddsutrustning" (personal protective equipment). The PPE Regulation (EU) 2016/425 on personal protective equipment (the PPE Regulation) became applicable on 21 April 2018 and replaced the former Directive 89/686/EEC. The PPE Regulation and its standards are legal requirements for all EU countries regardless of national legislation. Certifications are carried out in accordance with the PPE Regulation using the standards that follow the health and safety requirements in the "Essential Health and Safety Requirements" (EHSR). 

The purpose of the PPE Regulation is to ensure that workers in all EU countries have access to protection that is effective and safe. 

Summary

Harmonised regulation within the EU: The PPE Regulation sets consistent requirements across all member states, which means compliant PPE can be placed on the market throughout the EU.

Risk-related categorisation: The PPE Regulation categorises products according to the level and type of risk against which the PPE is intended to protect. 

EU Declaration: According to the PPE Regulation, the manufacturer must provide each product with an EU Declaration of Conformity.  

Validity of the certificate: When the independent third party assesses that the protective equipment (risk category II and III) meets the requirements, the product is granted a certificate with a validity period of five years. 

The PPE Regulation’s risk categories 

Category I - Low risk of injury

The lowest category applies to situations with a low risk of injury. A practical example may be that workers must have access to rainwear to protect themselves from rain. Even if rain does not pose a serious danger, protection is still important to avoid discomfort and possible health risks that may arise from prolonged exposure to water and moisture. 

Category II - Risk of injury

The middle category refers to situations where there is a tangible risk of injury. This may include protection against heat and flame, which is crucial in working environments where these risks are present, such as foundries and smelters. It may also apply to workplaces with trafficked environments where the protection instead concerns increasing the worker’s visibility. 

Category III - High risk of injury

The highest category covers protective clothing intended for tasks with a high risk of serious injury and/or death. This includes, among other things, protection against arc flash hazards, where an electric arc can cause burns and other life-threatening injuries. Protection against chemicals is also included in this category, where the right protection is crucial to prevent corrosive injuries from hazardous substances.

How do we ensure that mass-produced garments provide the same protection?

According to the PPE Regulation (EU) 2016/425, personal protective equipment that is included in category III must be checked by a notified body for homogeneity in production. Tranemo’s category III garments are included in the quality monitoring system Module D in accordance with the PPE Regulation in order to ensure that the garments protect against the stated risks.

How are standards developed? 

Each standard has a code name that starts with either EN, ISO or IEC, depending on which body is behind it. 

EN

CEN - Comité Européen de Normalisation, is the central body for European standards. CEN coordinates the national committees that together develop standards. The standards that have been developed by CEN start with EN.  

ISO

ISO - International Organization for Standardisation, is a standardisation organisation at a global level. The standards that start with EN ISO have been developed by ISO, but have also been accepted by CEN as a European standard.  

IEC

International Electrotechnical Commission, is a global standardisation organisation that develops and implements international standards within electrical engineering and electronics.

What are Committee 402, CEN/TC 402 and SIS/TK 402? 

CEN/TC 402 - European level 

The technical committee CEN/TC 402 is part of CEN and focuses specifically on personal protective equipment (PPE). 

Experts and stakeholders, such as manufacturers, users, test institutes and authorities, from different countries within the EU come together to develop and establish standards for safety, quality and performance. 

SIS/TK 402 National level (Sweden) 

The Swedish committee SIS/TK 402 has a nationally weighted voice within CEN and provides CEN/TC 402 with expertise from Swedish stakeholders. The work mainly consists of commenting on standards and, for example, proposing revisions. Tranemo is represented on this committee.