The Certification Process for Workwear
The certification process requires careful documentation and testing through approved notified bodies. The process depends on the protection classification, and several steps must be completed before CE marking becomes relevant.
Step-by-Step Process
It all starts with the manufacturer determining whether the product belongs to category I, II, or III based on risk level. Category I involves minimal risk and only requires self-declaration from the manufacturer.
Category II, on the other hand, requires type approval through a notified body. For category III, where it concerns protection against lethal danger, the process becomes significantly more extensive.
The manufacturer must conduct a risk assessment and determine which harmonized standards apply. This also includes preparing a technical construction file, user manual in Swedish, and an EU declaration of conformity.
The products are then sent to a notified body for testing and assessment. Once the certification is approved, a certificate valid for five years is issued.
For category III, annual follow-up inspections of the manufacturing process are also required to ensure that quality is maintained over time.
Choosing a Notified Body for Certification
Notified bodies are independent testing institutes that have been authorized by authorities to carry out conformity assessments. The manufacturer can freely choose from approved bodies within the EU.
In Sweden, RISE is a well-known notified body for the certification of personal protective equipment. There are also German TÜV and French APAVE as alternatives.
The choice is often guided by expertise in various product areas, proximity, and sometimes cost. Some bodies may know more about protective clothing, while others specialize in respiratory protection or fall protection.
The notified body must verify that the products meet safety requirements according to Regulation (EU) 2016/425. They also conduct annual production inspections for category III products.
Assessment and Testing of Products
First, the technical documentation and construction file are reviewed. The notified body checks whether the design complies with safety requirements and harmonized standards such as EN ISO 20471 for high visibility clothing.
Physical tests are conducted on selected product samples. Here, tear strength and abrasion resistance are tested, for example.
Chemical tests ensure that protection against chemicals and pH values actually works. Ergonomics are also tested to ensure comfort and fit.
The products are also tested for temperature resistance and colorfastness. If the product passes all these tests, an EC type certificate is issued, and CE marking becomes possible.
The CE symbol, identification number of the notified body, and information according to Article 8 of the PPE regulation must be present on the product. Traceability requirements ensure that each product can be linked to the manufacturer.
Standards and Safety Requirements for CE Marked Workwear
CE marked workwear must meet specific standards and safety requirements according to Regulation (EU) 2016/425 on personal protective equipment. Harmonized standards set the framework for testing methods and performance requirements, while safety requirements vary depending on the level of protection and use.
Harmonized Standards and Their Importance
Harmonized standards are the foundation for CE marking of workwear in the EU. They contain detailed requirements for design, materials, manufacturing, and labeling.
EN ISO 13688 is the basic standard for all protective clothing and specifies requirements for ergonomics, sizes, labeling, and information from the manufacturer.
Other standards complement:
- EN 343 – protection against rain and weather
- EN ISO 20471 – high visibility clothing
- EN 11612 – protection against heat and flames
- EN 13034 – protection against chemical substances
These standards specify testing methods to ensure quality and labeling requirements so users can see protection levels and limitations.
Specific Safety Requirements
Safety requirements depend on which category the workwear belongs to. Category I applies to minimal risk, category II to moderate risk, and category III to high risk with potential fatal danger.
Basic requirements apply to all:
- The material must not be harmful
- The clothing must be ergonomically designed
- Comfort and fit must suit the intended use
Category II clothing requires type approval by a notified body. This applies to most workwear that protects against mechanical impact, chemicals, or weather.
For category III, more extensive control and annual quality assurance are required. This includes clothing that protects against extreme temperatures, falls, or hazardous chemicals.
The manufacturer must document all safety requirements in technical documentation as a basis for the EU declaration of conformity.
Common Tests for Workwear
The tests for workwear follow standardized procedures to provide comparable results. They are conducted at accredited laboratories approved under the PPE regulation.
Mechanical tests check for abrasion resistance, tear strength, and resistance to puncture. EN ISO 13688 sets minimum requirements for protective clothing, while EN 381 applies to chainsaw clothing.
Chemical tests assess the material's resistance to various substances. EN 13034 tests liquid penetration, EN ISO 6529 tests gas and vapor permeation.
Thermal tests include:
- Flame spread and afterglow
- Heat insulation at various temperatures
- Melting behavior of synthetic materials
High visibility clothing is tested for visibility, retroreflection, and fluorescence according to EN ISO 20471. Both new and washed garments are tested to ensure performance is maintained.
The results are compiled in test reports that serve as the basis for CE marking. These reports must be kept for at least ten years after the product has been released on the market.