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When selecting personal protective equipment (PPE) for hazardous environments, particularly those involving chemical and particulate risks, understanding the certification process is essential. One area that often causes confusion is the approval process for powered air-purifying respirator (PAPR) suits designed to safeguard against both chemical splashes and airborne particulates. This guide outlines what safety managers, procurement specialists, and users need to know to ensure full compliance with European regulations.
CE Certification: Ensuring Legal Compliance
In the European Union, CE marking is a legal requirement for all types of PPE. It indicates that a product conforms to the applicable EU legislation. Specifically, the PPE Regulation (EU) 2016/425. For PAPR suits that provide both respiratory and chemical protection, the approval process is more comprehensive. The suit is considered a complex PPE ensemble rather than a standalone item.
Ensemble Testing Is Essential
A key point to understand is that the entire ensemble, including the powered respirator, hose, headtop and suit must be tested and certified together. Simply combining separately certified components does not guarantee compliance.
EN 12941: Respiratory Protection
This standard covers powered filtering devices incorporating a helmet or hood intended to protect against particles, gases or vapours. EN 12941 classifies systems by protection level and filter efficiency. For example, TH1, TH2 or TH3, with TH3 offering the highest protection.
To meet EN 12941 certification, the complete PAPR ensemble is tested for:
- Inward leakage
- Carbon Dioxide content
- Warning facility
- Practical Performance during operation
- Breathing resistance
- Noise levels
- Compatibility of all components
If any element is changed, such as the hood or suit, the system must be re-tested.
EN 14605: Chemical Protective Clothing
To ensure chemical splash protection, the ensemble must also comply with EN 14605. It is typically certified as Type 3 (liquid-tight) or Type 4 (spray-tight). This standard assesses:
- Seam strength and integrity
- Resistance to liquid penetration
- Compatibility with accessories and respirator parts
Again, testing must be conducted with the respirator in place. The connection between respirator and suit, such as an integrated hood or sealed neck ring, is a critical point of potential failure.
Understanding the Declaration of Conformity (DoC)
The Declaration of Conformity is a legal document issued by the manufacturer confirming that the product meets all relevant EU regulations and standards. This is a vital piece of documentation, not just a formality, and should be carefully reviewed when assessing compliance.
Key elements to look for:
- Product identification - It should clearly describe the entire ensemble, not just individual parts.
- Referenced standards - Look for both EN 12941 and EN 14605. For example, “Certified to EN 12941:1998+A2:2008 TH3 and EN 14605:2005+A1:2009 Type 3”.
- Notified Body details - The document should state the name and identification number of the independent notified body that performed the assessment.
- Authorised signature - The DoC must be signed by someone authorised to make declarations on behalf of the manufacturer.
Key Questions to Ask Your Suit Manufacturer
Before specifying or purchasing a powered respirator suit offering chemical and particulate protection, ask the manufacturer:
- Has the full system (suit, respirator, hose and hood) been tested and certified as a complete ensemble?
- Can you provide a Declaration of Conformity showing compliance with both EN 12941 and EN 14605?
- Which notified body conducted the testing and issued the certification?
- Is the suit certified as Type 3 or Type 4 under EN 14605, and does this apply with the respirator in place?
- Have any components changed since certification, such as materials, connectors or design features?
- Can you provide the EU Type-Examination Certificate and associated Test Reports upon request?
Final Thoughts
CE certification for PAPR suits designed for chemical and particulate protection is complex but essential. Individual component compliance is not sufficient. The full ensemble must be tested and approved as a system. By understanding the relevant standards and carefully reviewing the Declaration of Conformity, you can make informed decisions that ensure regulatory compliance and, most importantly, the safety of your workforce.
When in doubt, consult with a reputable PPE manufacturer who can explain their certification process and demonstrate full compliance with all applicable EU requirements.
