Conformity Assessment is a hot topic in the PPE Industry today–and compliance is confusing. The new PPE Regulation in the EU was published in April of this year (read the digest from FlashCert partner BTTG), and efforts in the U.S. are underway in to streamline processes for the evaluation of personal protective equipment (for example, the release of ANSI 125 and the ASTM work of the F23.50 Subcommittee on a document that, if passed, will detail conformity assessment and risk assessment).
It can be tough to navigate conformity assessment requirements in the arc rated and flame resistant PPE industry– who makes the call on compliance of my product? What is the manufacturer responsible for? What if I’m only making components like fabric or trim? If you’re confused about the testing and compliance process, you’re not alone; let us break it down for you.
1.) Know the Hazard you Want to Market and the Appropriate Standard
Unlike the PPE Regulation in the EU, the US has little legislation written around conformity assessment in the arc rated and flame resistant clothing industry. The voluntary, consensus-based standards drive the market (ASTM F1506 and NFPA 2112, for example) and each standard outlines requirements that must be achieved in order for you to label your product compliant.
To determine the conformity assessment process, you first need to identify the hazard your product is intended to be used for and the relevant specification for that hazard. Multi-Hazard PPE has gained traction in the last several years, and it’s possible that you may be looking to meet multiple standards. If you aren’t sure what you need, ask an expert. Each specification outlines what conformity assessment looks like per that standard, and all say something a little different (see No. 2). Specifications outline testing and labeling criteria that must be met in order to label compliance. In every case, the full standard must be met in order to label your product compliant with the referenced standard, and proof of compliance must be maintained. It is helpful to purchase a copy of the standard to have on hand for review. They are generally inexpensive; around $50 USD through ASTM, and NFPA standards can be accessed online by the public for free with the creation of a log-in.
2.) Ok, I’ve got the standard–what now?
Let’s begin by dissecting the simple differences between third-party certification, third-party testing, and self-declarations.
Third party certification usually refers to the involvement of a third-party certification body accredited to ISO 17065. This is the most stringent (and costly) of the three processes described and includes a testing program plus site audits to check quality management systems, recall procedures, and more. The certification body decides the acceptability of where the product is tested, but it typically must be performed by an ISO 17025 accredited laboratory (the laboratory is also audited and approved by the certification body). The certification body will also audit the manufacturing site(s), headquarters, or any other location of operation they deem necessary to review. The end result is the certification-body attestation of compliance, a stamp of approval on your product, and a listing on their online registry.
Example: NFPA 2112 is a standard that requires third-party certification for compliance at both the component and the garment levels; testing alone is not adequate to label the product to the standard.
Third party testing means just that: testing performed by a third-party. Some third-party testing laboratories are accredited to ISO 17025, which means another independent, third-party body has audited them for a quality management system and technical competence. Not all third-party laboratories are accredited. If your internal specifications or the standard you are working with require testing by an accredited, third-party laboratory, ask for the laboratory’s scope of accreditation.
Example 1: ANSI/ISEA 107-15, for high visibility products, requires background material to be tested by an ISO 17025 accredited third-party laboratory.
Self-Declaration can be described as a manufacturer’s attestation that they meet a certain standard. Some manufacturers have in-house testing facilities and produce their own compliance or quality control data (generally with the exception of large-scale testing, as there few facilities with these capabilities).
Example 1: ASTM F1506 is also a self-declaration standard, and it has no third-party requirements at all. A manufacturer could, theoretically, perform all testing in-house themselves and call their product compliant.
Example 2: ANSI 107 is a self-declaration standard for the finished product; however, there are third-party requirements for the components used in the garment. At the end of the day, the self-declaration of the finished product means the onus is on the manufacturer to ensure the proper process was followed and that the product is compliant. Keep in mind that all certification bodies and some third-party labs will perform this check for you upon request. It is not mandatory in self-declaration standards and it is an added cost, but if you are unsure about the requirements and you or your customer would be more comfortable with a third-party making the attestation, the service is always available to you.
All “levels” of conformity assessment have pros and cons, and when it comes to the arc flash and flash fire hazards in the U.S., it is currently at the discretion of the technical committees to determine the appropriate level of conformity assessment to label compliance with each standard. In addition to knowing the requirements of the standard, be sure to understand the needs of the customer; some users specify requirements even more stringent than the standards. While terms used in conformity assessment can differ market-to-market, we’ve created an example of a general outline below of accepted standards relevant to electric arc flash and flash fire hazards.
|Market||Electric Arc||Flash Fire|
|United States||NFPA 70E|
(ASTM F1506 and ASTM F1891)
(ASTM F1506 and ASTM F1891)
|Europe*||IEC 61482-2** or|
ISO 11612 + Arc Testing**
|EN ISO 11612*|
|*Third Party Testing||** Third Party Certification|
4.) Get Started!
Once you know where you’re going and how to get there, it’s time to get started! If working with outside laboratories and certification bodies, know that you have options. The team at ArcWear and of the FlashCert consortium are available to answer your specific conformity assessment questions; contact firstname.lastname@example.org.