National Consensus Standard for Conformity Assessment of Safety and Personal Protective Equipment
The American National Standards Institute (ANSI) has approved a new ISEA-developed national consensus standard for conformity assessment of safety and personal protective equipment.
- This standard, ANSI/ISEA 125-2014, provides an organized and systematic way for a supplier to verify that a product meets the requirements of a performance standard, and to communicate that verification to the purchaser and user.
- It includes standardized requirements for initial and ongoing testing, process quality management, record keeping and surveillance, and declaration of conformity.
- Recognizing the diversity of products, hazards, users and suppliers, it offers three alternative methods of conformity assessment, ranging from in-house testing and monitoring to full third-party certification.
It was developed under the leadership of the ISEA Standards Policy and Planning Committee and reviewed and approved by a consensus panel of producers, users, regulators and experts, prior to approval as an American National Standard on February 5, 2014. The ISEA effort coincides with a NIOSH National Personal Protective Technology Laboratory (NPPTL) project to develop a national strategy for PPE conformity assessment. The genesis of this project was a 2010 report from the Institute of Medicine Certifying Personal Protective Technologies – Protecting Worker Safety. ISEA has been involved in that project from the start and submitted comments to NIOSH/NPPTL detailing the association’s analysis of the shortcomings of the IOM report and ISEA recommendations on development of a national strategy.
A public meeting to review the NIOSH project was held in September 2013 at NPPTL. The announcement of the meeting included a summary report from the working group, and an analysis of PPE regulation in Europe. Before the meeting, NPPTL produced a draft framework document outlining an approach that ISEA feels is impractical, burdensome and not supported by data. ISEA’s comments and other comments can be accessed at www.regulations.gov, search by docket number CDC-2013-0015 (note that the draft framework document is not available at the site).