The new standard gives suppliers, users and regulators of personal protective equipment (PPE) a consistent way to demonstrate that their products meet standards of performance.
American National Standard for Conformity Assessment of Safety and Personal Protective Equipment, ANSI/ISEA 125-2014, was approved by the American National Standards Institute (ANSI) on February 5, 2014.
In the United States, there are no uniform requirements for conformity assessment of PPE. ANSI/ISEA 125 establishes a standardized process by which a supplier – manufacturer, importer, assembler distributor or any other entity that puts a product into commerce – determines that a product meets the requirements of a performance standard, and provides evidence to the purchaser.
The standard establishes three alternative methods of conformity assessment, enabling suppliers, purchasers, customers, regulators and standards writers to match a method with a product or standard where appropriate.
All three methods include requirements for product testing, process quality management, market surveillance, corrective action and recordkeeping, and a standardized way to inform the purchaser of how the product was evaluated for conformity.
For Level 1, the supplier tests the product in-house or at a third-party lab.
For Level 2, the product is tested in a facility that is accredited to international standard ISO 17025, and manufactured under an ISO 9001-registered quality system. Both Level 1 and Level 2 require issuance of a supplier’s declaration of conformity.
Level 3 of the standard is third-party certification, where the entire process from testing to surveillance is under the direction of an accredited certification body, whose mark is applied to conforming products.
ANSI/ISEA 125-2014 was developed by the ISEA Standards Policy and Planning Committee, and submitted to a comprehensive review by manufacturers, users, government agencies and safety and health experts globally.
“When life and health are at stake, users have to be confident in product performance,” said Eric Beck, executive director of marketing for MSA and chairman of the ISEA committee. “By formalizing conformity assessment in a consistent way, this standard gives users an important new tool to make confident decisions when purchasing PPE.”
The standard is available free of charge.