ISO 13485: Our Commitment to Excellence

ISO and CE Mark
Commitment to quality has been a hallmark of the Passy-Muir philosophy that is continually integrated into our products and services. As part of this commitment, Passy-Muir obtained the CE Marking of Conformance and ISO Certification (NSAI) in August, 1998 and upgraded to ISO 13485 in October, 2003.

Passy-Muir Inc. is committed to providing highly reliable, quality products that assure the patient the best opportunity for clear, uninterrupted speech and the added clinical benefits of a closed position "No Leak" design. Therefore, each valve is manufactured and tested to exceed the highest standards set for the industry.

We have dedicated significant resources to continued development of diagnostic equipment specifically designed to assess speaking valve performance. Our latest computerized instrumentation allows us to gather and assess breathing patterns and airflow data of actual tracheostomized patients. We are able to use this state-of-the-art technology to evaluate, test and continually improve Passy-Muir Valve designs and to further our understanding of the needs of this specialized patient population.

Quality Testing and Standards
All Passy-Muir products are produced according to FDA guidelines in a class 10,000 clean room facility, using only certified medical grade, non-latex materials. They are tested by an independent biomedical laboratory for tissue compatibility and analyzed to ensure material compliance. Every valve undergoes visual and microscopic inspection at the time of assembly and must pass our exacting proprietary testing systems before leaving production. Each Passy-Muir Valve is individually tested for:
  • Diaphragm size, shape, thickness and critical dimensioning that meets International Standards Organization (ISO) standards
  • Positive closure; to assure no air leak during exhalation
  • Less than .05cm H2O required to open valve
  • Necessary strength and dimensional accuracy of rivet which attaches and positions valve diaphragm
  • Strength of part assembly by stress testing and printed computerized analysis

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