|
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 insure 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
|