In a significant step towards safe healthcare technology, our FORM FIT LINE blowers, including the U65HN, U65MN and U65ML models, have passed the rigorous ISO 18562 biocompatibility test. This certification confirms our commitment to deliver not only efficient, but also environmentally and human friendly ventilation solutions.
The Test Procedure
For the ISO 18562 standard, we tested the three sub-standards ISO 18562-1 (Toxicological Assessment), ISO 18562-2 (Particulate Matter) and ISO 18562-3 (VOCs). The assessment was performed for a “permanent contact medical device” or >30 days, 24 hr./d. for neonates (>0.5kg) to adults (>70kg).
What is ISO 18562?
ISO 18562 is considered the gold standard for evaluating the biocompatibility of products intended for the human respiratory tract. This comprehensive test procedure guarantees that our blowers are free of harmful substances, thus ensuring the greatest possible safety for patients.
Why It Matters
Having passed these rigorous tests, our blowers are now officially recognized as meeting the highest international standards, promising a new era of safe and reliable medical technology.
The following blowers have successfully passed this test and thus meet the highest standards in terms of safety and quality: