The Applied Technical Services Family of Companies (FoC) evaluates the performance and safety of qualities of orotracheal and nasotracheal connectors and tubes. Medical devices are an essential part of modern society, and they’re required to undergo extensive testing because the poor performance or failure of a medical device could lead to disastrous circumstances.
What is ISO 5361?
The International Organization for Standardization published ISO 5361 to establish safety requirements for tracheal tubes and connectors. The standard prioritizes the safety of end users and specifically addresses key points of concern, such as:
- Airway obstruction
- The presence of leaks
- Biocompatibility
The standard includes bend and burst tests that properly assess the tube or connectors’ susceptibility to kinking, bursting, and other hazardous conditions.
Why is It Important to Test Orotracheal and Nasotracheal Tubes?
Orotracheal and nasotracheal are very important medical devices needed to help patients breathe when they’re unable to breathe on their own. These medical devices are instrumental in saving lives so their importance cannot be understated. Third-party testing labs such as ATS, offer specialized services that allow manufacturers to rest assured knowing their products will perform as expected in real-world applications. Failure to conduct proper testing on medical devices can result in patient injury or death which leads to irreparable damage to a manufacturer or medical facility.
More About Our Medical Device Testing Services
Our medical device testing lab conducts comprehensive tests on a wide array of medical devices, including biocompatibility, mechanical, and physical testing services. We recognize the importance of medical devices so our expert-lead teams work diligently to ensure that our clients’ products comply with rigorous quality standards which keeps medical professionals and patients safe. Upon completion of our services, we offer clear and concise reports that demonstrate our proficiency and detail our findings so that our clients can make informed decisions about their products and services. We provide numerous types of medical device testing services, including, but not limited to:
- Custom
- Dedicated screw testing
- Fatigue testing
- Shear Testing
- Wear Testing
Contact Us
Please complete an online request form or give us a call at +1 (888) 287-5227 to learn more about how our A2LA-accredited labs can help you and your company.