Ultrasonic Flow Sensor / Flow Meter Certification and Compliance



Contact

Home Resources Blog

1. Do CG and CM series flow sensors have medical-related certifications?
CG and CM series flow sensors are measurement components, not medical devices, so they do not require standalone medical certifications. The CG and CM series flow sensors / flow meters are typically integrated into the customer’s medical device for certification.
2. Does XY-TEK hold relevant certifications such as ISO 9001, ISO 13485, CE marking, or FDA approval?
ISO 9001 has been certified. CE certification is included in the application plan. FDA is a U.S. medical certification; the CG and CM series do not apply for FDA certification on their own and are generally certified together with the customer’s medical device.
3. Are the CG and CM series flow sensor / flow meters suitable for hospital/operating-room environments, and can they withstand common wipe disinfectants?
The CM series flow sensors are suitable for hospital/OR environments. Its surface is anodized and can withstand wiping with alcohol and similar disinfectants.
The CG series flow sensors are generally recommended for laboratory environments only.
4. Is the CM series flow sensors designed according to IEC 60601 and ISO 13485?
The CM series complies with the IEC 60601 medical safety standard.
5. Does the CM series flow sensors / flow meters internal software comply with IEC 62304 Class B (or Class C)?
In the initial design, the CM series flow sensors was not developed to IEC 62304 Class B or Class C. However, CM series sensors are now widely used in medical equipment. Future versions will be developed in accordance with IEC 62304 B/C.
6. If pursuing medical-use certification for an OEM sensor, what is the approximate cost for EMC and medical safety certification?
The EMC and medical safety certification will depend on the chosen certification institution. A formal quotation can be provided if needed.
7. If pursuing medical-use certification for an OEM sensor, which safety standards must the medical OEM flow sensor follow?
XY-TEK can provide sample medical safety certification documents from existing customers for reference.
8. If pursuing medical-use certification for an OEM sensor, what is the estimated timeline?
It depends on the specific case and requires case-by-case analysis.