Devices in the OB-GYN category are often in temporary or transient contact with the mother or child. Typical products include ultrasound equipment, sensor devices for the mother or fetal monitoring, and instruments used during natural birth or cesarean section (see also Urological and Reproductive Devices). Our technical specialists can help design the appropriate safety evaluation program for these devices.
Standards and Regulation
Depending on the end use of the device, it may be classified as skin contact, mucosal tissue contact, or wound contact. All materials would be subjected to the guidance in ISO 10993. First consideration should be given to vertical standards (an FDA guideline or ISO standard in use for a specific device). In the absence of such guidance, ISO 10993 should be consulted to determine potential areas of concern for these.
NOTE: This list provides an overview of tests that should be considered for obstetric and gynecological devices—our technical specialists and scientists will partner with you to develop specific, cost-effective test programs that minimize your time to market.