Code of Federal Regulations Title 21. Food and Drugs § 21.878.4371 Irrigating wound retractor device

(i) Characterize the tear resistance, tensile strength, and elongation properties of the barrier material;

(ii) Demonstrate that the liquid barrier material is resistant to penetration by blood, and is non-flammable;

(iii) Characterize the forces required to deploy the device;

(iv) Characterize the device's ranges of operation, including flow rates and maximum suction pressures;

(v) Demonstrate the ability of the device irrigation apparatus to maintain a user defined or preset flow rate to the surgical wound;  and

(vi) Demonstrate the ability of the device to maintain user defined or preset removal rates of fluid from the surgical wound.

(i) Device size or incision length range;

(ii) Method of sterilization;

(iii) Flammability classification;

(iv) Non-pyrogenic;

(v) Shelf life;  and

(vi) Maximum flow rate and suction pressure.