INTRODUCTION

The methods and requirements in this chapter apply to assemblies or devices labeled sterile and nonpyrogenic that are in contact directly or indirectly with the cardiovascular system, lymphatic system, or cerebrospinal fluid. This includes, but may not be limited to, the following:

• Fluid pathways of catheters and administration sets such as solution administration sets, extension sets, transfer sets, blood administration sets, intravenous catheters, implants, extracorporeal oxygenator tubing, dialysis tubing, intramuscular drug delivery catheters, and transfusion and infusion assemblies

• Liquid medical devices such as dialysate

• Implantable medical devices such as heart valves and vascular grafts, and other medical devices with a nonpyrogenic claim that may come into contact with blood or cerebrospinal fluid

• Gels with a nonpyrogenic claim including demineralized bone matrices and drug delivery systems