ABSTRACT
A medical device is an object fabricated from a synthetic biomaterial that is surgically implanted into a living body, where it is intended to remain for a signiŽcant period of time in order to perform a speciŽc function. Medical devices perform the following functions:
• Replace damaged anatomical part, for example, left ventricular assists and joint replacements
• Simulate an absent anatomical part due to disease or injury, for example, mammary or facial prostheses
• Aid in tissue healing, for example, artiŽcial skin in burn treatment • Correct congenital, traumatic, or pathological deformity, for example, spinal plates
and hydrocephalic shunts • Rectify mode of operation, for example, pacemakers, artiŽcial kidneys, and total
artiŽcial hearts • Therapeutic functions, for example, venous access catheters, nasogastric tubes,
and implantable ports • Diagnostic functions, for example, monitoring electrodes for chronic insulin
monitoring
27.5.11.14 Analysis for Nonvolatile Organic Compounds by LC/MS ........830 27.5.11.15 Acetate and Formate Detection by Ion Chromatography ...........830 27.5.11.16 Acidity/Alkalinity ............................................................................830 27.5.11.17 Total Organic Carbon ....................................................................... 831 27.5.11.18 Determination of Conductive Measurement ................................ 831 27.5.11.19 Accelerated Aging ............................................................................ 831
27.6 General Microbiology ........................................................................................................ 831 27.6.1 Bioburden Testing ................................................................................................ 831
27.6.1.1 ANSI/AAMI/ISO 11137 Bioburden Validation-Repetitive (Exhaustive) Recovery Method ....................................................... 831
27.6.1.2 ANSI/AAMI/ISO 11137 Bioburden Validation-Spore Inoculation ......................................................................................... 832
27.6.1.3 Gram Stain and IdentiŽcation ......................................................... 832 27.6.2 Sterility Testing .................................................................................................... 832
27.6.2.1 Bacteriostasis and Fungistasis Sterility Validation ...................... 832 27.6.2.2 Product Sterility Testing ..................................................................833
