USP <88> was originally written to consider plastics, but it has expanded over the years to be applied to many other material types. A Class VI tested material can be sold to medical device companies with a certain level of comfort about material safety. Medical device and drug companies ...
88BIOLOGICALREACTIVITYTESTS,INVIVO Thefollowingtestsaredesignedtodeterminethebiologicalresponseofanimalsto elastomerics,plastics,andotherpolymericmaterialwithdirectorindirectpatient contact,orbytheinjectionofspecificextractspreparedfromthematerialundertest.It isessentialtomakeavailablethespecificsurfaceareaforextraction.Whenthe...
USP Class VI testing is conducted by producing an extract of the product with different extraction fluids, such as polyethylene glycol and vegetable oil, and injecting it in specimen (rabbits and mice) in vivo (alive), to observe the biological response to the extract. Testing is commonly done...
88BIOLOGICALREACTIVITYTESTS,INVIVO Thefollowingtestsaredesignedtodeterminethebiologicalresponseof animalstoelastomerics,plastics,andotherpolymericmaterialwithdirector indirectpatientcontact,orbytheinjectionofspecificextractspreparedfrom thematerialundertest.Itisessentialtomakeavailablethespecificsurface ...
class IV plastic extracted at 121 , or I-50 , which represents a class I plastic extracted at 50 ). Plastics may be classified as USP Plastic Classes I–VI only on the basis of the response criteria prescribed in Table 1. This classification does not apply to plastics that are intended...
88 BIOLOGICAL REACTIVITY TESTS, IN VIVO The following tests are designed to determine the biological response of animals to elastomerics, plastics, and other polymeric material with direct or indirect patient contact, or by the injection of specific extracts prepared from the material under test. It...
内容提示: ADDITIONAL REQUIREMENTS• USP R EFERENCE S TANDARDS á11ñUSP High-Density Polyethylene RS (Negative Control)á88ñ BIOLOGICAL REACTIVITY TESTS, IN VIVOThe following tests are designed to determine the biological response of animals to elastomerics, plastics, and other poly-meric ...
Also, it is essential to exercise care in the preparation50°, which represents a class I plastic extracted at 50°).of the materials to be injected or instilled to prevent con-Plastics may be classified as USP Plastic Classes I–VI onlytamination with microorganisms and other foreign matter....
USP 88 生物实验.docx,88 BIOLOGICAL REACTIVITY TESTS, IN VIVOThe following tests are designed to determine the biological response of animals to elastomerics, plastics, and other polymeric material with direct or indirect patient contact, or by the inject
— Medical grade plastics include materials with either an FDA approval and/or USP Class VI approval. Professional Plastics offers a full range of medical grade plastics such as; medical tubing used for IV fluid handling & ventilation, and basic shapes used to manufacture precision instruments and...