Tiêu chuẩn quốc tế
|
Số hiệu
Standard Number
ASTM F755-99e1
Năm ban hành 1999
Publication date
Tình trạng
W - Hết hiệu lực
Status |
|
Tên tiếng Anh
Title in English Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
|
|
Chỉ số phân loại Quốc tế (ICS)
By field |
|
Số trang
Page 3
Giá:
Price Liên hệ / Contact us
|
|
Phạm vi áp dụng
Scope of standard 1.1 This specification covers the properties and test methods for porous high density and ultra high molecular weight polyethylenes intended for use in surgical implants. The porous polyethylene may be used as a free standing product or as a coating on a substrate in nonloaded applications..1.2 Evaluation of tissue response to a porous polyethylene must be completed. Guidance in establishing biocompatibility may be found in the list of references.1.3 Clinical experience and animal studies have shown that tissue will grow into the open pores of porous polyethylene. The tissue ingrowth into the pores may allow for the establishment of implant fixation.1.4 This section does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
|