A-A-51655
5 September 1986
COMMERCIAL ITEM DESCRIPTION
BUTTRESS, SUTURE (POLYTETRAFLUOROETHYLENE)
The General Services Administration has authorized the use of this commercial item description.
This commercial item description covers a suture buttress suitable for use in cardiovascular surgery.
Salient characteristics:
Style and design. The buttress shall be a 150 ± 5 mm wide by 150 ± 5 mm, 1.8 ± .2 mm thick, felt pad suture buttress. Shall be fabricated from the material specified below.
Material. The buttress shall be fabricated from polytetraflouroethylene (PTFE) felt.
Toxicity. The buttress shall be non-toxic when tested in accordance with the Systemic Injection Test and Intracutaneous Test specified in the latest edition of USP under Biological Tests – Plastics. This testing shall be done at the Class II level.
As an alternate, toxicity testing of suture buttresses may be done in accordance with ASTM F895.
Pyrogenicity. The buttress shall be non-pyrogenic when tested as specified in monograph #151 of the latest edition of the USP.
Thermal stability. The buttress shall pass the thermal stability test specified below.
Thermal stability test. Subject sample buttresses to cyclic steam autoclaving in a high speed sterilizer at 270° and 30 psig for 10 ± 1/2 minutes. Use a total of 10 cycles. After each cycle, examine the samples for swelling, tackiness, hardening, or staining.
As an alternate, sample buttresses may be steam autoclaved in a standard gravity sterilizer at 250°F and 15 psig for 30 ± 1/2 minutes. Complete this version of the test by following the examination and cycling procedures listed above.
DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.
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