Available RMs and those characteristics

Good and Scientific Safety Evaluation For Health and Life

For cytotoxicity test

Positive RMs
The positive RMs are the materials which are certified to show the given levels of cytotoxicity (moderate: RM-A and weak: RM-B) in colony formation assay (CFA). Size is 10x15cm, thickness <0.5mm, not sterilized.
RM-A: Polyurethane film containing 0.1% zinc diethyldithiocarbamate (ZDEC)
RM-B: Polyurethane film containing 0.25% zinc dibuthyldithiocarbamate (ZDBC)


 

Negative RM
RM-C: High density polyethylene film (10x15cm, thickness < 0.5mm, not sterilized)
The negative RM is used for the medium extract test of CFA according to the Japanese guidelines. The cytotoxicity has been checked by CFA which show negative response. In the case of the direct contact test, plastic sheets are available as negative RM from Wako Pure Chemical Industries,Ltd.(Cat.No.160-08893 or 160-08891).

For implantation test

Negative RMs
The negative RMs are the materials which are certified not to give any positive results in the short-term muscle implantation tests.
RM-D: High density polyethylene sheet (10x10cm, thickness 1mm, not sterilized)
RM-E: High density polyethylene rod (1mm dia.x10cm, 10rods, not sterilized)
RM-H
High density polyethylene rod (2mm dia.x10cm, 10rods, not sterilized)
* This is used for bone implantation in rabbit.

Positive RM
The positive RM is the material which is certified to give positive results in short-term muscle implantation.
RM-F: Polyurethane rod containing 0.75% ZDEC (1mmx1mmx5cm (10rods) or 1mmx2mmx5cm, not sterile)


*Sterilization
These RMs are not sterilized.
Sterilization with autoclave or EOG is recommended after cutting the RMs for extraction. Before you sterilize with autoclave (121C for 15 min), please peel off the cut sheets stuck together. Then put into an autoclave bottle, otherwise it may be easily adhesive each other.