Available RMs and those characteristics

For cytotoxicity test

-Positive RMs-

The positive RMs are the materials which show the given levels of cytotoxicity (moderate: RM-A and weak: RM-B) in colony formation assay (CFA) described in the Japanese test guideline.

♦ RM-A: Polyurethane film containing 0.1% zinc diethyldithiocarbamate (ZDEC)

♦ RM-B: Polyurethane film containing 0.25% zinc dibutyldithiocarbamate (ZDBC)

-Negative RM-

The negative RM is the negative control material for the medium extract test in CFA according to the Japanese test guideline.

♦ RM-C: High density polyethylene film

In RM-A, RM-B and RM-C, there are the following two types.
Sheet type: thickness ca.0.5 mm, ca. 100 x 150 mm, 1 sheet/pack., not sterilized.
Cut type: thickness ca.0.5 mm, ca. 2 x 15 mm, ca. 10 g/pack., not sterilized.

*Sterilization
Sterilization with an autoclave (121℃ for 15 min) or ethylene oxide gas (EOG) is recommended after cutting the RMs for extraction. When you sterilize RMs with an autoclave, please peel off cut RMs stuck together before sterilization. Otherwise they may easily adhere each other. Moreover, please avoid excessive conditions (temperature and/or time) to prevent them sticking to each other. When EOG sterilization is performed, it is recommended to degas RM sufficiently because of the toxicity of the gas. RM should be sterilized only once and not re-sterilized in order to prevent degradation.

For implantation test

-Negative RMs-

RM-D, RM-E and RM-H are the negative control materials which do not give any positive results in the muscle or bone implantation test according to the Japanese test guideline.

♦ RM-D: High density polyethylene sheet
Sheet type: thickness ca. 1 mm, ca. 50 x 100 mm, 3 sheets/pack. , not sterilized.

♦ RM-E: High density polyethylene rod
Rod type: diameter ca. 1 mm, length ca. 100 mm, 10 rods/pack., not sterilized.

♦ RM-H*:High density polyethylene rod
Rod type: diameter ca. 2 mm, length ca. 100 mm, 10 rods/packs, not sterilized.

*This is used for the bone implantation test in rabbits.

-Positive RM-

RM-F is the positive control material which gives positive results in short-term muscle implantation test according to the Japanese test guideline.

♦ RM-F: Polyurethane rod containing 0.75% ZDEC

Sheet type: thickness ca. 1 mm, ca. 20 x 50 mm, 1 sheet/pack., not sterilized.
Rod type 1: ca. 1 x 1 mm, length ca. 10 mm,　50 rods/pack., not sterilized.
Rod type2: ca. 1 x 1 mm, length ca. 50 mm,　10 rods/pack., not sterilized.

For hemolysis test

-Positive RM-

Y-3 is the positive control material which gives positive results in hemolysis test according to the Japanese test guideline

♦ Y-3: Plasticized polyvinyl chloride pellet containing 0.91% non-ionic surfactant(Y-3)

Pellet： ca. 100 g/pack., not sterilized

For in vitro skin irritation test

-Positive RM-

Y-4 is the positive control material which gives positive results in in vitro skin irritation test according to the Japanese test guideline and ISO 10993-23.

♦ Y-4: Plasticized polyvinyl chloride pellet containing 5.8% non-ionic surfactant(Y-4)

Pellet： ca. 100 g/pack., not sterilized.