[Reference Materials(RMs) for the Biological Tests of Medical Devices] RM-A, RM-B, RM-C, RM-D, RM-E, RM-H, RM-F, Y-3, Y-4 [Hatano, FDSC] - 코아사이언스

Reference Materials(RMs)

for the Biological Tests of Medical Devices 

 

What is RMs?

Hatano Research Institute (HRI), Food and Drug Safety Center (FDSC) distributes the reference materials (RMs) used in the following tests. These RMs are listed in the revision (draft) of Japanese guidelines for basic biological tests of medical devices (MHLW Japan) and ISO 10993 Series.

• RMs for the cytotoxicity test (as Positive and Negative Control Materials)
• RMs for the muscle implantation test (as Positive and Negative Control Materials)
• RM for the bone implantation test (as Negative Control Material)
• RM for the Hemolysis test (as Positive Control Material)
• RM for the in vitro skin irritation test (as Positive Control Material)

If you use sterilized RMs in your test, please sterilize them with an autoclave (121℃, 15 min) or ethylene oxide gas (EOG) .

 

Ordering Information

 

For Cytotoxicity Test

 

Positive RMs  (Size: 10x15cm x 1 sheet　thickness<0.5mm, not sterilized)

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.

• RM-A (Sheet): Polyurethane film containing 0.1% zinc diethyldithiocarbamate (ZDEC)
• RM-A (Cut): Polyurethane film containing 0.1% zinc diethyldithiocarbamate (ZDEC)
• RM-B (Sheet) Polyurethane film containing 0.25% zinc dibuthyldithiocarbamate (ZDBC)
• RM-B (cut): Polyurethane film containing 0.25% zinc dibuthyldithiocarbamate (ZDBC)

 

Neagative RMs (Size: 10 x 3cm x 5 sheets, thickness < 0.5mm, not sterilized)

• RM-C (sheet): High density polyethylene film
• RM-C (cut): High density polyethylene film

The negative RM is used for the medium extract test of CFA (colony formation assay) according

to the Japanese guidelines. The cytotoxicity has been checked by CFA which shows negative response.

 

For Short-term Implantation Test

 

Negative RM (not sterilized)

The negative RMs are the materials which is certified not to give any positive results in

short-term muscle implantation test. ＊　This is used for bone implantation in rabbit.

• RM-D: High density polyethylene sheet (1 mm x10 cm x 5 cm, 3 sheets)
• RM-E: High density polyethylene rod (1mm dia. x 10cm, 10rods)
• RM-H＊: High density polyethylene rod  (2mm dia. x 10cm, 10rods)

 

Positive RM (not sterilized)     

The positive RMs is the material which is certified to give positive results in short-term muscle implantation.

• RM-F (rod, length 50mm): Polyurethane rod containing 0.75% ZDEC (1mm x 1mm x 5cm, 10 rods)
• RM-F (rod, length 10mm): Polyurethane rod containing 0.75% ZDEC (1mm x1mm x 1cm, 50 rods)
• RM-F (sheet): Polyurethane rod containing 0.75% ZDEC (1mm x 2cm x 5cm, 1 sheet)

 

For Hemolysis Test

 

Positive RM (not sterilized)

• Y-3: Plasticized polyvinyl chloride pellet containing 0.91% non-ionic surfactant (pellets, 100 g/pack)

 

For In Vitro Irritation Test

 

Positive RM (not sterilized)

• Y-4: Plasticized polyvinyl chloride pellet containing 5.8% non-ionic surfactant Pellets (pellets, 100 g/pack)

coresciences 코아사이언스 Hatano Research Institute Food and Drug Safety Center FDSC 하타노 리서치 한국 대리점 Food and Drug Safety Center Hatano Research Institute