PT.

Riken Indonesia
MM2100 Industrial Town Blok H-9 Cikarang Barat Bekasi 17520
Phone : (62-21) 898-0461 Fax : (62-21) 898-0467

MAI-35L Natural Technical Data November, 2020

Product Description This grade can be used as injection application for Medical device.

Features  Flexible PVC Compound.

 DEHP medical grade.
 Meets the specification requirements of JMPA I.

Typical Physical Note:

Properties
- The following data should be considered representative or typical only and should not be
used for specification purposes.
- The following data are based on the result of compound tests, the accuracy or
completeness of such information for finish product is not guarantee.
- Extractive substance and material test item by JMPA I is specification for natural and Ca-
Zn stabilizer compound only. In case of Sn Stabilizer and color compound, the
specification of Sn, Cu, Ash content and UV absorbance depend on the content and kind
of pigment in each color formulation.

No Check Item Unit Specification Test Result Test Method

1 Specific Gravity at 23oC - 1.26 ± 0.01 1.27 JIS K 7112

Hardness (After 15 Sec. 3 mm, 24 hrs
2 HDA/HDD 90 ± 2 90 ASTM D 2240
at 23 ± 2º C)
3 Heat Stability at (180 ± 3)0C min Min 90 120 JIS K 6723
Appearance - Colorless,Clear Colorless,Clear
Foaming Test - Same as blank Same as blank
∆ pH - Max 1.5 0.50
Extractive
Sn µg/ml. Max 0.05 0.02 Medical PVC
Substances
4 Zn Max 0.5 0.12 Compound I
121º C X 60 min µg/ml. (J.M.P.A)
15 gr / 300 ml ∆ KMnO4 ml. Max 1.0 ≤ 0.10
Residues or
Max 2.0 ≤ 0.10
evaporation mg.
UV Spectrum - Max 0.10 0.02
SPECIAL REQUIREMENT
1 Tensile Strength Mpa Min 16.7 22.0 JIS K 6723
2 Elongation % Min 250 280 JIS K 6723

Pb µg/g Max 1.0 0.5

Material Test Cd µg/g Max 1.0 0.5 Rapindo

3
Compound Cu µg/g Max 1.0 0.5 Method

Sn µg/g Max 2.0 1.0

Remark : N/D = Non Detected, Detection Limit (µg/g) : Pb = 0.006 Cd = 0.001 Cu = 0.02 Sn = 0.02 Zn = 0.02