FDA (21 CFR 177.1550)
Rubber articles intended for repeated use, FDA ITEM 177.2600.
BfR
Recommendations and health assessments of the impact of plastics and other high polymers.
USP (CLASS VI)
Biological reactivity tests, IN VIVO klass VI - 121 ° C.
ISO (10993-4)
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood.
ISO (10993-6)
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation.
ISO (10993-10)
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitivity.
3A
Sanitary standard procedure No 18-03 Class I.
CE (10/2011)
Plastic materials and articles intended to come into contact with food.
CE (1935/2004)
Simulant B (3% aqueous solution of acetic acid) and Simulant Dl (50% ethanol).
EU PHARMA (3.1.9)
Silicone elastomer for sealing and tubing.