GIBRALTAR LABORATORIES
ISO TEST SERVICES

1.         

AAMI METHOD 1/ISO 11137 BIOBURDEN (METHOD I, METHOD 2 AND VDMAX)

7 Days

1 Lot of 10 Units

2.         

AAMI METHOD 1/ISO 11137 STERILITY (METHOD I, METHOD 2 AND VDMAX)

14 Days

100 Units

3.         

ISO 10993-5: BIOLOGICAL EVALUATION OF MEDICAL DEVICES – PART 5: TESTS FOR IN VITRO CYTOTOXICITY BIOCOMPATIBITY

  Varies

  Varies

4.         

ISO 10993-7: BIOLOGICAL EVALUATION OF MEDICAL DEVICES

5.         

ISO 11137 STERILIZATION

6.         

ISO 11607 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES

Varies

Varies

7.         

ISO 11737-2:1998 STERILIZATION OF MEDICAL DEVICES-MICROBIOLOGICAL METHODS

7 Days

Varies

8.         

ISO 14644-1 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS

Varies

Varies

9.         

ISO 4730 TEA TREE OIL

Varies

Varies

10.      

ISO 8871-1: 2003 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE -- PART 1: EXTRACTABLES IN AQUEOUS AUTOCLAVATES ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE -- PART 2: IDENTIFICATION AND CHARACTERIZATION

11.      

ISO 8871-1-4 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE

Varies

Varies