InterSpace® Trials are considered to be terminally sterilized if the following is performed:

Cleaning

• Clean the device with detergent‐diluted room temperature water that has a pH level of 6‐8
• Rinse repeatedly to eliminate any trace of detergent
• Final rinse with sterile water and dry immediately

Caution: Detergent or disinfectants containing chlorine, iodine acids, alkalis and mercury must be verified before using.

Sterilizing apparatus

Any sterilization device with a pre‐vacuum cycle and physical parameters in conformity with EN 554 may be used for trial spacer sterilization at 270◦F for 4 minutes, with a minimum dry time of 15 minutes (metal with lumens, porous, combination).

Also acceptable and in accordance with ANSI/AAMI ST37‐1996, the following sterilizers and protocols can be utilized:

Caution: These instructions have not been proven effective for sterilizing instruments contaminated with unconventional transmissible agents (prions) such as the causative agents of Creutzfeldt–Jakob Disease (CJD) and Bovine Spongiform Encephalopathy (BSE). It should not be assumed that the methods described are effective against such agents.

Download PDF of Sterilization Instructions.