US LAWS, STATUTES & CODES ON-LINE

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A59  Sterilization devices, when containing less than 30 mL per inner packaging with no more than 300 mL per outer packaging may be transported in accordance with provisions in §173.4(a)(11)(i). In addition, after filling, each inner packaging must be determined to be leak-tight by placing the inner packaging in a hot water bath at a temperature and for a period of time sufficient to ensure an internal pressure equal to the vapor pressure of ethylene oxide at 55 °C is achieved. Any inner packaging showing evidence of leakage, distortion or other defect under this test may not be transported under the terms of this special provision. In addition to the packaging required in §173.4, inner packagings must be placed in a sealed plastic bag compatible with ethylene oxide and capable of containing the contents in the event of breakage or leakage of the inner packaging. Glass inner packagings must be placed within a protective shield capable of preventing the glass from puncturing the plastic bag in the event of damage to the packaging (e.g., crushing).

A60  Articles such as sterilization devices, UN2014, Hydrogen peroxide, aqueous solutions with more than 40 percent but not more than 60 percent hydrogen peroxide (stabilized as necessary), when containing less than 30 mL per inner packaging with not more than 150 mL per outer packaging, may be transported in accordance with the provisions in §173.4, irrespective of §173.4(a)(11)(i), provided such packagings were first subjected to comparative fire testing. Comparative fire testing must show no difference in burning rate between a package as prepared for transport (including the substance to be transported) and an identical package filled with water.