Testing parameter requirements.

§ 761.389 Testing parameter requirements.

There are no restrictions on the variable testing parameters described in this section which may be used in the validation study. The conditions demonstrated in the validation study for these variables shall become the required conditions for decontamination using the solvent being validated and shall replace the comparable conditions in § 761.79(b)(3) through (b)(6). There are limited potential options for varying a single requirement in this section. If you change one of these variable requirements, change it only in the way listed in this section and do not change any other validated conditions. If you desire to change more than one of the requirements in this section, you must conduct a new study to validate the decontamination under the desired conditions.

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