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Standard to be satisfied by test facilities, etc. conducting toxicity investigation

Chapter 3 Facilities and Equipment (Article 8 - Article 9)

In Japanese

(Facilities)

Article 8 Test facilities, etc. shall be equipped with the following facilities.

Facilities for carrying out the studies

Facilities for managing the studies

Sample and material storage facilities (Archives)

Facilities for treating hygienically wastes generated as a result of execution of the study or facilities for storing safely and hygienically the relevant wastes before they are carried out from the test facilities, etc.

The facilities described in the preceding paragraph shall satisfy the following conditions in order to secure appropriate execution of the study

The facilities shall have suitable size and construction and are in a suitable location.

For each study, the duties related to the study concerned are properly separated for each facilities.

(Equipment)

Article 9 Test facilities, etc. shall be equipped with the machines, apparatus, and other equipment (hereinafter simply called the "equipment") necessary for securing the appropriate conduct of the study.

The equipment shall provide satisfactory performance and shall be given thoroughgoing consideration for securing safety and health.

The equipment shall be properly located so that the operation, inspection, and maintenance are easily carried out.

The equipment shall be managed as provided below.

To inspect and maintain periodically and as required in conformity to the standard operating procedures.

To record the results each time the inspection or maintenance of the preceding item has been carried out.