YY/T 0071-2018 in English

This standard outlines the specifications and requirements for rectal and sigmoidoscopes. It covers aspects such as design, performance, safety, and testing methods to ensure the devices meet necessary quality criteria. The document provides detailed guidelines for manufacturers, suppliers, and users to follow in the production, verification, and application of these medical devices. It includes information on materials, structural features, and operational parameters. Additionally, it specifies the conditions under which the devices should be tested and the procedures for assessing their compliance with established standards. The standard also addresses labeling, packaging, and storage requirements to support proper handling and use of the equipment.