YY/T 0506.1-2005 Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment—Part 1: General requirements for manufacturers, processors and products

Scope

This part of YY/T 0506 specifies the information provided to users and third-party certification bodies in addition to the general labeling of medical devices (see YY0466 and EN1041), involving manufacturing and processing requirements. This part provides general guidelines for the performance of surgical drapes, surgical gowns, and cleanroom garments used for single and repeated use on patients and medical staff, in order to prevent the transmission of infectious agents between patients and medical staff during surgical procedures and other invasive examinations. This part does not include surgical masks, surgical gloves, packaging materials, shoes, hats, and surgical incision membranes. GB 7543 specifies the requirements for medical gloves, while ISO 116071 specifies the requirements for packaging materials. This part does not include the flammability requirements for products used in laser surgery. ISO 118102 provides the test methods for flammability and penetration resistance during laser irradiation, as well as the corresponding grading system. Other basic requirements suitable for surgical gowns and surgical drapes will be included in YY/T 0506.2

Development Information

Same series standard

Superseded by the following standards

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