YY/T 0506.1-2005: Translated English of Chinese Standard. (YYT 0506.1-2005, YY/T0506.1-2005, YYT0506.1-2005): Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and productsThis part of YY/T 0506 stipulates the information in addition to the general labeling of medical devices (see YY 0466 and EN 1041) provided to users and third-party certification; involves manufacturing and processing requirements. This part provides general guidelines for the performance of single-use and reusable surgical drapes, surgical gowns, clean air suits for patients, clinical staff, equipment, to prevent the spread of infective agents between patients and clinical staff in the surgical procedure and other invasive examination process. |
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Innhold
3 | |
Information to be provided by manufacturers and processors | 9 |
Informative Prevention of infection in operating room | 15 |
Vanlige uttrykk og setninger
able adhesive tape affect and/or Appendix Application aspects body Bursting strength carried cause infection Center Characteristics classification clean air suits clinical staff clothes combination comfort confirmed contaminated corresponding covers critical dander depends Determination Dry state Tensile equipment Estimation fabric gloves gowns and clean infective agent Inspection isolation labeling laser manufacturing and processing materials mechanical medical devices Microbial Cleanliness microbial penetration microorganisms minimize monitoring Nonwoven Note operating room organizations particles Particulate matter Linting Performance requirements Permeability to air person prevent the spread reduce Resistance to liquid Resistance to microbial reusable reuse risk series of standards single-use skin specifications spread of infective staff and equipment Sterilization suitable suits for patients supplied surgery surgical area surgical drapes surgical gowns surgical procedure surgical staff surgical wound Table Tensile strength Test method test results transmission users wound surface YY/T