This standard specifies the basic requirements for polyurethane surgical membranes and polyethylene surgical membranes and their accessories that are adhered to the surgical site and provide sterile protection for the surgical incision. Surgical membranes made of other materials can be implemented accordingly.
YY 0852-2011 Referenced Document
GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use.Part 1:Chemical analysis methods
GB/T 16886.1 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process*, 2022-04-15 Update
YY/T 0466.1 Symbols for medical devices used for information provided by manufacturers Part 1: General requirements*, 2023-09-05 Update
YY/T 0471.3-2004 Test methods for primary wound dressings-Part 3:Waterproofness
YY/T 0471.4-2004 Test methods for primary wound dressing-Part 4:Conformability
YY/T 0615.1 Requirements for medical devices to be designated“STERILE”.part 1:Requirements for terminally sterilized medical devices