Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment - Part 8: Special requirements for products
1 Scope
This part of YY/T 0506 specifies the special requirements for surgical drapes, gowns and clean air suits for patients, clinical staff and equipment.
This part is applicable to surgical drapes, gowns and clean air suits that are used in operations with high requirements for purification and where the full body of the patient is required to be fully covered.
Note: The surgical drapes specified in this part do not include single-use and reusable surgical drapes that are used in small operations with small wound openings and low requirements for purification.
The clinical requirements for surgical drapes, gowns and clean air suits used in the operating room depend on the size of the surgical wound and the purification level of the clean operating room.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
GB/T 16886.7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
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
YY/T 0506.2-2016 Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment - Part 2: Performance requirements and test methods
YY/T 0615.1 Requirements for medical devices to be designated “STERILE” - Part 1: Requirements for terminally sterilized medical devices
YY 0852-2011 Sterile surgical films for single use
3 Terms and definitions
For the purposes of this document, the terms and definitions given in YY/T 0506.1-2005 and YY/T 0506.2-2016, as well as the following apply.
3.1
working condition for normal-use
state of surgical drape where it covers or is fixed on the patient on the operating table or simulative operating table in the way it is used
Note: During the test, a simulative operating table and a simulative patient can be used.
3.2
simulative operating table
operating table for simulating relevant operations, with a length of 2,000 mm±100 mm, a width of 550 mm±50 mm and a height of 500 mm~1,120 mm (adjustable)
3.3
simulative patient
healthy volunteer with a weight of 70 kg±5 kg and a height of 170 cm~175 cm or anthropometric dummy or simulate object for body of patient capable of forming prescribed body positions
3.4
YY/T 0506.8-2019 The following standards are cited：
YY/T 0506.8-2019 Cited by the following standards：
