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YY/T 0506 consists of the following parts under the general title Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment:
——Part 1: General requirements for manufacturers, processors and products;
——Part 2: Performance requirements and test methods;
——Part 4: Test method for linting in the dry state;
——Part 5: Test methods for resistance to dry microbial penetration;
——Part 6: Test method to determine the resistance to wet bacterial penetration;
——Part 7: Test methods for determination of cleanliness-microbial;
——Part 8: Special requirements for products.
This is Part 8 of YY/T 0506.
This part is developed in accordance with the rules given in GB/T 1.1-2009.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This part was proposed by the National Medical Products Administration of People’s Republic of China.
This part is under the jurisdiction of Shandong Quality Inspection Center for Medical Devices.
Introduction
The YY/T 0506 standard series specify the requirements for single-use and reusable coverings (i.e., surgical gowns, surgical drapes, and clean air suits) for patients, clinical staff and equipment. These products, as medical equipment, are designed to prevent the transmission of infectious agents between patients and clinical staff during traumatic operation.
During the implementation of the published YY/T 0506 standard series, it was found that the requirements specified in YY/T 0506.2-2016 focused on requirements for fabrics, while surgical drapes, surgical gowns and clean air suits meeting the requirements of YY/T 0506.2-2016 does not necessarily mean that they also meet the relevant clinical requirements, such as special requirements on structure, seams, fluid control, etc. Therefore, developing this part of YY/T 0506 is necessary.
This part of YY/T 0506 is designated to:
——further standardize the requirements for surgical drapes, surgical gowns and clean air suits on the basis of Parts 1 and 2 of YY/T 0506;
——provide further guidance to manufacturers of surgical drapes, surgical gowns and clean air suits (specified in YY/T 0506) for their design of products.
Note: See YY/T 0506.1 for further information on the products covered by this part.
The requirements for the surgical drapes specified in this part of YY/T 0506 are applicable to but not limited to: general surgical drapes, neurosurgical surgical drapes, thoracic surgical drapes, abdominal surgical drapes, urological surgical drapes, gynecologic surgical drapes, intraocular surgical drapes, head and neck surgical drapes, orthopedic surgical drapes, limb surgical drapes, joint replacement surgical drapes, cardiovascular surgical drapes, cardiovascular intervention surgical drapes, caesarean surgical drapes, cystoscope surgical drapes, thyroid surgical drapes, breast surgical drapes, hip surgical drapes, spine surgical drapes, shoulder joint surgical drapes, hernia surgical drapes, lithotomy surgical drapes, etc.
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
simulate object for body of patient
any object that can make the surgical drape present a working condition for normal-use on the operating table, such as a support wrap
3.5
operating hole
one or more holes on the surgical drape through which an operation may be performed on the operation site
3.6
liquid absorbent layer
material used to absorb body fluid or flushing fluid around the hole of surgical drape
3.7
liquid collection bag
bag wrapped around the hole of surgical drape for collecting exudate or flushing fluid from the operation site
4 General requirements
4.1 Sterilization requirements
4.1.1 Sterility assurance
If the product is provided in a sterile form, it shall meet the requirements of YY/T 0615.1.
4.1.2 Ethylene oxide residuals
If ethylene oxide is used for sterilization, the ethylene oxide residuals in the product shall not be more than 5 μg/g when the product is tested with the method specified in GB/T 16886.7 or equivalent method.
Note: GB/T 16886.7 also stipulates the method for controlling product release related to ethylene oxide residuals.
4.2 Biological requirements
Biological evaluation shall be performed to products according to GB/T 16886.1.
5 Requirements for design of surgical drape
5.1 Surgical drape for equipment
5.1.1 Performance
All areas (joints, if any) of surgical drape for equipment that are expected to be in direct or indirect contact with body fluids or flushing fluids during operation shall meet the requirements for high-performance critical areas specified in Table 2 of YY/T 0506.2-2016.
5.1.2 Structural design
The surgical drape for equipment shall be capable of covering the expected applicable surgical equipment table and equipment, ensuring that the surgical equipment placed on it is sterile.
5.1.3 Folding requirements
The manufacturer shall confirm the folding form of the surgical drape for equipment to ensure that it can be placed on the equipment table in a manner that minimizes contamination and facilitates sterile operation.
Foreword i
Introduction ii
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Sterilization requirements
4.1.1 Sterility assurance
4.1.2 Ethylene oxide residuals
4.2 Biological requirements
5 Requirements for design of surgical drape
5.1 Surgical drape for equipment
5.1.1 Performance
5.1.2 Structural design
5.1.3 Folding requirements
5.2 Surgical drape for patients
5.2.1 Classification of critical areas
5.2.2 General performance
5.2.3 Coverage
5.2.4 Units related to operating hole
5.2.5 Liquid control assembly - liquid absorbent layer (if any)
5.2.6 Liquid control assembly - liquid collection bag (if any)
5.2.7 Other fixing devices for equipment
5.2.8 Folding requirements
5.2.9 Permeability to air
6 Surgical gowns
6.1 Classification of critical areas
6.2 Performance
6.3 Specifications
6.4 Permeability to air
6.5 Folding
6.6 Firmness of lacing connection
6.7 Washing resistance of reusable surgical gowns
7 Clean air suits
7.1 Type
7.2 Performance
8 Sampling
Annex A (Informative) Example of markings of surgical drapes
Annex B (Informative) Common types and recommended specifications of surgical gowns
Annex C (Informative) Recommended methods for folding surgical gowns
Annex D (Informative) Rules for cutting test samples on products
Bibliography
Figure 1 Schematic diagram for critical area and less critical area of surgical drape
Figure 2 Schematic diagram for critical area and less critical area of surgical gown
Figure 3 Typical clean air suits
Figure A.1 Example of type and dimensioning of cesarean surgical drapes
Figure A.2 Example of markings and dimensioning of critical areas of abdominal surgical drapes
Figure B.1 Schematic diagram for type and specification of surgical gown
Figure C.1 Recommended method for folding surgical gowns
Table A.1 Example of dimensions of caesarean surgical drapes
Table A.2 Example of dimensions of abdominal surgical drapes
Table B.1 Recommended specifications of surgical gowns
