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YY/T 0506.8-2019 English PDF (YYT0506.8-2019)
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YY/T 0506.8-2019: Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment - Part 8: Special requirements for products
YY/T 0506.8-2019
Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment-Part 8. Special requirements for products
ICS 11.040
C46
People's Republic of China Pharmaceutical Industry Standard
Surgical sheets, surgical gowns and
Clean clothing. Part 8. Product specific requirements
2019-07-24 release
2020-08-01 implementation
Issued by the State Drug Administration
Contents
Foreword Ⅲ
Introduction IV
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 General requirements 2
4.1 Sterilization requirements 2
4.1.1 Sterility assurance 2
4.1.2 Residual amount of ethylene oxide 2
4.2 Biological requirements 2
5 Surgical sheet design requirements 2
5.1 Instrument Surgery Sheet 2
5.1.1 Performance 2
5.1.2 Structural design 2
5.1.3 Folding requirements 2
5.2 Patient Operating Sheet 3
5.2.1 Division of key areas 3
5.2.2 General performance 3
5.2.3 Coverage capacity 3
5.2.4 Components related to the surgical opening 4
5.2.5 Liquid control assembly-liquid absorption layer (if any) 4
5.2.6 Liquid control assembly-liquid collection bag (if available) 4
5.2.7 Fixing devices of other instruments 5
5.2.8 Folding requirements 5
5.2.9 Breathability 5
6 Surgical gown 5
6.1 Division of key areas 5
6.2 Performance 5
6.3 Specification 6
6.4 Breathability 6
6.5 Fold 6
6.6 Tie connection solidity 6
6.7 Repetitive surgical gown anti-wash life 6
7 Clean clothes 6
7.1 Type 6
7.2 Performance 6
8 Sampling 7
Appendix A (Informative Appendix) Example of Surgery Labeling 8
Appendix B (informative appendix) Common types and recommended specifications for surgical gowns 10
Appendix C (informative appendix) Recommended surgical gown folding method 11
Appendix D (informative appendix) Rules for cutting test samples on products 12
References 14
Figure 1 Illustration of the critical area and non-critical area of the surgical order 3
Figure 2 Schematic diagram of the critical area and non-critical area of the surgical gown 5
Figure 3 Typical clean clothing type 7
Figure A.1 Single-type caesarean section and dimensions (example) 8
Figure A.2 Identification and dimensioning of key areas of abdominal surgery sheet (example) 9
Figure B.1 Examples of surgical gown types and specifications Figure 10
Figure C.1 Recommended surgical gown folding method 11
Table A.1 Sizes of cesarean section (example) 8
Table A.2 Dimensions of abdominal surgery sheet (example) 9
Table B.1 Recommended surgical gown specifications 10
Foreword
YY/T 0506 "Surgical sheets, surgical gowns and clean clothes for patients, medical staff and instruments", consists of the following parts.
--- Part 1. General requirements for manufacturers, treatment plants and products;
--- Part 2. Performance requirements and test methods;
--- Part 4. Dry flocculation test method;
--- Part 5. Test method for blocking penetration of dry microorganisms;
--- Part 6. Test method for penetration of moisture-resistant microorganisms;
--- Part 7. Cleanliness-Microbiological Test Method;
--- Part 8. Product-specific requirements.
This part is Part 8 of YY/T 0506.
This section was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some content of this document may involve patents. The issuer of this document does not assume responsibility for identifying these patents.
This part is proposed by the State Drug Administration.
This part is under the jurisdiction of Shandong Medical Device Product Quality Inspection Center.
This section was drafted by. Shandong Medical Device Product Quality Inspection Center, Zhende Medical Supplies Co., Ltd., Shandong Kangli Medical
Instrument Technology Co., Ltd., Wenjian Medical Supplies Co., Ltd.
The main drafters of this section. Zhang Qing, Lu Jianguo, Chen Sheguang, He Qian, Shi Guangbo, Pan Ziqiang, Liu Zhuang, Wang Huan, Ai Chongchong.
introduction
The YY/T 0506 series of standards stipulates single-use and reusable coverings (ie surgical gowns,
Surgical sheets and clean clothes), these products are used as medical devices to prevent infection in patients and medical staff during traumatic surgery
Spread between.
During the implementation of the published YY/T 0506 series of standards, it was found that the requirements specified in YY/T 0506.2-2016 are more important
Requirements, surgical sheets, surgical gowns and clean clothes that meet YY/T 0506.2-2016 are not enough to prove that they meet the relevant clinical requirements.
Special requirements for structure, joints, liquid control, etc. Therefore, it is necessary to develop this part of YY/T 0506.
The intended purposes of this part of YY/T 0506 include.
--- Based on Part 1 and Part 2 of YY/T 0506, further standardize the requirements for surgical drapes, surgical gowns and clean clothes;
--- Provide further guidance when designing products for YY/T 0506 surgical sheets, surgical gowns and clean clothing manufacturers.
Note. For more information about the products included in the scope of this section, see YY/T 0506.1.
The requirements of the surgical order specified in this part of YY/T 0506 apply to but are not limited to. general surgical order, neurosurgery surgical order, chest hand
Surgery, abdominal surgery, urological surgery, gynecological surgery, intraocular surgery, head and neck surgery, orthopedic surgery, limbs
Surgical sheet, joint replacement surgical sheet, cardiovascular surgical sheet, cardiovascular intervention surgical sheet, caesarean section surgical sheet, cystoscopy surgical sheet, thyroid surgery
Single, breast surgery, hip surgery, hip surgery, spine surgery, shoulder surgery, hernia surgery, stone removal surgery, etc.
Surgical sheets, surgical gowns and
Clean clothing. Part 8. Product specific requirements
1 Scope
This part of YY/T 0506 specifies the special requirements for surgical sheets, surgical gowns and clean clothes for patients, medical personnel and instruments.
This section applies to surgical drapes, surgical gowns, and clean clothes that require a high degree of purification and require full body coverage of the patient.
Note. The surgical sheets specified in this section do not include single-use and reusable surgical sheets for small surgery with small open wounds and low surgical cleansing requirements.
The clinical requirements of operating sheets, surgical gowns and clean clothes for the operating room depend on the degree of openness of the surgical wound and the purification level of the clean operating room.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
Pieces. For the cited documents without date, the latest version (including all amendments) applies to this document.
GB/T 16886.1 Biological evaluation of medical devices Part 1. Evaluation and testing in the process of risk management
GB/T 16886.7 Biological evaluation of medical devices Part 7. Residue of ethylene oxide sterilization
YY/T 0506.1-2005 Surgical sheets, surgical gowns and clean clothes for patients, medical personnel and instruments Part 1. Manufacturing plant, handling
General requirements for factories and products
YY/T 0506.2-2016 Surgical sheets, surgical gowns and clean clothes for patients, medical staff and instruments Part 2. Performance requirements and
experiment method
YY/T 0615.1 Requirements for labeling "sterile" medical devices Part 1. Requirements for terminally sterilized medical devices
YY 0852-2011 disposable sterile surgical membrane
3 Terms and definitions
The terms and definitions defined in YY/T 0506.1-2005 and YY/T 0506.2-2016 and the following apply to this document.
3.1
Working condition for normal-use
The surgical drape is in a state where it is covered or fixed on the operating table or the patient on the simulated operating table according to the way it is used.
Note. During the test, a simulated operating table and a simulated patient can be used.
3.2
Simulative operating table
Its length.2000mm ± 100mm, width 550mm ± 50mm, height 500mm ~ 1120mm (adjustable) is used to simulate the corresponding surgery
Operating table.
3.3
Simulative patient
Healthy volunteers with a weight of 70kg ± 5kg and a height of 170cm ~ 175cm or a mannequin or mannequin that can form a prescribed position
Quasi-object.
3.4
Simulateobjectforbodyofpatient
It can make the operation table show any objects in the normal working state on the operating table, such as support wraps.
3.5
Operating hole
One or more openings on the surgical drape used to perform surgery on the surgical site.
3.6
Liquidabsorbentlayer
A material used to absorb body fluids or irrigation fluid around the opening of the surgical sheet.
3.7
Liquid collection bag
A bag wrapped around the opening of the surgical single hole for collecting exudate or irrigation fluid from the surgical site.
4 General requirements
4.1 Sterilization requirements
4.1.1 Sterility assurance
If the product is provided aseptically, it shall meet the requirements of YY/T 0615.1.
4.1.2 Residue of ethylene oxide
If ethylene oxide is used for sterilization, the residual amount of ethylene oxide in the product shall be tested according to the method specified in GB/T 16886.7 or equivalent
Not more than 5μg/g.
Note. GB/T 16886.7 also specifies the control method for the release of residual ethylene oxide.
4.2 Biological requirements
The product should be biologically evaluated in accordance with GB/T 16886.1.
5 surgical sheet design requirements
5.1 Instrument Surgery Sheet
5.1.1 Performance
All areas (joints, if any) of the instrument's surgical drape that are expected to be in direct or indirect contact with body fluids or irrigation fluids during the surgery
YY/T 0506.2-2016 Table 2 requirements for high-performance critical areas.
5.1.2 Structural design
The instrument surgical sheet should be able to cover the expected applicable surgical instrument table and instruments to ensure that the surgical instruments placed on it are in a sterile state.
5.1.3 Folding requirements
The manufacturer shall confirm the folded form of the instrument surgical sheet to ensure that it is placed on the device in a manner that minimizes contamination and facilitates aseptic operation
On the stage.
5.2 Patient Operating Sheet
5.2.1 Division of key areas
The surgical drape should have at least a key area (area A shown in Figure 1). The manufacturer should give the key areas of the surgical sheet in the accompanying documents
Out logo.
For surgical sheets with liquid collection bags (see 5.2.6), when the surgical sheets are tiled, the area of the critical area should completely cover the liquid collection bag
Bag mouth.
Note. The configuration of the surgical drape and the location of the key areas of different operations are different, depending on the needs of different operations. Identification and dimension of key areas of surgical drapes
See Appendix A for examples of notes.
Explanation.
A --- Key areas;
B --- non-critical area.
Figure 1 The key area and non-key area of the surgical sheet
5.2.2 General performance
The key areas of the surgical drape, including the internal joints of the key areas (if any), shall comply with the corresponding provisions specified in Table 2 of YY/T 0506.2-2016
The level of key area requirements.
The junction of the critical area and non-critical area of the surgical drape (if any) should meet the non-critical requirements specified in Table 2 of YY/T 0506.2-2016
Regional requirements.
The non-critical areas of the surgical drape, including the internal joints of the non-critical areas (if any), shall comply with the provisions of Table 2 in YY/T 0506.2-2016
Requirements for non-critical areas.
5.2.3 Coverage
The two sides of the operation table in the normal working state should be at least 30cm below the operation table.
The manufacturer shall provide an illustration of the size of the surgical drape in the accompanying documents.
Note. The size and dimensions of the surgical drape vary according to the type of surgery and the position of the patient during the operation. Appendix A gives the size chart of cesarean section
Example.
5.2.4 Related components of surgical opening
5.2.4.1 Fixing and sealing devices
The surgical opening of the surgical drape should be provided with a device that secures and effectively seals around the surgical site (such as double-sided tape, elastic materials, etc.) to prevent
The drape was displaced or the surgical exudate flowed to the patient site where the drape was expected to be covered during the procedure.
Note. See also Appendix B of YY/T 0506.1-2005.
5.2.4.2 Surgical membrane
If the surgical membrane is equipped with a surgical membrane at the surgical opening, the surgical membrane should cover the periphery of the surgical opening, and the performance should be consistent with YY 0852-2011
Requirements in Chapter 5.
5.2.4.3 Liquid control components
There should be one or two of the following fluid control components around the surgical opening of the surgical sheet.
a) A liquid-absorbing layer that can absorb surgical exudate in time (see 5.2.5);
b) A fluid collection bag that can collect surgical exudate in a timely manner and is integrated with the surgical order (see 5.2.6)
Note. The liquid collection bag is suitable for surgeries with large amount of exudate or lavage fluid, such as bone and joint replacement surgery, cesarean section surgery and so on.
5.2.5 Liquid control assembly-liquid absorption layer (if any)
5.2.5.1 Liquid absorption layer
The area where the liquid absorption layer is located should meet the requirements of the critical area.
It is advisable to have a liquid absorbing layer with a larger size in the direction of high sagging around the surgical opening of the surgical sheet in the normal use working state.
5.2.5.2 Absorbent layer liquid retention performance requirements
According to the provisions of B.1 in YY/T 0506.2-2016, when the liquid absorption layer is tested, the liquid retention rate s...
Get Quotation: Click YY/T 0506.8-2019 (Self-service in 1-minute)
Historical versions (Master-website): YY/T 0506.8-2019
Preview True-PDF (Reload/Scroll-down if blank)
YY/T 0506.8-2019: Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment - Part 8: Special requirements for products
YY/T 0506.8-2019
Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment-Part 8. Special requirements for products
ICS 11.040
C46
People's Republic of China Pharmaceutical Industry Standard
Surgical sheets, surgical gowns and
Clean clothing. Part 8. Product specific requirements
2019-07-24 release
2020-08-01 implementation
Issued by the State Drug Administration
Contents
Foreword Ⅲ
Introduction IV
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 General requirements 2
4.1 Sterilization requirements 2
4.1.1 Sterility assurance 2
4.1.2 Residual amount of ethylene oxide 2
4.2 Biological requirements 2
5 Surgical sheet design requirements 2
5.1 Instrument Surgery Sheet 2
5.1.1 Performance 2
5.1.2 Structural design 2
5.1.3 Folding requirements 2
5.2 Patient Operating Sheet 3
5.2.1 Division of key areas 3
5.2.2 General performance 3
5.2.3 Coverage capacity 3
5.2.4 Components related to the surgical opening 4
5.2.5 Liquid control assembly-liquid absorption layer (if any) 4
5.2.6 Liquid control assembly-liquid collection bag (if available) 4
5.2.7 Fixing devices of other instruments 5
5.2.8 Folding requirements 5
5.2.9 Breathability 5
6 Surgical gown 5
6.1 Division of key areas 5
6.2 Performance 5
6.3 Specification 6
6.4 Breathability 6
6.5 Fold 6
6.6 Tie connection solidity 6
6.7 Repetitive surgical gown anti-wash life 6
7 Clean clothes 6
7.1 Type 6
7.2 Performance 6
8 Sampling 7
Appendix A (Informative Appendix) Example of Surgery Labeling 8
Appendix B (informative appendix) Common types and recommended specifications for surgical gowns 10
Appendix C (informative appendix) Recommended surgical gown folding method 11
Appendix D (informative appendix) Rules for cutting test samples on products 12
References 14
Figure 1 Illustration of the critical area and non-critical area of the surgical order 3
Figure 2 Schematic diagram of the critical area and non-critical area of the surgical gown 5
Figure 3 Typical clean clothing type 7
Figure A.1 Single-type caesarean section and dimensions (example) 8
Figure A.2 Identification and dimensioning of key areas of abdominal surgery sheet (example) 9
Figure B.1 Examples of surgical gown types and specifications Figure 10
Figure C.1 Recommended surgical gown folding method 11
Table A.1 Sizes of cesarean section (example) 8
Table A.2 Dimensions of abdominal surgery sheet (example) 9
Table B.1 Recommended surgical gown specifications 10
Foreword
YY/T 0506 "Surgical sheets, surgical gowns and clean clothes for patients, medical staff and instruments", consists of the following parts.
--- Part 1. General requirements for manufacturers, treatment plants and products;
--- Part 2. Performance requirements and test methods;
--- Part 4. Dry flocculation test method;
--- Part 5. Test method for blocking penetration of dry microorganisms;
--- Part 6. Test method for penetration of moisture-resistant microorganisms;
--- Part 7. Cleanliness-Microbiological Test Method;
--- Part 8. Product-specific requirements.
This part is Part 8 of YY/T 0506.
This section was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some content of this document may involve patents. The issuer of this document does not assume responsibility for identifying these patents.
This part is proposed by the State Drug Administration.
This part is under the jurisdiction of Shandong Medical Device Product Quality Inspection Center.
This section was drafted by. Shandong Medical Device Product Quality Inspection Center, Zhende Medical Supplies Co., Ltd., Shandong Kangli Medical
Instrument Technology Co., Ltd., Wenjian Medical Supplies Co., Ltd.
The main drafters of this section. Zhang Qing, Lu Jianguo, Chen Sheguang, He Qian, Shi Guangbo, Pan Ziqiang, Liu Zhuang, Wang Huan, Ai Chongchong.
introduction
The YY/T 0506 series of standards stipulates single-use and reusable coverings (ie surgical gowns,
Surgical sheets and clean clothes), these products are used as medical devices to prevent infection in patients and medical staff during traumatic surgery
Spread between.
During the implementation of the published YY/T 0506 series of standards, it was found that the requirements specified in YY/T 0506.2-2016 are more important
Requirements, surgical sheets, surgical gowns and clean clothes that meet YY/T 0506.2-2016 are not enough to prove that they meet the relevant clinical requirements.
Special requirements for structure, joints, liquid control, etc. Therefore, it is necessary to develop this part of YY/T 0506.
The intended purposes of this part of YY/T 0506 include.
--- Based on Part 1 and Part 2 of YY/T 0506, further standardize the requirements for surgical drapes, surgical gowns and clean clothes;
--- Provide further guidance when designing products for YY/T 0506 surgical sheets, surgical gowns and clean clothing manufacturers.
Note. For more information about the products included in the scope of this section, see YY/T 0506.1.
The requirements of the surgical order specified in this part of YY/T 0506 apply to but are not limited to. general surgical order, neurosurgery surgical order, chest hand
Surgery, abdominal surgery, urological surgery, gynecological surgery, intraocular surgery, head and neck surgery, orthopedic surgery, limbs
Surgical sheet, joint replacement surgical sheet, cardiovascular surgical sheet, cardiovascular intervention surgical sheet, caesarean section surgical sheet, cystoscopy surgical sheet, thyroid surgery
Single, breast surgery, hip surgery, hip surgery, spine surgery, shoulder surgery, hernia surgery, stone removal surgery, etc.
Surgical sheets, surgical gowns and
Clean clothing. Part 8. Product specific requirements
1 Scope
This part of YY/T 0506 specifies the special requirements for surgical sheets, surgical gowns and clean clothes for patients, medical personnel and instruments.
This section applies to surgical drapes, surgical gowns, and clean clothes that require a high degree of purification and require full body coverage of the patient.
Note. The surgical sheets specified in this section do not include single-use and reusable surgical sheets for small surgery with small open wounds and low surgical cleansing requirements.
The clinical requirements of operating sheets, surgical gowns and clean clothes for the operating room depend on the degree of openness of the surgical wound and the purification level of the clean operating room.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
Pieces. For the cited documents without date, the latest version (including all amendments) applies to this document.
GB/T 16886.1 Biological evaluation of medical devices Part 1. Evaluation and testing in the process of risk management
GB/T 16886.7 Biological evaluation of medical devices Part 7. Residue of ethylene oxide sterilization
YY/T 0506.1-2005 Surgical sheets, surgical gowns and clean clothes for patients, medical personnel and instruments Part 1. Manufacturing plant, handling
General requirements for factories and products
YY/T 0506.2-2016 Surgical sheets, surgical gowns and clean clothes for patients, medical staff and instruments Part 2. Performance requirements and
experiment method
YY/T 0615.1 Requirements for labeling "sterile" medical devices Part 1. Requirements for terminally sterilized medical devices
YY 0852-2011 disposable sterile surgical membrane
3 Terms and definitions
The terms and definitions defined in YY/T 0506.1-2005 and YY/T 0506.2-2016 and the following apply to this document.
3.1
Working condition for normal-use
The surgical drape is in a state where it is covered or fixed on the operating table or the patient on the simulated operating table according to the way it is used.
Note. During the test, a simulated operating table and a simulated patient can be used.
3.2
Simulative operating table
Its length.2000mm ± 100mm, width 550mm ± 50mm, height 500mm ~ 1120mm (adjustable) is used to simulate the corresponding surgery
Operating table.
3.3
Simulative patient
Healthy volunteers with a weight of 70kg ± 5kg and a height of 170cm ~ 175cm or a mannequin or mannequin that can form a prescribed position
Quasi-object.
3.4
Simulateobjectforbodyofpatient
It can make the operation table show any objects in the normal working state on the operating table, such as support wraps.
3.5
Operating hole
One or more openings on the surgical drape used to perform surgery on the surgical site.
3.6
Liquidabsorbentlayer
A material used to absorb body fluids or irrigation fluid around the opening of the surgical sheet.
3.7
Liquid collection bag
A bag wrapped around the opening of the surgical single hole for collecting exudate or irrigation fluid from the surgical site.
4 General requirements
4.1 Sterilization requirements
4.1.1 Sterility assurance
If the product is provided aseptically, it shall meet the requirements of YY/T 0615.1.
4.1.2 Residue of ethylene oxide
If ethylene oxide is used for sterilization, the residual amount of ethylene oxide in the product shall be tested according to the method specified in GB/T 16886.7 or equivalent
Not more than 5μg/g.
Note. GB/T 16886.7 also specifies the control method for the release of residual ethylene oxide.
4.2 Biological requirements
The product should be biologically evaluated in accordance with GB/T 16886.1.
5 surgical sheet design requirements
5.1 Instrument Surgery Sheet
5.1.1 Performance
All areas (joints, if any) of the instrument's surgical drape that are expected to be in direct or indirect contact with body fluids or irrigation fluids during the surgery
YY/T 0506.2-2016 Table 2 requirements for high-performance critical areas.
5.1.2 Structural design
The instrument surgical sheet should be able to cover the expected applicable surgical instrument table and instruments to ensure that the surgical instruments placed on it are in a sterile state.
5.1.3 Folding requirements
The manufacturer shall confirm the folded form of the instrument surgical sheet to ensure that it is placed on the device in a manner that minimizes contamination and facilitates aseptic operation
On the stage.
5.2 Patient Operating Sheet
5.2.1 Division of key areas
The surgical drape should have at least a key area (area A shown in Figure 1). The manufacturer should give the key areas of the surgical sheet in the accompanying documents
Out logo.
For surgical sheets with liquid collection bags (see 5.2.6), when the surgical sheets are tiled, the area of the critical area should completely cover the liquid collection bag
Bag mouth.
Note. The configuration of the surgical drape and the location of the key areas of different operations are different, depending on the needs of different operations. Identification and dimension of key areas of surgical drapes
See Appendix A for examples of notes.
Explanation.
A --- Key areas;
B --- non-critical area.
Figure 1 The key area and non-key area of the surgical sheet
5.2.2 General performance
The key areas of the surgical drape, including the internal joints of the key areas (if any), shall comply with the corresponding provisions specified in Table 2 of YY/T 0506.2-2016
The level of key area requirements.
The junction of the critical area and non-critical area of the surgical drape (if any) should meet the non-critical requirements specified in Table 2 of YY/T 0506.2-2016
Regional requirements.
The non-critical areas of the surgical drape, including the internal joints of the non-critical areas (if any), shall comply with the provisions of Table 2 in YY/T 0506.2-2016
Requirements for non-critical areas.
5.2.3 Coverage
The two sides of the operation table in the normal working state should be at least 30cm below the operation table.
The manufacturer shall provide an illustration of the size of the surgical drape in the accompanying documents.
Note. The size and dimensions of the surgical drape vary according to the type of surgery and the position of the patient during the operation. Appendix A gives the size chart of cesarean section
Example.
5.2.4 Related components of surgical opening
5.2.4.1 Fixing and sealing devices
The surgical opening of the surgical drape should be provided with a device that secures and effectively seals around the surgical site (such as double-sided tape, elastic materials, etc.) to prevent
The drape was displaced or the surgical exudate flowed to the patient site where the drape was expected to be covered during the procedure.
Note. See also Appendix B of YY/T 0506.1-2005.
5.2.4.2 Surgical membrane
If the surgical membrane is equipped with a surgical membrane at the surgical opening, the surgical membrane should cover the periphery of the surgical opening, and the performance should be consistent with YY 0852-2011
Requirements in Chapter 5.
5.2.4.3 Liquid control components
There should be one or two of the following fluid control components around the surgical opening of the surgical sheet.
a) A liquid-absorbing layer that can absorb surgical exudate in time (see 5.2.5);
b) A fluid collection bag that can collect surgical exudate in a timely manner and is integrated with the surgical order (see 5.2.6)
Note. The liquid collection bag is suitable for surgeries with large amount of exudate or lavage fluid, such as bone and joint replacement surgery, cesarean section surgery and so on.
5.2.5 Liquid control assembly-liquid absorption layer (if any)
5.2.5.1 Liquid absorption layer
The area where the liquid absorption layer is located should meet the requirements of the critical area.
It is advisable to have a liquid absorbing layer with a larger size in the direction of high sagging around the surgical opening of the surgical sheet in the normal use working state.
5.2.5.2 Absorbent layer liquid retention performance requirements
According to the provisions of B.1 in YY/T 0506.2-2016, when the liquid absorption layer is tested, the liquid retention rate s...
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