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YY/T 0506.8-2019

Chinese Standard: 'YY/T 0506.8-2019'
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YY/T 0506.8-2019English359 Add to Cart Days<=4 Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment - Part 8: Special requirements for products Valid YY/T 0506.8-2019
YY/T 0506.8-2019Chinese17 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]  

   

BASIC DATA
Standard ID YY/T 0506.8-2019 (YY/T0506.8-2019)
Description (Translated English) Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment - Part 8: Special requirements for products
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C46
Classification of International Standard 11.040
Word Count Estimation 18,164
Date of Issue 2019-07-24
Date of Implementation 2020-08-01
Drafting Organization Shandong Medical Device Product Quality Inspection Center, Zhende Medical Products Co., Ltd., Shandong Kangli Medical Device Technology Co., Ltd., Steady Medical Products Co., Ltd.
Administrative Organization Shandong Medical Device Product Quality Inspection Center
Proposing organization State Drug Administration
Issuing agency(ies) State Drug Administration

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 patients, medical personnel, and equipment
Clean clothes Part 8. Product specific requirements
Surgicaldrapes, gownsandcleanairsuitsforpatients,clinicalstaffand
equipment-Part 8. Specialrequirementsforproducts
Published on.2019-07-24
2020-08-01 implementation
State Drug Administration issued
Content
Foreword III
Introduction IV
1 range 1
2 Normative references 1
3 Terms and Definitions 1
4 General requirements 2
4.1 Sterilization Requirements 2
4.1.1 Aseptic Guarantee 2
4.1.2 Ethylene oxide residue 2
4.2 Biological requirements 2
5 surgical single design requirements 2
5.1 Device Surgical Sheet 2
5.1.1 Performance 2
5.1.2 Structural Design 2
5.1.3 Folding requirements 2
5.2 Patient Surgical Sheet 3
5.2.1 Division of key areas 3
5.2.2 General performance 3
5.2.3 Covering capacity 3
5.2.4 Surgical Portal Related Components 4
5.2.5 Liquid Control Assembly - Liquid Absorbing Layer (if any) 4
5.2.6 Liquid Control Assembly - Liquid Collection Bag (if available) 4
5.2.7 Other equipment fixtures 5
5.2.8 Folding requirement 5
5.2.9 Gas permeability 5
6 Surgical gown 5
6.1 Division of key areas 5
6.2 Performance 5
6.3 Size 6
6.4 Breathability 6
6.5 folding 6
6.6 strap connection robustness 6
6.7 Repetitive surgical gowns resistant to washing life 6
7 clean clothes 6
7.1 Type 6
7.2 Performance 6
8 sampling 7
Appendix A (informative) Surgical order labeling example 8
Appendix B (informative) Common types of surgical gowns and recommended specifications 10
Appendix C (informative) Recommended surgical clothing folding method 11
Appendix D (informative) Rules 12 for the determination of test samples on products
Reference 14
Figure 1 Operational key and non-critical areas Figure 3
Figure 2 Key and non-critical areas of the surgical gown Figure 5
Figure 3 Typical clean clothing type 7
Figure A.1 Caesarean section single type and dimensioning (example) 8
Figure A.2 Identification and dimensioning of key areas for abdominal surgery (example) 9
Figure B.1 Surgical gown type and specification example Figure 10
Figure C.1 Recommended surgical gown folding method 11
Table A.1 Caesarean section size (example) 8
Table A.2 Single size for abdominal surgery (example) 9
Table B.1 Recommended Surgical Gown Size 10
Foreword
YY/T 0506 "Surgical, medical, and surgical gowns for patients, medical personnel, and equipment" consists of the following.
--- Part 1. General requirements for manufacturers, treatment plants and products;
--- Part 2. Performance requirements and test methods;
---Part 4. Dry drop test method;
---Part 5. Test method for resistance to dry microbial penetration;
---Part 6. Test method for penetration resistance of microorganisms;
---Part 7. Cleanliness - Microbiological test methods;
--- Part 8. Product-specific requirements.
This part is part 8 of YY/T 0506.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible 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 drafted by. Shandong Province Medical Device Product Quality Inspection Center, Zhende Medical Products Co., Ltd., Shandong Kangli Medical
Instrument Technology Co., Ltd., Steady Medical Supplies Co., Ltd.
The main drafters of this section. Zhang Qing, Lu Jianguo, Chen Fuguang, He Qian, Shi Guangbo, Pan Ziqiang, Liu Zhuang, Wang Huan, Ai Chongchong.
introduction
The YY/T 0506 series of standards specifies disposable and reusable coverings for patients, healthcare personnel and devices (ie surgical gowns,
Requirements for surgical orders and cleansing suits, these products as medical devices are expected to prevent infectious agents 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 were biased towards fabrics.
Requirements, surgical orders, surgical gowns and cleansing suits in accordance with YY/T 0506.2-2016 are not sufficient to demonstrate compliance with clinical requirements, eg,
Special requirements such as structure, joints, and liquid control. Therefore, it is necessary to develop this part of YY/T 0506.
The intended purpose of this part of YY/T 0506 includes.
--- Further standardize the requirements for surgical orders, surgical gowns and clean clothes on the basis of Part 1 and Part 2 of YY/T 0506;
--- Manufacturers of YY/T 0506 surgical, surgical, and cleansing garments provide further guidance when designing products.
Note. For more information on the products included in this section, see YY/T 0506.1.
The requirements for the surgical procedure specified in this section of YY/T 0506 apply to, but are not limited to, general surgical procedures, neurosurgery procedures, and thoracic hand
Surgery, abdominal surgery, urological surgery, gynecological surgery, intraocular surgery, head and neck surgery, orthopedic surgery, limbs
Surgical procedures, joint replacement surgery, cardiovascular surgery, cardiovascular interventional procedures, caesarean section, cystoscopy, thyroid surgery
Single, breast surgery, hip surgery, hip surgery, spinal surgery, shoulder surgery, hernia surgery, stone surgery, etc.
Surgical sheets, surgical gowns, and patients, medical personnel, and equipment
Clean clothes Part 8. Product specific requirements
1 Scope
This section of YY/T 0506 specifies the specific requirements for surgical, surgical, and cleansing garments for patients, health care providers, and equipment.
This section applies to surgical drapes, surgical gowns and cleansing suits that require a high level of cleansing and require full coverage of the patient.
Note. The surgical procedures specified in this section do not include single-use and repetitive surgical procedures for small surgery with small wound opening and low surgical purification level.
The clinical requirements for operating rooms, surgical gowns, and cleansing suits in the operating room depend on the degree of openness of the surgical wound and the level of cleansing of the clean operating room.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (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. Resin residues
YY/T 0506.1-2005 Surgical sheets, surgical gowns and cleansing suits for patients, medical staff and instruments - Part 1. Manufacturing, processing
General requirements for plants and products
YY/T 0506.2-2016 Surgical sheets, surgical gowns and cleansing suits for patients, medical staff and equipment - Part 2. Performance requirements and
experiment method
YY/T 0615.1 Requirements for "sterile" medical devices - Part 1. Requirements for terminally sterilized medical devices
YY 0852-2011 Disposable sterile surgical film
3 Terms and definitions
The following terms and definitions as defined in YY/T 0506.1-2005 and YY/T 0506.2-2016 apply to this document.
3.1
Normal use working condition workingconditionfornormal-use
The surgical sheet is in a state of being covered or fixed to the patient on the operating table or the simulated operating table according to its use.
Note. Simulated operating tables and simulated patients can be used during the test.
3.2
Simulated operating table simpleoperatingtable
Its length is.2000mm±100mm, width is 550mm±50mm, height is 500mm~1120mm (adjustable) to simulate the corresponding operation
Operating table.
3.3
Simulated patient
A healthy volunteer with a body weight of 70kg ± 5kg and a height of 170cm ~ 175cm or a human body model or a human body model capable of forming a prescribed body position
Imitation.
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 patients, medical personnel, and equipment
Clean clothes Part 8. Product specific requirements
Surgicaldrapes, gownsandcleanairsuitsforpatients,clinicalstaffand
equipment-Part 8. Specialrequirementsforproducts
Published on.2019-07-24
2020-08-01 implementation
State Drug Administration issued
Content
Foreword III
Introduction IV
1 range 1
2 Normative references 1
3 Terms and Definitions 1
4 General requirements 2
4.1 Sterilization Requirements 2
4.1.1 Aseptic Guarantee 2
4.1.2 Ethylene oxide residue 2
4.2 Biological requirements 2
5 surgical single design requirements 2
5.1 Device Surgical Sheet 2
5.1.1 Performance 2
5.1.2 Structural Design 2
5.1.3 Folding requirements 2
5.2 Patient Surgical Sheet 3
5.2.1 Division of key areas 3
5.2.2 General performance 3
5.2.3 Covering capacity 3
5.2.4 Surgical Portal Related Components 4
5.2.5 Liquid Control Assembly - Liquid Absorbing Layer (if any) 4
5.2.6 Liquid Control Assembly - Liquid Collection Bag (if available) 4
5.2.7 Other equipment fixtures 5
5.2.8 Folding requirement 5
5.2.9 Gas permeability 5
6 Surgical gown 5
6.1 Division of key areas 5
6.2 Performance 5
6.3 Size 6
6.4 Breathability 6
6.5 folding 6
6.6 strap connection robustness 6
6.7 Repetitive surgical gowns resistant to washing life 6
7 clean clothes 6
7.1 Type 6
7.2 Performance 6
8 sampling 7
Appendix A (informative) Surgical order labeling example 8
Appendix B (informative) Common types of surgical gowns and recommended specifications 10
Appendix C (informative) Recommended surgical clothing folding method 11
Appendix D (informative) Rules 12 for the determination of test samples on products
Reference 14
Figure 1 Operational key and non-critical areas Figure 3
Figure 2 Key and non-critical areas of the surgical gown Figure 5
Figure 3 Typical clean clothing type 7
Figure A.1 Caesarean section single type and dimensioning (example) 8
Figure A.2 Identification and dimensioning of key areas for abdominal surgery (example) 9
Figure B.1 Surgical gown type and specification example Figure 10
Figure C.1 Recommended surgical gown folding method 11
Table A.1 Caesarean section size (example) 8
Table A.2 Single size for abdominal surgery (example) 9
Table B.1 Recommended Surgical Gown Size 10
Foreword
YY/T 0506 "Surgical, medical, and surgical gowns for patients, medical personnel, and equipment" consists of the following.
--- Part 1. General requirements for manufacturers, treatment plants and products;
--- Part 2. Performance requirements and test methods;
---Part 4. Dry drop test method;
---Part 5. Test method for resistance to dry microbial penetration;
---Part 6. Test method for penetration resistance of microorganisms;
---Part 7. Cleanliness - Microbiological test methods;
--- Part 8. Product-specific requirements.
This part is part 8 of YY/T 0506.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible 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 drafted by. Shandong Province Medical Device Product Quality Inspection Center, Zhende Medical Products Co., Ltd., Shandong Kangli Medical
Instrument Technology Co., Ltd., Steady Medical Supplies Co., Ltd.
The main drafters of this section. Zhang Qing, Lu Jianguo, Chen Fuguang, He Qian, Shi Guangbo, Pan Ziqiang, Liu Zhuang, Wang Huan, Ai Chongchong.
introduction
The YY/T 0506 series of standards specifies disposable and reusable coverings for patients, healthcare personnel and devices (ie surgical gowns,
Requirements for surgical orders and cleansing suits, these products as medical devices are expected to prevent infectious agents 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 were biased towards fabrics.
Requirements, surgical orders, surgical gowns and cleansing suits in accordance with YY/T 0506.2-2016 are not sufficient to demonstrate compliance with clinical requirements, eg,
Special requirements such as structure, joints, and liquid control. Therefore, it is necessary to develop this part of YY/T 0506.
The intended purpose of this part of YY/T 0506 includes.
--- Further standardize the requirements for surgical orders, surgical gowns and clean clothes on the basis of Part 1 and Part 2 of YY/T 0506;
--- Manufacturers of YY/T 0506 surgical, surgical, and cleansing garments provide further guidance when designing products.
Note. For more information on the products included in this section, see YY/T 0506.1.
The requirements for the surgical procedure specified in this section of YY/T 0506 apply to, but are not limited to, general surgical procedures, neurosurgery procedures, and thoracic hand
Surgery, abdominal surgery, urological surgery, gynecological surgery, intraocular surgery, head and neck surgery, orthopedic surgery, limbs
Surgical procedures, joint replacement surgery, cardiovascular surgery, cardiovascular interventional procedures, caesarean section, cystoscopy, thyroid surgery
Single, breast surgery, hip surgery, hip surgery, spinal surgery, shoulder surgery, hernia surgery, stone surgery, etc.
Surgical sheets, surgical gowns, and patients, medical personnel, and equipment
Clean clothes Part 8. Product specific requirements
1 Scope
This section of YY/T 0506 specifies the specific requirements for surgical, surgical, and cleansing garments for patients, health care providers, and equipment.
This section applies to surgical drapes, surgical gowns and cleansing suits that require a high level of cleansing and require full coverage of the patient.
Note. The surgical procedures specified in this section do not include single-use and repetitive surgical procedures for small surgery with small wound opening and low surgical purification level.
The clinical requirements for operating rooms, surgical gowns, and cleansing suits in the operating room depend on the degree of openness of the surgical wound and the level of cleansing of the clean operating room.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (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. Resin residues
YY/T 0506.1-2005 Surgical sheets, surgical gowns and cleansing suits for patients, medical staff and instruments - Part 1. Manufacturing, processing
General requirements for plants and products
YY/T 0506.2-2016 Surgical sheets, surgical gowns and cleansing suits for patients, medical staff and equipment - Part 2. Performance requirements and
experiment method
YY/T 0615.1 Requirements for "sterile" medical devices - Part 1. Requirements for terminally sterilized medical devices
YY 0852-2011 Disposable sterile surgical film
3 Terms and definitions
The following terms and definitions as defined in YY/T 0506.1-2005 and YY/T 0506.2-2016 apply to this document.
3.1
Normal use working condition workingconditionfornormal-use
The surgical sheet is in a state of being covered or fixed to the patient on the operating table or the simulated operating table according to its use.
Note. Simulated operating tables and simulated patients can be used during the test.
3.2
Simulated operating table simpleoperatingtable
Its length is.2000mm±100mm, width is 550mm±50mm, height is 500mm~1120mm (adjustable) to simulate the corresponding operation
Operating table.
3.3
Simulated patient
A healthy volunteer with a body weight of 70kg ± 5kg and a height of 170cm ~ 175cm or a human body model or a human body model capable of forming a prescribed body position
Imitation.
Related standard:   YY/T 0506.2-2016  YY/T 0506.4-2016
Related PDF sample:   YY/T 0506.4-2016  YY/T 0506.5-2009
   
 
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