Powered by Google www.ChineseStandard.net Database: 189759 (14 Jul 2024)

YY/T 0506.1-2023 related PDF English

YY/T 0506.1-2023 (YY/T0506.1-2023, YYT 0506.1-2023, YYT0506.1-2023) & related versions
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)See DetailStatusSimilar PDF
YY/T 0506.1-2023English469 Add to Cart 4 days Technical specification for continuous power generation performance evaluation of photovoltaic system YY/T 0506.1-2023 Valid YYT 0506.1-2023
YY/T 0506.1-2005English210 Add to Cart 0-9 seconds. Auto delivery. Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment. Part 1: General requirements for manufacturers, processors and products YY/T 0506.1-2005 Obsolete YYT 0506.1-2005



YY/T 0506.1-2023: PDF in English (YYT 0506.1-2023)
YY/T 0506.1-2023
ICS 11.040
CCSC46
Pharmaceutical Industry Standard of the People's Republic of China
Replacing YY/T 0506.1-2005, YY/T 0506.2-2016, YY/T 0506.7-2014
Medical surgical drapes, surgical gowns and clean clothes
Part 1.General requirements
Part 1.General requirements
2024-01-15 Implementation
Released by the State Drug Administration
table of contents
Preface III
Introduction IV
1 Range 1
2 Normative references 1
3 Terms and Definitions 1
4 Performance requirements 3
4.1 Surgical gowns 3
4.2 Drapes 4
4.3 Clean clothes 5
5 Manufacture and handling requirements and documentation requirements 5
6 Information supplied with the product6
6.1 Information provided to users6
6.2 Information provided to processors6
Appendix A (Normative) Test Method 7
Appendix B (Normative) Bioburden Test Method 10
Appendix C (Informative) Other characteristic information 13
Appendix D (Informative) User's Guide to Selecting Products 14
Reference 16
foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules for Standardization Documents"
drafting.
This document is Part 1 of YY/T 0506 "Medical Surgical Drapes, Surgical Gowns and Clean Clothes". YY/T 0506 has issued the following
part.
--- Part 1.General requirements for manufacturing plants, processing plants and products;
--- Part 2.Performance requirements and test methods;
--- Part 4.Dry flocculation test method;
--- Part 5.Test method for resistance to dry microbial penetration;
--- Part 6.Test method for moisture resistance to microbial penetration;
--- Part 7.Cleanliness - microbiological test methods;
--- Part 8.Product-specific requirements.
This document replaces YY/T 0506.1-2005 "Surgical drapes, surgical gowns and clean clothes for patients, medical staff and instruments - Part 1.Manufacturing
General requirements for manufacturing plants, processing plants and products", YY/T 0506.2-2016 "Surgical drapes, surgical gowns and cleanliness for patients, medical staff and equipment
Clothing Part 2.Performance requirements and test methods", YY/T 0506.7-2014 "Surgical drapes, surgical gowns and gowns for patients, medical staff and equipment
Clean clothing - Part 7.Cleanliness - Microbiological test methods". This document is based on YY/T 0506.2-2016, integrating
The content of YY/T 0506.1-2005 and YY/T 0506.7-2014, compared with YY/T 0506.2-2016, except for structural adjustment and editing
In addition to sexual changes, the main technical changes are as follows.
a) Delete the requirement of "cleanliness - particulate matter" (see Table 1, Table 2 and Table 3, Table 1, Table 2 and Table 3 of the.2016 edition);
b) Changed the general rules of "Appendix A" (see A.1 in Appendix A, A.1 in Appendix A of the.2016 edition), and deleted "Cleanliness-particulate matter
"Quality evaluation test method" (see A.3 of the.2016 edition), added "result processing" (see A.3);
c) Added "bioburden test method" (see Appendix B);
d) Deleted "Optional Test Method" (see Appendix B of the.2016 edition).
Please note that some contents of this document may refer to patents. The issuing agency of this document assumes no responsibility for identifying patents.
This document is proposed by the State Drug Administration.
This document is under the jurisdiction of Shandong Academy of Medical Devices and Drug Packaging Inspection.
This document was drafted by. Shandong Institute of Medical Devices and Drug Packaging Inspection, Zhende Medical Supplies Co., Ltd., Weihai Weigao
Medical Materials Co., Ltd., Beijing Quexiang Tengfei Medical Technology Co., Ltd., Henan Yadu Industrial Co., Ltd., Jiangsu Weihu Medical Technology Co., Ltd.
Company, Hefei Gaobeisi Medical and Sanitary Products Co., Ltd., Pujie Nonwovens (China) Co., Ltd.
The main drafters of this document. Zhang Qing, Wang Wenqing, Chang Gailing, Yu Xujie, Jiang Liheng, Liu Bin, Duan Shuxia, Kou Wei, Nie Jiaqi, Gao Ming, Jin Yongji,
Li Cui, Li Xiuting, Zhu Yixin.
The release status of previous versions of this document and the documents it replaces are as follows.
---First published as YY/T 0506.1-2005 in.2005;
---This is the first revision, incorporating YY/T 0506.2-2016 "Surgical Drapes, Surgical Gowns and Cleaning Equipment for Patients, Medical Staff and Instruments"
Clean clothes Part 2.Performance requirements and test methods" and YY/T 0506.7-2014 "Patients, medical staff and equipment for surgery
Sheets, Surgical gowns and clean clothes - Part 7.Cleanliness - microbiological test method" (YY/T 0506.2-2016 history
The minor version releases are. YY/T 0506.2-2009, YY/T 0506.2-2016).
introduction
During invasive surgical procedures, infectious agents can be transmitted through various routes.
Surgical drapes and gowns are expected to serve as the establishment of a sterile field to minimize the possibility of transmission of infectious agents to or from wounds,
Thus helping to prevent postoperative infection.
Depending on the type of surgery, the timing and degree of moisture in the surgical field, the degree of mechanical stress on the material and the susceptibility of the patient to infection, the
The performance required for coverings for people, healthcare workers and equipment also varies.
The use of surgical gowns that prevent the penetration of liquids can also reduce the risk of transmission of infectious agents carried in blood or body fluids to medical staff.
Hygienic gowns are used to reduce the spread of infectious agents to surgical sites and instruments by preventing the spread of bacteria-laden skin debris from healthcare workers,
This helps prevent postoperative surgical site infection. In invasive surgical procedures with infectious agents, a combination of ventilation and proper handling
In this way, clean clothes can reduce the risk of infection.
Antimicrobial treatment of surgical drapes and surgical gowns may lead to environmental risks such as drug resistance and environmental contamination. This document does not apply to surgical gowns and hand
The antibacterial treatment of surgical drapes shall be regulated, but the surgical drapes and surgical gowns that have undergone antibacterial treatment belong to this standard when they are used as surgical drapes and surgical gowns.
Scope of application of the document.
YY/T 0506 aims to promote communication between manufacturers and third parties on the characteristics and performance of materials and products.
The purpose of YY/T 0506 is to ensure that disposable and reusable surgical gowns, surgical drapes and clean clothes are
It has the same security level inside and is proposed to be composed of five parts.
--- Part 1.General requirements. It specifies the performance requirements, manufacturing requirements, reusable
Disposal requirements for products after use and information requirements provided by manufacturers, etc.
--- Part 4.Test method for dry flocculation. It specifies the measurement of lint falling in surgical drapes, surgical gowns and clean clothes and materials under dry conditions
test method.
--- Part 5.Test method for blocking dry microbial penetration. Specified for the evaluation of surgical drapes, surgical gowns and clean clothing barrier materials
Test method for penetration resistance of bacteria-carrying particles.
--- Part 6.Test method for moisture resistance microbial penetration. It stipulates that surgical drapes, surgical gowns and clean clothing materials are subjected to mechanical friction
Test method for penetration of bacteria in time-resistant liquids.
--- Part 8.Product-specific requirements. It stipulates surgical drapes that require a high degree of purification and require the patient's whole body to be covered,
Specific requirements for surgical gowns and clean clothing products.
Medical surgical drapes, surgical gowns and clean clothes
Part 1.General requirements
1 Scope
This document specifies the general requirements for medical surgical drapes, surgical gowns and clean clothes. Include performance requirements, manufacturing requirements, reusable product
Requirements for post-use disposal of products and information requirements provided by manufacturers. Does not include anti-laser penetration properties, antimicrobial treatment of gowns or drapes
Require.
This document applies to medical surgical drapes, surgical gowns and clean clothes.
This document does not apply to surgical membranes.
Note 1.See YY/T 0506.8 for special requirements on surgical drapes, surgical gowns and clean clothes.
Note 2.See YY/T 0855 for the test method and classification of anti-laser penetration performance.
2 Normative references
The contents of the following documents constitute the essential provisions of this document through normative references in the text. Among them, dated references
For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to
this document.
GB/T 4744 Testing and Evaluation of Waterproof Performance of Textiles Hydrostatic Pressure Method
GB/T 6529 Standard atmosphere for textile humidity conditioning and testing
GB/T 7742.1 Burst properties of textile fabrics - Part 1.Determination of burst strength and burst expansion by hydraulic method
GB/T 16886.1 Biological evaluation of medical devices Part 1.Evaluation and testing in the risk management process
GB/T 24218.3 Test methods for textiles and nonwovens - Part 3.Determination of breaking strength and elongation at break (strip method)
YY/T 0287 Medical device quality management system for regulatory requirements
YY/T 0506.4 Surgical drapes, surgical gowns and clean clothes for patients, medical staff and instruments - Part 4.Test method for dry lint
YY/T 0506.5 Surgical drapes, surgical gowns and clean clothes for patients, medical staff and instruments - Part 5.Blocking the penetration of dry microorganisms
experiment method
YY/T 0506.6 Surgical drapes, surgical gowns and clean clothes for patients, medical staff and instruments Part 6.Resistance to penetration of microorganisms in wet state
experiment method
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Colony forming unit colonyforming unit; CFU
A unit of expression for the number of culturable microorganisms.
Note. The number of culturable microorganisms is the number of single-celled or aggregated microorganisms that can form colonies on solid nutrient media.
......

BASIC DATA
Standard ID YY/T 0506.1-2023 (YY/T0506.1-2023)
Description (Translated English) (Medical surgical drapes, surgical gowns and clean clothes - Part 1: General requirements)
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of International Standard 11.040
Word Count Estimation 24,218
Date of Issue 2023-01-13
Date of Implementation 2024-01-15
Drafting Organization Shandong Provincial Institute of Medical Devices and Drug Packaging Inspection, Zhende Medical Supplies Co., Ltd., Weihai Weigao Medical Materials Co., Ltd., Beijing Quexiang Tengfei Medical Technology Co., Ltd., Henan Yadu Industrial Co., Ltd., Jiangsu Weihu Medical Technology Co., Ltd., Hefei Gobes Medical and Sanitary Products Co., Ltd., Pujie Nonwovens (China) Co., Ltd.
Administrative Organization Shandong Institute of Medical Devices and Drug Packaging Inspection
Proposing organization State Drug Administration
Issuing agency(ies) State Drug Administration
Summary This standard specifies the general requirements for medical surgical drapes, surgical gowns and clean clothes. Including performance requirements, manufacturing requirements, post-use disposal requirements for reusable products, and information requirements provided by the manufacturer. Does not include anti-laser penetration properties, antimicrobial treatment requirements for gowns or drapes. This standard applies to medical surgical drapes, surgical gowns and clean clothes. This standard does not apply to surgical membranes.