YY/T 0506.2-2016 PDF EnglishUS$135.00 · In stock · Download in 9 seconds
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 Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Obsolete YY/T 0506.2: Historical versions
Similar standardsYY/T 0506.2-2016: Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment. Part 2: Performance requirements and test methods---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0506.2-2016 PHARMACEUTICAL INDUSTRY STANDARD ICS 11.040 C 46 Replacing YY/T 0506.2-2009, YY/T 0506.3-2005 Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment - Part 2. Performance requirements and test methods Issued on. JANUARY 26, 2016 Implemented on. JANUARY 01, 2017 Issued by. China Food and Drug Administration Table of ContentsForeword... 3 Introduction... 5 1 Scope... 6 2 Normative references... 6 3 Terms and definitions... 7 4 Performance requirements... 8 Appendix A (Normative) Test method... 11 Appendix B (Informative) Optional test method... 14 References... 16ForewordYY/T 0506 "Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment" is divided into 7 parts. - Part 1.General requirements for manufacturers processors and products; - Part 2.Performance requirements and performance levels; - Part 4.Test method for linting in the dry state; - Part 5.Test method 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. This part is part 2 of YY/T 0506. This part was drafted in accordance with the rules given in GB/T 1.1-2009. This part replaces YY/T 0506.2-2009 "Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment - Part 2.Performance requirements and test methods" and YY/T 0506.3-2005 "Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment - Part 3.Test methods”. Compared with YY/T 0506.2-2009 and YY/T 0506.3-2005, except for editorial changes, the main technical changes in this part are as follows. - COMBINE the performance requirements, performance levels, test methods into one standard; - UPDATE the normative references; - MODIFY the unit of the performance requirements for prevention of microbial penetration-dry state and cleanliness-microbial; - CHANGE the cleanliness-microbial test method to quoting YY/T 0506.7; - MODIFY the calculation formula of cleanliness-particulate matter; - ADD Appendix B optional test methods. This part was modified with reference to the test methods, performance requirements and performance levels in EN 13795.2011 "Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels". 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 shall be under the jurisdiction of the Jinan Medical Device Quality Supervision and Inspection Center of the China Food and Drug Administration. The main drafting organization of this part. Shandong Medical Device Product Quality Inspection Center. Participated drafting organization of this part. Wenjian Industrial (Shenzhen) Co., Ltd. The main drafters of this part. Yu Xiaohui, Yao Xiujun, Wang Jinhong, Zheng Duozi.1 ScopeThis part of YY/T 0506 specifies the performance requirements and test methods of surgical drapes, surgical gowns and clean air suits.2 Normative referencesThe following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) are applicable to this standard. GB/T 4744 Textile fabrics - Determination of resistance to water penetration - Hydrostatic pressure test GB/T 6529 Textiles - Standard atmospheres for conditioning and testing GB/T 7742.1 Textiles. Bursting properties of fabrics - Part 1.Hydraulic method for determination of bursting strength and bursting distension GB/T 24218.3 Textiles - Test methods for nonwovens - Part 3.Determination of tensile strength and elongation (strip method)3 Terms and definitionsThe terms and definitions as defined in YY/T 0506.1 and the following terms and definitions apply to this document. 3.1 cfu (colony forming unit) A unit for expressing the number of microorganisms that can be cultivated. 3.2 Less critical product area Areas on the product that are unlikely to spread the infectious agent to or from the wound surface, such as the back of the surgical gown. 3.3 Performance level The product is determined as the "standard" or "high performance" level according to the performance requirements of this part. Note. The YY/T 0506 series of standards introduces two performance levels to the product based on different surgical procedures, surgical time, mechanical stress, the size of the liquid to withstand. 3.4 Product Surgical gowns, surgical drapes and clean air suits. Note. For surgical kits, each surgical gown or drape is considered a product. 3.5 Sterile field The area covered by the sterile surgical drape for aseptic procedures.4 Performance requirementsThe product must comply with the YY/T 0506 series of standards. When tested according to this standard, it shall meet the requirements specified in Table 1, Table 2 or Table 3.See Appendix A for detailed information on the corresponding test method and its application.Appendix A(Normative) Test method A.1 General Unless otherwise specified, the atmosphere for pre-conditioning, conditioning and testing shall be carried out in accordance with GB/T 6529.Before the test, the sample shall be state-conditioned without restrictions. A.2 Cleanliness-microbial evaluation test method It shall follow the test method given in YY/T 0506.7 to evaluate the cleanliness- microbial. A.3 Test method for the evaluation of cleanliness-particulate matter It shall follow the test method given in YY/T 0506.4 to estimate the cleanliness- particulate matter. A.4 Test method for evaluation of lint It shall follow the test method given in YY/T 0506.4 to evaluate the lint of the product. A.5 Test method for evaluation of water permeability It shall follow the test methods as given in GB/T 4744 to evaluate the water permeability of product. The following modifications to the GB/T 4744 test apply to this part. A.6 Test method for evaluation of bursting strength in dry state and wet state ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. 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