標(biāo)準(zhǔn)編號(hào):	YY/T 0506.2-2016
中文名稱:	病人、醫(yī)護(hù)人員和器械用手術(shù)單、手術(shù)衣和潔凈服 第2部分：性能要求和試驗(yàn)方法
英文名稱:	Surgical drapes，gowns and clean air suits for patients， clinical staff and equipment- Part 2:Performance requirements and test methods
行業(yè)分類:	YY    醫(yī)藥行業(yè)標(biāo)準(zhǔn)
發(fā)布機(jī)構(gòu):	國(guó)家食品藥品監(jiān)督管理總局
發(fā)布日期:	2016-01-26
實(shí)施日期:	2017-1-1
標(biāo)準(zhǔn)狀態(tài):	superseded
被新標(biāo)準(zhǔn)替代:	YY/T 0506.1-2023 醫(yī)用手術(shù)單、手術(shù)衣和潔凈服 第1部分：通用要求
被替代日期:	2024-1-15
替代舊標(biāo)準(zhǔn):	YY/T 0506.2-2009 病人、醫(yī)護(hù)人員和器械用手術(shù)單、手術(shù)衣和潔凈服　第2部分：性能要求和性能水平 YY/T 0506.3-2005 病人、醫(yī)護(hù)人員和器械用手術(shù)單、手術(shù)衣和潔凈服 第3部分：試驗(yàn)方法
翻譯語言:	英文
文件格式:	PDF
中文字符數(shù):	11000 字
翻譯價(jià)格(元):	300.0
交付時(shí)間:	付款后 1 個(gè)工作日

Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment— Part 2: Performance requirements and test methods 1 Scope This part of YY/T 0506 specifies the performance requirements and test methods for surgical drapes, gowns and clean air suits. 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 4744 Textile fabrics—Determination of resistance to water penetration—Hydro static 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) YY/T 0506.1 Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment—Part 2: Performance requirements and test methods YY/T 0506.4 Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment—Part 4: Test method for linting in the dry state YY/T 0506.5 Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment—Part 5: Test method for resistance to dry microbial penetration YY/T 0506.6 Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment—Part 6: Test method to determine the resistance to wet bacterial penetration YY/T 0506.7 Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment—Part 7: Test methods for determination of cleanliness-microbial 3 Terms and definitions For the purposes of this standard, the terms and definitions specified in YY/T 0506.1 as well as the followings apply. 3.1 cfu (colony forming unit) unit by which the culturable number of microorganisms is expressed Note: The culturable number is the number of microorganisms, single cells or aggregates, able to form colonies on solid nutrient medium. 3.2 less critical product area product area with less likely to be involved in the transfer of infective agents to or from the wound, e.g. back of surgical gowns Note 1: See YY/T 0506.1 for the definition of critical product area. Note 2: If the manufacturer distinguishes between critical product area and less critical product area, the manufacturer is required by YY/T 0506.1 to identify these areas and provide explanatory information on the difference upon request. For additional information, see YY/T 0506.1. 3.3 performance level discrete standard defined to classify products according to the performance requirements of this part Note: Within the introduction of two performance levels, YY/T 0506 series standards acknowledge the fact that products are challenged to differing extents during surgical procedures, dependent upon the duration, mechanical stress and liquid challenge.

Foreword i Introduction iii 1 Scope 2 Normative references 3 Terms and definitions 4 Performance requirements Annex A (Normative) Test methods Annex B (Informative) Optional test methods Bibliography