GB 15979-2002 一次性使用卫生用品卫生标准
代替GB 15979-1995 一次性使用卫生用品卫生标准 (word格式,已作废)
本标准规定了一次性使用卫生用品的产品和生产环境卫生标准、消毒效果生物监测评价标准和相应检验方法,以及原料与产品生产、消毒、贮存、运输过程卫生要求和产品标识要求。
在本标准中,一次性使用卫生用品是指:本标准适用于国内从事一次性使用卫生用品的生产与销售的部门、单位或个人,也适用于经销进口一次性使用卫生用品的部门、单位或个人。
3.5 经环氧乙烷消毒的卫生用品出厂时,环氧乙烷残留量必须≤250μg/g。
Chromosorb 101 HP 60~80目;玻璃柱长2m,f 3 mm
浩瀚色谱(山东)应用技术开发有限公司建立顶空气相色谱测定一次性医疗用品中环氧乙烷残留量的方法。方法:取适量样品置于顶空瓶中,60℃恒温水浴中平衡60 min,取液上气1.0 ml进行气相色谱分析测定。结果:方法在线性范围98.3μg~491.2μg内呈良好线性关系(r=0.9999),*低检出浓度为0.1μg/g,相对标准偏差为2.3%~5.5%。结论:该方法简单、可靠,适用于一次性医疗用品中环氧乙烷残留的测定。
此柱柱效高,峰型对称,分离好,结果满意。
GB 15979-2002 Hygiene Standard for Disposable Hygiene Products
Replaces GB 15979-1995 Hygiene Standard for Disposable Hygiene Products (word format, obsolete)
This standard specifies product and production environment sanitation standards for disposable sanitary products, biological monitoring and evaluation standards for disinfection effects and corresponding inspection methods, as well as hygienic requirements and product identification requirements during the production, disinfection, storage, and transportation of raw materials and products.
In this standard, single-use sanitary products refer to: This standard applies to domestic departments, units or individuals engaged in the production and sales of single-use sanitary products, and also applies to departments, units or individuals that distribute imported single-use sanitary products. personal.
3.5 When the sanitary products sterilized by ethylene oxide leave the factory, the residual amount of ethylene oxide must be less than or equal to 250μg/g.
Chromosorb 101 HP 60~80 mesh; glass column length 2m, f 3 mm
Haohan Chromatography (Shandong) Application Technology Development Co., Ltd. established a method for the determination of ethylene oxide residues in disposable medical supplies by headspace gas chromatography. Methods: Take an appropriate amount of samples and put them in a headspace bottle, equilibrate in a constant temperature water bath at 60 ℃ for 60 min, and take 1.0 ml of liquid to carry out gas chromatography analysis and determination. Results: The method showed a good linear relationship within the linear range of 98.3μg~491.2μg (r=0.9999), the lowest detection concentration was 0.1μg/g, and the relative standard deviation was 2.3%~5.5%. Conclusion: The method is simple, reliable, and suitable for the determination of ethylene oxide residues in disposable medical products.
The column has high efficiency, good separation and satisfactory results.