Abstract：
A Best Practice Guideline about Dialysis fluid purity was developed under the leadership of the Spanish Society of Nephrology in 2004. The second edition revised Guideline considered new evidences and International Standard. The Guideline has established recommendations for standards for preparing dialysate: water, concentrates and hemodialysis proportioning systems. This Guideline is based on the ISO13959, European Pharmacopoeia, the Real Farmacopea Española, the AAMI Standards and Recommended Practices, European Best Practice Guidelines for Haemodialysis, literature reviews, according to their level of evidence, and the opinion of the expert Spanish group. Two levels of quality of water were defined: purified water and high purified water (ultra pure) and for dialysate: ultra pure dialysate. Regular use of ultra pure dialysate is recommended for all type of hemodialysis to prevent and delay the occurrence of complications: inflammation, malnutrition, anaemia and amiloidosis. Water, concentrates and dialysate quality requirements are defined as maximum allowable contaminant levels: chemicals (4.1.2), conductivity, microbial and endotoxins (4.1.1): Monitoring frequency, maintenance and corrective actions were specified. Methods of sampling and analysis were described in appendix (anexos). For microbiological monitoring, R2A medium is recommended, incubated during 7-14 days at a temperature of 17-23°C. The dialysate quality assurance process involves all dialysis staff members and requires strict protocols. The physician in charge of hemodialysis has the ultimate responsibility for dialysate quality. All suggestions and questions about this Guideline are wellcome to www.senefro.org.
摘要：
2004年，在西班牙肾脏病学会的领导下，制定了有关透析液纯度的最佳实践指南。第二版修订的准则考虑了新的证据和国际标准。该指南为准备透析液的标准建立了建议：水，浓缩物和血液透析配比系统。本指南基于ISO13959，欧洲药典，真正的FarmacopeaEspañola,AAMI标准和推荐做法，欧洲血液透析最佳实践指南，文献综述，根据他们的证据水平,以及西班牙专家组的意见。定义了水的两个质量水平:纯净水和高纯净水(超纯),并且对于透析液:超纯透析液。建议对所有类型的血液透析定期使用超纯透析液，以预防和延迟并发症的发生：炎症，营养不良,贫血和胺样病。水,浓缩物和透析液质量要求定义为最大允许污染物水平：化学品（4.1.2），电导率，微生物和内毒素(4.1.1)：监测频率，指定了维护和纠正措施。抽样和分析方法见附录(anexos)。微生物监测，建议使用R2A培养基，在17-23°C的温度下孵育7-14天。透析液质量保证过程涉及所有透析工作人员并且需要严格的协议。负责血液透析的医师对透析液质量负有最终责任。关于本指南的所有建议和问题都请访问www。senefro.org.
