ISO 13958:2014
血液透析和相关治疗用浓缩液
Concentrates for haemodialysis and related therapies
ISO 13958:2014 发布历史
This International Standard specifies minimum requirements for concentrates used for haemodialysis and related therapies. For the purpose of this International Standard, “concentrates” are a mixture of chemicals and water, or chemicals in the form of dry powder or other highly concentrated media, that are delivered to the end user to make dialysis fluid used to perform haemodialysis and related therapies. This International Standard is addressed to the manufacturer of such concentrates. In several instances in this International Standard, it became necessary to address the dialysis fluid, which is made by the end user, to help clarify the requirements for manufacturing concentrates. Because the manufacturer of the concentrate does not have control over the final dialysis fluid, any reference to dialysis fluid is for clarification and is not a requirement of the manufacturer. This International Standard includes concentrates in both liquid and powder forms. Also included are additives, also called spikes, which are chemicals that may be added to the concentrate to increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid. This International Standard also gives requirements for equipment used to mix acid and bicarbonate powders into concentrate at the user’s facility. Concentrates prepared from prepackaged salts and water at a dialysis facility for use in that facility are excluded from the scope of this International Standard. Although references to dialysis fluid appear herein, this International Standard does not address dialysis fluid as made by the end user. Also excluded from the scope of this International Standard are requirements for the monitoring frequency of water purity used for the making of dialysis fluid by the dialysis facility. Recommendations from the technical committee responsible for this International Standard for monitoring water quality are contained in fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid.
ISO 13958:2014由国际标准化组织 IX-ISO 发布于 2014-04。
ISO 13958:2014在国际标准分类中归属于: 11.040.20 输血、输液和注射设备,11.040.40 外科植入物、假体和矫形。
ISO 13958:2014 发布之时，引用了标准
- IEC 60601-1:2005 医用电气设备.第1部分:基本安全和基本性能的一般要求
- IEC 60601-2-16:2012 医用电气设备.第2-16部分:血液透析、血液透析滤过和血液滤过设备的基本安全和主要性能的特殊要求
- IEC 61010-1:2010 测量、控制和实验室用电气设备的安全性要求.第1部分：一般要求
- ISO 11663:2014 血液透析及相关治疗用透析液的质量
- ISO 13959:2014 血液透析及相关疗法用水
- ISO 14971:2007 医疗装置.医疗装置风险管理的应用
- ISO 15223-1:2012 医疗器械.用于医疗器械标签、作标记和提供信息的符号.第1部分:通用要求
- ISO 23500:2014 血液透析和相关治疗方法用流体的制备和质量管理指南
ISO 13958:2014的历代版本如下：
- 2014年 ISO 13958:2014 血液透析和相关治疗用浓缩液
- 2009年 ISO 13958:2009 血液透析和相关治疗用浓缩物
- 2002年 ISO 13958:2002 血液透析和相关治疗的浓缩物
- 标准号
- ISO 13958:2014
- 发布
- 2014年
- 发布单位
- 国际标准化组织
- 当前最新
- ISO 13958:2014
- 引用标准
- IEC 60601-1:2005 IEC 60601-2-16:2012 IEC 61010-1:2010 ISO 11663:2014 ISO 13959:2014 ISO 14971:2007 ISO 15223 AMD 1:2002 ISO 15223 AMD 2:2004 ISO 15223-1:2012 ISO 23500:2014
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