|
FORMAT
BOOKS
PACKAGES
EDITION
PUBLISHER
CONTENT TYPE
Act
Admin Code
Announcements
Bill
Book
CADD File
CAN
CEU
Charter
Checklist
City Code
Code
Commentary
Comprehensive Plan
Conference Paper
County Code
Course
DHS Documents
Document
Errata
Executive Regulation
Federal Guideline
Firm Content
Guideline
Handbook
Interpretation
Journal
Land Use and Development
Law
Legislative Rule
Local Amendment
Local Code
Local Document
Local Regulation
Local Standards
Manual
Model Code
Model Standard
Notice
Ordinance
Other
Paperback
PASS
Periodicals
PIN
Plan
Policy
Product
Program
Provisions
Requirements
Revisions
Rules & Regulations
Standards
State Amendment
State Code
State Manual
State Plan
State Standards
Statute
Study Guide
Supplement
Technical Bulletin
All
|
Description of BS EN ISO 23500-4:2019 2019This document specifies minimum requirements for concentrates used for haemodialysis and related therapies. This document is addressed to the manufacturer of such concentrates. In several instances in this document, the dialysis fluid is addressed, 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 document includes concentrates in both liquid and powder forms. It also includes additives, also called spikes, which are chemicals that can be added to the concentrate to supplement or increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid. This document also specifies requirements for equipment used to mix acid and bicarbonate powders into concentrate at the user's facility. Concentrates prepared from pre-packaged salts and water at a dialysis facility for use in that facility are excluded from the scope of this document. Although references to dialysis fluid appear herein, this document does not address dialysis fluid as made by the end user. This document also excludes requirements for the surveillance frequency of water purity used for the making of dialysis fluid by the dialysis facility. This document does not address bags of sterile dialysis fluid or sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid. This document does not cover the dialysis fluid that is used to clinically dialyse patients. Dialysis fluid is covered in ISO 23500‑5. The making of dialysis fluid involves the proportioning of concentrate and water at the bedside or in a central dialysis fluid delivery system. Although the label requirements for dialysis fluid are placed on the labelling of the concentrate, it is the user's responsibility to ensure proper use. This document does not cover haemodialysis equipment, which is addressed in IEC 60601‑2‑16:2012.
About BSIBSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses. |
GROUPS
|
|
MADCAD.com
by Compu-tecture, Inc.
|
Contact Us
3000 Connecticut Ave, NW
Suite 200
Washington, DC 20008
+1 800.798.9296
+1 202.265.1940
|
|
Partnerships
|