iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
CEN

FprEN ISO 23500-5

(Main)

Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO/FDIS 23500-5:2024)

Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO/FDIS 23500-5:2024)

This document specifies the minimum chemical and microbiological quality requirements for dialysis fluids used in haemodialysis and related therapies.
This document applies to
—     dialysis fluids used for haemodialysis and haemodiafiltration,
—     substitution fluid produced online for haemodiafiltration and haemofiltration based on dialysis fluid
This document does not apply to
—     the water and concentrates used to prepare dialysis fluid or the equipment to produce dialysis fluid
—     sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid,
—     systems for continuous renal replacement therapy that use pre-packaged solutions, and
—     systems and solutions for peritoneal dialysis.
The delivery and monitoring of the dialysis fluid composition and its permitted deviation from set points is governed by protective systems defined in IEC 60601-2-16.

Herstellung und Qualitätsmanagement von Flüssigkeiten für die Hämodialyse und verwandte Therapien - Teil 5: Qualität von Flüssigkeiten für die Hämodialyse und verwandte Therapien (ISO/FDIS 23500-5:2024)

Dieses Dokument legt die Mindestanforderungen an die chemische und mikrobiologische Qualität von Dialysierflüssigkeiten fest, die bei der Hämodialyse und verwandten Therapien zum Einsatz kommen.
Dieses Dokument gilt für:
   Dialysierflüssigkeiten, die für die Hämodialyse und die Hämodiafiltration eingesetzt werden;
   online-hergestellte Substitutionsflüssigkeit für die Hämodiafiltration und die Hämofiltration, basierend auf Dialysierflüssigkeit.
Dieses Dokument gilt nicht für:
   das Wasser und die Konzentrate oder die Ausrüstung zur Herstellung der Dialysierflüssigkeit;
   Sorbent basierte Dialysierflüssigkeits-Wiederaufbereitungssysteme, in denen kleine Volumina der Dialysierflüssigkeit wiederaufbereitet und wieder in Umlauf gebracht werden;
   Systeme für die kontinuierliche Nierenersatztherapie, bei denen vorverpackte Lösungen zum Einsatz kommen; und
   Systeme und Lösungen für die Peritonealdialyse.
Die Anlieferung und Überwachung der Zusammensetzung der Dialysierflüssigkeiten und ihrer erlaubten Abweichungen von festgelegten Punkten ist in IEC 60601 2 16 festgelegt.

Préparation et management de la qualité des liquides d'hémodialyse et de thérapies annexes - Partie 5: Qualité des liquides de dialyse pour hémodialyse et thérapies apparentées (ISO/FDIS 23500-5:2024)

Le présent document spécifie les exigences minimales de qualité chimique et microbiologique pour les liquides de dialyse dans le cadre d’hémodialyses et de thérapies apparentées.
Le présent document s’applique à ce qui suit:
—     les liquides de dialyse utilisés à des fins d’hémodialyse et d’hémodiafiltration;
—     le liquide de substitution produit en ligne à des fins d’hémodiafiltration et d’hémofiltration sur la base du liquide de dialyse.
Le présent document ne s’applique pas à ce qui suit:
—     l’eau et les concentrés utilisés pour préparer le liquide de dialyse ou l’équipement permettant de produire du liquide de dialyse;
—     les systèmes de régénération de liquide de dialyse à base de sorbants qui régénèrent et recyclent de petites quantités de liquide de dialyse;
—     les systèmes d’épuration extrarénale continue qui utilisent des solutions prêtes à l’emploi; et
—     les systèmes et solutions utilisés en dialyse péritonéale.
La fourniture et la surveillance de la composition du liquide de dialyse et ses écarts admis par rapport aux points de consigne sont régis par des systèmes de protection définis dans l’IEC 60601-2-16.

Priprava in vodenje kakovosti tekočin za hemodializo in podobne terapije - 5. del: Kakovost tekočin za hemodializo in podobne terapije (ISO/FDIS 23500-5:2024)

General Information

Status
Not Published
Publication Date
17-Jun-2024
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
CEN/TC 205 - Non-active medical devices
Drafting Committee
CEN/TC 205 - Non-active medical devices
Current Stage
5060 - Closure of Vote - Formal Approval
Start Date
15-Mar-2024
Completion Date
15-Mar-2024
Ref Project
kSIST FprEN ISO 23500-5:2024 - Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO/FDIS 23500-5:2024)

Relations

Revises
EN ISO 23500-5:2019 - Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2019)
Effective Date
19-Jan-2023

Buy Standard

prEN ISO 23500-5:2023prEN ISO 23500-5:2023
PreviousNext
Draft
prEN ISO 23500-5:2023
English language
19 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 23500-5:2023
01-januar-2023
Priprava in vodenje kakovosti tekočin za hemodializo in podobne terapije - 5. del:
Kakovost tekočin za hemodializo in podobne terapije (ISO/DIS 23500-5:2022)
Preparation and quality management of fluids for haemodialysis and related therapies -
Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO/DIS 23500-
5:2022)
Herstellung und Qualitätsmanagement von Flüssigkeiten für die Hämodialyse und
verwandte Therapien - Teil 5: Qualität von Flüssigkeiten für die Hämodialyse und
verwandte Therapien (ISO/DIS 23500-5:2022)
Préparation et management de la qualité des liquides d'hémodialyse et de thérapies
annexes - Partie 5: Qualité des liquides de dialyse pour hémodialyse et thérapies
apparentées(ISO/DIS 23500-5:2022)
Ta slovenski standard je istoveten z: prEN ISO 23500-5
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
oSIST prEN ISO 23500-5:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 23500-5:2023

---------------------- Page: 2 ----------------------
oSIST prEN ISO 23500-5:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 23500-5
ISO/TC 150/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2022-11-18 2023-02-10
Preparation and quality management of fluids for
haemodialysis and related therapies —
Part 5:
Quality of dialysis fluid for haemodialysis and related
therapies
Préparation et management de la qualité des liquides d'hémodialyse et de thérapies annexes —
Partie 5: Qualité des liquides de dialyse pour hémodialyse et thérapies apparentées
ICS: 11.040.40
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 23500-5:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022

---------------------- Page: 3 ----------------------
oSIST prEN ISO 23500-5:2023
ISO/DIS 23500-5:2022(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 23500-5
ISO/TC 150/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:

Preparation and quality management of fluids for
haemodialysis and related therapies —
Part 5:
Quality of dialysis fluid for haemodialysis and related
therapies
Préparation et management de la qualité des liquides d'hémodialyse et de thérapies annexes —
Partie 5: Qualité des liquides de dialyse pour hémodialyse et thérapies apparentées
ICS: 11.040.40
This document is circulated as received from the committee secretariat.
COPYRIGHT PROTECTED DOCUMENT
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2022
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: +41 22 749 01 11
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: copyright@iso.org
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 23500-5:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
  © ISO 2022 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022

---------------------- Page: 4 ----------------------
oSIST prEN ISO 23500-5:2023
ISO/DIS 23500-5:2022(E)
Contents Page
Foreword .
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

This May Also Interest You

CEN
EN ISO 8637-1:2020(Main)
Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)
SIST EN ISO 8637-1:2020

ISO 8637-1:2017 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as "the device", for use in humans.
ISO 8637-1:2017 does not apply to:
-      extracorporeal blood circuits;
-      plasmafilters;
-      haemoperfusion devices;
-      vascular access devices;
-      blood pumps;
-      pressure monitors for the extracorporeal blood circuit;
-      air detection devices;
-      systems to prepare, maintain or monitor dialysis fluid;
-      systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration;
-      reprocessing procedures and equipment.
NOTE       Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8637‑2.

  • Standard
    30 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 7199:2017/A1:2020(Amendment)
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) - Amendment 1: Connectors (ISO 7199:2016/Amd 1:2020)
SIST EN ISO 7199:2017/A1:2020

2019-11-11-JO:  CEN/TC 205 Decision 19/2019 on delinking EN ISO 7199:2017/prA1 from MDD.
DOW = DAV + 36 months

  • Amendment
    15 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 23500-1:2019(Main)
Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements (ISO 23500-1:2019)
SIST EN ISO 23500-1:2019

1.1  General  This document is the base standard for a number of other standards dealing with water treatment equipment, water, dialysis water, concentrates, and dialysis fluid (ISO 23500 series) and provides dialysis practitioners with guidance on the preparation of dialysis fluid for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration. As such, this document functions as a recommended practice.
This document does not address clinical issues that might be associated with inappropriate usage of the water, dialysis water, concentrates, or dialysis fluid. Healthcare professionals involved in the provision of treatment for kidney failure should make the final decision regarding the applications with which these fluids are used, for example, haemodialysis, haemodiafiltration, high-flux haemodialysis, and the reprocessing of dialysers, and need to be aware of the issues that the use of inappropriate fluid quality raises in each of the therapies.
The concepts incorporated in this document should not be considered inflexible or static. The recommendations presented here should be reviewed periodically in order to assimilate increased understanding of the role of dialysis fluid purity in patient outcomes and technological developments.
1.2  Inclusions  This document addresses the user's responsibility for dialysis fluid once the equipment used in its preparation has been delivered and installed.
For the purposes of this document, dialysis fluid includes:
a)    dialysis water (see 3.17 for definition) used for the preparation of dialysis fluid and substitution fluid,
b)     dialysis water used for the preparation of concentrates at the user's facility,
c)    concentrates,
d)    the final dialysis fluid and substitution fluid.
The scope of this document includes
a)    the quality management of equipment used to treat and distribute water used for the preparation of dialysis fluid and substitution fluid, from the point at which municipal water enters the dialysis facility to the point at which the final dialysis fluid enters the dialyser or the point at which substitution fluid is infused,
b)    equipment used to prepare concentrate from powder or other highly concentrated media at a dialysis facility, and
c)    preparation of the final dialysis fluid or substitution fluid from dialysis water and concentrates.
NOTE       Because water used to prepare dialysis fluid can also be used to reprocess dialysers not marked intended for single use, this aspect of water use is also covered by this document.
1.3  Exclusions  This document does not apply to sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid, systems for continuous renal replacement therapy that use pre-packaged solutions, and systems and solutions for peritoneal dialysis.

  • Standard
    96 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 23500-3:2019(Main)
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO 23500-3:2019)
SIST EN ISO 23500-3:2019

This document specifies minimum requirements for water to be used in haemodialysis and related therapies.
This document includes water to be used in the preparation of concentrates, dialysis fluids for haemodialysis, haemodiafiltration and haemofiltration, and for the reprocessing of haemodialysers.
This document excludes the operation of water treatment equipment and the final mixing of treated water with concentrates to produce dialysis fluid. Those operations are the sole responsibility of dialysis professionals. This document does not apply to dialysis fluid regenerating systems.

  • Standard
    27 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 23500-2:2019(Main)
Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies (ISO 23500-2:2019)
SIST EN ISO 23500-2:2019

1.1  General  This document is addressed to the manufacturer and/or supplier of water treatment systems and/or devices used for the express purpose of providing water for haemodialysis or related therapies.
1.2  Inclusions  This document covers devices used to treat potable water intended for use in the delivery of haemodialysis and related therapies, including water used for:
a)    the preparation of concentrates from powder or other highly concentrated media at a dialysis facility;
b)    the preparation of dialysis fluid, including dialysis fluid that can be used for the preparation of substitution fluid;
c)    the reprocessing of dialysers intended for single use where permitted for multiple uses,
d)    the reprocessing of dialysers not specifically marked as intended for single use.
This document includes all devices, piping and fittings between the point at which potable water is delivered to the water treatment system, and the point of use of the dialysis water. Examples of the devices are water purification devices, online water quality monitors (such as conductivity monitors), and piping systems for the distribution of dialysis water.
1.3  Exclusions  This document excludes dialysis fluid supply systems that proportion water and concentrates to produce dialysis fluid, sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid, dialysis concentrates, haemodiafiltration systems, haemofiltration systems, systems that process dialysers for multiple uses, and peritoneal dialysis systems. Some of these devices, such as dialysis fluid delivery systems and concentrates, are addressed in other documents such as ISO 23500-4 and ISO 23500‑5,
This document also excludes the on-going surveillance of the purity of water used for dialysis fluid, concentrate preparation, or dialyser reprocessing which is addressed in ISO 23500‑1.

  • Standard
    43 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 23500-4:2019(Main)
Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO 23500-4:2019)
SIST EN ISO 23500-4:2019

This 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.

  • Standard
    31 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 23500-5:2019(Main)
Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2019)
SIST EN ISO 23500-5:2019

This document specifies minimum quality requirements for dialysis fluids used in haemodialysis and related therapies.
This document includes dialysis fluids used for haemodialysis and haemodiafiltration, including substitution fluid for haemodiafiltration and haemofiltration.
This document excludes the water and concentrates used to prepare dialysis fluid or the equipment used in its preparation. Those areas are covered by other International Standards.
Sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid, systems for continuous renal replacement therapy that use pre-packaged solutions, and systems and solutions for peritoneal dialysis are excluded from this document.

  • Standard
    22 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 8637-2:2018(Main)
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018)
SIST EN ISO 8637-2:2018

This document specifies requirements for the blood circuit for devices used in extracorporeal blood filtration therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration and transducer protectors (integral and non-integral) intended for use in such circuits.
This document does not apply to:
—          haemodialysers, haemodiafilters or haemofilters;
—          plasmafilters;
—          haemoperfusion devices;
—          vascular access devices;
—          blood pumps;
—          pressure monitors for the extracorporeal blood circuit;
—          air detection devices;
—          systems to prepare, maintain or monitor dialysis fluid;
—          systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration.
NOTE 1    Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637‑1, and requirements for plasmafilters are specified in ISO 8637‑3.
NOTE 2    Extracorporeal blood tubing sets can also be used for other extracorporeal therapies such as haemoperfusion, plasmafiltration and plasma adsorption.

  • Standard
    27 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 7199:2017(Main)
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016)
SIST EN ISO 7199:2017

ISO 7199:2016 specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for supply of oxygen to, and removal of carbon dioxide from, the blood of humans.
ISO 7199:2016 also applies to heat exchangers and arterial filters that are integral parts of the oxygenator.
ISO 7199:2016 also applies to external equipment unique to the use of the oxygenator.
ISO 7199:2016 does not apply to
-      implanted oxygenators,
-      liquid oxygenators,
-      extracorporeal circuits (blood tubing),
-      separate heat exchangers,
-      separate ancillary devices, and
-      separate arterial line filter.

  • Standard
    27 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
prEN ISO 7199(Main)
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO/DIS 7199:2023)
oSIST prEN ISO 7199:2023

ISO 7199:2016 specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for supply of oxygen to, and removal of carbon dioxide from, the blood of humans.
ISO 7199:2016 also applies to heat exchangers and arterial filters that are integral parts of the oxygenator.
ISO 7199:2016 also applies to external equipment unique to the use of the oxygenator.
ISO 7199:2016 does not apply to
- implanted oxygenators,
- liquid oxygenators,
- extracorporeal circuits (blood tubing),
- separate heat exchangers,
- separate ancillary devices, and
- separate arterial line filter.

  • Draft
    19 pages
    English language
    sale 10% off
    e-Library read for
    1 day