iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
SIST

SIST EN 13867:2003/kprA1:2009

(Amendment)

Concentrates for haemodialysis and related therapies

Concentrates for haemodialysis and related therapies

Konzentrate für die Hämodialyse und verwandte Therapien

Concentrés pour hémodialyse et thérapies associées

Koncentrati za hemodializo in podobne terapije

General Information

Status
Not Published
Public Enquiry End Date
09-Apr-2009
ICS
11.120.99 - Other standards related to pharmaceutics
Technical Committee
VAZ - Healthcare
Current Stage
98 - Abandoned project (Adopted Project)
Start Date
11-May-2012
Due Date
16-May-2012
Completion Date
11-May-2012
Directive
2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
EN 13867:2002/prA1 - Concentrates for haemodialysis and related therapies

Relations

Amends
SIST EN 13867:2003 - Concentrates for haemodialysis and related therapies
Effective Date
01-Apr-2009
Consolidated By
SIST EN 13867:2003+A1:2009 - Concentrates for haemodialysis and related therapies
Effective Date
18-Jan-2023
Consolidated By
SIST EN 13867:2003+A1:2009 - Concentrates for haemodialysis and related therapies
Effective Date
19-Jan-2023
Consolidated By
SIST EN 13867:2003+A1:2009 - Concentrates for haemodialysis and related therapies
Effective Date
01-Oct-2009

Buy Standard

EN 13867:2003/kprA1:2009EN 13867:2003/kprA1:2009
PreviousNext
Draft
EN 13867:2003/kprA1:2009
English language
5 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 13867:2003/kprA1:2009
01-april-2009
Koncentrati za hemodializo in podobne terapije
Concentrates for haemodialysis and related therapies
Konzentrate für die Hämodialyse und verwandte Therapien
Concentrés pour hémodialyse et thérapies associées
Ta slovenski standard je istoveten z: EN 13867:2002/prA1
ICS:
11.120.99 Drugi standardi v zvezi s Other standards related to
farmacijo pharmaceutics
SIST EN 13867:2003/kprA1:2009 en,fr
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN 13867:2003/kprA1:2009

---------------------- Page: 2 ----------------------

SIST EN 13867:2003/kprA1:2009
EUROPEAN STANDARD
FINAL DRAFT
EN 13867:2002
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA1
January 2009
ICS 11.120.99

English Version
Concentrates for haemodialysis and related therapies
Concentrés pour hémodialyse et thérapies associées Konzentrate für die Hämodialyse und verwandte Therapien
This draft amendment is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee
CEN/TC 205.
This draft amendment A1, if approved, will modify the European Standard EN 13867:2002. If this draft becomes an amendment, CEN
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this amendment
into the relevant national standard without any alteration.
This draft amendment was established by CEN in three official versions (English, French, German). A version in any other language made
by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same
status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 13867:2002/prA1:2009: E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST EN 13867:2003/kprA1:2009
EN 13867:2002/prA1:2009 (E)
Contents Page
Foreword .3
1 Modification to Annex ZA .
...

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

SIST
SIST EN ISO 22413:2021(Main)
Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO 22413:2021)
EN ISO 22413:2021

This document specifies requirements and test methods for sterilized single-use transfer sets that are used for pharmaceutical preparations.

  • Standard
    23 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    19 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST 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)
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
SIST
SIST 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)
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
SIST
SIST 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)
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
SIST
SIST 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)
EN ISO 23500-2:2019

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.

  • Standard
    43 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST 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)
EN ISO 23500-1:2019

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.

  • Standard
    96 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    104 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 22413:2021(Main)
Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO 22413:2021)
EN ISO 22413:2021

This document specifies requirements and test methods for sterilized single-use transfer sets that are used for pharmaceutical preparations.

  • Standard
    23 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    19 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 21976:2020(Main)
Packaging - Tamper verification features for medicinal product packaging (ISO 21976:2018)
EN ISO 21976:2020

This document specifies requirements and provides guidance for the application, use and check of tamper verification features to the packaging of medicinal products.

  • Standard
    25 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    22 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST 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)
EN ISO 23500-2:2019

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.

  • Standard
    43 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST 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)
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