EN 13867:2002/prA1

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
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• ICS: 11.120.99 - Other standards related to pharmaceutics
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205/WG 11 - Transfusion, infusion and injection equipment
• Current Stage: 5060 - Closure of Vote - Formal Approval
• Start Date: 15-Apr-2009
• Completion Date: 15-Apr-2009
• 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
• Directive: 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: SIST EN 13867:2003/kprA1:2009 - Concentrates for haemodialysis and related therapies

Relations

• Merged Into: EN 13867:2002+A1:2009 - Concentrates for haemodialysis and related therapies
• Effective Date: 29-Apr-2009
• Amends: EN 13867:2002 - Concentrates for haemodialysis and related therapies
• Effective Date: 22-Dec-2008

Overview

EN 13867:2002/prA1 (Concentrates for haemodialysis and related therapies) is a CEN draft amendment prepared by Technical Committee CEN/TC 205 “Non‑active medical devices”. The prA1 amendment (January 2009) updates the original European Standard on concentrates used to produce dialysis fluids and-critically-replaces Annex ZA to clarify the standard’s relationship with the EU Medical Devices Directive 93/42/EEC. This draft amendment was submitted for unique acceptance and, until formally adopted and published, remains a review document.

Key topics and requirements

• Scope and subject matter: Focuses on concentrates for haemodialysis and related therapies (liquid or powder concentrates used to prepare dialysis fluid).
• Regulatory linkage: Annex ZA provides the mapping between clauses of EN 13867 and the Essential Requirements of Directive 93/42/EEC, establishing a presumption of conformity when the standard is cited in the Official Journal and implemented nationally.
• Amendment content: prA1 replaces the existing Annex ZA with an updated correspondence table that identifies which clauses of EN 13867 address specific essential requirements of the Directive.
• Normative status: The document was prepared under mandate from the European Commission and EFTA; once cited and adopted nationally, compliance with the specified clauses helps demonstrate conformity with EU regulatory requirements.
• Languages and adoption: The draft exists in English, French and German and can be translated by CEN members for national implementation (example: SIST EN 13867:2003/kprA1:2009 for Slovenia).

Applications and who uses this standard

This standard and its amendment are used by:

• Manufacturers and suppliers of haemodialysis concentrates to design, label and document products in line with EU requirements.
• Regulatory affairs and quality managers to prepare conformity assessment documentation referencing the standard.
• Notified bodies and conformity assessors when evaluating compliance with Directive 93/42/EEC for dialysis‑related products.
• Clinical engineering, procurement teams and hospitals to verify that supplied concentrates meet recognized European standardization practices.
• Testing laboratories that assess product characteristics in support of regulatory submissions.

Related standards

• Other CEN standards for medical devices and non‑active medical devices may apply. Annex ZA and the amendment explicitly warn that other EU Directives or standards may also be relevant to products within the scope.

Keywords: EN 13867:2002/prA1, concentrates for haemodialysis, dialysis concentrate standard, CEN/TC 205, Annex ZA, 93/42/EEC, medical devices conformity.

Standards Content (Sample)

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

Contents Page
Foreword .3
1 Modification to Annex ZA .
...