EN 13641:2002

Elimination or reduction of risk of infection related to in vitro diagnostic reagents

This standard specifies requirements related to design and manufacture in order to effectively control the risk of infection caused by in vitro diagnostic reagents including reagent products, calibrators, control materials and kits, hereinafter called IVD reagents. The standard is applicable to in vitro diagnostic reagents containing material of human origin. The standard is also applicable to in vitro diagnostic reagents containing materials obtained by biotechnology processes or materials of animal origin, in particular in view of relevant zoonoses, when the results of a risk analysis reveal that there is a risk of human infection.
The standard does not apply to the following:
   - instruments and specimen receptacles;
   NOTE 1   The prevention of infection due to handling of biological materials throughout such  equipment is addressed in other relevant International and/or European Standards.
   - general aspects of workers' protection;
   - transportation of infectious goods;
   - disposal measures.
   NOTE 2   Some of the most relevant documents relating to aspects not covered by this standard are listed in Bibliography for information.

Eliminierung oder Herabsetzung des von Reagenzien für in-vitro-diagnostische Untersuchungen ausgehenden Infektionsrisikos

Diese Norm legt Anforderungen fest bezüglich des Designs und der Herstellung, um das Infektionsrisiko durch Reagenzien für in-vitro-diagnostische Untersuchungen einschließlich Reagenzprodukten, Kalibriermaterialien, Kontrollmaterialien und Kits, nachstehend IVD-Reagenzien genannt, wirksam unter Kontrolle zu halten. Die Norm gilt für IVD-Reagenzien, die Material menschlichen Ursprungs enthalten. Die Norm gilt ebenfalls für IVD-Reagenzien, die mittels biotechnologischer Verfahren hergestellte Materialien oder Materialien tierischen Ursprungs enthalten, insbesondere im Hinblick auf relevante Zoonosen, wenn die Ergebnisse einer Risikoanalyse zeigen, dass ein Infektionsrisiko für Menschen besteht.
Die Norm gilt nicht für
¾ Geräte und Probengefäße;
ANMERKUNG 1   Die Verhütung einer Infektion durch Handhabung biologischer Materialien mittels solcher Ausrüstungsgegenstände wird in anderen relevanten Internationalen und/oder Europäischen Normen angesprochen.
¾ allgemeine Gesichtspunkte des Arbeitsschutzes;
¾ Transport von infektiösen Materialien;
¾ Entsorgungsmaßnahmen.
ANMERKUNG 2   Einige der wichtigsten Dokumente, die sich auf von dieser Norm nicht erfasste Aspekte beziehen, sind zur Information in den Literaturhinweisen aufgelistet.

Elimination ou réduction du risque d'infection relatif aux réactifs de diagnostic in vitro

La présente Norme européenne spécifie les exigences relatives à la conception et la fabrication afin de maîtriser efficacement le risque d'infection inhérent aux réactifs de diagnostic in vitro, y compris les produits réactifs, étalons, matériels de contrôle et trousses de réactifs, appelés ci-après réactifs DIV. La présente norme s'applique aux réactifs de diagnostic in vitro contenant des matières d'origine humaine. Elle est également applicable aux réactifs de diagnostic in vitro contenant des matières obtenus par des processus de biotechnologie ou des matières d'origine animale, particulièrement dans l'optique de zoonoses significatives, lorsque les résultats d'une analyse des risques révèlent l'existence d'un risque d'infection humaine.
La norme ne s'applique pas aux éléments suivants :
¾ instruments et matériel de collecte de prélèvements ;
NOTE 1   La prévention des infections provoquées par la manipulation de matières biologiques au moyen de ces équipements est abordée dans d'autres normes internationales et/ou européennes appropriées.
¾ aspects généraux concernant la protection des travailleurs ;
¾ transport des produits infectieux ;
¾ mesures d'élimination.
NOTE 2   Certains des documents les plus pertinents concernant les aspects non couverts par la présente norme sont énumérés dans la bibliographie à titre d'information.

Izločitev ali zmanjšanje tveganja okužbe v povezavi z diagnostičnimi reagenti in vitro

General Information

• Status: Published
• Publication Date: 07-May-2002
• ICS: 11.100 - Laboratory medicine
• Technical Committee: CEN/TC 140 - In vitro diagnostic systems
• Drafting Committee: CEN/TC 140/WG 2 - Quality systems for IVD MDs
• Current Stage: 9060 - Closure of 2 Year Review Enquiry - Review Enquiry
• Start Date: 02-Sep-2025
• Completion Date: 02-Sep-2025
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
• Mandate: M/252 - Standardization Mandate to CEN/CENELEC concerning the development of European standards relating to in vitro diagnostic medical devices
• Ref Project: SIST EN 13641:2002 - Elimination or reduction of risk of infection related to in vitro diagnostic reagents

Overview

EN 13641:2002 (CEN) specifies requirements for the design and manufacture of in vitro diagnostic reagents (IVD reagents) to eliminate or reduce the risk of infection. It applies mainly to reagents that contain human-derived material, and-where a risk analysis shows potential human infection-also to materials from biotechnology processes or animal origin (including relevant zoonoses). The standard supports essential requirements of EU Directive 98/79/EC and complements other safety and transport rules.

Key Topics and Requirements

• Scope and exclusions
  • Applies to reagent products, calibrators, control materials and kits (IVD reagents).
  • Does NOT apply to instruments, specimen receptacles, general worker protection, transportation of infectious goods, or disposal measures.
• Rationale for use
  • Use of infectious material must be justified and documented; potentially infectious materials must be critically assessed.
• Raw material specifications
  • Define sourcing and testing requirements for any infectious or potentially infectious biological materials.
  • Document supplier, material type (blood, serum, tissue, cells), origin and purification/treatment steps.
• Testing requirements
  • Test for relevant infection markers (examples cited: HIV‑1/HIV‑2 antibodies, HCV antibodies, HBsAg).
  • Prefer CE‑marked IVD tests; use equivalent validated techniques where necessary.
  • Individual donation testing is required for human blood/plasma/serum; pooled testing only with highly sensitive methods (e.g., PCR) and justified validation.
  • Ensure traceability and consider certificates of analysis.
• Manufacturing controls
  • Apply inactivation or other measures to reduce infectivity unless product performance is compromised; provide evidence of effectiveness/limitations.
  • Implement hygiene and organisational measures to prevent secondary contamination and cross‑contamination.
  • Use appropriate containers and filling practices to avoid dissemination of agents.
• Information for users
  • Instructions for use must state which infection markers were tested and results.
  • Warnings must match the residual risk level; explicit warnings and mitigation advice are required when infectious material is intentionally present.

Applications and Users

EN 13641:2002 is used by:

• IVD manufacturers (design, quality, and regulatory teams) to define material specifications, manufacturing controls, and labeling.
• Regulatory affairs and notified bodies assessing conformity with Directive 98/79/EC.
• Quality managers and risk assessors performing supply-chain controls and validation of inactivation steps.
• Laboratories and procurement teams selecting reagents with minimized infection risk.

Related Standards

• EN 375, EN 376 (manufacturer information for IVD reagents)
• EN 12442 (animal tissues-risk analysis and controls)
• Directive 98/79/EC (in vitro diagnostic medical devices)
• WHO Laboratory Biosafety Manual and other biosafety/transport guidance (bibliography referenced in EN 13641)

Keywords: EN 13641:2002, in vitro diagnostic reagents, IVD reagents, infection risk, CEN, design and manufacture, raw material specifications, testing requirements, inactivation, Directive 98/79/EC.

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Elimination or reduction of risk of infection related to in vitro diagnostic reagentsYLWURElimination ou réduction du risque d'infection relatif aux réactifs de diagnostic in vitroEliminierung oder Herabsetzung des von Reagenzien für in-vitro-diagnostische Untersuchungen ausgehenden InfektionsrisikosTa slovenski standard je istoveten z:EN 13641:2002SIST EN 13641:2002en11.100.10In vitro diagnostic test systemsICS:SLOVENSKI
STANDARDSIST EN 13641:200201-november-2002

EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13641May 2002ICS 11.100English versionElimination or reduction of risk of infection related to in vitrodiagnostic reagentsElimination ou réduction du risque d'infection relatif auxréactifs de diagnostic in vitroEliminierung oder Herabsetzung des von Reagenzien für in-vitro-diagnostische Untersuchungen ausgehendenInfektionsrisikosThis European Standard was approved by CEN on 5 January 2002.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2002 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 13641:2002 E

The prevention of infection due to handling of biological materials throughout such equipment isaddressed in other relevant International and/or European Standards.– general aspects of workers' protection;– transportation of infectious goods;– disposal measures.NOTE 2
Some of the most relevant documents relating to aspects not covered by this standard are listed inBibliography for information.2Normative referencesThis European Standard incorporates by dated or undated reference, provisions from other publications. Thesenormative references are cited at the appropriate places in the text, and the publications are listed hereafter. Fordated references, subsequent amendments to or revisions of any of these publications apply to this EuropeanStandard only when incorporated in it by amendment or revision. For undated references the latest edition of thepublication referred to applies (including amendments).EN 375, Information supplied by the manufacturer with in vitro diagnostic reagents for professional use.EN 376, Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing.3Terms and definitionsFor the purposes of this European Standard, the following terms and definitions apply.3.1potentially infectious biological materialmaterial which might contain infectious viable transmissible agents albeit with a low probabilityNOTE
Potentially infectious biological material includes all human and all animal sourced materials, including the specimens forroutine diagnostic examination and biological materials of unknown origin.3.2infectious biological materialmaterial which is known or highly likely to contain viable microorganisms or other transmissible agents which areknown or suspected to cause disease in humansNOTE
Other transmissible agents are e.g. prions.

For the definition of an in vitro diagnostic medical device see [1].NOTE 2
In some cases a particular IVD reagent, as defined for use in human medicine, may serve also in veterinary medicine.[EN 375:2001]4Requirements related to design and manufacture4.1GeneralIn order to eliminate or reduce to a minimum the risk of infection related to IVD reagents the following aspects shallbe considered:– rationale for using infectious or potentially infectious biological material;– sourcing and testing requirements (stipulated in material specifications);– inactivation or other appropriate measures to reduce the risk of infection;– warnings to b
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