SIST EN 13532:2002

General requirements for in vitro diagnostic medical devices for self-testing

This standard specifies general requirements for in vitro diagnostic medical devices (IVD MDs) for self-testing in order to ensure that IVD MDs for self-testing are safe and suitable for the purposes as specified by the manufacturer.
This standard does not address medical aspects of IVD MDs for self-testing.

Allgemeine Anforderungen an In-vitro-Diagnostika zur Eigenanwendung

Diese Europäische Norm legt allgemeine Anforderungen an In-vitro-Diagnostika zur Eigenanwendung fest. Sie soll sicherstellen, dass In-vitro-Diagnostika zur Eigenanwendung sicher und für die vom Hersteller angegebenen Zwecke geeignet sind.
Diese Norm behandelt keine medizinischen Aspekte von In-vitro-Diagnostika zur Eigenanwendung.

Exigences générales relatives aux dispositifs médicaux de diagnostic in vitro pour auto-test

La présent Norme européenne spécifie les exigences générales relatives aux dispositifs médicaux de diagnostic in vitro (DM - DIV) pour auto-test, afin de s'assurer que les DMs - DIV pour auto-test sont sûrs et adaptés aux besoins, comme spécifié par le fabricant.
La présente norme n'aborde pas les aspects médicaux des DMs - DIV pour auto-test.

Splošne zahteve za diagnostične pripomočke in vitro za samopreskušanje

General Information

• Status: Published
• Publication Date: 31-Oct-2002
• ICS: 11.100.10 - In vitro diagnostic test systems
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 01-Nov-2002
• Due Date: 01-Nov-2002
• Completion Date: 01-Nov-2002
• 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: EN 13532:2002 - General requirements for in vitro diagnostic medical devices for self-testing

Overview

SIST EN 13532:2002 is a European standard developed by CEN that specifies the general requirements for in vitro diagnostic medical devices (IVD MDs) intended for self-testing. The main goal of this standard is to ensure that IVD MDs designed for use by lay persons outside professional healthcare settings are both safe and suitable for their intended purposes, as specified by the manufacturer.

This standard focuses on the design, marking, user instructions, performance, and safety aspects specifically for self-testing devices. It does not cover the medical aspects or clinical performance evaluations of the devices. SIST EN 13532:2002 supports compliance with EU Directive 98/79/EC on in vitro diagnostic medical devices, providing manufacturers and regulatory bodies with a clear framework to ensure product safety and usability for non-professional users.

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Key Topics

• Scope and Terms
  Defines the intended use of IVD MDs for self-testing by lay persons and establishes key definitions such as “lay person” and “self-testing”.

• Design Criteria
  Emphasizes ergonomic and human factor considerations to ensure ease of use. This includes:

  • Identification of intended users
  • User-friendly operation and maintenance
  • Readability and interpretation of results
  • Handling foreseeable environmental and user errors

  Electrical safety, mechanical resistance, electromagnetic compatibility, and environmental resistance are also integral design requirements.

• Risk Analysis
  Manufacturers must conduct risk assessments considering factors such as misuse, user skill limitations, performance limitations, environmental conditions, and disposal methods.

• Markings and Information
  Devices must bear clear markings including the intended purpose and instructions for use, following relevant standards (e.g., EN 1658 for instruments and EN 376 for reagents). Instructions should be easy to understand to guide lay users correctly.

• Performance Evaluation and User Verification
  Performance standards per EN 13612 apply. Users, where possible, should be able to verify correct device function and test execution at the time of use to avoid erroneous results.

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Applications

SIST EN 13532:2002 applies to a wide range of self-testing in vitro diagnostic devices used by individuals in home or similar environments. Common applications include:

• Blood glucose monitors for diabetes management
• Pregnancy test kits
• Home cholesterol or lipid testing devices
• Self-administered infectious disease screening tests

By adhering to EN 13532, manufacturers can ensure their self-testing devices provide reliable and safe results, empowering patients and consumers to manage their health with confidence.

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Related Standards

SIST EN 13532:2002 references and aligns with several harmonized European and international standards, including:

• EN 376 – Information supplied by manufacturers with self-testing reagents
• EN 592 – Instructions for use for self-testing diagnostic instruments
• EN 1658 – Marking requirements for in vitro diagnostic instruments
• EN 13612 – Performance evaluation of in vitro diagnostic medical devices
• EN 61010-1 – Safety requirements for electrical equipment for laboratory use
• EN 61326 – EMC requirements for measurement and control equipment
• EN 1441 – Medical devices risk analysis guidelines
• ISO 14971 – Risk management for medical devices

Manufacturers intending to place IVD self-testing devices on the European market can leverage EN 13532 in conjunction with these standards to satisfy regulatory requirements and demonstrate conformity to the EU directive.

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Summary

SIST EN 13532:2002 provides essential general requirements for safe and user-friendly in vitro diagnostic self-testing devices, balancing technical performance with usability for non-professional users. Compliance with this standard supports regulatory approval and promotes consumer trust by ensuring devices are designed to minimize risks, clearly labeled, and easy to operate in everyday environments. This makes it a critical reference for manufacturers, regulators, and healthcare professionals involved in self-testing medical device development and oversight.

Keywords: EN 13532, in vitro diagnostic, self-testing devices, IVD MD safety, medical device standards, EU Directive 98/79/EC, medical device risk analysis, user instructions, diagnostic device design, manufacturer requirements.

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.General requirements for in vitro diagnostic medical devices for self-testingãDQMHExigences générales relatives aux dispositifs médicaux de diagnostic in vitro pour auto-testAllgemeine Anforderungen an In-vitro-Diagnostika zur EigenanwendungTa slovenski standard je istoveten z:EN 13532:2002SIST EN 13532:2002en11.100.10In vitro diagnostic test systemsICS:SLOVENSKI
STANDARDSIST EN 13532:200201-november-2002

EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13532April 2002ICS 11.100English versionGeneral requirements for in vitro diagnostic medical devices forself-testingExigences générales relatives aux dispositifs médicaux dediagnostic in vitro destinés à des auto-diagnosticsAllgemeine Anforderungen an In-vitro-Diagnostika zurEigenanwendungThis European Standard was approved by CEN on 27 December 2001.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 13532:2002 E

A specimen receptacle, whether vacuum-type or not, specifically intended by its manufacturer for the primary containmentand preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination is considered to be anin vitro diagnostic medical device.NOTE 2
Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of theircharacteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination.3.2lay personindividual who does not have specific medical education[EN 376:2002]3.3markinginscription, in writing or as a graphical symbol, permanently affixed to a productNOTE
Examples for inscriptions are manufacturer’s or distributor’s trademark, model or type number, identification of intendedfunctions, supply voltage, particular warnings.
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