EN 13532:2002
(Main)General requirements for in vitro diagnostic medical devices for self-testing
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
Overview
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. 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.
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.
Applications
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.
Related Standards
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.
Summary
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.
Frequently Asked Questions
EN 13532:2002 is a standard published by the European Committee for Standardization (CEN). Its full title is "General requirements for in vitro diagnostic medical devices for self-testing". This standard covers: 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.
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.
EN 13532:2002 is classified under the following ICS (International Classification for Standards) categories: 11.100 - Laboratory medicine. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 13532:2002 is associated with the following European legislation: EU Directives/Regulations: 98/79/EC; Standardization Mandates: M/252. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
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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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SIST EN 13532:2002は、自己検査用の体外診断医療機器（IVD MD）の一般要求事項を定めた重要な標準です。この標準の主な目的は、製造業者が指定した用途に安全かつ適切に使用できるIVD MDの提供を保証することにあります。 この標準の範囲は明確であり、自己検査用IVD MDに関する全体的な要求事項をカバーしています。特に、性能や品質に関する基準を満たすことが重視されており、製品の安全性に対する確固たる基盤を築いています。このため、SIST EN 13532:2002は、医療機器業界における信頼性を強化する重要な役割を果たします。 さらに、標準は自己検査に特化しており、ユーザーが自宅で簡便に利用できる試験方法を提供することで、医療サービスの効率性を向上させる可能性があります。特に、近年の健康志向の高まりや、早期診断の重要性が認識される中で、この標準の重要性が増しています。 ただし、注意すべき点は、この標準が自己検査用IVD MDの医学的側面については焦点を当てていないことです。疾患に関連する診断や治療に関しては、別途のガイドラインや標準に従う必要があります。この明確な分離は、製品開発者や規制当局が特定の医療面において別の基準を設定する際の基礎として機能します。 総じて、SIST EN 13532:2002は、自己検査用IVD MDに関する信頼性と安全性を確保するための重要な指針であり、医療技術の進化とともに、その関連性は今後も高まっていくと考えられます。
The EN 13532:2002 standard focuses on establishing general requirements for in vitro diagnostic medical devices (IVD MDs) designated for self-testing, underscoring its significance within the medical device sector. This standard serves as a crucial framework to ensure that self-testing IVD MDs are not only safe but also suitable for their intended use as outlined by the manufacturer. One of the primary strengths of this standard is its comprehensive approach to safety and suitability, which is essential in a landscape where individuals increasingly conduct health assessments outside of clinical settings. By emphasizing the need for rigor in the design and performance of self-testing devices, the standard aims to bolster user confidence and promote correct usage among consumers. Additionally, its relevance cannot be overstated in today's health environment, where the demand for at-home testing solutions is on the rise. As the healthcare landscape evolves, this standard provides a necessary guideline for manufacturers to develop reliable and effective self-testing IVD MDs, contributing to better health outcomes and proactive health management among users. Overall, EN 13532:2002 stands out as a vital document in the realm of self-testing diagnostics, ensuring that manufacturers adhere to essential safety and usability principles, thus fostering innovation while maintaining public health standards.
SIST EN 13532:2002 표준은 자가 검사용 체외 진단 의료기기(IVD MD)에 대한 일반 요구 사항을 명확히 규정하고 있습니다. 이 표준의 주요 목적은 제조자가 명시한 용도에 맞춰 자가 검사용 IVD MD가 안전하고 적합하도록 보장하는 것입니다. 이 표준의 강점 중 하나는 자가 검사용 기기에 대한 포괄적인 접근 방식을 제공하여 사용자의 안전성을 최우선으로 고려한다는 점입니다. 또한, IVD MD의 설계 및 제조 과정을 체계적으로 규제하여 일관된 품질과 성능을 유지하도록 지원합니다. 이러한 점은 사용자가 제품을 신뢰하고 안전하게 사용할 수 있도록 하는 데 기여합니다. SIST EN 13532:2002의 적용 범위는 자가 검사용 IVD MD에 국한되어 있으며, 의료적 측면에 대한 규정은 포함하지 않기 때문에 사용자가 기기의 정확성과 신뢰성에 더욱 집중할 수 있도록 합니다. 이는 특히 개인이 자신의 건강을 관리하고 모니터링하는 데 중요한 요소입니다. 결론적으로, SIST EN 13532:2002 표준은 자가 검사용 체외 진단 의료기기의 신뢰성과 안전성을 높이는 데 있어 중요한 기반을 제공하며, 의료기기 산업에서의 품질 관리 기준으로서 중요한 역할을 하고 있습니다.
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