98/79/EC - In vitro diagnostic medical devices
Directive 98/79/EC establishes harmonised rules for in vitro diagnostic medical devices (IVDs) within the European Union to ensure their safety, health protection, and performance, thereby facilitating their free movement in the internal market. It covers all devices intended for in vitro examination of human specimens for medical purposes, excluding products for general laboratory use unless specifically designed for diagnostic purposes. The Directive defines essential requirements relating to design, manufacture, and packaging, including risk minimisation, with conformity assessed through specified procedures that may involve notified bodies depending on the device’s risk class. It mandates CE marking for compliant devices, enables market surveillance and vigilance reporting, and requires manufacturers to notify authorities about new products. The Directive also addresses particularities such as devices emitting ionising radiation and includes provisions for accessories, self-testing devices, and performance evaluation systems. It harmonises regulations to remove trade barriers, protects patient and user health, and aligns with wider Community legislation on medical devices, while allowing Member States to maintain public health measures consistent with EU law.
Purpose
Directive 98/79/EC of 27 October 1998 aims to harmonize laws relating to in vitro diagnostic medical devices (IVDs) across the European Union. The Directive ensures the free movement of IVDs within the internal market while providing a high level of health protection for patients, users, and third parties. It establishes essential safety, health protection, and performance requirements for IVD devices, thereby removing trade barriers caused by differing national regulations. The Directive also aligns with the EU’s broader medical devices regulatory framework, complementing Directives 90/385/EEC and 93/42/EEC.
Key Obligations
Scope and Definitions: The Directive applies to in vitro diagnostic medical devices and their accessories. It defines IVDs as devices intended for in vitro examination of specimens derived from the human body-such as blood or tissue donations-used for providing medical information related to physiological or pathological states, congenital abnormalities, recipient safety, or therapeutic monitoring.
Essential Requirements: Manufacturers must design and manufacture devices to meet essential safety and performance requirements. These include minimizing health risks and ensuring devices perform as intended throughout their lifetime.
Conformity Assessment: Devices are classified into two main product classes based on their risk. Low-risk devices may undergo conformity assessment primarily under manufacturer responsibility, while higher-risk devices (especially those for blood transfusion, AIDS and hepatitis prevention) require third-party assessment by notified bodies.
CE Marking: Devices which comply with the Directive must bear the CE marking, indicating conformity and allowing free market access within the EU.
Manufacturer Responsibilities: Manufacturers are responsible for design, manufacture, packaging, labeling, and ensuring compliance with the Directive. Those placing devices on the market under their own name also bear these obligations.
Authorized Representatives: Manufacturers without a Community establishment must designate an authorized representative within the EU to act on their behalf in relation to the Directive.
Vigilance and Market Surveillance: Member States must ensure market surveillance and have systems for adverse incident reporting (‘vigilance procedures’) to monitor device safety and performance post-market.
Harmonized Standards and Common Technical Specifications: The Directive encourages the use of harmonized European standards and common technical specifications to aid conformity assessment and risk prevention.
Exclusions and Specific Provisions: Reagents produced and used within health institution laboratories for in-house use are exempt. The Directive also includes requirements related to devices emitting ionizing radiation but does not affect radiation protection standards established under other EU legislation.
Amendments and Updating Procedures: The list of devices requiring third-party assessment and other technical provisions are subject to updating through the Commission’s empowered legislative procedures to reflect technological progress.
Affected Products and Actors
In Vitro Diagnostic Medical Devices: This covers reagents, control materials, calibrators, kits, instruments, apparatus, equipment, and systems used for in vitro examination of human-derived specimens for diagnostic purposes.
Accessories: Articles specifically intended to be used together with an IVD device to enable its use, considered devices in their own right under the Directive.
Manufacturers: Natural or legal persons responsible for design, manufacturing, packaging, labeling, and placing devices on the market under their name.
Authorized Representatives: Entities established in the EU designated by manufacturers to fulfill obligations under the Directive.
Notified Bodies: Third-party organizations designated by Member States to perform conformity assessment tasks for higher risk devices.
Competent Authorities: National bodies responsible for market surveillance, enforcement, and coordination with other Member States and the Commission.
Implementation Timeline
The Directive was adopted on 27 October 1998.
Member States were required to adopt and publish the laws, regulations, and administrative provisions necessary to comply with the Directive and to bring those provisions into force within a deadline set by the Directive-typically within two years from its adoption, though specific implementation dates may vary by Member State.
Devices compliant with the Directive could then bear the CE marking and be placed on the market throughout the EU.
Subsequent updates and amendments have been enacted to keep the rules aligned with technological and scientific advances, and to prepare for transition to the EU Regulation on in vitro diagnostic medical devices (IVDR 2017/746) which supersedes this Directive as of May 2022.
This Directive applies to in vitro diagnostic medical devices and their accessories intended by the manufacturer to be used in vitro for the examination of specimens derived from the human body, including blood and tissue donations, primarily to provide information concerning physiological or pathological states, congenital abnormalities, safety and compatibility with recipients, or to monitor therapeutic measures. The scope includes reagents, reagent products, calibrators, control materials, kits, instruments, apparatus, equipment, systems, and specimen receptacles specifically designed for in vitro diagnostic examination. Accessories intended to be used together with such devices are also included. The Directive excludes products for general laboratory use unless specifically intended for in vitro diagnostics, devices used solely for research without medical objectives, reagents produced and used within health-institution laboratories without commercial transactions, and invasive sampling devices covered under other directives. It covers devices for professional use as well as those intended for self-testing by laypersons in the home environment.
Die Richtlinie 98/79/EG regelt die Vereinheitlichung der Vorschriften für In-vitro-Diagnostika innerhalb des Europäischen Binnenmarktes, um einen freien Warenverkehr unter optimalen Sicherheitsbedingungen zu gewährleisten. Sie legt Mindestanforderungen an Sicherheit, Gesundheitsschutz und Leistungsmerkmale solcher Produkte fest und richtet sich an Hersteller, Behörden und benannte Stellen. Die Richtlinie definiert In-vitro-Diagnostika als Medizinprodukte, die zur Untersuchung von Proben menschlichen Ursprungs für medizinische Zwecke verwendet werden. Sie umfasst auch Zubehör und bestimmt Konformitätsbewertungsverfahren sowie Anforderungen an Kennzeichnung und Marktüberwachung. Besonderer Schutz gilt Produkten, die in der Blutversorgung und bei der Prävention von Infektionskrankheiten eingesetzt werden. Die Vorschriften dienen dem Schutz von Patienten, Anwendern und Dritten und verpflichten zur Zusammenarbeit der Mitgliedstaaten. Forschungstools ohne medizinischen Zweck sowie in-house hergestellte Reagenzien sind ausgenommen. Damit trägt die Richtlinie zur Harmonisierung und Verbesserung der Qualität und Sicherheit von Diagnostika in der EU bei und ist Voraussetzung für das Inverkehrbringen dieser Produkte im Binnenmarkt.
Zweck
Die Richtlinie 98/79/EG hat zum Ziel, den freien Verkehr von In-vitro-Diagnostika (IVD) innerhalb des Europäischen Binnenmarktes sicherzustellen und dabei einen hohen Schutz für Patienten, Anwender und Dritte zu gewährleisten. Sie harmonisiert die unterschiedlichen nationalen Vorschriften der Mitgliedstaaten bezüglich Sicherheit, Gesundheits- und Leistungsanforderungen sowie Zulassungsverfahren für IVD-Produkte. Dies dient der Beseitigung von Handelshemmnissen im Gemeinschaftsgebiet bei gleichzeitigem Erhalt oder der Verbesserung des erreichten Gesundheitsniveaus. Die Grundlage bilden Mindestanforderungen, die an den Stand von Technik und medizinischer Praxis angeglichen werden.
Wesentliche Verpflichtungen
Erfüllung grundlegender Sicherheits- und Leistungsanforderungen: Hersteller müssen gewährleisten, dass IVD-Produkte sicher sind und ihre vom Hersteller angegebenen Leistungen erfüllen. Dies schließt die Minimierung von Risiken entsprechend dem Stand der Technik ein.
Konformitätsbewertung und CE-Kennzeichnung: Produkte müssen einem Konformitätsbewertungsverfahren unterzogen werden, das je nach Risikoklasse entweder allein vom Hersteller oder unter Einbeziehung benannter Stellen erfolgt. Die CE-Kennzeichnung ist Pflicht für den freien Verkehr und die Inbetriebnahme in der Gemeinschaft.
Klassifizierung der Produkte: IVD-Produkte werden zwei Hauptklassen zugeordnet. Für Produkte mit höherem Risiko – z.B. im Zusammenhang mit der Blutübertragung oder HIV-Tests – ist eine Konformitätsbewertung durch benannte Stellen notwendig.
Marktüberwachung und Informationsaustausch: Mitgliedstaaten müssen effektive Marktüberwachungsverfahren sicherstellen, die Zusammenarbeit untereinander fördern und eine zentrale Datenbank betreiben, welche Hersteller, Produkte, Zertifikate und Meldungen umfasst.
Kennzeichnung und Haltbarkeitsangabe: Hersteller sind verpflichtet, ein Haltbarkeitsdatum anzugeben, das garantiert, dass das Produkt innerhalb dieses Zeitraumes sicher verwendet werden kann.
Meldung von „neuen Produkten“: Hersteller müssen neuartige Produkte – insbesondere neue Technologien wie DNA-Sonden („Mikrochips“) – den zuständigen Behörden melden.
Verbot und Beschränkung auf Gesundheitsgründen: Mitgliedstaaten können aus begründeten Gründen Vorsichtsmaßnahmen erlassen (z.B. Verbot), die nach Prüfung und Konsultation mit der Kommission auf Gemeinschaftsebene harmonisiert werden.
Betroffene Produkte und Akteure
In-vitro-Diagnostika (IVD): Produkte zur In-vitro-Untersuchung von Proben menschlichen Ursprungs (z.B. Blut, Gewebe) zur Diagnose, Überwachung, Prävention oder Behandlung von Krankheiten und physiologischen Zuständen. Hierzu zählen Reagenzien, Geräte, Systeme, Kalibriermaterialien, Kontrollmaterialien, Kits sowie Probenbehältnisse.
Zubehör: Produkte, die selbst kein IVD sind, aber speziell zur Verwendung zusammen mit einem IVD-Produkt bestimmt sind.
Ausgenommene Produkte: Forschungsgeräte ohne medizinischen Zweck, zertifizierte Referenzmaterialien und bestimmte Materialien für externe Qualitätsbewertung.
Hersteller: Natürliche oder juristische Personen, die ein Produkt entwerfen, herstellen, verpacken oder etikettieren und in Eigenverantwortung in Verkehr bringen.
Benannte Stellen: Unabhängige Stellen, die für die Durchführung bestimmter Konformitätsbewertungen zugelassen sind.
Marktüberwachungsbehörden: Nationale Behörden, welche die Einhaltung der Richtlinie überwachen, Hersteller kontaktieren und erforderlichenfalls Schutzmaßnahmen ergreifen.
Umsetzungszeitraum
Die Richtlinie wurde am 27. Oktober 1998 verabschiedet und bildete die Grundlage für nationale Umsetzungen in den Mitgliedstaaten. Die Mitgliedstaaten mussten die Richtlinie innerhalb einer bestimmten Frist in nationales Recht umsetzen (typischerweise innerhalb von 2 Jahren nach Inkrafttreten). Seither gilt sie als wesentlicher Rechtsrahmen für In-vitro-Diagnostika im Europäischen Wirtschaftsraum.
Nach Inkrafttreten werden laufend Anpassungen und Fortschreibungen der verpflichteten Produktlisten und Konformitätsverfahren entsprechend technischen Fortschritten und gesundheitlichen Erfordernissen vorgenommen. Die Zusammenarbeit zwischen EU-Institutionen und Mitgliedstaaten sowie mit benannten Stellen stellt sicher, dass die Richtlinie aktuell und wirksam umgesetzt wird.
Die Richtlinie 98/79/EG gilt für In-vitro-Diagnostika und deren Zubehör. In-vitro-Diagnostika sind Medizinprodukte, die zur In-vitro-Untersuchung von Proben aus dem menschlichen Körper, einschließlich Blut- und Gewebespenden, bestimmt sind und dazu dienen, Informationen über physiologische oder pathologische Zustände, angeborene Anomalien, Unbedenklichkeit bei Empfängern oder zur Überwachung therapeutischer Maßnahmen zu liefern. Dazu gehören Reagenzien, Geräte, Instrumente und Systeme, die einzeln oder in Verbindung verwendet werden. Zubehör wird als eigenständiges In-vitro-Diagnostikum behandelt. Die Richtlinie erstreckt sich auf Produkte, die im professionellen und kommerziellen Rahmen hergestellt und verwendet werden, jedoch nicht auf Produkte, die nur zu Forschungszwecken oder in Laboratorien von Gesundheitseinrichtungen für den Eigengebrauch hergestellt werden. Probenbehältnisse für die Sammlung und Lagerung von menschlichen Proben zählen ebenfalls dazu. Die Richtlinie zielt auf die Harmonisierung der Vorschriften zur Sicherheit und Leistungsfähigkeit dieser Produkte ab, um den freien Warenverkehr im Binnenmarkt zu gewährleisten.
La directive 98/79/CE réglemente les dispositifs médicaux de diagnostic in vitro (DMDIV) au sein de l'Union européenne. Elle vise à harmoniser les réglementations nationales pour assurer un niveau élevé de protection sanitaire tout en facilitant la libre circulation de ces dispositifs sur le marché intérieur. La directive définit les DMDIV comme les instruments, réactifs, matériels et systèmes destinés à examiner des échantillons humains in vitro afin de fournir des informations sur des états physiologiques, pathologiques, anomalies congénitales ou la compatibilité pour des transfusions ou traitements. Elle établit des exigences essentielles relatives à la sécurité et aux performances des dispositifs, impose l'obligation du marquage CE et précise les procédures d’évaluation de conformité, incluant le rôle des organismes notifiés pour certains produits à risque élevé. La directive prévoit aussi un système de surveillance post-commercialisation, notamment par la notification des incidents. Par ailleurs, elle prévoit la coopération entre États membres pour la supervision du marché et la mise à jour régulière des exigences techniques en fonction des évolutions scientifiques et technologiques. La directive exclut les réactifs produits et utilisés en interne dans les laboratoires non commerciaux.
Objectif
La directive 98/79/CE du Parlement européen et du Conseil, datée du 27 octobre 1998, vise à harmoniser les législations des États membres relatives aux dispositifs médicaux de diagnostic in vitro (DMDIV) afin d’assurer le bon fonctionnement du marché intérieur de l’Union européenne. Elle établit les exigences essentielles en matière de sécurité, de performance et de fiabilité des dispositifs médicaux utilisés pour le diagnostic in vitro, tout en protégeant la santé des patients, des utilisateurs et de tiers.
Cette harmonisation cherche à supprimer les entraves au commerce causées par des disparités dans les législations nationales, en fixant des règles communes qui garantissent la libre circulation des dispositifs tout en maintenant ou en améliorant le niveau de protection sanitaire dans les États membres.
Obligations clés
Conformité aux exigences essentielles : Les dispositifs doivent respecter les exigences en matière de conception, fabrication, conditionnement, sécurité et performances pour assurer un haut niveau de protection sanitaire.
Distinction des catégories de dispositifs : La directive divise les DMDIV en deux grandes catégories selon leur niveau de risque, déterminant la procédure d’évaluation de conformité applicable (auto-certification du fabricant ou intervention obligatoire d’un organisme notifié).
Évaluation de conformité et marquage CE : Les dispositifs doivent faire l’objet d’une procédure d’évaluation de conformité avant leur mise sur le marché. La plupart peuvent être évalués sous la responsabilité du fabricant, mais certains à risque élevé nécessitent l’intervention d’organismes notifiés. Tous doivent porter le marquage CE pour circuler librement dans l’Union.
Notification des nouveaux produits : Les fabricants doivent notifier aux autorités compétentes la mise sur le marché des nouveaux dispositifs, en particulier ceux incorporant des technologies innovantes comme les micropuces à haute densité de sondes à ADN.
Surveillance du marché et vigilance : Mise en place d’un système de surveillance et de notification des incidents avec un échange d’informations entre États membres pour garantir un suivi continu des performances et de la sécurité des dispositifs.
Transparence et coopération : La directive prévoit la création d’une base de données contenant des informations sur les fabricants, dispositifs, certificats et incidents, facilitant la coopération entre autorités nationales.
Maintien de l’indépendance des organismes notifiés : Les organismes intervenant dans l’évaluation de conformité doivent être indépendants, sans conflit d’intérêts avec les fabricants.
Possibilité de mesures nationales transitoires : En cas de risque grave pour la santé, un État membre peut temporairement restreindre ou interdire la mise à disposition d’un dispositif, sous réserve d’une procédure communautaire.
Produits et acteurs concernés
Produits concernés : Tous dispositifs médicaux de diagnostic in vitro et leurs accessoires. Cela inclut, entre autres, réactifs, produits réactifs, matériaux d’étalonnage et de contrôle, instruments, appareils, équipements, systèmes et logiciels spécialement conçus pour analyser des échantillons humains in vitro, y compris les dons de sang et de tissus.
Exclusions : Les dispositifs destinés uniquement à la recherche sans objectif médical, les réactifs produits en laboratoire pour usage interne sans mise sur le marché, ainsi que les matériaux de référence certifiés internationaux ne sont pas concernés.
Acteurs impliqués :
- Les fabricants, responsables de la conception, fabrication, conditionnement et mise sur le marché des dispositifs.
- Les organismes notifiés, chargés de l’évaluation de conformité pour certains dispositifs à risque élevé.
- Les autorités nationales compétentes, responsables de la surveillance du marché et de la coordination européenne.
- Les utilisateurs professionnels et le personnel de santé.
Calendrier de mise en œuvre
La directive est adoptée en octobre 1998, avec une période transitoire pour permettre aux États membres de modifier leurs législations nationales et aux acteurs économiques de se conformer aux nouvelles exigences.
La date exacte de mise en œuvre obligatoire ou de fin de période transitoire doit être précisée dans les textes d’application et/ou dans les dispositions nationales.
La liste des dispositifs soumis à évaluation par un organisme notifié est progressive et susceptible d’être mise à jour selon l’évolution technologique et sanitaire, selon une procédure communautaire de consultation.
Des révisions ou adaptations ultérieures de la directive peuvent être adoptées pour intégrer les avancées technologiques, réglementaires et scientifiques dans le domaine des DMDIV.
Cette directive constitue un cadre juridique fondamental pour garantir la qualité et la sécurité des dispositifs médicaux de diagnostic in vitro dans l’Union européenne, favorisant ainsi la confiance des professionnels de santé et des patients tout en stimulant l’innovation et le marché unique.
La directive 98/79/CE s'applique aux dispositifs médicaux de diagnostic in vitro (DMDIV) et à leurs accessoires, considérés comme des dispositifs à part entière. Ces dispositifs incluent tout réactif, produit réactif, matériau d’étalonnage, matériau de contrôle, trousse, instrument, appareil, équipement ou système destinés à être utilisés in vitro pour examiner des échantillons provenant du corps humain (y compris les dons de sang et de tissus) dans le but de fournir des informations sur un état physiologique ou pathologique, une anomalie congénitale, la compatibilité avec des receveurs potentiels ou le contrôle de mesures thérapeutiques. Sont exclus les instruments, appareils, équipements, matériaux ou logiciels destinés uniquement à la recherche sans objectifs médicaux, ainsi que les réactifs produits et utilisés dans les laboratoires des institutions de santé sans transaction commerciale. Sont également couverts les dispositifs émettant des radiations ionisantes et les appareils de laboratoire destinés aux examens diagnostiques in vitro. Cette directive vise à assurer la protection sanitaire, la sécurité et la libre circulation de ces dispositifs dans l'Union européenne.
Direktiva 98/79/ES ureja in vitro diagnostične medicinske pripomočke v Evropski uniji, z namenom zagotavljanja prostega pretoka teh pripomočkov na notranjem trgu ob hkratnem ohranjanju visoke ravni varnosti in zdravstvenega varstva. Določa bistvene zahteve za načrtovanje, izdelavo, označevanje in trženje pripomočkov, vključno z dodatki, ter zahteve glede presoje skladnosti, kategorij tveganja in označevanja CE. Direktiva vključuje pravila za pripomočke za samotestiranje in ovrednotenje delovanja ter določa vlogo proizvajalcev, pooblaščenih zastopnikov in pristojnih organov. Predpisuje obveznosti držav članic glede spremljanja varnosti na trgu in vzpostavitve postopkov za posredovanje v primerih tveganj. Prav tako predvideva usklajene standarde in postopke za posodobitev seznama pripomočkov, ki zahtevajo sodelovanje priglašenih organov. Direktiva ne velja za pripomočke, izdelane in uporabljene znotraj iste zdravstvene ustanove, in ne posega v nacionalne predpise o oskrbi na zdravniški recept. Namen je zagotoviti ustrezno zaščito zdravja uporabnikov ob spodbujanju inovacij in konkurenčnosti na trgu.
Namen
Direktiva 98/79/ES ureja in vitro diagnostične medicinske pripomočke z namenom zagotoviti visoko raven varstva zdravja bolnikov, uporabnikov in tretjih oseb ter omogočiti prosti pretok teh izdelkov znotraj notranjega trga Evropske unije. Z uskladitvijo tehničnih in varnostnih zahtev direktiva odpravlja nacionalne razlike, ki bi lahko povzročale trgovinske ovire in ovirale prosto gibanje pripomočkov med državami članicami.
Cilj je zagotoviti, da so in vitro diagnostični medicinski pripomočki zasnovani, izdelani in pakirani tako, da zadovoljijo bistvene zahteve glede varnosti in učinkovitosti, hkrati pa upoštevajo tehnološki razvoj in visoko raven zaščite zdravja.
Ključne obveznosti
- Zagotavljanje skladnosti z bistvenimi zahtevami: Pripomočki morajo izpolnjevati bistvene zahteve, določene v prilogi I direktive, upoštevajoč njihov predvideni namen.
- Presoja skladnosti: Pred dajanjem na trg mora proizvajalec izvesti presojo skladnosti, ki v določenih primerih zahteva vključitev priglašenega organa za overitev.
- Oznaka CE: Pripomočki, ki izpolnjujejo zahteve direktive, morajo biti označeni z oznako CE kot dokaz skladnosti, kar omogoča njihov prost pretok na trgu Skupnosti.
- Obveznosti proizvajalcev: Proizvajalci so odgovorni za načrtovanje, izdelavo, pakiranje, označevanje in zagotavljanje skladnosti svojih pripomočkov s to direktivo, vključno s pooblaščenimi zastopniki s sedežem v EU.
- Nadzor trga in budnost: Države članice morajo vzpostaviti sisteme nadzora trga in obveščanja o morebitnih škodljivih dogodkih (postopek budnosti) ter sodelovati med seboj in s Komisijo.
- Posebne določbe: Za določene skupine pripomočkov, na primer tiste, povezane s transfuzijo krvi in preprečevanjem nekaterih okužb, obstajajo strožji postopki presoje skladnosti zaradi tveganj za zdravje.
- Izjeme: Pripomočki, izdelani za uporabo samo znotraj iste zdravstvene ustanove in laboratoriji za lastno uporabo v neposredni bližini, so izvzeti iz direktive, prav tako izdelki, namenjeni raziskavam brez medicinskih ciljev.
- Označevanje roka uporabnosti: Proizvajalci morajo določiti in jasno označiti rok, do katerega pripomočki delujejo varno in pravilno.
Vplivani izdelki in akterji
- Izdelki: Direktiva pokriva vse in vitro diagnostične medicinske pripomočke in njihove dodatke, vključno s posodami za zbiranje vzorcev, kontrolnimi materiali in reagenti, namenjenimi profesionalni in komercialni uporabi. Izvzeti so laboratorijski izdelki za splošno uporabo, če niso posebej namenjeni in vitro diagnostičnim preiskavam.
- Proizvajalci: Tisti, ki načrtujejo, izdelujejo, pakirajo, označujejo ali dajo na trg pripomočke pod lastnim imenom. Prav tako vključuje tiste, ki izvedo pomembne spremembe na gotovih izdelkih in jim določijo predvideni namen.
- Pooblaščeni zastopniki: Osebe s sedežem v EU, ki proizvajalcu zastopajo pravice in obveznosti v Skupnosti.
- Priglašeni organi: Neodvisni subjekti imenovani za preverjanje skladnosti izdelkov, kadar je to zahtevano.
- Države članice: Morajo izvajati nadzor trga, upoštevati usklajeno zakonodajo in omogočati prosti pretok skladnih pripomočkov ter varovati javno zdravje.
- Uporabniki: Zdravstveni delavci in nestrokovnjaki (pri pripomočkih za samotestiranje).
Rok implementacije
Direktiva je bila sprejeta 27. oktobra 1998, države članice so morale implementirati njene določbe v nacionalno zakonodajo v skladu z določenimi roki, ki so običajno določeni v samem aktu (navadno dve leti po sprejetju). Po preteku tega obdobja morajo vse države članice zagotavljati, da so in vitro diagnostični medicinski pripomočki, dane na trg, skladni z zahtevami direktive.
Za dokončne roke in nadaljnje uskladitve je treba upoštevati tudi morebitne spremembe in nadgradnje direktive, kot so bile sprejete v zameno ali dopolnitev te uredbe.
Direktiva 98/79/ES se uporablja za in vitro diagnostične medicinske pripomočke ter njihove dodatke, ki so izdelki namenjeni za diagnostične, preventivne, spremljevalne, terapevtske ali druge medicinske namene, pri čemer njihov glavni učinek ni dosežen s farmakološkimi, imunološkimi ali presnovnimi sredstvi. Vključuje pripomočke za določanje fizioloških ali patoloških stanj, prirojenih nepravilnosti, varnosti in kompatibilnosti z možnimi prejemniki ter spremljanje terapevtskih ukrepov. Direktiva zajema tudi posode za vzorce, posebne laboratorijske pripomočke in mehansko opremo za in vitro diagnostične preiskave, razen izdelkov, namenjenih zgolj za raziskovalne namene brez zdravstvenih ciljev, ter reagentov, ki jih proizvajajo zdravstvene ustanove za lastno rabo, če niso predmet trgovine. Nanaša se na profesionalno in komercialno uporabo teh pripomočkov, prav tako ureja izdelavo, pakiranje, varnost in skladnost z zahtevami za prosti pretok blaga v Evropski uniji.
General Information
IEC 61326-2-6:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of IN VITRO DIAGNOSTIC MEDICAL ELECTRICAL EQUIPMENT (IVD MEE). This part of IEC 61326 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of IVD MEE in the presence of electromagnetic disturbances and to electromagnetic disturbances emitted by IVD MEE.
BASIC SAFETY with regard to electromagnetic disturbances is applicable to all IVD MEE.
NOTE 1 Performance with respect to electromagnetic disturbances other than ESSENTIAL PERFORMANCE is the subject of IEC 61326-1:2020
NOTE 2 IT equipment can be a part of an IVD MEE, if it is required to maintain BASIC SAFETY or ESSENTIAL PERFORMANCE.
This edition includes the following significant technical changes with respect to the previous edition:
- Update of the document with respect to test levels and documentation.
- Standard36 pagesEnglish languagee-Library read for1 day
IEC 61326-2-6:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of IN VITRO DIAGNOSTIC MEDICAL ELECTRICAL EQUIPMENT (IVD MEE). This part of IEC 61326 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of IVD MEE in the presence of electromagnetic disturbances and to electromagnetic disturbances emitted by IVD MEE. BASIC SAFETY with regard to electromagnetic disturbances is applicable to all IVD MEE. NOTE 1 Performance with respect to electromagnetic disturbances other than ESSENTIAL PERFORMANCE is the subject of IEC 61326-1:2020 NOTE 2 IT equipment can be a part of an IVD MEE, if it is required to maintain BASIC SAFETY or ESSENTIAL PERFORMANCE. This edition includes the following significant technical changes with respect to the previous edition: - Update of the document with respect to test levels and documentation.
- Standard36 pagesEnglish languagee-Library read for1 day
This document specifies general requirements for the design of tests for identifying and quantifying
degradation products from final metallic medical devices or corresponding material samples finished
as ready for clinical use.
This document is applicable only to those degradation products generated by chemical alteration of the
final metallic device in an in vitro degradation test. Because of the nature of in vitro tests, the test results
approximate the in vivo behaviour of the implant or material. The described chemical methodologies
are a means to generate degradation products for further assessments.
This document is applicable to both materials designed to degrade in the body as well as materials that
are not intended to degrade.
This document is not applicable to evaluation of degradation which occurs by purely mechanical
processes; methodologies for the production of this type of degradation product are described in
specific product standards, where available.
NOTE Purely mechanical degradation causes mostly particulate matter. Although this is excluded from the
scope of this document, such degradation products can evoke a biological response and can undergo biological
evaluation as described in other parts of ISO 10993.
Because of the wide range of metallic materials used in medical devices, no specific analytical
techniques are identified for quantifying the degradation products. The identification of trace elements
(<10–6 w/w) contained in the specific metal or alloy is not addressed in this document, nor are specific
requirements for acceptable levels of degradation products provided in this document.
This document excludes the biological activity of the degradation products. (See instead the applicable
clauses of ISO 10993-1 and ISO 10993-17).
- Standard26 pagesEnglish languagee-Library read for1 day
2022-06-21 - lack of compliance - publication on hold
- Amendment13 pagesEnglish languagee-Library read for1 day
2022-06-21 - lack of compliance - publication on hold
- Amendment13 pagesEnglish languagee-Library read for1 day
This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.
It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized.
It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
- Amendment11 pagesEnglish languagee-Library read for1 day
This document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.
It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized.
It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
It does not describe a quality assurance system for control of all stages of manufacture.
It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.
- Amendment11 pagesEnglish languagee-Library read for1 day
NEW!IEC 61010-2-101:2018 is available as IEC 61010-2-101:2018 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.
IEC 61010-2-101:2018 applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes. It has the status of a group safety publication, as specified in IEC Guide 104. This document has been prepared in close collaboration with Working Group CENELEC BTTF 88.1. This third edition cancels and replaces the second edition published in 2015. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
- adaptation of changes introduced by Amendment 1 of IEC 61010-1;
- added tolerance for stability of AC voltage test equipment to Clause 6.
This Part 2-101 is intended to be used in conjunction with IEC 61010-1. It was established on the basis of the third edition (2010) and its Amendment 1 (2016).
- Standard19 pagesEnglish languagee-Library read for1 day
NEW!IEC 61010-2-101:2018 is available as IEC 61010-2-101:2018 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 61010-2-101:2018 applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes. It has the status of a group safety publication, as specified in IEC Guide 104. This document has been prepared in close collaboration with Working Group CENELEC BTTF 88.1. This third edition cancels and replaces the second edition published in 2015. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: - adaptation of changes introduced by Amendment 1 of IEC 61010-1; - added tolerance for stability of AC voltage test equipment to Clause 6. This Part 2-101 is intended to be used in conjunction with IEC 61010-1. It was established on the basis of the third edition (2010) and its Amendment 1 (2016).
- Standard19 pagesEnglish languagee-Library read for1 day
This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.
It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized.
It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
- Amendment11 pagesEnglish languagee-Library read for1 day
This document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.
It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized.
It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
It does not describe a quality assurance system for control of all stages of manufacture.
It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.
- Amendment11 pagesEnglish languagee-Library read for1 day
- Amendment27 pagesEnglish languagee-Library read for1 day
- Amendment13 pagesEnglish languagee-Library read for1 day
This document specifies the requirements for and provides guidance on the specification, selection, qualification, bio-decontamination, validation, operation and control of isolator systems related to aseptic processing of health care products and processing of cell-based health care products.
This document does not specify requirements for restricted access barrier systems (RABS).
This document does not supersede or replace national regulatory requirements such as Good Manufacturing Practices (GMPs) and/or compendia requirements that pertain in particular to national or regional jurisdictions.
This document does not specify requirements for isolators used for sterility testing; however, some of the principles and information in this document could be applicable to this application.
This document does not define biosafety containment requirements.
- Standard39 pagesEnglish languagee-Library read for1 day
- Amendment27 pagesEnglish languagee-Library read for1 day
This document specifies requirements and test methods for specialized single-use evacuated and non-evacuated containers, intended by their manufacturers, for the primary containment and preservation of specimens, other than blood specimens, derived from the human body, for the purposes of in vitro diagnostic examination. It is not intended to cover specimen containers for forensic investigations.
Examples of such specimens include, but are not limited to, cerebral spinal fluid (CSF), faeces, infected bodily fluids, saliva, ejaculate, sputum, urine, tissue samples.
Specimens and types of devices specifically excluded are specialized containers for cryo-preservation, samples for nucleic acid testing and swabs.
NOTE Requirements and test methods for evacuated and non-evacuated single-use human venous blood specimen collection containers are specified in ISO 6710.
This document does not specify requirements for auxiliary devices used in conjunction with specimen containers.
- Standard21 pagesEnglish languagee-Library read for1 day
This document specifies requirements and test methods for specialized single-use evacuated and non-evacuated containers, intended by their manufacturers, for the primary containment and preservation of specimens, other than blood specimens, derived from the human body, for the purposes of in vitro diagnostic examination. It is not intended to cover specimen containers for forensic investigations.
Examples of such specimens include, but are not limited to, cerebral spinal fluid (CSF), faeces, infected bodily fluids, saliva, ejaculate, sputum, urine, tissue samples.
Specimens and types of devices specifically excluded are specialized containers for cryo-preservation, samples for nucleic acid testing and swabs.
NOTE Requirements and test methods for evacuated and non-evacuated single-use human venous blood specimen collection containers are specified in ISO 6710.
This document does not specify requirements for auxiliary devices used in conjunction with specimen containers.
- Standard21 pagesEnglish languagee-Library read for1 day
IEC 61326-2-6:2020 is available as IEC 61326-2-6:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.
IEC 61326-2-6:2020 specifies minimum requirements for immunity and emissions regarding electromagnetic compatibility for IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT, taking into account the particularities and specific aspects of this electrical equipment and their electromagnetic environment.
- Standard19 pagesEnglish languagee-Library read for1 day
This document specifies technical requirements and documentation necessary to establish metrological traceability of values assigned to calibrators, trueness control materials and human samples for quantities measured by IVD MDs. The human samples are those intended to be measured, as specified for each IVD MD. Metrological traceability of values for quantities in human samples extends to the highest available reference system component, ideally to RMPs and certified reference materials (CRMs).
All parties having a role in any of the steps described in a calibration hierarchy for an IVD MD are subject to the requirements described. These parties include but are not limited to manufacturers (of IVD MDs), RMP developers (see ISO 15193), RM producers (see ISO 15194), and reference/calibration laboratories (see ISO 15195) supporting calibration hierarchies for IVD MDs.
NOTE 1 Producers of RMs intended for use in standardization or calibration of IVD MDs include commercial and non-commercial organizations producing RMs for use by many end-users of IVD MDs and/or calibration laboratories, or for use by a single end-user medical laboratory, as in the case of a measurement standard (calibrator) intended to be used exclusively for calibration of a laboratory-developed MP.
This document is applicable to:
a) all IVD MDs that provide measurement results in the form of numeric values, i.e. rational (ratio) and/or differential (interval) scales, and counting scales.
b) IVD MDs where the measurement result is reported as a qualitative value established with a ratio of two measurements (i.e. the signal from a specimen being tested and the signal from a RM with a specified concentration or activity at the cut-off), or a counting scale, with corresponding decision threshold(s). This also includes IVD MDs where results are categorized among ordinal categories based on pre-established quantitative intervals for a quantity.
c) RMs intended for use as trueness control materials for verification or assessment of calibration of IVD MDs, i.e. some commutable CRMs and some external quality assessment (EQA) materials (if so indicated in the RM's intended use statement).
d) IVD MD-specific calibrators and trueness control materials with assigned values, intended to be used together with a specified IVD MD.
e) IVD MDs as described in a) and b), where no end-user performed calibration is required (i.e. when the manufacturer performs a factory calibration of the IVD MD).
This document is not applicable to:
a) calibrators and trueness control materials for IVD MDs which, due to their formulation, are known to have zero amount of measurand;
b) control materials that are used only for internal quality control purposes in medical laboratories to assess the imprecision of an IVD MD, either its repeatability or reproducibility, and/or for assessing changes in IVD MD results compared to a previously established calibration condition;
c) control materials that are used only for internal quality control purposes in medical laboratories and which are supplied with intervals of suggested acceptable values that are not metrologically traceable to higher order reference system components;
d) properties reported as nominal scales and ordinal scales, where no magnitude is involved.
NOTE 2 Nominal scales are typically used to report e.g. identity of blood cell types, microorganism types, identity of nucleic acid sequences, identity of urine particles.
NOTE 3
- Standard68 pagesEnglish languagee-Library read for1 day
This document specifies the requirements for and provides guidance on the specification, selection, qualification, bio-decontamination, validation, operation and control of isolator systems related to aseptic processing of health care products and processing of cell-based health care products.
This document does not specify requirements for restricted access barrier systems (RABS).
This document does not supersede or replace national regulatory requirements such as Good Manufacturing Practices (GMPs) and/or compendia requirements that pertain in particular to national or regional jurisdictions.
This document does not specify requirements for isolators used for sterility testing; however, some of the principles and information in this document could be applicable to this application.
This document does not define biosafety containment requirements.
- Standard39 pagesEnglish languagee-Library read for1 day
IEC 61326-2-6:2020 is available as IEC 61326-2-6:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 61326-2-6:2020 specifies minimum requirements for immunity and emissions regarding electromagnetic compatibility for IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT, taking into account the particularities and specific aspects of this electrical equipment and their electromagnetic environment.
- Standard19 pagesEnglish languagee-Library read for1 day
This document specifies technical requirements and documentation necessary to establish metrological traceability of values assigned to calibrators, trueness control materials and human samples for quantities measured by IVD MDs. The human samples are those intended to be measured, as specified for each IVD MD. Metrological traceability of values for quantities in human samples extends to the highest available reference system component, ideally to RMPs and certified reference materials (CRMs).
All parties having a role in any of the steps described in a calibration hierarchy for an IVD MD are subject to the requirements described. These parties include but are not limited to manufacturers (of IVD MDs), RMP developers (see ISO 15193), RM producers (see ISO 15194), and reference/calibration laboratories (see ISO 15195) supporting calibration hierarchies for IVD MDs.
NOTE 1 Producers of RMs intended for use in standardization or calibration of IVD MDs include commercial and non-commercial organizations producing RMs for use by many end-users of IVD MDs and/or calibration laboratories, or for use by a single end-user medical laboratory, as in the case of a measurement standard (calibrator) intended to be used exclusively for calibration of a laboratory-developed MP.
This document is applicable to:
a) all IVD MDs that provide measurement results in the form of numeric values, i.e. rational (ratio) and/or differential (interval) scales, and counting scales.
b) IVD MDs where the measurement result is reported as a qualitative value established with a ratio of two measurements (i.e. the signal from a specimen being tested and the signal from a RM with a specified concentration or activity at the cut-off), or a counting scale, with corresponding decision threshold(s). This also includes IVD MDs where results are categorized among ordinal categories based on pre-established quantitative intervals for a quantity.
c) RMs intended for use as trueness control materials for verification or assessment of calibration of IVD MDs, i.e. some commutable CRMs and some external quality assessment (EQA) materials (if so indicated in the RM's intended use statement).
d) IVD MD-specific calibrators and trueness control materials with assigned values, intended to be used together with a specified IVD MD.
e) IVD MDs as described in a) and b), where no end-user performed calibration is required (i.e. when the manufacturer performs a factory calibration of the IVD MD).
This document is not applicable to:
a) calibrators and trueness control materials for IVD MDs which, due to their formulation, are known to have zero amount of measurand;
b) control materials that are used only for internal quality control purposes in medical laboratories to assess the imprecision of an IVD MD, either its repeatability or reproducibility, and/or for assessing changes in IVD MD results compared to a previously established calibration condition;
c) control materials that are used only for internal quality control purposes in medical laboratories and which are supplied with intervals of suggested acceptable values that are not metrologically traceable to higher order reference system components;
d) properties reported as nominal scales and ordinal scales, where no magnitude is involved.
NOTE 2 Nominal scales are typically used to report e.g. identity of blood cell types, microorganism types, identity of nucleic acid sequences, identity of urine particles.
NOTE 3
- Standard68 pagesEnglish languagee-Library read for1 day
1.1 This document specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent which has been reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process.
1.2 This document is not applicable to:
a) sterility testing for routine release of product that has been subjected to a sterilization process,
b) performing a test for sterility (see 3.12),
NOTE 1 The performance of a) or b) is not a requirement of ISO 11135, ISO 11137-1, ISO 11137-2, ISO 14160, ISO 14937, ISO 17665-1 or ISO 20857.
c) test of sterility or test for sterility for demonstration of product shelf life, stability and/or package integrity, and
d) culturing of biological indicators or inoculated products.
NOTE 2 Guidance on culturing biological indicators is included in ISO 11138-7.
- Standard35 pagesEnglish languagee-Library read for1 day
ISO 6710:2017 specifies requirements and test methods for evacuated and non-evacuated single-use venous blood specimen containers.
It does not specify requirements for blood collection needles, needle holders, blood culture receptacles or "arterial" blood gas collection devices that can be used for venous blood.
- Standard27 pagesEnglish languagee-Library read for1 day
2019-04-04-JO-: link to legislation to the MDD 93/42/EEC and mandate M/432 removed following CLC/BT decision D162/C076
- Amendment22 pagesEnglish languagee-Library read for1 day
This document describes one reference method, broth micro-dilution, for determination of MICs. The MIC can be a guide for the clinician, and reflects the activity of the drug under the described test conditions, by taking into account other factors, such as drug pharmacology, pharmacokinetics, or bacterial resistance mechanisms. This allows categorisation of bacteria as "susceptible" (S), "intermediate" (I), or "resistant" (R). In addition, MIC distributions can be used to define wild type or non-wild type bacterial populations. Although clinical interpretation of the MIC value is beyond the scope of this document, modifications of the basic method are required for certain antimicrobial agent - bacteria combinations to facilitate clinical interpretation. These modifications are included in a separate annex of this document. It is necessary to compare other susceptibility testing methods (e.g. disc diffusion or diagnostic test devices) with this reference method for validation, in order to ensure comparable and reliable results.
- Standard27 pagesEnglish languagee-Library read for1 day
2019-04-04-JO-: link to legislation to the MDD 93/42/EEC and mandate M/432 removed following CLC/BT decision D162/C076
- Amendment22 pagesEnglish languagee-Library read for1 day
This document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.
It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized.
It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
It does not describe a quality assurance system for control of all stages of manufacture.
It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.
- Standard52 pagesEnglish languagee-Library read for1 day
This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.
It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized.
It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
- Standard21 pagesEnglish languagee-Library read for1 day
This document describes one reference method, broth micro-dilution, for determination of MICs. The MIC can be a guide for the clinician, and reflects the activity of the drug under the described test conditions, by taking into account other factors, such as drug pharmacology, pharmacokinetics, or bacterial resistance mechanisms. This allows categorisation of bacteria as "susceptible" (S), "intermediate" (I), or "resistant" (R). In addition, MIC distributions can be used to define wild type or non-wild type bacterial populations. Although clinical interpretation of the MIC value is beyond the scope of this document, modifications of the basic method are required for certain antimicrobial agent - bacteria combinations to facilitate clinical interpretation. These modifications are included in a separate annex of this document. It is necessary to compare other susceptibility testing methods (e.g. disc diffusion or diagnostic test devices) with this reference method for validation, in order to ensure comparable and reliable results.
- Standard27 pagesEnglish languagee-Library read for1 day
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
The requirements of this document are applicable to all phases of the life cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability.
The process described in this document can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical device life cycle.
This document does not apply to:
— decisions on the use of a medical device in the context of any particular clinical procedure; or
— business risk management.
This document requires manufacturers to establish objective criteria for risk acceptability but does not specify acceptable risk levels.
Risk management can be an integral part of a quality management system. However, this document does not require the manufacturer to have a quality management system in place.
NOTE Guidance on the application of this document can be found in ISO/TR 24971[9].
- Standard46 pagesEnglish languagee-Library read for1 day
- Standard – translation44 pagesSlovenian languagee-Library read for1 day
1.1 This document specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent which has been reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process.
1.2 This document is not applicable to:
a) sterility testing for routine release of product that has been subjected to a sterilization process,
b) performing a test for sterility (see 3.12),
NOTE 1 The performance of a) or b) is not a requirement of ISO 11135, ISO 11137-1, ISO 11137-2, ISO 14160, ISO 14937, ISO 17665-1 or ISO 20857.
c) test of sterility or test for sterility for demonstration of product shelf life, stability and/or package integrity, and
d) culturing of biological indicators or inoculated products.
NOTE 2 Guidance on culturing biological indicators is included in ISO 11138-7.
- Standard35 pagesEnglish languagee-Library read for1 day
1.1 Inclusions
1.1.1 This document specifies requirements for the development, validation and routine control of a low temperature steam and formaldehyde (LTSF) sterilization process for medical devices using a mixture of low temperature steam and formaldehyde as sterilizing agent and which operates below ambient pressure.
NOTE Although the scope of this document is limited to medical devices, it specifies requirements and provides guidance that can be applicable to other products and equipment.
1.1.2 This document is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized and the organizations with responsibility for sterilizing medical devices (see ISO 14937:2009, Table E.1).
1.2 Exclusions
1.2.1 This document does not specify requirements for the development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.
NOTE See ISO 22442‑1, ISO 22442‑2 and ISO 22442‑3.
1.2.2 This document does not specify requirements for designating a medical device as "STERILE". Such requirements are given in EN 556‑1.
1.2.3 This document does not specify a quality management system for the control of all stages of production of medical devices.
NOTE It is not a requirement of this document to have a complete quality management system during manufacture or reprocessing, but those elements of such a system that are required are normatively referenced at appropriate places in the text. Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices including the sterilization process. Further guidance is given in E.4 of ISO 14937:2009.
1.2.4 This document does not specify requirements for occupational safety associated with the design and operation of LTSF sterilization facilities.
NOTE 1 Safety requirements for sterilizers are specified in IEC 61010‑2‑040.
NOTE 2 Attention is also drawn to the existence in some countries of regulations stipulating safety requirements.
1.2.5 This document does not cover analytical methods for determining levels or residues of formaldehyde and/or its reaction products.
NOTE 1 Attention is drawn to EN 14180.
NOTE 2 Attention is drawn to the possible existence in some countries of statutory regulations specifying limits for the level of formaldehyde residues on medical devices and products.
1.2.6 This document does not cover preparatory measures that might be necessary before sterilization such as cleaning, disinfection and packing.
NOTE For reprocessable medical devices, the manufacturer(s) of these devices can supply information on the preparatory measures (see ISO 17664).
- Standard63 pagesEnglish languagee-Library read for1 day
20191119 - Negative assessment addressed through BT decision C168/2019 (SV)
2019-03-07-JO- under HAS assessment at PUB stage. E&Y Report was due on 03 March 2019. Awaiting for assessement report from E&Y.
2018-10-17 - TAN : Lack of compliance
- Amendment22 pagesEnglish languagee-Library read for1 day
20191119 - Negative assessment addressed through BT decision C168/2019 (SV)
2019-03-07-JO- under HAS assessment at PUB stage. E&Y Report was due on 03 March 2019- Awaiting for the assessment report E&Y Report
- Amendment19 pagesEnglish languagee-Library read for1 day
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
The requirements of this document are applicable to all phases of the life cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability.
The process described in this document can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical device life cycle.
This document does not apply to:
— decisions on the use of a medical device in the context of any particular clinical procedure; or
— business risk management.
This document requires manufacturers to establish objective criteria for risk acceptability but does not specify acceptable risk levels.
Risk management can be an integral part of a quality management system. However, this document does not require the manufacturer to have a quality management system in place.
NOTE Guidance on the application of this document can be found in ISO/TR 24971[9].
- Standard46 pagesEnglish languagee-Library read for1 day
- Standard – translation44 pagesSlovenian languagee-Library read for1 day
NEXT ACTION: TC ACTION BY 2022-10-26 : TC to send a revised annex ZA for assessment at PUB
2020-02-19- JO-CEN/TC 206 to take decision either to remove the link or send a revised annex ZA for assessment at PUB
- Standard26 pagesEnglish languagee-Library read for1 day
This document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.
It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized.
It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
It does not describe a quality assurance system for control of all stages of manufacture.
It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.
- Standard52 pagesEnglish languagee-Library read for1 day
This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.
It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized.
It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
- Standard21 pagesEnglish languagee-Library read for1 day
20191119 - Negative assessment addressed through BT decision C168/2019 (SV)
2019-03-07-JO- under HAS assessment at PUB stage. E&Y Report was due on 03 March 2019- Awaiting for the assessment report E&Y Report
- Amendment19 pagesEnglish languagee-Library read for1 day
1.1 Inclusions
1.1.1 This document specifies requirements for the development, validation and routine control of a low temperature steam and formaldehyde (LTSF) sterilization process for medical devices using a mixture of low temperature steam and formaldehyde as sterilizing agent and which operates below ambient pressure.
NOTE Although the scope of this document is limited to medical devices, it specifies requirements and provides guidance that can be applicable to other products and equipment.
1.1.2 This document is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized and the organizations with responsibility for sterilizing medical devices (see ISO 14937:2009, Table E.1).
1.2 Exclusions
1.2.1 This document does not specify requirements for the development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.
NOTE See ISO 22442‑1, ISO 22442‑2 and ISO 22442‑3.
1.2.2 This document does not specify requirements for designating a medical device as "STERILE". Such requirements are given in EN 556‑1.
1.2.3 This document does not specify a quality management system for the control of all stages of production of medical devices.
NOTE It is not a requirement of this document to have a complete quality management system during manufacture or reprocessing, but those elements of such a system that are required are normatively referenced at appropriate places in the text. Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices including the sterilization process. Further guidance is given in E.4 of ISO 14937:2009.
1.2.4 This document does not specify requirements for occupational safety associated with the design and operation of LTSF sterilization facilities.
NOTE 1 Safety requirements for sterilizers are specified in IEC 61010‑2‑040.
NOTE 2 Attention is also drawn to the existence in some countries of regulations stipulating safety requirements.
1.2.5 This document does not cover analytical methods for determining levels or residues of formaldehyde and/or its reaction products.
NOTE 1 Attention is drawn to EN 14180.
NOTE 2 Attention is drawn to the possible existence in some countries of statutory regulations specifying limits for the level of formaldehyde residues on medical devices and products.
1.2.6 This document does not cover preparatory measures that might be necessary before sterilization such as cleaning, disinfection and packing.
NOTE For reprocessable medical devices, the manufacturer(s) of these devices can supply information on the preparatory measures (see ISO 17664).
- Standard63 pagesEnglish languagee-Library read for1 day
20191119 - Negative assessment addressed through BT decision C168/2019 (SV)
2019-03-07-JO- under HAS assessment at PUB stage. E&Y Report was due on 03 March 2019. Awaiting for assessement report from E&Y.
2018-10-17 - TAN : Lack of compliance
- Amendment22 pagesEnglish languagee-Library read for1 day
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.
The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system by monitoring, maintaining, and controlling the processes.
If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to ISO 13485:2016 reflect any exclusion of design and development controls.
If any requirement in Clauses 6, 7 or 8 of ISO 13485:2016 is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system. For any clause that is determined to be not applicable, the organization records the justification as described in 4.2.2.
- Standard68 pagesEnglish languagee-Library read for1 day
- Standard78 pagesGerman languagee-Library read for1 day
- Standard – translation131 pagesSlovenian and English languagee-Library read for1 day
ISO 13408-2:2018 specifies requirements for sterilizing filtration as part of aseptic processing of health care products conducted in accordance with ISO 13408‑1. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process.
ISO 13408-2:2018 is not applicable to removal of viruses.
Sterilizing filtration is not applicable to fluids that intentionally contain particles larger than the pore size of the filter (e.g. bacterial whole-cell vaccines).
ISO 13408-2:2018 is not applicable to high efficiency particulate air (HEPA) filters.
ISO 13408-2:2018 does not specify requirements for the development, validation and routine control of a process for removing the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.
- Standard47 pagesEnglish languagee-Library read for1 day
ISO 11737-1:2018 specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package.
NOTE 1 The nature and extent of microbial characterization is dependent on the intended use of bioburden data.
NOTE 2 See Annex A for guidance on Clauses 1 to 9.
ISO 11737-1:2018 does not apply to the enumeration or identification of viral, prion or protozoan contaminants. This includes the removal and detection of the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.
NOTE 3 Guidance on inactivating viruses and prions can be found in ISO 22442‑3, ICH Q5A(R1) and ISO 13022.
ISO 11737-1:2018 does not apply to the microbiological monitoring of the environment in which health care products are manufactured.
- Standard58 pagesEnglish languagee-Library read for1 day
PWI created for possible future // procedures
- Amendment45 pagesEnglish languagee-Library read for1 day
ISO 15197:2013 specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples, for specific design verification procedures and for the validation of performance by the intended users. These systems are intended for self-measurement by lay persons for management of diabetes mellitus.
ISO 15197:2013 is applicable to manufacturers of such systems and those other organizations (e.g. regulatory authorities and conformity assessment bodies) having the responsibility for assessing the performance of these systems.
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ISO 23640:2011 is applicable to the stability evaluation of in vitro diagnostic medical devices, including reagents, calibrators, control materials, diluents, buffers and reagent kits, hereinafter called IVD reagents. ISO 23640:2011 can also be applied to specimen collection devices that contain substances used to preserve samples or to initiate reactions for further processing of the sample in the collection device.
ISO 23640:2011 specifies general requirements for stability evaluation and gives specific requirements for real time and accelerated stability evaluation when generating data in:
the establishment of IVD reagent shelf life, including transport conditions suitable to ensure that product specifications are maintained;
the establishment of stability of the IVD reagent in use after the first opening of the primary container;
the monitoring of stability of IVD reagents already placed on the market;
the verification of stability specifications after modifications of the IVD reagent that might affect stability.
- Standard15 pagesEnglish languagee-Library read for1 day
ISO 13408-2:2018 specifies requirements for sterilizing filtration as part of aseptic processing of health care products conducted in accordance with ISO 13408‑1. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process.
ISO 13408-2:2018 is not applicable to removal of viruses.
Sterilizing filtration is not applicable to fluids that intentionally contain particles larger than the pore size of the filter (e.g. bacterial whole-cell vaccines).
ISO 13408-2:2018 is not applicable to high efficiency particulate air (HEPA) filters.
ISO 13408-2:2018 does not specify requirements for the development, validation and routine control of a process for removing the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.
- Standard47 pagesEnglish languagee-Library read for1 day
CCMC - creation of a 2nd corrigendum as the instructions in the 1st corrigendum were incomplete and unclear
- Corrigendum9 pagesEnglish languagee-Library read for1 day
Frequently Asked Questions
An EU Directive is a legislative act of the European Union that sets out goals that all EU member states must achieve. However, it is up to each member state to devise their own laws on how to reach these goals through national transposition. Directives are used to harmonize laws across the EU, particularly for the functioning of the single market.
Directive 98/79/EC covers "In vitro diagnostic medical devices". There are 301 standards associated with this directive.
Harmonized standards under 98/79/EC are European standards (ENs) developed by CEN, CENELEC, or ETSI in response to a mandate from the European Commission. When these standards are cited in the Official Journal of the European Union, products manufactured in conformity with them benefit from a presumption of conformity with the essential requirements of 98/79/EC, facilitating CE marking and free movement within the European Economic Area.