90/385/EEC - Active implantable medical devices
Council Directive 90/385/EEC aims to harmonize the laws of EU Member States concerning active implantable medical devices, ensuring a high level of safety and performance when implanted in humans. It applies to devices powered by electrical energy or other sources that are intended to remain in the body after surgical or medical intervention. The Directive sets essential requirements related to design, manufacture, and packaging, replacing varying national provisions to facilitate the free movement of these devices within the EU without compromising health and safety standards. Compliance is demonstrated through conformity assessment procedures, including CE marking, which indicates conformity with harmonized standards or approval by notified bodies. The Directive also addresses custom-made devices and those intended for clinical investigations, establishing rules for their market introduction and usage. Member States must adopt national measures to enforce the Directive, monitor incidents, and take corrective action if devices pose risks. It requires confidentiality among involved parties and provides mechanisms to review and update standards and procedures to maintain safety and public health.
Purpose
Council Directive 90/385/EEC aims to harmonize the laws of EU Member States related to active implantable medical devices (AIMDs). The primary objectives are to ensure a high level of protection for patients, users, and others by standardizing essential safety and performance requirements for these devices across the EU. This harmonization facilitates the free movement of active implantable medical devices within the internal market without compromising safety or health standards. The Directive establishes essential requirements, conformity assessment procedures, and controls to achieve these goals.
Key Obligations
- Safety and Performance: AIMDs must meet essential safety and health requirements laid out in Annex 1, which consider the intended purpose of the device. These include technical safety, reliability, and performance criteria.
- CE Marking: Devices must bear the CE marking to be placed on the market and put into service within the EU. This indicates conformity with the Directive's essential requirements.
- Conformity Assessment: Manufacturers must follow prescribed conformity assessment procedures, choosing among options such as EC declaration of conformity or EC type-examination combined with verification or declaration of conformity to type. These procedures often engage notified bodies designated by Member States.
- Notified Bodies: Member States shall designate and notify the Commission of bodies responsible for conformity assessments. These bodies must meet minimum criteria outlined in Annex 8.
- Clinical Investigations and Custom-Made Devices: Special rules apply to devices intended for clinical investigations or custom-made devices. These devices are exempt from CE marking but must comply with relevant procedural requirements.
- Incident Reporting and Market Surveillance: Member States must record and centrally evaluate any incidents involving AIMDs that may affect health or safety. Necessary market withdrawals, prohibitions, or restrictions must be promptly communicated to the Commission and other Member States.
- Information and Transparency: Manufacturers must provide instructions for use and other relevant information in national languages upon putting devices into service. Decisions to restrict or refuse device placement must state precise grounds and inform concerned parties of remedies available.
- Confidentiality: All parties involved must observe confidentiality concerning proprietary or sensitive information, except as required for dissemination of warnings or mutual information exchange.
Affected Products and Actors
- Active Implantable Medical Devices: Defined as any active medical device intended to be totally or partially introduced surgically or medically into the human body (or via a natural orifice) and to remain after the procedure. Examples include pacemakers, implantable defibrillators, and neurostimulators.
- Manufacturers and Authorized Representatives: Responsible for ensuring conformity, maintaining technical documentation, and affixing CE marking.
- Notified Bodies: Officially recognized bodies designated by Member States to perform conformity assessments.
- Competent Authorities of Member States: Oversee market surveillance, incident reporting, and enforcement actions.
- Specialist Doctors: Users of devices intended for clinical investigations.
- Patients and Users: End users benefiting from the regulated safety and performance standards.
Implementation Timeline
- Adoption and Publication by Member States: By 1 July 1992, Member States were required to adopt and publish laws or regulations necessary to comply with the Directive.
- Application Date: The provisions of the Directive became applicable from 1 January 1993.
- Transitional Period: Up to 31 December 1994, Member States could permit placing on the market and putting into service devices compliant with national laws in force as of 31 December 1992.
- Ongoing Oversight: Member States and the Commission maintain ongoing information exchange and cooperation mechanisms, including updates to the list of notified bodies and monitoring the performance of harmonized standards.
This Directive serves as a cornerstone for regulating active implantable medical devices within the EU, ensuring both high safety standards and smooth functioning of the internal market for these critical health products.
This Directive applies specifically to active implantable medical devices intended for use in human beings. These devices are characterized as active medical devices that rely on a power source other than the human body or gravity and are meant to be totally or partially introduced surgically or medically into the human body or a natural orifice, remaining there after the procedure. The scope includes devices used for diagnosis, prevention, monitoring, treatment, or alleviation of disease or injury, as well as devices involved in the investigation, replacement, or modification of anatomy or physiological processes, and for controlling conception. The Directive covers devices that do not achieve their principal action through pharmacological, chemical, immunological, or metabolic means but may be assisted by such means. It also includes custom-made devices made for individual patients and devices intended for clinical investigation by specialist doctors. The Directive excludes any substance within a device that is considered a medicinal product, which falls under separate marketing authorization rules.
Die Richtlinie 90/385/EWG zielt auf die Harmonisierung der Rechtsvorschriften der EU-Mitgliedstaaten zu aktiven implantierbaren medizinischen Geräten ab, um ein hohes Sicherheits- und Leistungsniveau für Patienten, Anwender und Dritte zu gewährleisten. Solche Geräte, die ganz oder teilweise im menschlichen Körper implantiert werden, müssen grundlegende Sicherheits- und Leistungsanforderungen erfüllen, ohne den freien Warenverkehr innerhalb der EU zu behindern. Die Richtlinie definiert wichtige Begriffe, legt Anforderungen an Konformitätsbewertungsverfahren und Kennzeichnung (EG-Konformitätszeichen) fest sowie die Verpflichtungen der Hersteller, Behörden und benannten Stellen. Zugelassene harmonisierte Normen unterstützen die Einhaltung der grundlegenden Anforderungen. Zudem regelt die Richtlinie Meldepflichten bei Vorkommnissen und die Rücknahme gefährlicher Produkte. Für klinische Prüfungen und Sonderanfertigungen gelten besondere Vorschriften. Die Mitgliedstaaten müssen Überwachungs- und Durchsetzungsmechanismen einrichten und sind verpflichtet, Entscheidungen über Beschränkungen des Inverkehrbringens transparent zu begründen. Ziel ist die Verbesserung und Sicherung des Gesundheits- und Verbraucherschutzes unter Wahrung des Binnenmarktes.
Zweck
Die Richtlinie 90/385/EWG zielt darauf ab, die Rechtsvorschriften der EU-Mitgliedstaaten über aktive implantierbare medizinische Geräte zu harmonisieren. Dabei soll ein hohes Sicherheitsniveau für Patienten, Anwender und Dritte gewährleistet und gleichzeitig der freie Warenverkehr innerhalb des Binnenmarkts ermöglicht werden. Die Richtlinie strebt an, das in den Mitgliedstaaten bestehende und gerechtfertigte Sicherheitsniveau nicht zu verringern, sondern mindestens zu erhalten oder gar zu verbessern. Sie legt grundlegende Anforderungen an diese Geräte fest und harmonisiert die Konformitätsbewertungsverfahren, um deren sichere Verwendung beim Menschen sicherzustellen.
Wesentliche Verpflichtungen
- Grundlegende Anforderungen: Aktive implantierbare medizinische Geräte müssen die im Anhang 1 definierten grundlegenden Anforderungen an Sicherheit und Leistung erfüllen, unter Berücksichtigung ihrer Zweckbestimmung.
- Konformitätsbewertung: Hersteller müssen vor dem Inverkehrbringen der Geräte ein Konformitätsbewertungsverfahren durchlaufen (z. B. EG-Konformitätserklärung, Baumusterprüfung), durch benannte Stellen begutachtet und dokumentiert (Anhang 2–5).
- Kennzeichnung: Entsprechende Geräte (außer Sonderanfertigungen und Geräte für klinische Prüfungen) sind mit dem EG-Konformitätszeichen zu versehen, das die Einhaltung der harmonisierten Sicherheits- und Gesundheitsanforderungen dokumentiert.
- Meldung von Vorkommnissen: Mitgliedstaaten müssen sicherstellen, dass gefährliche Vorfälle, Änderungen oder Rücknahmen von Geräten zentral erfasst, bewertet und unverzüglich der Kommission sowie anderen Mitgliedstaaten gemeldet werden.
- Marktüberwachung: Bei festgestellten Gefahren oder Nicht-Konformitäten können Mitgliedstaaten das Inverkehrbringen oder die Inbetriebnahme beschränken oder verbieten und müssen solche Maßnahmen der Kommission melden.
- Benannte Stellen: Mitgliedstaaten benennen Stellen, die die Konformitätsbewertungsverfahren durchführen, überwachen diese auf Einhaltung definierter Mindestkriterien und veröffentlichen eine Liste der benannten Stellen.
- Klinische Prüfungen und Sonderanfertigungen: Für diese Gerätetypen gibt es besondere Regeln, bspw. Anmelde- und Dokumentationsverfahren vor Prüfungen, die keine EG-Kennzeichnung tragen.
Betroffene Produkte und Akteure
- Aktive implantierbare medizinische Geräte: Geräte, die ganz oder teilweise durch chirurgischen oder medizinischen Eingriff in den menschlichen Körper implantiert werden und die auf elektrische oder andere Energiequellen angewiesen sind.
- Hersteller: Sie tragen die Verantwortung für die Einhaltung der Anforderungen, Durchführung der Konformitätsbewertungen und die Kennzeichnung.
- Benannte Stellen: Unabhängige Prüf- und Zertifizierungsstellen, die von Mitgliedstaaten benannt werden, um die Übereinstimmung der Produkte mit der Richtlinie zu bewerten.
- Mitgliedstaatliche Behörden: Zuständig für Marktüberwachung, Meldung von Sicherheitsvorkommnissen sowie für die Genehmigung klinischer Prüfungen.
- Klinische Prüfer: Spezialisten, die Geräte im Rahmen medizinischer Prüfungen einsetzen dürfen.
- Endnutzer, Patienten und medizinisches Personal: Anwender der Produkte, deren Sicherheit und Gesundheit geschützt werden sollen.
Umsetzungszeitplan
Die Richtlinie wurde am 20. Juni 1990 verabschiedet. Die Mitgliedstaaten sind verpflichtet, die Richtlinie in nationales Recht umzusetzen und sicherzustellen, dass alle aktiven implantierbaren medizinischen Geräte, die auf ihrem Markt in Verkehr gebracht oder in Betrieb genommen werden, den Anforderungen entsprechen. Die Richtlinie sieht vor, dass vor der Inverkehrbringung eine Konformitätsbewertung durchgeführt wird. Für klinische Prüfungen müssen vor dem Beginn mindestens 60 Tage Vorlaufzeit eingehalten werden, damit die zuständigen Behörden prüfen können.
Die Kommission sorgt zusammen mit den Mitgliedstaaten über ständige Ausschüsse für die Überwachung der Umsetzung und gegebenenfalls Anpassungen der harmonisierten Normen. Die Mitgliedstaaten haben eine zeitnahe und transparente Kommunikation über Entscheidungen zur Marktüberwachung an die Kommission und andere Mitgliedstaaten sicherzustellen.
Diese Richtlinie bildet die Grundlage für den sicheren Einsatz aktiver implantierbarer medizinischer Geräte in der Europäischen Union und stellt die Harmonisierung von Sicherheits- und Gesundheitsanforderungen sicher, um den Binnenmarkt effektiv zu betreiben.
Die Richtlinie 90/385/EWG gilt für aktive implantierbare medizinische Geräte, also medizinische Geräte, die zur Implantation ganz oder teilweise durch einen chirurgischen oder medizinischen Eingriff in den menschlichen Körper oder durch eine natürliche Körperöffnung bestimmt sind und dort verbleiben sollen. Diese Geräte sind aktiv, das heißt, ihr Betrieb beruht auf einer elektrischen oder anderen Energiequelle. Die Richtlinie umfasst auch Sonderanfertigungen, die speziell nach ärztlicher Verordnung für einen einzelnen Patienten hergestellt werden, sowie Geräte, die für klinische Prüfungen bestimmt sind. Sie regelt u.a. die Sicherheit, Gesundheitsschutzanforderungen und das Inverkehrbringen dieser implantierbaren Geräte innerhalb der Mitgliedstaaten der EU, um ein hohes Schutzniveau für Patienten, Anwender und Dritte zu gewährleisten und den freien Warenverkehr sicherzustellen. Dabei sind auch Geräte einbezogen, die Stoffe abgeben, sofern diese Stoffe nicht bereits unter Arzneimittelregelungen fallen.
La directive 90/385/CEE vise à harmoniser les législations des États membres concernant les dispositifs médicaux implantables actifs (DMIA). Elle établit des exigences essentielles que ces dispositifs doivent satisfaire pour garantir un niveau élevé de sécurité et de performance, protégeant ainsi la santé des patients, des utilisateurs et des tiers. La directive définit les catégories de dispositifs concernés, y compris les dispositifs sur mesure et ceux destinés aux investigations cliniques. Elle précise les procédures d’évaluation de conformité, incluant l’apposition du marquage CE, obligatoire pour la mise sur le marché des DMIA, sauf pour certains dispositifs spécifiques. Les États membres doivent désigner des organismes notifiés pour contrôler la conformité et prendre des mesures en cas de risques sanitaires liés à ces dispositifs. La directive garantit la libre circulation des DMIA dans la Communauté européenne tout en maintenant un niveau rigoureux de sécurité. Elle prévoit également la centralisation et la transmission des données concernant les incidents liés aux dispositifs, et impose la confidentialité des informations obtenues dans le cadre de son application.
Objet
La directive 90/385/CEE du Conseil du 20 juin 1990 vise à harmoniser les législations des États membres relatives aux dispositifs médicaux implantables actifs, afin d'assurer un niveau élevé de protection pour les patients, utilisateurs et tiers, sans restreindre la libre circulation des produits dans le marché communautaire. Elle fixe des exigences essentielles pour garantir la sécurité et la performance de ces dispositifs lorsqu'ils sont implantés dans le corps humain.
Principales obligations
Respect des exigences essentielles : Les dispositifs médicaux implantables actifs doivent satisfaire aux exigences essentielles énoncées, portant notamment sur la sécurité, la performance, et l'information relative à leur usage (article 3, annexe I).
Marquage CE : Les dispositifs non sur mesure ni destinés à des investigations cliniques doivent porter le marquage CE, attestant leur conformité aux exigences essentielles, selon les procédures appropriées décrites aux annexes II à V (articles 9, 12).
Procédures d'évaluation : Le fabricant doit suivre soit une déclaration CE de conformité, soit un examen CE de type combiné avec une vérification, selon les modalités prévues (article 9).
Organismes notifiés : Les États membres désignent des organismes notifiés chargés d’évaluer la conformité des dispositifs, qui doivent respecter des critères minimaux et collaborer avec les fabricants pour fixer des délais d’évaluation (article 11).
Signalement des incidents : Les États membres doivent recenser et évaluer de façon centralisée tout incident sérieux ou retrait du marché lié aux dispositifs, et informer la Commission et les autres États membres (article 8).
Gestion des risques et mesures nationales : En cas de risque pour la santé ou la sécurité, les États membres doivent prendre des mesures adéquates (retrait, interdiction, restriction) et informer la Commission (article 7).
Confidentialité : Les informations obtenues dans le cadre de la mise en œuvre de la directive doivent être confidentielles, sauf pour les échanges nécessaires entre États membres ou pour diffusion des mises en garde (article 15).
Produits et acteurs concernés
Dispositifs médicaux implantables actifs : Tout dispositif médical actif conçu pour être entièrement ou partiellement implanté dans le corps humain ou un orifice naturel, devant rester en place après l’intervention (article 1).
Dispositifs sur mesure : Fabriqués spécifiquement pour un patient donné sous prescription écrite d’un médecin spécialiste ; ne portent pas le marquage CE mais doivent répondre à des exigences documentées (article 1, 4).
Dispositifs destinés à des investigations cliniques : Utilisés à des fins d’essais cliniques, devant faire l’objet d’une notification préalable aux autorités compétentes (articles 1, 4, 10).
Fabricants et mandataires : Responsables de la conformité des dispositifs, de la procédure d’évaluation et de la mise sur le marché.
Organismes notifiés : Entités désignées par les États membres pour contrôler la conformité technique des dispositifs suivant les exigences de la directive.
Calendrier de mise en œuvre
- La directive est entrée en vigueur le 20 juin 1990.
- Les États membres devaient prendre les mesures nécessaires pour sa transposition avant le 1er juillet 1992 (article 16, début).
- La mise sur le marché des dispositifs selon les dispositions harmonisées devait être effective suite à cette date.
Ce calendrier fixe un cadre clair pour que tous les États membres garantissent une application uniforme des règles, facilitant ainsi la libre circulation des dispositifs médicaux implantables actifs au sein du marché intérieur tout en garantissant un haut niveau de protection sanitaire.
La directive 90/385/CEE s'applique aux dispositifs médicaux implantables actifs, c'est-à-dire tout dispositif médical actif destiné à être implanté en totalité ou en partie dans le corps humain par intervention chirurgicale ou médicale, destiné à rester après cette intervention. Un dispositif médical est défini comme un instrument, appareil, équipement ou autre article utilisé seul ou en association, y compris ses accessoires et logiciels associés, destiné par le fabricant à l'usage humain pour le diagnostic, la prévention, le contrôle, le traitement ou l'atténuation d'une maladie ou d'une blessure, ou la modification de l’anatomie ou d’un processus physiologique. La directive concerne également les dispositifs sur mesure, fabriqués spécifiquement pour un patient donné, ainsi que les dispositifs destinés à des investigations cliniques. Elle exclut les substances considérées comme médicaments lorsqu'elles sont utilisées seules mais englobe les dispositifs incorporant de telles substances dans leur ensemble.
Direktiva 90/385/EGS ureja uskladitev zakonodaje držav članic glede aktivnih medicinskih pripomočkov za vsaditev, s ciljem zagotavljanja visoke ravni varnosti, učinkovitosti ter prostega pretoka teh pripomočkov v EU. Aktivni medicinski pripomoček za vsaditev je opredeljen kot pripomoček, ki se kirurško vstavi v človeško telo ali v naravno odprtino in tam ostane. Direktiva določa bistvene zahteve za načrtovanje, izdelavo in uporabo teh pripomočkov, ter zahteve glede skladnosti, vključno z označevanjem CE, postopki ocenjevanja, ter nadzorom uporabniške varnosti. Prav tako ureja postopke za klinične preiskave, obveščanje o zapletih, spremljanje trga in ukrepe ob ugotovitvi tveganj za uporabnike. Države članice morajo sprejeti ustrezne ukrepe za upoštevanje teh zahtev in zagotoviti, da so priglašeni organi zadolženi za preverjanje skladnosti s predpisano zakonodajo. Direktiva prispeva k izboljšanju varnosti pacientov ter usklajevanju trga medicinskih pripomočkov v Evropski uniji.
Namen
Direktiva 90/385/EEC določa usklajene zahteve za aktivne medicinske pripomočke za vsaditev z namenom zagotavljanja visoke ravni varnosti in učinkovitosti teh pripomočkov, ki se kirurško ali zdravstveno vsadijo v človeško telo ali v naravno odprtino in tam ostanejo. Cilj je omogočiti prosto pretakanje teh pripomočkov znotraj EU, ne da bi bila ogrožena varnost pacientov, uporabnikov in drugih oseb, hkrati pa ohraniti ali izboljšati trenutno varnostno raven v državah članicah.
Ključne obveznosti
- Aktivni medicinski pripomočki za vsaditev morajo izpolnjevati bistvene zahteve glede varnosti, učinkovitosti in kakovosti, ki so določene v Prilogi I direktive.
- Pripomočki ne smejo ogrožati zdravja pacientov, uporabnikov ali drugih oseb ob pravilni uporabi, vzdrževanju in vsaditvi.
- Proizvajalci morajo prilagoditi pripomočke predvidenemu namenu in zagotoviti ustrezno sterilnost, trajnost in zanesljivo delovanje.
- Označevanje mora vključevati oznako CE, ki potrjuje skladnost z direktivo.
- Države članice morajo urediti postopke ocenjevanja in overjanja skladnosti s priglašenimi organi.
- Proizvajalci morajo pred začetkom kliničnih preiskav obvestiti pristojne organe, razen v primeru prilagojenih ali kliničnih pripomočkov.
- Države članice so dolžne spremljati in obveščati o morebitnih zapletih, poslabšanju varnosti ali učinkovitosti pripomočkov.
- Ob nepravilnostih morajo države članice sprejeti ukrepe za umik ali omejitev dajanja pripomočkov v promet ter o tem nemudoma obvestiti Komisijo in druge države članice.
- Vse strani, vključene v izvajanje direktive, morajo spoštovati zaupnost pridobljenih podatkov.
Zadevni izdelki in akterji
- Aktivni medicinski pripomočki za vsaditev, ki so medicinski pripomočki, ki za delovanje uporabljajo vir energije (npr. električno energijo) in so namenjeni vsaditvi v človeka (delno ali v celoti).
- Uporabniku prilagojeni aktivni medicinski pripomočki za vsaditev, izdelani po pisnem receptu za posameznega pacienta.
- Pripomočki za klinične preiskave, ki jih uporabljajo specialisti v humani medicini.
- Proizvajalci in njihovi pooblaščenci s sedežem v EU.
- Države članice EU, ki morajo imenovati priglašene organe za izvedbo ocenjevanja skladnosti.
- Priglašeni organi, ki izvajajo postopke skladnosti in nadzor.
Roki za implementacijo
- Države članice morajo sprejeti potrebne nacionalne zakone in druge predpise za uskladitev s to direktivo do 1. julija 1992.
- Nova zakonodaja se mora uporabljati od 1. januarja 1993.
- Do 31. decembra 1994 je dovoljena prodaja in uporaba pripomočkov, ki so skladni z nacionalno zakonodajo veljavno do 31. decembra 1992.
- Proizvajalci morajo vsaj 60 dni pred začetkom kliničnih preiskav obvestiti pristojne organe.
- Priglašeni organi in proizvajalci morajo soglasno določiti roke za zaključek postopkov ocenjevanja in overjanja skladnosti.
Direktiva predstavlja ključen zakonodajni okvir za zagotavljanje kakovosti, varnosti in prostega pretoka aktivnih medicinskih pripomočkov za vsaditev v državah članicah Evropske unije.
Direktiva 90/385/EGS se nanaša na aktivne medicinske pripomočke za vsaditev, torej medicinske pripomočke, ki se v celoti ali delno kirurško ali z zdravstvenim posegom vsadijo v človeško telo ali se z zdravstvenim posegom vstavljajo v naravno odprtino in tam ostanejo. Ti pripomočki so aktivni, kar pomeni, da za svoje delovanje uporabljajo električno energijo ali drug vir energije, razen tistega, ki izhaja iz človeškega telesa ali gravitacije. Namen uporabe teh pripomočkov vključuje diagnozo, preprečevanje, spremljanje, zdravljenje ali lajšanje bolezni oziroma poškodbe, nadomestitev ali spremembo anatomije ali fiziološkega procesa ter nadzorovanje zanositve. Direktiva ureja proizvodnjo, varnost, učinkovitost in nadzor teh pripomočkov ter določa zahteve za njihovo dajanje v promet in uporabo znotraj Evropske unije, pri čemer zagotavlja usklajenost zakonodaje držav članic na tem področju.
General Information
1.1 This document specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.
NOTE Although the scope is limited to medical devices, this document can be applicable to other products and equipment.
This document covers radiation processes employing irradiators using:
a) the radionuclide 60Co or 137Cs;
b) a beam from an electron generator; or
c) a beam from an X-ray generator.
1.2 This document is not applicable to processes for inactivating viruses or the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.
NOTE For information on such processes, see ISO 22442-1, ISO 22442-2, ISO 22442-3, ISO 13022 and ICH Q5A.
1.2.1 This document does not specify requirements for designating a medical device as sterile.
NOTE Regional and national requirements can designate medical devices as sterile. See, for example, EN 556-1 or ANSI/AAMI ST67.
1.2.2 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, but the elements of a quality management system that are the minimum necessary to control the sterilization process are normatively referenced at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production of medical devices, including the sterilization process. Regional and national regulations for the provision of medical devices can require implementation of a complete quality management system and the assessment of that system by a third party.
1.2.3 This document does not require that biological indicators be used for validation or monitoring of radiation sterilization, nor does it require that a pharmacopoeial test for sterility be carried out for product release.
1.2.4 This document does not specify requirements for occupational safety associated with the design and operation of irradiation facilities.
NOTE Regulations on safety requirements for occupational safety related to radiation can exist in some countries.
1.2.5 This document does not specify requirements for the sterilization of used or reprocessed devices.
- Standard61 pagesEnglish languagee-Library read for1 day
1.1 This document specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.
NOTE Although the scope is limited to medical devices, this document can be applicable to other products and equipment.
This document covers radiation processes employing irradiators using:
a) the radionuclide 60Co or 137Cs;
b) a beam from an electron generator; or
c) a beam from an X-ray generator.
1.2 This document is not applicable to processes for inactivating viruses or the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.
NOTE For information on such processes, see ISO 22442-1, ISO 22442-2, ISO 22442-3, ISO 13022 and ICH Q5A.
1.2.1 This document does not specify requirements for designating a medical device as sterile.
NOTE Regional and national requirements can designate medical devices as sterile. See, for example, EN 556-1 or ANSI/AAMI ST67.
1.2.2 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, but the elements of a quality management system that are the minimum necessary to control the sterilization process are normatively referenced at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production of medical devices, including the sterilization process. Regional and national regulations for the provision of medical devices can require implementation of a complete quality management system and the assessment of that system by a third party.
1.2.3 This document does not require that biological indicators be used for validation or monitoring of radiation sterilization, nor does it require that a pharmacopoeial test for sterility be carried out for product release.
1.2.4 This document does not specify requirements for occupational safety associated with the design and operation of irradiation facilities.
NOTE Regulations on safety requirements for occupational safety related to radiation can exist in some countries.
1.2.5 This document does not specify requirements for the sterilization of used or reprocessed devices.
- Standard61 pagesEnglish languagee-Library read for1 day
- Amendment6 pagesEnglish languagee-Library read for1 day
- Amendment6 pagesEnglish languagee-Library read for1 day
This document specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and the estimation and control of biological risks from material constituents, using a generally stepwise approach to the chemical characterization which can include one or more of the following:
— the identification of its materials of construction (medical device configuration);
— the characterization of the materials of construction via the identification and quantification of their chemical constituents (material composition);
— the characterization of the medical device for chemical substances that were introduced during manufacturing (e.g. mould release agents, process contaminants, sterilization residues);
— the estimation (using laboratory extraction conditions) of the potential of the medical device, or its materials of construction, to release chemical substances under clinical use conditions (extractables);
— the measurement of chemical substances released from a medical device under its clinical conditions of use (leachables).
This document can also be used for chemical characterization (e.g. the identification and/or quantification) of degradation products. Information on other aspects of degradation assessment are covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15.
The ISO 10993 series is applicable when the material or medical device has direct or indirect body contact (see ISO 10993-1 for categorization by nature of body contact).
This document is intended for suppliers of materials and manufacturers of medical devices, to support a biological evaluation.
- Standard81 pagesEnglish languagee-Library read for1 day
2022-06-21 - lack of compliance - publication on hold
- Amendment13 pagesEnglish languagee-Library read for1 day
ISO 14708-3:2017 is applicable to active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system.
The tests that are specified in this document are type tests and are to be carried out on a sample of a device to assess device behavioural responses, and are not intended to be used for the routine testing of manufactured products.
- Standard63 pagesEnglish languagee-Library read for1 day
This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization.
This document includes:
— details of in vivo skin sensitization test procedures;
— key factors for the interpretation of the results.
NOTE Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.
- Standard60 pagesEnglish languagee-Library read for1 day
This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization.
This document includes:
— details of in vivo skin sensitization test procedures;
— key factors for the interpretation of the results.
NOTE Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.
- Standard60 pagesEnglish languagee-Library read for1 day
2022-06-21 - lack of compliance - publication on hold
- Amendment13 pagesEnglish languagee-Library read for1 day
ISO 14708-3:2017 is applicable to active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system.
The tests that are specified in this document are type tests and are to be carried out on a sample of a device to assess device behavioural responses, and are not intended to be used for the routine testing of manufactured products.
- Standard63 pagesEnglish languagee-Library read for1 day
This document specifies requirements for safety and performance of active implantable circulatory support devices, including type tests, animal studies and clinical evaluation requirements.
NOTE The device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify main requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device.
The tests that are specified in this document are type tests and are to be carried out on a sample of a device to assess device behavioural responses and are not intended to be used for the routine testing of manufactured products.
Included in the scope of this document are:
— ventricular assist devices (VAD), left or right heart support;
— total artificial hearts (TAH);
— biventricular assist devices (biVAD);
— percutaneous assist devices;
— paediatric assist devices.
- Standard79 pagesEnglish languagee-Library read for1 day
This document specifies requirements that are applicable to implantable cardioverter defibrillators and CRT-Ds and the functions of active implantable medical devices intended to treat tachyarrhythmia.
The tests that are specified in ISO 14708 are type tests and are to be carried out on samples of a device to show compliance.
This document was designed for tachyarrhythmia pulse generators used with either endocardial leads or epicardial leads. At the time of this edition, the authors recognized the emergence of technologies that do not use endocardial or epicardial leads for which adaptations of this part will be required. Such adaptations are left to the discretion of manufacturers incorporating these technologies.
This document is also applicable to some non-implantable parts and accessories of the devices (see Note 1).
The characteristics of the implantable pulse generator or lead shall be determined by either the appropriate method detailed in this document or by any other method demonstrated to have accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this document shall apply.
Any aspect of an active implantable medical device intended to treat bradyarrhythmias or cardiac resynchronization is covered by ISO 14708-2.
NOTE 1 The device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device.
NOTE 2 In this document, terms printed in italics are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in italics unless the concept thus qualified is also defined.
- Standard75 pagesEnglish languagee-Library read for1 day
This document specifies requirements that are applicable to those active implantable medical devices intended to treat bradyarrhythmias and devices that provide therapies for cardiac resynchronization.
The tests that are specified in this document are type tests, and are to be carried out on samples of a device to show compliance.
This document was designed for bradyarrhythmia pulse generators used with endocardial leads or epicardial leads. At the time of this edition, the authors recognized the emergence of leadless technologies for which adaptations of this part will be required. Such adaptations are left to the discretion of manufacturers incorporating these technologies.
This document is also applicable to some non-implantable parts and accessories of the devices (see Note 1).
The electrical characteristics of the implantable pulse generator or lead are determined either by the appropriate method detailed in this particular standard or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In case of dispute, the method detailed in this particular standard applies.
Any features of an active implantable medical device intended to treat tachyarrhythmias are covered by ISO 14708-6.
NOTE 1 The device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device.
NOTE 2 In this document, terms printed in italics are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in italics unless the concept thus qualified is also defined.
- Standard80 pagesEnglish languagee-Library read for1 day
This document specifies particular requirements for active implantable medical devices intended to deliver a medicinal substance to site-specific locations within the human body, to provide basic assurance of safety for both patients and users. It amends and supplements ISO 14708-1:2014. The requirements of this document take priority over those of ISO 14708-1.
This document is applicable to active implantable medical devices intended to deliver medicinal substances to site-specific locations within the human body.
This document is also applicable to some non-implantable parts and accessories of the devices defined in Clause 3.
The tests that are specified in this document are type tests intended to be carried out on a sample of a device to show compliance and are not intended to be used for the routine testing of manufactured products.
NOTE This document is not intended to apply to non-implantable infusion systems.
- Standard68 pagesEnglish languagee-Library read for1 day
This document specifies requirements that are applicable to those active implantable medical devices that are intended to treat hearing impairment via electrical stimulation of the auditory pathways. Devices which treat hearing impairment via means other than electrical stimulation are not covered by this document.
The tests that are specified in this document are type tests and are to be carried out on samples of a device to show compliance.
This document is also applicable to non-implantable parts and accessories of the devices (see NOTE).
The electrical characteristics of the implantable part are determined by either the appropriate method detailed in this document or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this document applies.
NOTE A device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, this document specifies those requirements of non-implantable parts and accessories which could affect the safety or performance of the implantable part.
- Standard77 pagesEnglish languagee-Library read for1 day
IEC Corrected version
- Corrigendum5 pagesFrench 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
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
IEC Corrected version
- Corrigendum5 pagesFrench languagee-Library read for1 day
This document specifies particular requirements for active implantable medical devices intended to deliver a medicinal substance to site-specific locations within the human body, to provide basic assurance of safety for both patients and users. It amends and supplements ISO 14708-1:2014. The requirements of this document take priority over those of ISO 14708-1.
This document is applicable to active implantable medical devices intended to deliver medicinal substances to site-specific locations within the human body.
This document is also applicable to some non-implantable parts and accessories of the devices defined in Clause 3.
The tests that are specified in this document are type tests intended to be carried out on a sample of a device to show compliance and are not intended to be used for the routine testing of manufactured products.
NOTE This document is not intended to apply to non-implantable infusion systems.
- Standard68 pagesEnglish languagee-Library read for1 day
This document specifies requirements for safety and performance of active implantable circulatory support devices, including type tests, animal studies and clinical evaluation requirements.
NOTE The device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify main requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device.
The tests that are specified in this document are type tests and are to be carried out on a sample of a device to assess device behavioural responses and are not intended to be used for the routine testing of manufactured products.
Included in the scope of this document are:
— ventricular assist devices (VAD), left or right heart support;
— total artificial hearts (TAH);
— biventricular assist devices (biVAD);
— percutaneous assist devices;
— paediatric assist devices.
- Standard79 pagesEnglish languagee-Library read for1 day
This document specifies requirements that are applicable to implantable cardioverter defibrillators and CRT-Ds and the functions of active implantable medical devices intended to treat tachyarrhythmia.
The tests that are specified in ISO 14708 are type tests and are to be carried out on samples of a device to show compliance.
This document was designed for tachyarrhythmia pulse generators used with either endocardial leads or epicardial leads. At the time of this edition, the authors recognized the emergence of technologies that do not use endocardial or epicardial leads for which adaptations of this part will be required. Such adaptations are left to the discretion of manufacturers incorporating these technologies.
This document is also applicable to some non-implantable parts and accessories of the devices (see Note 1).
The characteristics of the implantable pulse generator or lead shall be determined by either the appropriate method detailed in this document or by any other method demonstrated to have accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this document shall apply.
Any aspect of an active implantable medical device intended to treat bradyarrhythmias or cardiac resynchronization is covered by ISO 14708-2.
NOTE 1 The device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device.
NOTE 2 In this document, terms printed in italics are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in italics unless the concept thus qualified is also defined.
- Standard75 pagesEnglish languagee-Library read for1 day
This document specifies requirements that are applicable to those active implantable medical devices intended to treat bradyarrhythmias and devices that provide therapies for cardiac resynchronization.
The tests that are specified in this document are type tests, and are to be carried out on samples of a device to show compliance.
This document was designed for bradyarrhythmia pulse generators used with endocardial leads or epicardial leads. At the time of this edition, the authors recognized the emergence of leadless technologies for which adaptations of this part will be required. Such adaptations are left to the discretion of manufacturers incorporating these technologies.
This document is also applicable to some non-implantable parts and accessories of the devices (see Note 1).
The electrical characteristics of the implantable pulse generator or lead are determined either by the appropriate method detailed in this particular standard or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In case of dispute, the method detailed in this particular standard applies.
Any features of an active implantable medical device intended to treat tachyarrhythmias are covered by ISO 14708-6.
NOTE 1 The device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device.
NOTE 2 In this document, terms printed in italics are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in italics unless the concept thus qualified is also defined.
- Standard80 pagesEnglish languagee-Library read for1 day
This document specifies requirements that are applicable to those active implantable medical devices that are intended to treat hearing impairment via electrical stimulation of the auditory pathways. Devices which treat hearing impairment via means other than electrical stimulation are not covered by this document.
The tests that are specified in this document are type tests and are to be carried out on samples of a device to show compliance.
This document is also applicable to non-implantable parts and accessories of the devices (see NOTE).
The electrical characteristics of the implantable part are determined by either the appropriate method detailed in this document or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this document applies.
NOTE A device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, this document specifies those requirements of non-implantable parts and accessories which could affect the safety or performance of the implantable part.
- Standard77 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
This document provides general principles for the systematic evaluation of the potential and observed degradation of medical devices through the design and performance of in vitro degradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series.
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:
a) the 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.
b) leachable components which are not degradation products;
c) medical devices or components that do not contact the patient's body directly or indirectly.
- Standard22 pagesEnglish languagee-Library read for1 day
- Amendment27 pagesEnglish languagee-Library read for1 day
This document specifies requirements for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of single-use medical devices comprising, in whole or in part, materials of animal origin.
This document covers the control of risks arising from contamination with bacteria and fungi by application of a liquid chemical sterilization process. Risks associated with other microorganisms can be assessed using other methods (see NOTE 1).
This document is not applicable to material of human origin.
This document does not describe methods for the validation of the inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (see NOTE 2 and NOTE 3).
This document does not describe methods for validation of the inactivation or elimination of protozoa and parasites.
The requirements for validation and routine control described in this document are only applicable to the defined sterilization process of a medical device, which is performed after the manufacturing process, and do not take account of the lethal effects of other bioburden reduction steps (see NOTE 4).
This document does not specify tests to establish the effects of any chosen sterilization process upon the fitness for use of the medical device (see NOTE 5).
This document does not cover the level of residual sterilizing agent within medical devices (see NOTE 6).
Guidance for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of single-use medical devices comprising, in whole or in part, materials of animal origin is provided in informative Annex A.
NOTE 1 The prior application of risk management principles to medical devices utilizing animal tissues, as described in ISO 22442-1 is important. ISO 18362 provides information on control of microbial risks during processing of cell-based health-care products.
NOTE 2 Liquid chemical sterilizing agents traditionally employed to sterilize animal tissues in medical devices might not be effective in inactivating the causative agents of TSE such as bovine spongiform encephalopathy (BSE), or scrapie. Satisfactory validation in accordance with this document does not necessarily demonstrate inactivation of infective agents of this type. Risk controls related to sourcing, collection and handling of animal materials are described in ISO 22442-2.
NOTE 3 The validation of the inactivation, elimination, or elimination and inactivation of viruses and TSE agents is described in ISO 22442-3.
NOTE 4 Manufacturing processes for medical devices containing animal tissues frequently include exposure to chemical agents which can significantly reduce the bioburden on the medical device. Following the manufacturing process, a medical device is exposed to a specified sterilization process.
NOTE 5 Such testing is a crucial part of the design and development of a medical device.
NOTE 6 ISO 10993-17 specifies a method to establish allowable limits for residues of sterilizing agents.
NOTE 7 Standards for quality management systems (see ISO 13485) can be used in the control of all stages of manufacture including the sterilization process.
- Standard50 pagesEnglish languagee-Library read for1 day
This document specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing primarily in biological test systems primarily in accordance with one or more parts of the ISO 10993 series.
Specifically, this document addresses the following:
— test sample selection;
— selection of representative portions from a medical device;
— test sample preparation;
— experimental controls;
— selection of, and requirements for, reference materials;
— preparation of extracts.
This document is not applicable to live cells but can be relevant to the material or medical device components of combination products containing live cells.
Extractions for chemical characterization are covered in ISO 10993-18. Clause 7, 8, 9, 10 [with the exception of 10.3.5 and 10.3.11 b)], and 11 can apply to extractions for chemical characterization. Information given in C.1 to C.4 can also be relevant.
- Standard32 pagesEnglish languagee-Library read for1 day
- Amendment13 pagesEnglish languagee-Library read for1 day
This document provides general principles for the systematic evaluation of the potential and observed degradation of medical devices through the design and performance of in vitro degradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series.
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:
a) the 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.
b) leachable components which are not degradation products;
c) medical devices or components that do not contact the patient's body directly or indirectly.
- Standard22 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
2021-08-25-JO: BT Decision (BT169/DG12292/DV) to remove the link to the MDR
2021-06-24: blocked so that the link to the MDD can be removed by BT from the document
2019-12-03-JO-Assessment at ENQ uplaoded with due date of 06 Jan.2020 plus extention requested by HAS Consultant
- Amendment58 pagesEnglish languagee-Library read for1 day
2021-08-25-JO: BT Decision (BT169/DG12292/DV) to remove the link to the MDR
2021-06-24: blocked so that the link to the MDD can be removed by BT from the document
2019-12-03-JO-Assessment at ENQ uplaoded with due date of 06 Jan.2020 plus extention requested by HAS Consultant
- Amendment58 pagesEnglish languagee-Library read for1 day
This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation. The tests are designed to predict and classify the irritation potential of medical devices, materials or their extracts according to ISO 10993‑1 and ISO 10993‑2.
This document includes:
— pre-test considerations for irritation, including in silico and in vitro methods for dermal exposure;
— details of in vitro and in vivo irritation test procedures;
— key factors for the interpretation of the results.
- Standard76 pagesEnglish languagee-Library read for1 day
2020-11-16_JO_BT167/DG11868/DV to remove the link to (MDD 93/42/EEC) , 90/385/EEC (AIMD) and M/295
- Amendment12 pagesEnglish languagee-Library read for1 day
This document specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing primarily in biological test systems primarily in accordance with one or more parts of the ISO 10993 series.
Specifically, this document addresses the following:
— test sample selection;
— selection of representative portions from a medical device;
— test sample preparation;
— experimental controls;
— selection of, and requirements for, reference materials;
— preparation of extracts.
This document is not applicable to live cells but can be relevant to the material or medical device components of combination products containing live cells.
Extractions for chemical characterization are covered in ISO 10993-18. Clause 7, 8, 9, 10 [with the exception of 10.3.5 and 10.3.11 b)], and 11 can apply to extractions for chemical characterization. Information given in C.1 to C.4 can also be relevant.
- Standard32 pagesEnglish languagee-Library read for1 day
2020-11-16_JO_BT167/DG11868/DV to remove the link to (MDD 93/42/EEC) , 90/385/EEC (AIMD) and M/295
- Amendment12 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
This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation. The tests are designed to predict and classify the irritation potential of medical devices, materials or their extracts according to ISO 10993‑1 and ISO 10993‑2.
This document includes:
— pre-test considerations for irritation, including in silico and in vitro methods for dermal exposure;
— details of in vitro and in vivo irritation test procedures;
— key factors for the interpretation of the results.
- Standard76 pagesEnglish languagee-Library read for1 day
This document specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and the estimation and control of biological risks from material constituents, using a generally stepwise approach to the chemical characterization which can include one or more of the following:
— the identification of its materials of construction (medical device configuration);
— the characterization of the materials of construction via the identification and quantification of their chemical constituents (material composition);
— the characterization of the medical device for chemical substances that were introduced during manufacturing (e.g. mould release agents, process contaminants, sterilization residues);
— the estimation (using laboratory extraction conditions) of the potential of the medical device, or its materials of construction, to release chemical substances under clinical use conditions (extractables);
— the measurement of chemical substances released from a medical device under its clinical conditions of use (leachables).
This document can also be used for chemical characterization (e.g. the identification and/or quantification) of degradation products. Information on other aspects of degradation assessment are covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15.
The ISO 10993 series is applicable when the material or medical device has direct or indirect body contact (see ISO 10993-1 for categorization by nature of body contact).
This document is intended for suppliers of materials and manufacturers of medical devices, to support a biological evaluation.
- Standard81 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
2020-10-13:JO-CLC/TC 62 Decision 2019-05-21/22 in Oslo to remove the link to the published standard
- Amendment9 pagesEnglish languagee-Library read for1 day
2020-10-13:JO-CLC/TC 62 Decision 2019-05-21/22 in Oslo to remove the link to the published standard
- Amendment9 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 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
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 90/385/EEC covers "Active implantable medical devices". There are 432 standards associated with this directive.
Harmonized standards under 90/385/EEC 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 90/385/EEC, facilitating CE marking and free movement within the European Economic Area.