Helsevesen, teknikk

This document sprecifies requirements and their test methods for adaptibility between implant Body and superstructure in dental implant systems.

This International Standard specifies the performance requirements and test methods for chemical indicators and hollow devices and porous devices within which they are intended to function, to be used for testing the steam penetration performance of type B cycles of small steam sterilizers; small steam sterilizers are defined in EN 13060. The hollow and porous devices described in this standard do not substantiate their suitability as surrogate devices for lumened, hollow and porous medical devices used in health care facilities. Chemical indicators used with a porous device specified in this standard are designed to demonstrate the adequacy of steam penetration into a porous device in small steam sterilizers (see EN 13060). The relevant sections of this International Standard covering porous loads specify the requirements for — a reference porous device to be used in the small load test for porous loads in small steam sterilizers and as a reference device by which alternative porous devices can be shown to be equivalent in performance according to this standard; ie, a textile test pack in which steam penetration is judged by thermometric means; — an alternative porous device equivalent in performance to the reference porous device; ie, an alternative porous device, usually commercially manufactured, of any design. Chemical indicator systems used with a hollow load device specified in this standard are designed to demonstrate the adequacy of steam penetration into a hollow device in small steam sterilizers (see EN 13060). The relevant sections of this International Standard covering hollow loads specify the requirements for — a reference hollow device used as a reference device in this standard; ie, a lumened device with attached capsule in which steam penetration is judged by inactivation or survival of a specified biological indicator; — an alternative hollow device employing the same specific test load as defined for the reference hollow device and an indicator system designed specifically for use in the reference hollow test load; ie, a lumened device with an attached capsule in which steam penetration is judged by visual examination of an indicator system; — an alternative hollow device equivalent in performance to the reference hollow device; ie, an alternative hollow device, usually commercially manufactured, of any design.

Dieses Dokument legt Anforderungen an anwenderbetriebene tragbare Wiederbelebungsgeräte (Handbeatmungsgeräte) fest, die zur Anwendung an Menschen aller Altersstufen und zur Lungenbeatmung bei Patienten mit unzureichender Atemtätigkeit vorgesehen sind. Anwenderbetriebene Wiederbelebungsgeräte werden entsprechend dem idealen Körpergewichtsbereich festgelegt. ANMERKUNG 1 Patienten, die mit einem Wiederbelebungsgerät behandelt werden, können beatmungsabhängig sein. Beispiele für anwenderbetriebene Wiederbelebungsgeräte sind: - selbstaufblasende Beutel-Wiederbelebungsgeräte, die dafür vorgesehen sind, von dem Anwender gedrückt zu werden und durch elastischen Rückstoß neu befüllt werden; und ANMERKUNG 2 Selbstaufblasende Beutel-Wiederbelebungsgeräte sind im Allgemeinen während des Transports verwendbar. - durchfluss-aufblasbare Beutel-Wiederbelebungsgeräte, die dafür vorgesehen sind, von dem Anwender mit der Hand gedrückt zu werden, und durch den Durchfluss aus einer medizinischen Gasquelle wieder gefüllt werden. Dieses Dokument gilt außerdem für Zubehör, das für die Anwendung mit Wiederbelebungsgeräten vorgesehen ist und wo die Eigenschaften dieses Zubehörs die Sicherheit des anwenderbetriebenen Wiederbelebungsgeräts beeinflussen kann. Beispiele für solches Zubehör sind Masken, PEEP-Ventile, kapnometrische Anzeigegeräte, Manometer, Metronome, Durchflussbegrenzer, Filter, Gasnachfüllventile, Sauerstoff-Gasmischer, Verbindungsstücke, Gebrauchsverpackungen, elektronische Rückmeldeeinrichtungen, elektronische Sensoren und die Übertragung von Daten an andere Geräte. Dieses Dokument legt keine Anforderungen fest für: - gasbetriebene Notwiederbelebungsgeräte, die in ISO 10651-5 [8] aufgeführt sind; - elektrisch betriebene Wiederbelebungsgeräte; - gasbetriebene Wiederbelebungsgeräte für professionelle Gesundheitseinrichtungen; und - Anästhesie-Reservoirbeutel, die in ISO 5362 [4] aufgeführt sind. ANMERKUNG 3 Dieses Dokument wurde erstellt, um die relevanten grundsätzlichen Prinzipien [22] und Kennzeichnungsrichtlinien [23] des Internationalen Forums der Aufsichtsbehörden für Medizinprodukte (en: International Medical Devices Regulators Forum, IMDRF) zu behandeln, wie in Anhang D angegeben. ANMERKUNG 4 Dieses Dokument wurde erstellt, um die relevanten grundsätzlichen Prinzipien der Sicherheit und Leistung nach ISO 16142-1:2016 [11] zu behandeln, wie in Anhang E angegeben. ANMERKUNG 5 Dieses Dokument wurde erstellt, um die relevanten grundlegenden Sicherheits- und Leistungsanforderungen der europäischen Verordnung (EU) 2017/745 [21] zu behandeln, wie in Anhang F angegeben.

<p>This document specifies minimum requirements and test methods for <italic>Bupleurum chinense</italic>, <italic>Bupleurum scorzonerifolium</italic> and <italic>Bupleurum falcatum</italic> root.</p><p>This document applies to <italic>Bupleurum chinense</italic>, <italic>Bupleurum scorzonerifolium</italic> and <italic>Bupleurum falcatum</italic> root that are sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces.</p>

<p>This International Standard specifies requirements for packaged sterile rubber gloves intended for use in surgical procedures to protect the patient and the user from cross-contamination. It is applicable to single-use gloves that are worn once and then discarded. It does not apply to examination or procedure gloves. It covers gloves with smooth surfaces and gloves with textured surfaces over part or the whole glove.</p><p>This International Standard is intended as a reference for the performance and safety of rubber surgical gloves. The safe and proper usage of surgical gloves and sterilization procedures with subsequent handling, packaging, and storage procedures are outside the scope of this International Standard.</p>

<p>This document specifies the shape, dimensions, fill capacities and performance requirements of tubular glass vials for metering pumps. It also specifies the material for the manufacturing of such containers as well as the secondary packaging.</p><p>It applies to colourless or amber containers made of tubular glass and intended to be used for packaging, storage or transportation of medicinal products.</p>

<p>This document specifies the shape, dimensions, fill capacities and performance requirements of moulded glass bottles for metering pumps. It also specifies the material for the manufacturing of such containers as well as the secondary packaging.</p><p>It applies to colourless or amber glass containers moulded from borosilicate or soda-lime-silica glass and intended to be used in the packaging, storage or transportation of products intended for medicinal use.</p>

<p>This document specifies the shape, dimensions, fill capacities and performance requirements of plastic bottles for metering pumps. It also specifies the material for the manufacturing of such containers as well as the secondary packaging.</p><p>It applies to colourless or coloured containers moulded from plastic and intended to be used in the packaging, storage or transportation of products intended for medicinal use.</p>