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Terminology used in the instructions for use for ophthalmic implants, surgical tools & instruments, OVDs, ophthalmic irrigating fluids

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Created by: Leoneska

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In United States safety standards, precautionary statements are sentences providing information on potential hazards, and proper procedures. They are used in situations from consumer product on labels and manuals, to descriptions of physical activities. Various methods are used to bring focus to them, such as setting apart from normal text, graphic icons, changes in text's font and color. Texts will often clarify the types of statements and their meanings within the text. Common precautionary statements are described below.

Domain: Biotechnology; Health care; Life Sciences; Medical; Medical devices; Regulatory; Category: 

In Vereinigten Staaten Sicherheitsstandards sind Sicherheitshinweise Sätze, die Bereitstellung von Informationen über Gefahren und richtige Verfahren. Sie werden in Situationen von Consumer-Produkt auf den Etiketten und Handbücher, um Beschreibungen der körperlichen Aktivitäten verwendet. Verschiedene Methoden werden verwendet, den Fokus auf, z. B. Einstellung neben normalen Text, grafische Symbole, Änderungen in Farbe und Schriftart des Textes zu legen. Texte werden oft die Arten von Anweisungen und ihre Bedeutung innerhalb des Textes klären. Allgemeine Sicherheitshinweise sind unten beschrieben.

Domain: Biotechnology; Health care; Life Sciences; Medical; Medical devices; Regulatory; Category: 

In medicine, an adverse effect is a harmful and undesired effect resulting from a medication or other intervention such as surgery. An adverse effect may be termed a "side effect", when judged to be secondary to a main or therapeutic effect, and may result from an unsuitable or incorrect dosage or procedure, which could be due to medical error. Adverse effects are sometimes referred to as "iatrogenic" because they are generated by a physician/treatment. Some adverse effects only occur only when starting, increasing or discontinuing a treatment. Using a drug or other medical intervention which is contraindicated may increase the risk of adverse effects. Adverse effects may cause medical complications of a disease or procedure and negatively affect its prognosis. They may also lead to non-compliance with a treatment regimen. The harmful outcome is usually indicated by some result such as morbidity, mortality, alteration in body weight, levels of enzymes, loss of function, or as a pathological change detected at the microscopic, macroscopic or physiological level. It may also be indicated by symptoms reported by a patient. Adverse effects may cause a reversible or irreversible change, including an increase or decrease in the susceptibility of the individual to other chemicals, foods, or procedures, such as drug interactions. In clinical trials, a distinction is made between adverse events (AEs) and serious adverse events (SAEs). Generally, any event which causes death, permanent damage, birth defects, or requires hospitalization is considered an SAE.[1] The results of these trials are often included in the labeling of the medication to provide information both for patients and the prescribing physicians.

Domain: Biotechnology; Health care; Life Sciences; Medical; Medical devices; Regulatory; Category: 

In medicine, an adverse effect is a harmful and undesired effect resulting from a medication or other intervention such as surgery. An adverse effect may be termed a "side effect", when judged to be secondary to a main or therapeutic effect, and may result from an unsuitable or incorrect dosage or procedure, which could be due to medical error. Adverse effects are sometimes referred to as "iatrogenic" because they are generated by a physician/treatment. Some adverse effects only occur only when starting, increasing or discontinuing a treatment. Using a drug or other medical intervention which is contraindicated may increase the risk of adverse effects. Adverse effects may cause medical complications of a disease or procedure and negatively affect its prognosis. They may also lead to non-compliance with a treatment regimen. The harmful outcome is usually indicated by some result such as morbidity, mortality, alteration in body weight, levels of enzymes, loss of function, or as a pathological change detected at the microscopic, macroscopic or physiological level. It may also be indicated by symptoms reported by a patient. Adverse effects may cause a reversible or irreversible change, including an increase or decrease in the susceptibility of the individual to other chemicals, foods, or procedures, such as drug interactions. In clinical trials, a distinction is made between adverse events (AEs) and serious adverse events (SAEs). Generally, any event which causes death, permanent damage, birth defects, or requires hospitalization is considered an SAE.[1] The results of these trials are often included in the labeling of the medication to provide information both for patients and the prescribing physicians.

Domain: Biotechnology; Health care; Life Sciences; Medical; Medical devices; Regulatory; Category: 

Packaging is the science, art and technology of enclosing or protecting products for distribution, storage, sale, and use. Packaging also refers to the process of design, evaluation, and production of packages. Packaging can be described as a coordinated system of preparing goods for transport, warehousing, logistics, sale, and end use. Packaging contains, protects, preserves, transports, informs, and sells.[1] In many countries it is fully integrated into government, business, institutional, industrial, and personal use.

Domain: Biotechnology; Health care; Life Sciences; Medical; Medical devices; Regulatory; Category: 

Verpackung ist die Wissenschaft, Kunst und Technik des einschließenden oder Produkte für Vertrieb, Lagerung, Verkauf und Verwendung zu schützen. Verpackung bezieht sich auch auf das Design, Evaluierung und Herstellung von Paketen. Verpackung kann als ein koordiniertes System der Vorbereitung waren für Transport, Lagerung, Logistik, Verkauf und Verwendung beschrieben werden. Verpackung enthält, schützt, bewahrt, Transporte, informiert und verkauft.[1] in vielen Ländern ist es vollständig in Regierung, Wirtschaft, institutionelle, industrielle und persönlichen Einsatz.

Domain: Biotechnology; Health care; Life Sciences; Medical; Medical devices; Regulatory; Category: 

A contraindication (pronounced as contra-indication) is a condition or factor that speaks against a certain measure. It is mostly used in medicine, with regard to factors that increase the risks involved in using a particular drug, carrying out a medical procedure, or engaging in a particular activity. Some contraindications are absolute, meaning that there are no reasonable circumstances for undertaking a course of action. For example, a baby with a fever should never be given aspirin because of the risk of Reye's syndrome, and a person with an anaphylactic food allergy should never eat the food to which they are allergic. Similarly, a person with hemochromatosis should not be administered iron preparations. Other contraindications are relative, meaning that the patient is at higher risk of complications, but that these risks may be outweighed by other considerations or mitigated by other measures. For example, a pregnant woman should normally avoid getting X-rays, but the risk may be far less than the risk of not diagnosing or being able to treat a serious condition such as tuberculosis or a broken bone. Relative contraindications may also be referred to as cautions, such as in the British National Formulary.

Domain: Biotechnology; Health care; Life Sciences; Medical; Medical devices; Regulatory; Category: Diseases; Hospitals; Diseases; Herbal medicine; Medicine; Implants & interventional materials

Eine Kontraindikation (ausgesprochen als Contra-Angabe) ist eine Bedingung oder ein Faktor, der gegen eine bestimmte Maßnahme spricht. Es dient vor allem in der Medizin, im Hinblick auf Faktoren, die die Verwendung eines bestimmten Medikaments, Durchführung ein medizinisches Verfahren oder eine bestimmte Tätigkeit verbundenen Risiken zu erhöhen. Einige Kontraindikationen sind absolut, d. h., es keinen angemessenen Umständen gibt für die Durchführung einer Vorgehensweise. Zum Beispiel ein Baby mit Fieber sollte nie Aspirin gegeben werden, wegen der Gefahr des Reye-Syndroms, und eine Person mit einer anaphylaktische Lebensmittelallergie sollten nie essen, das Essen, auf dem sie allergisch sind. Ebenso sollte eine Person mit Hämochromatose verabreichte Eisenpräparate nicht sein. Weitere Kontraindikationen sind relativ, was bedeutet, dass der Patient höheres Risiko von Komplikationen ist, sondern dass diese Risiken überwiegen andere Überlegungen oder durch andere Maßnahmen entschärft werden. Beispielsweise kann eine schwangere Frau sollte normalerweise vermeiden, dass Röntgenstrahlen, das Risiko jedoch weit weniger als das Risiko einer Diagnose oder nicht in der Lage, eine schwere Erkrankung wie Tuberkulose oder ein Knochenbruch zu behandeln. Relative Kontraindikationen können auch als warnt, wie z. B. in der British National Formulary bezeichnet werden.

Domain: Biotechnology; Health care; Life Sciences; Medical; Medical devices; Regulatory; Category: Diseases; Hospitals; Diseases; Herbal medicine; Medicine; Implants & interventional materials

description a statement presenting something in words, from verb describe

Domain: Biotechnology; Health care; Life Sciences; Medical; Medical devices; Regulatory; Category: Biochemistry; Biofuel; Biomedical; Behavioral science; Cancer treatment; Dentistry; Diseases; Hematology; Hospitals; Medical research; Nursing homes; Psychiatry; Vaccines; Regulatory; Herbal medicine; Histology; Medicine; Cardiac supplies; Clinical analytical instruments; Clinical trials; Dental equipment; Dermatology instruments; Emergency room apparatus; ENT instruments; Eye instruments; General assay & diagnostic instruments; Implants & interventional materials; Medical cryogenic equipment; OBGYN equipment; Orthopaedic supplies; Pharmacology instruments; Physical therapy equipment; Radiology equipment; Sterilization equipment; Surgical instruments; Ultrasonic & optical equipment; Ward nursing equipment

Beschreibung einer Anweisung, die Präsentation etwas in Worten, vom Verb beschreiben

Domain: Biotechnology; Health care; Life Sciences; Medical; Medical devices; Regulatory; Category: Biochemistry; Biofuel; Biomedical; Behavioral science; Cancer treatment; Dentistry; Diseases; Hematology; Hospitals; Medical research; Nursing homes; Psychiatry; Vaccines; Regulatory; Herbal medicine; Histology; Medicine; Cardiac supplies; Clinical analytical instruments; Clinical trials; Dental equipment; Dermatology instruments; Emergency room apparatus; ENT instruments; Eye instruments; General assay & diagnostic instruments; Implants & interventional materials; Medical cryogenic equipment; OBGYN equipment; Orthopaedic supplies; Pharmacology instruments; Physical therapy equipment; Radiology equipment; Sterilization equipment; Surgical instruments; Ultrasonic & optical equipment; Ward nursing equipment

"a manual usually accompanying a technical device and explaining how to install or operate it" Essential Requirements - Medical Device Directive 93/42/EEC - Annex I, 13.1: Each device must be accompanied by the information needed to use it safely and to identify the manufacturer, taking account of the training and knowledge of the potential user. This information comprises the details on the label and the data in the instructions for use. As far as practicable and appropriate, the information needed to use the device safely must be set out on the device itself and/or on the packaging of each unit. If not practicable, the information must be set out in the leaflet supplied with one or more devices. Instructions for use must be included in the packaging for every device. By way of exception, no such instruction leaflet is needed for devices in Class I or Class IIa if they can be used completely safely without any such instructions.

Domain: Biotechnology; Health care; Life Sciences; Medical; Medical devices; Regulatory; Category: Biochemistry; Biofuel; Biomedical; Behavioral science; Cancer treatment; Dentistry; Diseases; Hematology; Hospitals; Medical research; Nursing homes; Psychiatry; Vaccines; Regulatory; Herbal medicine; Histology; Medicine; Cardiac supplies; Clinical analytical instruments; Clinical trials; Dental equipment; Dermatology instruments; Emergency room apparatus; ENT instruments; Eye instruments; General assay & diagnostic instruments; Implants & interventional materials; Medical cryogenic equipment; OBGYN equipment; Orthopaedic supplies; Pharmacology instruments; Physical therapy equipment; Radiology equipment; Sterilization equipment; Surgical instruments; Ultrasonic & optical equipment; Ward nursing equipment

Gebrauchsanweisung

Domain: Biotechnology; Health care; Life Sciences; Medical; Medical devices; Regulatory; Category: Biochemistry; Biofuel; Biomedical; Behavioral science; Cancer treatment; Dentistry; Diseases; Hematology; Hospitals; Medical research; Nursing homes; Psychiatry; Vaccines; Regulatory; Herbal medicine; Histology; Medicine; Cardiac supplies; Clinical analytical instruments; Clinical trials; Dental equipment; Dermatology instruments; Emergency room apparatus; ENT instruments; Eye instruments; General assay & diagnostic instruments; Implants & interventional materials; Medical cryogenic equipment; OBGYN equipment; Orthopaedic supplies; Pharmacology instruments; Physical therapy equipment; Radiology equipment; Sterilization equipment; Surgical instruments; Ultrasonic & optical equipment; Ward nursing equipment

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