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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

Number of Blossarys: 1

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在美国的安全标准,防范说明是句子提供潜在的危险和适当的程序信息。他们在从消费产品上的标签和手册,对体育活动的说明的情况下使用。使用各种方法将焦点移到它们,如除了正常文本、 图形图标,更改文本的字体和颜色设置。案文往往将澄清类型的语句和它们的含义的文本内。共同防范说明如下。

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

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; 分类: 

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; 分类: 

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; 分类: 

禁忌症是反对使用某种疗法的条件或因素。通常用在医学中,这些因素会增加使用特定药物、实施医疗程序或从事特定活动所引发的风险。某些禁忌症是绝对的,这意味着任何时候都不能实施某个治疗方案。例如,发烧的儿童不得服用阿司匹林,因为这存在引发雷尔氏综合症的风险,一个对过敏性食物过敏的人不得吃导致其过敏的食物。同样,一个身患血色沉着病的人不得服用铁制剂。其他禁忌症是相对的,也就是说患者出现并发症的风险较高,但这些风险可能超过其他注意事项或可通过其他方式缓解。例如,孕妇通常应避免接触 X 射线,但这种风险可能远小于没有诊断出或能够治疗严重的病情(例如肺结核或骨折)所产生的风险。相对禁忌症还可能称为注意事项,例如英国国家处方手册。

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

人工晶状体 (IOL) 是在眼中,因为它玷污了由白内障手术,或作为一种形式的屈光手术改变了眼内的光功率通常更换现有的水晶体植入式的镜头。它通常包括一个小的塑料镜头与塑料侧高视阔步,称为触觉,在眼球内囊袋内地方举行镜头。[引证需要]Iol 传统上了坚定的材料 (PMMA),虽然这很大程度上已被使用的柔性材料取代。今天安装的大多数 Iol 被固定的  镜片匹配到距离视觉。然而,其他类型都可用,多焦点 Iol,为病人提供多集中视觉远和阅读距离和自适应 Iol,为病人提供有限的视觉住宿等。

Domain: Biotechnology; Health care; Life Sciences; Medical; Medical devices; Regulatory; 分类: Implants & interventional materials

Intraokularlinse (IOL) Eine Intraokularlinse ist eine kuenstliche Linse im Auge. Meistens wird die im Rahem der Operation des Grauen Stars nach Entferning der natierlichen Linse dauz implantiert.

Domain: Biotechnology; Health care; Life Sciences; Medical; Medical devices; Regulatory; 分类: Implants & interventional materials

异种环植入物 (INTACS) 是近视的一个视觉校正选项,以低至中等水平治疗。INTACS 用来矫正近视有圆锥角膜和那些有残余近视后激光屈光或 LASIK 手术的患者。

Domain: Biotechnology; Health care; Life Sciences; Medical; Medical devices; Regulatory; 分类: Implants & interventional materials

Intracorneal Ring Implantate (INTACS) sind eine Vision-Korrektur-Option niedrig zu gemäßigten Niveaus der Myopie zu behandeln. INTACS werden verwendet, um Myopie bei Patienten haben Keratokonus und diejenigen, die verbleibende Kurzsichtigkeit nach refraktiven Laser oder LASIK Operation zu korrigieren.

Domain: Biotechnology; Health care; Life Sciences; Medical; Medical devices; Regulatory; 分类: Implants & interventional materials

"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; 分类: 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; 分类: 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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