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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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List of symbols used on the package/label and their explanation

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

符号的包装标签和他们的解释上使用的列表

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

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; Category: Diseases; Hospitals; Diseases; Herbal medicine; Medicine; Implants & interventional materials

List of symbols used on the package/label and their explanation

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

符号的包装标签和他们的解释上使用的列表

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

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: 

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; Category: 

Dose means quantity in the following fields: In nutrition, medicine, and toxicology: * Dose (biochemistry), the quantity of something that may be eaten by or administered to an organism, or that an organism may be exposed to In medicine and toxicology: * Absorbed dose, an amount of radiation received * Dosing, the process of administering a measured amount of a medicine or chemical to an inanimate object or non-human animal * Effective dose, the smallest amount of a substance required to produce a measurable effect on a living organism * Equivalent dose, a measure of radiation dosage to tissue * Maximum tolerated dose, the highest dose of a radiological or pharmacological treatment that will produce the desired effect without unacceptable toxicity. * Optimal Biological Dose, the quantity of a radiological or pharmacological treatment that will produce the desired effect with acceptable toxicity. * Reference dose, the United States Environmental Protection Agency's maximum acceptable oral dose of a toxic substance Dosage is a synonym for the biochemical term dose!

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

剂量是指数量的以下字段中: 在营养、 医药、 和毒理学: * 剂量 (生化) 的数量的东西,可能会被吃掉或管理到有机体,或那一个有机体可能会接触到在医学和毒理学: * 吸收剂量、 受到的辐射量 * 配料,到生命的物体或非人类动物管理的医学或化学测量的量的进程 * 有效剂量最小数量的产生可衡量的效果上一个生物体所需的物质 * 等效剂量、 辐射剂量对组织的一项措施 * 容忍的最大剂量,最高剂量的放射性或药物的治疗,将产生预期的效果不是不能接受的毒性。* 最佳生物剂量放射或药物的治疗,将产生预期的效果,可以接受毒性的数量。* 参考剂量,美国环境保护署的一种有毒物质剂量最大可接受口服剂量是生化一词剂量的代名词!

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

In medicine, most medications can be safely used with other medicines, but particular combinations of medicines need to be monitored for interactions, often by the pharmacist. In molecular biology, the knowledge on gene/protein interaction among themselves and with their metabolites is referred to as molecular pathways. Interactions between medications (drug interactions) fall generally into one of two main categories: 1. pharmacodynamic : Involving the actions of the two interacting drugs. 2. pharmacokinetic : Involving the absorption, distribution, metabolism, and excretion of one or both of the interacting drugs upon the other. In terms of efficacy, there can be three types of interactions between medications: additive, synergistic, and antagonistic. Additive interaction means the effect of two chemicals is equal to the sum of the effect of the two chemicals taken separately. This is usually due to the two chemicals acting on the body in the same way. Examples would be Aspirin and Motrin, Alcohol and Depressant, tranquilliser and Painkiller. Synergistic interaction means that the effect of two chemicals taken together is greater than the sum of their separate effect at the same doses. An example is Pesticide and Fertilizer, the biological effect is devastating. Antagonistic interaction means that the effect of two chemicals is actually less than the sum of the effect of the two drugs taken independently of each other. This is because the second chemical increases the excretion of the first, or even directly blocks its toxic actions. Antagonism forms the basis for antidotes of poisonings.

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

在医学上,大多数药物可安全地用于其它药物,但药物的特定组合需要经常由药剂师之间的相互作用,为监测。在分子生物学、 基因/蛋白质相互作用相互之间以及与及其代谢物的知识被称为分子途径。药物治疗 (药物相互作用) 之间的交互通常分为两个主要类别之一: 1.药效学: 涉及的两种相互作用药物行动。2.药代动力学: 涉及吸收、 分布、 代谢、 和排泄的一个或两个后其他药物的相互作用。功效,可以有三种类型的药物之间的相互作用: 添加剂、 协同,和拮抗。添加剂相互作用意味着两种化学品的影响是等于总和分别采取的两种化学物质的影响。这通常是由于身体上以相同的方式行事的两种化学物质。示例将阿司匹林和布洛芬、 酒精和抑制剂、 镇静剂和止痛药。协同相互作用意味着一起采取的两种化学物质的影响大于他们在相同剂量的单独作用的总和。一个例子是农药、 化肥、 生物效应是造成的破坏性。拮抗互动意味着两种化学品的影响是实际小于采取相互独立的两种药物的疗效的总和。这是因为第二个化学增加排泄的第一、 或甚至直接阻止其有毒的行动。拮抗作用的基础为中毒的解毒剂。

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 hospitalisation is considered an SAE.[1] The results of these trials are often included in the labelling 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: 

Complication, in medicine, is an unfavourable evolution of a disease, a health condition or a medical treatment. The disease can become worse in its severity or show a higher number of signs, symptoms or new pathological changes, become widespread throughout the body or affect other organ systems. A medical treatment, such as drugs or surgery may produce adverse effects and/or produce new health problem(s) by itself. A new disease may also appear as a complication to a previous existing disease. Therefore, a complication may be iatrogenic, i.e., literally brought forth by the physician. Medical knowledge about a disease, procedure or treatment usually entails a list of the most common complications, so that they can be foreseen, prevented or recognised more easily and speedily. Depending on the degree of vulnerability, susceptibility, age, health status, immune system condition, etc. complications may arise more easily. Complications affect adversely the prognosis of a disease. Non-invasive and minimally invasive medical procedures usually favour fewer complications in comparison to invasive ones. Examples of complications * generalised septicemia (infection of the blood) may occur as a complication of an infected wound or abscess * Allergic shock can be a reaction to several kinds of anesthetics, as a complication in a surgery * Fractured ribs and sternum may be a complication of cardiopulmonary resuscitation attempts in people suffering severe osteoporosis * Puerperal fever may be a common complication of childbirth and used to kill a large proportion of mothers before the advent of antisepsis and antibiotics * Diabetes mellitus may present a series of complications in an advanced or more severe stage, such as gangrene, diabetic foot, blindness, infections, etc. * Thrombosis in the heart or brain, causing stroke or acute myocardial infarction can be complications of blood coagulation disorders, phlebitis (inflammation of the veins), endocarditis and artificial heart valves * Eczema vaccinatum is a rare and severe complication of smallpox vaccination in people with eczema * Hepatotoxic dementia is a possible complication of hepatitis and liver cirrhosis * Mental retardation is a common complication of untreated hydrocephalus * A paradoxical reaction to a drug; that is, a reaction that is the opposite to the intended purpose of the drug. An example is benzodiazepines, a class of psychoactive drugs considered minor tranquillisers with varying hypnotic, sedative, anxiolytic, anticonvulsant, and muscle relaxant effects; paradoxically they may also create hyperactivity, anxiety, convulsions etc. in susceptible individuals. [1] * Erectile dysfunction and urinary incontinence are prevalent to prostatectomy.

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

并发症,在医学上,是不赞同的演变的一种疾病、 健康状况或医疗。这种疾病可以变得更糟,其严重程度,或显示更多的迹象表明,症状或新的病理变化,变得很普遍,整个身体或影响其他器官系统。药物治疗,如药物或手术可能产生的不利影响和/或通过本身产生新的健康问题。一种新疾病也可能显示为一个以前的现有疾病的并发症。因此,一种并发症可能医源性,即字面上所带来的医师。有关疾病、 过程或治疗的医学知识通常需要一个列表的最常见的并发症,以便他们可以预见、 预防或承认更容易和迅速。根据脆弱性、 易感性、 年龄、 健康状况、 免疫系统条件的程度,等并发症可能会更容易出现。并发症产生不利影响预后的一种疾病。无创和微创医疗程序通常倾向于较少并发症与侵袭性的。并发症的例子 * 广义败血症 (血液感染) 可作为伤口感染或脓肿的并发症出现 * 过敏性休克可以是一种反应对几种麻醉药,作为一个外科手术并发症 * 裂缝肋骨和胸骨可能是一种心肺复苏尝试在人民遭受严重的骨质疏松症的并发症 * 产褥热可能是一种常见的分娩并发症和用来杀死母亲的防腐和抗生素到来前的很大比例 * 糖尿病糖尿病可能在高级或更严重的阶段,如坏疽、 糖尿病足、 失明、 感染等提出一系列的并发症。* 血栓形成心脏或脑部,造成脑卒中或心肌梗死可以是并发症的血液凝血功能障碍、 静脉炎 (静脉的炎症)、 心内膜炎和人工心脏瓣膜 * 湿疹 vaccinatum 是一种罕见而严重的湿疹的人在接种天花疫苗并发症 * 铅中毒痴呆症是一种可能的肝炎和肝硬化患者并发症 * 精神发育迟滞是未经治疗脑积水的常见并发症 * 矛盾反应的一种药物 ;就是与这种药物的目的相反的反应。一个例子是杂,一类的精神科药物视为轻微镇静剂与不同催眠、 镇静、 焦虑、 抗惊厥、 肌肉松弛作用 ;奇怪的是他们还可以创建多动、 焦虑、 抽搐等在易受影响的个人。[1] * 勃起功能障碍和性尿失禁是普遍对前列腺切除术。

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

In medicine, an indication is a valid reason to use a certain test, medication, procedure, or surgery. The opposite of indication is contraindication.

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

在医学上,征兆是正当理由需要使用某些测试、 药物治疗、 过程或外科手术。征兆的对面是禁忌。

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

instructions for use

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

Intracorneal Ring Implants (INTACS) are a vision correction option to treat low to moderate levels of myopia. INTACS are used to correct myopia in patients who have keratoconus and those who have residual myopia following laser refractive or LASIK surgery.

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

An intraocular lens (IOL) is an implanted lens in the eye, usually replacing the existing crystalline lens because it has been clouded over by a cataract, or as a form of refractive surgery to change the eye's optical power. It usually consists of a small plastic lens with plastic side struts, called haptics, to hold the lens in place within the capsular bag inside the eye.[citation needed] IOLs were traditionally made of an inflexible material (PMMA), although this has largely been superseded by the use of flexible materials. Most IOLs fitted today are fixed monofocal lenses matched to distance vision. However, other types are available, such as multifocal IOLs which provide the patient with multiple-focused vision at far and reading distance, and adaptive IOLs which provide the patient with limited visual accommodation.

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

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