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

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

パッケージ/ラベルに使用される記号とその説明のリスト

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

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

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

パッケージ/ラベルに使用される記号とその説明のリスト

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, Tranquilizer 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: 

医学では、ほとんどの薬は安全に他の薬と併用できますが、医薬品の特定の組み合わせは、相互作用のため、多くの場合、薬剤師によって監視される必要がありますすることができます。分子生物学では、自分自身の中とその代謝物による遺伝子/タンパク質相互作用に関する知見は、分子経路と呼ばれます。1:薬(薬物相互作用)の間の相互作用は、主に2つのカテゴリのいずれかに一般に分類されます。薬力学:2つの相互作用薬の作用を伴う。2。薬物動態:吸収、分布、代謝、そして他の時に相互作用する薬の一つまたは両方の排泄を伴う。添加剤、相乗、および拮抗:有効性の面では、薬物間相互作用の3つのタイプが存在する可能性があります。添加剤の相互作用は2つの化学物質の影響は別々に撮影した2種類の化学物質の影響の和に等しいことを意味します。これは、通常と同じ方法で、体に作用する2種類の化学物質によるも​​のです。例としては、アスピリンとモトリン、アルコールとうつ、精神安定剤と鎮痛剤となります。相乗的相互作用は、一緒に2つの化学物質の影響は、同じ用量でそれぞれ別々の効果の和よりも大きいことを意味する。の例では、農薬や肥料である、生物学的効果は計り知れないです。拮抗的相互作用は2つの化学物質の影響は互いに独立して撮影した二つの薬剤の効果の合計より少なくなることを意味します。第2の化学が最初の排泄を増加させる、あるいは直接その毒性の操作をブロックするためです。拮抗作用は、中毒の解毒剤のための基礎を形成する。

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: 

米国安全規格の予防に潜在的な危険と適切な手順に関する情報を提供する文章。彼らは身体活動の説明をラベル、マニュアル、上の消費者製品からの状況で使用されます。様々 な方法は、通常のテキスト、アイコン、テキストのフォントと色の変更から離れて設定など、それらをフォーカスをもたらすに使用されます。テキストはステートメントとテキスト内でその意味の種類を明確にしばしば。一般的な予防ステートメントは次のとおりです。

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: 

線量は、次のフィールドで数量を意味します: 栄養、内科、毒性: * 線量 (生化学) によって食べまたは有機体に投与されることや、生物医学および毒物学にさらされる可能性が何かの量: * 吸収線量、受信した放射線の量 * 投薬、薬または化学物質の量を測定した生気のないオブジェクトやヒト以外の動物を管理するためのプロセス * 実効線量、生きている有機体で測定可能な効果を生成するために必要な物質の最小量 * 等価線量、組織への放射線量の測定 * 最大許容線量、受け入れられない毒性のない目的の効果をもたらす、放射線や薬理学的治療の最高の線量。* 最適な生物学的線量、許容毒性と所望の効果をもたらす、放射線や薬理学的治療の量。* 参照用量、米国環境保護庁の最大許容経口投与毒性物質投与量は生化学的用量のシノニムです !

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

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

言葉では、動詞から何かを提示するステートメントの説明を記述します。

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

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: 

complications that may arise following surgery

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

次の手術を発生する可能性があります合併症

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

intraoperative complications, are complications, problems within operation, intraoperative problems.

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

術中合併症は、合併症、操作、術中の問題内の問題です。

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

Complication, in medicine, is an unfavorable 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 recognized 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 favor fewer complications in comparison to invasive ones. Examples of complications * Generalized 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 tranquilizers 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

医学では、合併症、病気や健康状態、医療の不利な進化です。病気は、その重症度悪化症状または新しい病理学的変化、体全体に広まってまたは他の器官系に影響を与える徴候の高い数を表示したりできます。薬や手術などの治療は副作用を生成または新しい健康問題自体によって生成します。新しい病気が以前既存疾患を合併症としても表示されます。したがって、合併症かもしれない医原性、すなわち、文字通りなどの医師によって持って来られます。彼らを予見、防止またはより簡単かつ迅速に認識するように病気、処置または治療に関する医療知識は通常最も一般的な合併症のリストを伴います。脆弱性、感受性、年齢、健康状態、免疫システムの状態の度合いなどの合併症がより簡単に発生します。合併症に病気の予後は影響悪影響。非侵襲性と低侵襲医療処置は通常侵襲的なものと比較して少ない合併症を支持します。合併症例 * 一般化敗血症 (血の感染症) 感染した傷や膿瘍の合併症として発生する可能性 * アレルギー性ショックは、手術の合併症として麻酔薬のいくつかの種類に反応することができます * フラクチャされた肋骨そして胸骨重大骨粗鬆症に苦しんでいる人々 の心肺蘇生の試みの合併症があります * 産褥熱出産の一般的な合併症がありますおよび消毒と抗生物質の出現の前に母親の大きい割合を殺すために使用される * 糖尿病真性壊疽、糖尿病性足、失明、感染症など、高度なまたはより深刻な段階で一連の合併症を提示可能性があります。* 血栓、心臓や脳、脳卒中や心筋梗塞の原因と人工心臓弁の心内膜炎、静脈炎 (静脈の炎症)、血液凝固障害の合併症をすることができます * vaccinatum アトピー性皮膚炎アトピー性皮膚炎を持つ人々 の天然痘のワクチン接種の稀で重篤な合併症である * 肝毒性認知症は肝炎・肝硬変の可能な合併症 * 精神遅滞未処理水頭症の一般的な合併症である * 薬です; に逆説的な反作用薬の本来の目的に反対である反応は。例はベンゾジアゼピン系と様々 な催眠鎮静剤、抗不安薬、抗けいれん薬、筋弛緩効果; マイナー精神安定剤を考慮の向精神薬のクラス逆説的に影響を受けやすい個人の多動、不安、痙攣なども作成可能性があります。[1] * 勃起不全と尿失禁前立腺摘除術に流行しています。

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

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

禁忌は(コントラ指標として発音される)条件または要因ある程度に対して話すです。これは主に、医療処置を行うか、特定の活動に従事し、特定の薬物の使用に関連するリスクを高める要因については、医療で使用されています。いくつかの禁忌は、アクションのコースを実施するための合理的な事情があることを意味し、絶対です。たとえば、発熱している赤ちゃんはライ症候群のリスクがあるため、アスピリン、彼らはアレルギーのある食べ物を食べてはいけませんアナフィラキシー食物アレルギーをしている人を与えてはいけません。同様に、ヘモクロマトーシスをしている人は、鉄剤を投与すべきではない。その他の禁忌患者は、合併症のリスクが高いされていることが、これらのリスクは他の考慮事項で上回ることができる、またはその他の措置によって軽減することを意味する、相対的です。たとえば、妊娠中の女性は通常、X線を避ける必要がありますリスクはこれまでの診断は、結核や骨折などの深刻な状態を治療することができるというリスクよりも小さくなることがあります。相対的禁忌はまた、このようなイギリスの国民の処方のように、注意して呼ばれることもあります。

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

医学では、表示は、特定のテスト、薬、プロシージャ、または手術を使用するための有効な理由です。指示の反対は禁忌である。

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

眼内レンズは、(IOL)のそれは、白内障で曇っているため、目の光パワーを変更するには屈折矯正手術の一形態として、通常、既存の水晶を交換する、目に移植レンズです。これは通常の眼の中の莢膜袋内の所定の位置にレンズを保持するためにプラスチック製サイドの支柱と呼ばれる触覚、小さなプラスチックレンズで構成されています[要出典]これはあるものの、眼内レンズは伝統的に柔軟性材料(PMMA)の行われた主れは、可撓性材料の使用によって置き換えられています。ほとんどの眼内レンズを取り付けて、今日の距離のビジョンにマッチした単焦点レンズを固定されている。ただし、他の種類はこれまでとの距離を読んで、複数の焦点を当てたビジョンを持って患者を提供する多眼内レンズ、そして限定された視覚的な宿泊施設を患者に提供する適応型眼内レンズなど、ご利用いただけます。

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

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

角膜内リングインプラントは、(INTACS)近視の中程度のレベルの低治療する視力矯正のオプションです。 INTACSは、角膜を持っている患者では近視を修正するために使用されている人レーザー屈折矯正やレーシック手術後の残留近視を持つ。

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

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: 

パッケージは、科学、芸術、囲んでいる、または配布、保管、販売、使用するための製品を保護するための技術です。パッケージは、設計、評価のプロセス、およびパッケージの生産に関連付けられています。梱包、物流、販売、倉庫、輸送のための商品を準備の連携システム、およびエンドユーザーによる使用として記述することができます。パッケージは、保護、保存、転送、通知、含まれており、販売しています。[1]、それは完全に政府、企業、機関、産業用、個人用に統合されている多くの国では。

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

"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

「それをインストールするか、または操作する方法に通常、技術的なデバイスに伴って、説明するマニュアル」必須の条件(医療機器指令93/42/EEC)はIを付加します、13.1: 安全にそれを使用して、メーカーを特定するのに必要である情報で各デバイスに伴わなければなりません、潜在的ユーザに関するトレーニングと知識を考慮に入れて。 この情報はラベルに関する詳細と使用上の注意におけるデータを包括します。 実用的であるのと同じくらい遠くて、適切です、デバイス自体の外それぞれのユニットのパッケージの上に安全にデバイスを使用するのに必要である情報を設定しなければなりません。 そうでなければ、実用的であることで、1台以上のデバイスが供給されたリーフレットで情報を出さなければなりません。 あらゆるデバイスのためのパッケージに使用上の注意を含まなければなりません。 例外として、完全な安全な少しもそのような指示なしで彼らを使用できるなら、どんなそのような使用説明書もクラスIかクラスIIaのデバイスに必要ではありません。

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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