Why You Must Know the Difference Between 'Intended

Intended use = what you say on the label that the device is to be used for. Indications of use = the conditions or reasons for using the device. 'Intended Use' and the 510(k) FDA wants you to be very "to the point" about your stated intended use

The Difference Between Intended Use and Indications of

2020-05-02· A lot of people think that intended use means what your medical device could be used for. And once again, that's not what intended use means, intended use is all about what we say, our label claims. In the regulatory

Protocol on Prohibitions or Restrictions on the Use of Mines,

"Anti-handling device" means a device intended to protect a mine and which is part of, linked to, attached to or placed under the mine and which activates when an attempt is made to tamper with the mine. 15. 5.It is prohibited to use mines, booby-traps or other devices which employa mechanism or

Intended Use Description Johner Institute

The authorised use, including the intended use, but also other planned actions of the user with this medical device such as storage, transport, update or cleaning. Die IEC 60601-1:2013 defines the "usage in accordance to regulations" as operation, including routine inspection and adjustments through user, and standby correspondent to instruction manual .

Determination of Intended Use for 510(k) Devices; Guidance for

2018-10-08· 1 Determination of Intended Use for 510(k) Devices; Guidance for CDRH Staff This document is intended to provide guidance. It represents the

Intended purpose of using the medical device including indication

2017-08-28· Intended purpose of using the medical device including indication: SunBall is a medical device that is used as an interactive rehabilitation tool that works on the principle of biological feedback and can be part of compensatory exercises for afflicted and healthy people.

MEDICAL DEVICES Guidance document Classification of medical

“Intended purpose” means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional materials. 3.1.2.

intended use中文翻譯,intended use是什麼意思:預期的用途

Quality standards selected depend on intended use of the water . 水質標準的選擇取決于水的預定用途。 That was the primary intended use of the tape 那才是為這種帶子設計的主要用途。 The intended use of these methods is for versioning 這些方法旨在進行版本控制。 Summarizes each authority level and its intended use

Demining Wikipedia

2020-05-02· Demining or mine clearance is the process of removing land mines from an area. In military operations, the object is to rapidly clear a path through a minefield, and this is often done with devices such as mine plows and blast waves. By contrast, the goal of humanitarian demining is to remove all of the landmines to a given depth and make the land safe for human use.

Guidance for products without an intended medical purpose

2018-10-12· Guidance for products without an intended medical purpose (Annex XVI) under the new Medical Device Regulation (EU 2017/745) How certain products without an intended medical purpose will be regulated as medical devices, and the impact that this will have on those manufacturing,

Mines vs Mine What's the difference? WikiDiff

(military) A device intended to explode when stepped upon or touched, or when approached by a ship, vehicle, or person. His left leg was blown off after he stepped on a mine . The warship was destroyed by floating mines . (pyrotechnics) A type of firework that explodes on the ground, shooting sparks upward.

intended use Übersetzung Englisch-Deutsch

Limited Input Mode Mehr als 1000 ungeprüfte Übersetzungen! Du kannst trotzdem eine neue Übersetzung vorschlagen, wenn du dich einloggst und andere Vorschläge im Contribute-Bereich überprüfst. Pro Review kannst du dort einen neuen Wörterbuch-Eintrag eingeben (bis zu einem Limit von 500 unverifizierten Einträgen pro Benutzer).

Land mine Wikipedia

2020-05-01· A land mine is an explosive device concealed under or on the ground and designed to destroy or disable enemy targets, ranging from combatants to vehicles and tanks, as they pass over or near it. Such a device is typically detonated automatically by way of pressure when a target steps on it or drives over it, although other detonation mechanisms are also sometimes used.

Intended purpose EU MDR

Intended purpose is defined in Article 2 (12): “‘intended purpose’ means the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation;” In the product

Why You Must Know the Difference Between 'Intended

Intended use = what you say on the label that the device is to be used for. Indications of use = the conditions or reasons for using the device. 'Intended Use' and the 510(k) FDA wants you to be very "to the point" about your stated intended use

intended 뜻 영어 사전 intended 의미 해석

에서 한국어 내부, 우리는 어떻게 설명 할intended영어 단어 그것은? intended영어 단어는 다음과 같은 의미를 한국어 :예정된, 의도. Meaning of intended for the defined word. 문법적으로, 이 워드 "intended" 는 형용사, 좀 더 구체적으로, 서로 비교할 수가 없 형용사.

Mine dictionary definition mine defined

2020-04-20· mine definition: Mine is defined as a very large hole made in the ground to remove stones, coal and other minerals. (noun) An example of a mine is a cavern made in the Earth in order to remove gold....

Protocol on Prohibitions or Restrictions on the Use of Mines,

2017-02-13· Protocol on Prohibitions or Restrictions on the Use of Mines, Booby-Traps and Other Devices as amended on 3 "Anti-handling device" means a device intended to

Anti-personnel mine Wikipedia

2020-04-18· Anti-personnel mines are a form of mine designed for use against humans, as opposed to anti-tank mines, which are designed for use against vehicles.Anti-personnel mines may be classified into blast mines or fragmentation mines, the latter may or may not be a bouncing mine.. The mines

Intended Use VS Indications For Use Advena Ltd

The “intended use” of a device is critical for determining its classification, and is usually defined during the initial regulatory stages. However, the “intended use” is often misunderstood. Its purpose is not to describe what the device is intended to be used for. Instead, it should lay out the claims of what your device is meant to do.

8 Questions That Define Your Medical Device User Needs

2020-05-02· There are two things to think about when defining user needs. First, “intended use” is the general purpose—what the device does. Second, the “indications for use” describe the medical conditions your device will help diagnose, treat, prevent, cure, or mitigate. On the surface, defining user needs for medical devices probably seems simple.

Difference between intended purpose and intended use

2018-10-09· The specification of the intended use shall include all detailed information required for the safe and efficient use of the device including intended user, reference material, use environment, indications, contra-indications, measuring inaccuracies etc. So basically they want the use specification.

Land mine Wikipedia

2020-05-01· A land mine is an explosive device concealed under or on the ground and designed to destroy or disable enemy targets, ranging from combatants to vehicles and tanks, as they pass over or near it. Such a device is typically detonated automatically by way of pressure when a target steps on it or drives over it, although other detonation mechanisms are also sometimes used.

intended 뜻 영어 사전 intended 의미 해석

에서 한국어 내부, 우리는 어떻게 설명 할intended영어 단어 그것은? intended영어 단어는 다음과 같은 의미를 한국어 :예정된, 의도. Meaning of intended for the defined word. 문법적으로, 이 워드 "intended" 는 형용사, 좀 더 구체적으로, 서로 비교할 수가 없 형용사.

intended use Übersetzung Englisch-Deutsch

Kennst du Übersetzungen, die noch nicht in diesem Wörterbuch enthalten sind? Hier kannst du sie vorschlagen! Bitte immer nur genau eine Deutsch-Englisch-Übersetzung eintragen (Formatierung siehe Guidelines), möglichst mit einem guten Beleg im Kommentarfeld.Wichtig: Bitte hilf auch bei der Prüfung anderer Übersetzungsvorschläge mit!

intended use of the device Traduction française Linguee

The manufacturer is not liable for personal injury and property damage arising from non-intended use of the device or unauthorized modifications to the device and its

Medical Device Usability BSI Group

2018-02-09· line with ergonomic principles, taking account of the intended purpose of the device. • ER 13.1 Each device must be accompanied by the information needed to use it safely and properly, taking account of the training and knowledge of the potential users, and to identify the manufacturer.”

Mobile and transportable plant for use on mines and petroleum

2020-01-08· and transportable plant intended for use at mines and petroleum sites. This guideline does not apply to mobile and transportable plant for use at underground at coal mines. Scope and application This guideline applies generally to mobile and transportable plant used at surface mines

Medical devices European Medicines Agency

Medical devices are products or equipment intended generally for a medical use. They are regulated by national competent authorities, but the European Medicines Agency (EMA) is also involved in the assessment of certain categories of medical device under European Union (EU) legislation.

Software in Medical Devices

2018-06-29· Also known as User Validation Confirm that the correct device was designed and meets the intended use(s) Design Validation (820.3(g)) Confirm that the design outputs meet the design inputs Design Verification (820.3(f)) Looks for consistency, completeness, and correctness of the software and its supporting documentation, as it is being developed

What is a medical device? in TÜV Rheinland

What is a Medical Devices? Definition ‘accessory’ means an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device.

GHTF SG5 Clinical Evaluation IMDRF

2012-11-13· Clinical Evaluation Study Group 5 Final Document SG5/N2R8 May 8, 2007 Page 6 of 28 • how to document a clinical evaluation in a clinical evaluation report. The guidance contained within this document is intended to apply to medical devices generally and the device component of combination products. It is not intended to cover IVDDs.

Mines definition of mines by The Free Dictionary

Define mines. mines synonyms, mines pronunciation, mines translation, English dictionary an explosive device laid in the water with the intention of damaging or sinking ships or of deterring This information should not be considered complete, up to date, and is not intended

Demining Wikipedia

2020-05-02· Demining or mine clearance is the process of removing land mines from an area. In military operations, the object is to rapidly clear a path through a minefield, and this is often done with devices such as mine plows and blast waves. By contrast, the goal of humanitarian demining is to remove all of the landmines to a given depth and make the land safe for human use.

Naval mine Wikipedia

2020-05-02· A naval mine is a self-contained explosive device placed in water to damage or destroy surface ships or submarines.Unlike depth charges, mines are deposited and left to wait until they are triggered by the approach of, or contact with, any vessel.Naval mines can be used offensively, to hamper enemy shipping movements or lock vessels into a harbour; or defensively, to protect friendly vessels

WHO Medical Device Full Definition

2 天前· Medical Device Full Definition ‘Medical device’ means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of:

intended use of the device Traduction française Linguee

The manufacturer is not liable for personal injury and property damage arising from non-intended use of the device or unauthorized modifications to the device and its

Step 1: Decide the intended use and classification EU MDR

Consider and decide the “intended purpose” of your anticipated product. It is not for the user to decide the intended purpose but the manufacturer. Check whether the anticipated device fulfils the definition of a medical device in Article 2 (1). If it does, decide the classification in accordance with Article 51 and the rules contained in Annex VIII.

Information Technology Responsible Administrative Unit: Appropriate Use Inside Mines

2014-05-08· Appropriate Use Policy Computing, Communications & Information Responsible Administrative Unit: Appropriate Use Policy Computing, Communications & Information Responsible Administrative Unit All data that belongs to the Colorado School of Mines that is stored on any mobile device, and disclosure of which poses a security