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  • 307
    충실도(정확도) (Fidelity)
    .
    IEC TR 62366-2:2016
      Definition

    degree to which a model or SIMULATION reproduces the state and behaviour of a real world object or the perception of a real world object, feature or condition
    Note 1 to entry: Low-FIDELITY models share only a limited number of common elements with the actual MEDICAL DEVICE of interest.
    Note 2 to entry: High-FIDELITY models share many common elements with the actual MEDICAL DEVICE of interest.
    [SOURCE: ISO 16781:2013, 2.4, modified – deleted ‘, or chosen standard in a measurable or perceivable manner’ and added Notes 1 and 2 to entry.] [8]

    모델 또는 시뮬레이션이 현실 세계 물체의 상태와 행동 또는 현실 세계 물체, 특징 또는 조건의 지각을 재현하는 정도
    노트 1. 저-충실도 모델은 실제 의료기기와 제한된 수의 공통요소만을 공유한다.
    노트 2. 고-충실도 모델은 실제 의료기기와 많은 공통요소를 공유한다.

    • 306
      개념적 모델 다이어그램 (Conceptual model diagram)
      .
      IEC TR 62366-2:2016
        Definition

      graphical description of the underlying organization and relationships in a USER INTERFACE design.
      EXAMPLE A diagram that simply shows labelled circles – perhaps as few as three to five.

      사용자 인터페이스 설계에서 구조 및 관계에 대한 그래픽 설명
      예시. 레이블이 지정된 원을 간단히 보여주는 다이어그램 – 약 3개에서 5개 정도

      • 305
        클로스콜 (Close call)
        .
        IEC TR 62366-2:2016
          Definition

        case in which a USER almost commits a USE ERROR while performing a TASK, but recovers in time to avoid making the USE ERROR
        EXAMPLE A USER might initially place his or her thumb on the wrong end of an injection pen, but then rotates the pen into the proper position enabling a safe and effective injection.
        Note 1 to entry: A CLOSE CALL does not include a case in which an initial USE ERROR evokes an ALARM CONDITION, for example, leading the USER to correct the USE ERROR; this is a case of a RISK CONTROL working properly.

        태스크를 수행하는 동안, 사용자가 거의 사용오류를 범하지만 사용오류의 발생을 피하기 위해 제시간에 복구하는 사례
        예시. 사용자가 처음에 인젝션 펜의 끝에 자신의 손가락을 잘못 위치할 수 있지만, 이 후, 펜을 안전하고 효과적인 주입이 가능한 올바른 위치로 회전한다.
        노트 1. 위기일발 상황은 초기 사용오류가 알람 조건을 유발하는 경우를 포함하지 않는다. 예를 들어, 사용자가 사용오류를 바로잡을 수 있게 만드는 경우; 이것은 적합하게 위험통제 작동이 되는 사례이다.

        • 304
          알람시스템 (ALARM SYSTEM)
          .
          IEC TR 62366-2:2016
            Definition

          parts of the MEDICAL DEVICE that detect ALARM CONDITIONS and, as appropriate, generate ALARM SIGNALS
          [SOURCE: IEC 60601-1-8:2006, 3.11, modified – ‘ME EQUIPMENT or a ME SYSTEM’ has been replaced by ‘MEDICAL DEVICE’] [1]

          • 303
            알람신호 (ALARM SIGNAL)
            .
            IEC TR 62366-2:2016
              Definition

            type of signal generated by the ALARM SYSTEM to indicate the presence (or occurrence) of an ALARM CONDITION
            [SOURCE: IEC 60601-1-8:2006, 3.9] [1]

            • 302
              알람제한 (ALARM LIMIT)
              .
              IEC TR 62366-2:2016
                Definition

              threshold used by an ALARM SYSTEM to determine an ALARM CONDITION
              [SOURCE: IEC 60601-1-8:2006, 3.3] [1]

              • 301
                알람상태 (ALARM CONDITION)
                .
                IEC TR 62366-2:2016
                  Definition

                state of the ALARM SYSTEM when it has determined that a potential or actual HAZARDOUS SITUATION exists for which OPERATOR awareness or response is required
                Note 1 to entry: An ALARM CONDITION can be invalid, i.e. a false positive ALARM CONDITION.
                Note 2 to entry: An ALARM CONDITION can be missed, i.e. a false negative ALARM CONDITION.
                [SOURCE: IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012, 3.1] [1]

                • 300
                  이상반응 (ADVERSE EVENT)
                  .
                  IEC TR 62366-2:2016
                    Definition

                  event associated with a MEDICAL DEVICE that led to death or serious injury of a PATIENT, USER or other person, or that might lead to death or serious injury of a PATIENT, USER or other person if the event recurs
                  Note 1 to entry: This definition is consistent with guidance in GHTF/SG2/N54/R8:2006. [6]
                  Note 2 to entry: This definition includes malfunction or deterioration of a device which has not yet caused death or serious injury, but which could lead to death or serious injury.
                  [SOURCE: ISO TS 19218-1:2011, 2.1] [7]

                  • 299
                    구성품 (ACCESSORY)
                    .
                    IEC TR 62366-2:2016
                      Definition

                    additional part for use with MEDICAL DEVICE in order to:
                    – achieve the INTENDED USE,
                    – adapt it to some special use,
                    – facilitate its use,
                    – enhance its performance, or
                    – enable its functions to be integrated with those of other MEDICAL DEVICE
                    [SOURCE: IEC 60601-1:2005, 3.3, modified – ‘equipment’ is replaced by ‘MEDICAL DEVICE’] [5]

                    • 298
                      사용자 프로파일 (User profile)
                      .
                      IEC 62366-1:2015
                        Definition

                      summary of the mental, physical and demographic traits of an intended USER GROUP, as well as any special characteristics, such as occupational skills, job requirements and working conditions, which can have a bearing on design decisions

                      의도된 사용자 그룹의 정신적, 물리적 및 인구학적 특성 및 설계 결정에 관련될 수 있는 직업의 숙련도, 직무 요구사항, 업무 조건의 요약

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