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  • 39
    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.

    • 38
      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      [SOURCE: IEC 60601-1-8:2006, 3.11, modified – ‘ME EQUIPMENT or a ME SYSTEM’ has been replaced by ‘MEDICAL DEVICE’] [1]

      • 37
        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]

        • 36
          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]

          • 35
            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]

            • 34
              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]

              • 33
                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]

                • 32
                  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

                  • 31
                    사용자 인터페이스 규격 (User interface specification)
                    .
                    IEC 62366-1:2015
                      Definition

                    collection of specifications that comprehensively and prospectively describe the USER INTERFACE of a MEDICAL DEVICE

                    의료기기의 사용자 인터페이스를 종합적으로 전향적으로 기술하는 규격의 수집

                    • 30
                      사용자 인터페이스 평가 (User interface evaluation)
                      .
                      IEC 62366-1:2015
                        Definition

                      PROCESS by which the MANUFACTURER explores or assesses the USER interactions with the USER INTERFACE
                      Note 1 to entry: A USER INTERFACE EVALUATION may consist of one or more of the following techniques, amongst others, USABILITY TESTS, expert reviews, heuristic analyses, design audits or a cognitive walk through.
                      Note 2 to entry: USER INTERFACE EVALUATION is frequently performed iteratively throughout the design and development PROCESS (this is FORMATIVE EVALUATION).
                      Note 3 to entry: USER INTERFACE EVALUATION is a part of the activities involved in verifying and validating the overall MEDICAL DEVICE design (this is SUMMATIVE EVALUATION).

                      제조업자가 사용자 인터페이스와 사용자 상호작용을 탐색하거나 분석, 평가하는 프로세스
                      노트 1: 사용자 인터페이스 평가는 사용적합성 시험, 전문가 검토, 휴리스틱 분석, 설계 감사 또는 인지적 워크스루 사이에 하나 이상으로 구성될 수 있다.
                      노트 2: 사용자 인터페이스 평가는 설계 및 개발 프로세스 전체에서 반복적으로 수행된다(이것은 형성적 평가이다.).
                      노트 3: 사용자 적합성 평가는 전체 의료기기 설계를 검증하고 유효성 확인하는 활동의 일부이다(이것은 포괄적 평가이다.).

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