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ISO 14155:2020
Clinical investigation of medical devices for human subjects — Good clinical practice- 발행일 : 2020-07-28
- 발행기관 : ISO
상세정보
| 분야 | ISO/TC 194 : Biological and clinical evaluation of medical devices |
|---|---|
| 적용범위 | This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices. For post-market clinical investigations, the principles set forth in this document are intended to be followed as far as relevant, considering the nature of the clinical investigation (see Annex I). This document specifies general requirements intended to — protect the rights, safety and well-being of human subjects, — ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results, — define the responsibilities of the sponsor and principal investigator, and — assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices. NOTE 1 Users of this document need to consider whether other standards and/or national requirements also apply to the investigational device(s) under consideration or the clinical investigation. If differences in requirements exist, the most stringent apply. NOTE 2 For Software as a Medical Device (SaMD) demonstration of the analytical validity (the SaMD's output is accurate for a given input), and where appropriate, the scientific validity (the SaMD's output is associated to the intended clinical condition/physiological state), and clinical performance (the SaMD's output yields a clinically meaningful association to the target use) of the SaMD, the requirements of this document apply as far as relevant (see Reference [4]). Justifications for exemptions from this document can consider the uniqueness of indirect contact between subjects and the SaMD. This document does not apply to in vitro diagnostic medical devices. However, there can be situations, dependent on the device and national or regional requirements, where users of this document might consider whether specific sections and/or requirements of this document could be applicable. |
| 국제분류(ICS)코드 | 11.100.20 : 의료 장비의 생물학적 평가 |
| 페이지수 | 83 |
| Edition | 3 |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 14155:2020상세보기 | Clinical investigation of medical devices for human subjects — Good clinical practice | 2020-07-28 | 표준 |
| 2 | ISO 14155:2020(REDLINE)상세보기 | Clinical investigation of medical devices for human subjects — Good clinical practice | 2020-07-28 | 표준 |
| 3 | ISO 14155:2011/Cor 1:2011상세보기 | Clinical investigation of medical devices for human subjects — Good clinical practice — Technical Corrigendum 1 | 2011-07-15 | 구판 |
| 4 | ISO 14155:2011상세보기 | Clinical investigation of medical devices for human subjects — Good clinical practice | 2011-01-21 | 구판 |
| 5 | ISO 14155:1996상세보기 | Clinical investigation of medical devices | 1996-02-29 | 구판 |
관련상품
- 관련상품이 존재하지 않습니다.
다른 사람이 함께 구입한 상품
- ISO 14971:2019 - Medical devices — Application of risk management to medical devices
- ISO 11607-1:2019 - Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
- ISO 11737-1:2018 - Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products
- ISO 11737-2:2019 - Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
- ISO 10993-12:2021 - Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
추천 상품
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