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|분야||ISO/TC 194 : Biological and clinical evaluation of medical devices|
This document specifies:
— the general principles governing the biological evaluation of medical devices within a risk management process;
— the general categorization of medical devices based on the nature and duration of their contact with the body;
— the evaluation of existing relevant data from all sources;
— the identification of gaps in the available data set on the basis of a risk analysis;
— the identification of additional data sets necessary to analyse the biological safety of the medical device;
— the assessment of the biological safety of the medical device.
This document applies to evaluation of materials and medical devices that are expected to have direct or indirect contact with:
— the patient's body during intended use;
— the user's body, if the medical device is intended for protection (e.g., surgical gloves, masks and others).
This document is applicable to biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices.
This document also gives guidelines for the assessment of biological hazards arising from:
— risks, such as changes to the medical device over time, as a part of the overall biological safety assessment;
— breakage of a medical device or medical device component which exposes body tissue to new or novel materials.
Other parts of ISO 10993 cover specific aspects of biological assessments and related tests. Device-specific or product standards address mechanical testing.
This document excludes hazards related to bacteria, moulds, yeasts, viruses, transmissible spongiform encephalopathy (TSE) agents and other pathogens.
|국제분류(ICS)코드||11.100.20 : 의료 장비의 생물학적 평가|
|1||ISO 10993-1:2018||Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process||2018-08-17||표준|
|2||ISO 10993-1:2009/Cor 1:2010||2010-06-04||구판|
|3||ISO 10993-1:2009||Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process||2009-10-13||구판|
|4||ISO 10993-1:2003||Biological evaluation of medical devices -- Part 1: Evaluation and testing||2003-07-28||구판|
|5||ISO 10993-1:1997||Biological evaluation of medical devices -- Part 1: Evaluation and testing||1997-12-11||구판|
|6||ISO 10993-1:1992/Cor 1:1992||1992-09-09||구판|
|7||ISO 10993-1:1992||Biological evaluation of medical devices -- Part 1: Guidance on selection of tests||1992-04-23||구판|
ISO 10993-17 - Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents 상세보기
ISO 10993-4:1992/DAmd 1 - 상세보기
ISO 10993-12:2002/DAmd 1 - 상세보기
ISO 10993-8:2000 - Biological evaluation of medical devices -- Part 8: Selection and qualification of reference materials for biological tests 상세보기
ISO 10993-14:2001 - Biological evaluation of medical devices -- Part 14: Identification and quantification of degradation products from ceramics 상세보기
ISO 14971:2019 - Medical devices -- Application of risk management to medical devices 상세보기
ISO 10993-11:2017 - Biological evaluation of medical devices — Part 11: Tests for systemic toxicity 상세보기
ISO 10993-18:2020 - Biological evaluation of medical devices -- Part 18: Chemical characterization of medical device materials within a risk management process 상세보기
ISO 10993-5:2009 - Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity 상세보기
ISO 11607-1:2019 - Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems 상세보기
IEC TS 63134:2020 - Active assisted living (AAL) use cases 상세보기
IEC 60034-5:2020 RLV - Rotating electrical machines - Part 5: Degrees of protection provided by the integral design of rotating electrical machines (IP code) - Classification 상세보기
KS B ISO TS 25740-1 - 에스컬레이터 및 무빙워크에 대한 안전요건 — 제1부: 세계공통 필수 안전요건(GESRs) 상세보기
KS B ISO TS 8100-21 - 승객 및 화물 운송용 엘리베이터 —제21부: 세계공통 필수안전요건(GESRs)을 충족하는 세계공통 안전 파라미터(GSPs) 상세보기
KS C IEC TS 62872 - 산업 시설과 스마트 그리드 사이의 산업 공정 측정, 제어 및 자동화 시스템 인터페이스 상세보기