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ISO 10993-17:2023
Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents- 발행일 : 2023-09-13
- 발행기관 : ISO
상세정보
분야 | ISO/TC 194 : Biological and clinical evaluation of medical devices |
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적용범위 | This document specifies the process and requirements for the toxicological risk assessment of medical device constituents. The methods and criteria used to assess whether exposure to a constituent is without appreciable harm are also specified. The toxicological risk assessment can be part of the biological evaluation of the final product, as described in ISO 10993-1. The process described in this document applies to chemical characterization information obtained in line with ISO 10993-18. When a toxicological risk assessment of either the compositional information or analytical chemistry data (e.g. extractable data or leachable data) are required to determine whether the toxicological risks related to the constituents are negligible or tolerable. The process described in this document is not intended to apply to circumstances where the toxicological risk has been estimated by other means, such as: — constituents, excluding cohort of concern or excluded chemicals, that are present in or extracted from a medical device at an amount representative of patient exposure below a relevant, toxicologically-based reporting threshold (see applicable requirements in ISO 10993-18:2020, Annex E and ISO/TS 21726); — a new or changed medical device for which chemical or biological equivalence has been established with an existing biocompatible or clinically established medical device (see applicable requirements in ISO 10993-18:2020, Annex C). The process described in this document is also not applicable to: — medical device constituents that do not contact the body (e.g. in vitro diagnostics); — biological risks associated with physical interactions of the medical device with the body (i.e. application of mechanical forces, energy or surface morphology, etc.), provided that the chemical exposure is not changed; — active pharmaceutical ingredients of device-drug combination products or biologic components of device-biologic combination products as additional regulatory considerations can apply; — exposure to a particular constituent that arises from sources other than the device, such as food, water or air. |
국제분류(ICS)코드 | 11.100.20 : 의료 장비의 생물학적 평가 |
페이지수 | 65 |
Edition | 2 |
이력정보
No. | 표준번호 | 표준명 | 발행일 | 상태 |
---|---|---|---|---|
1 | ISO 10993-17:2023상세보기 | Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents | 2023-09-13 | 표준 |
2 | ISO 10993-17:2002상세보기 | Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances | 2002-11-27 | 구판 |
3 | ISO 10993-17:2023/DAmd 1상세보기 | Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents — Amendment 1 | 초안 |
관련상품
- ISO/DIS 10993-18 - Biological evaluation of medical devices — Part 18: Chemical characterization of materials
- ISO/DIS 10993-6 - Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
- ISO 10993-12:2002/DAmd 1 - Biological evaluation of medical devices — Part 12: Sample preparation and reference materials — Amendment 1
- ISO/DIS 10993-6 - Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
- ISO/DIS 10993-1 - Biological evaluation of medical devices — Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process
다른 사람이 함께 구입한 상품
- ISO 10993-18:2020/Amd 1:2022 - Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process — Amendment 1: Determination of the uncertainty factor
- ISO 10993-2:2022 - Biological evaluation of medical devices — Part 2: Animal welfare requirements
- ISO 10993-16:2017 - Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
- ISO 10993-18:2020 - Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process
- ISO 11607-1:2019/Amd 1:2023 - Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1: Application of risk management
추천 상품
- IEC TS 63134:2020 - Active assisted living (AAL) use cases
- 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
- KS B ISO TS 25740-1 - 에스컬레이터 및 무빙워크에 대한 안전요건 — 제1부: 세계공통 필수 안전요건(GESRs)
- KS B ISO TS 8100-21 - 승객 및 화물 운송용 엘리베이터 —제21부: 세계공통 필수안전요건(GESRs)을 충족하는 세계공통 안전 파라미터(GSPs)
- KS C IEC TS 62872 - 산업 시설과 스마트 그리드 사이의 산업 공정 측정, 제어 및 자동화 시스템 인터페이스
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