ISO 14971:2000 PDF
Medical devices — Application of risk management to medical devices
Medical devices — Application of risk management to medical devices
- Статус документа:
- Отменён
- Формат:
- Электронный (PDF)
- Количество страниц:
- 32
- Дата публикации:
- 30 ноября 2000 г.
- Издание:
- ISO IS 14971 edition 1 version 1
- ICS:
- 11.040.01
La présente Norme internationale spécifie une procédure pour permettre au fabricant d'identifier les phénomènes dangereux associés aux dispositifs médicaux et à leurs accessoires, y compris les dispositifs médicaux de diagnostic in vitro, d'estimer et d'évaluer les risques, de maîtriser ces risques et de surveiller l'efficacité de cette maîtrise. Les exigences de la présente Norme internationale sont applicables à tous les stades du cycle de vie d'un dispositif médical. La présente Norme internationale n'est pas applicable aux jugements cliniques relatifs à l'utilisation d'un dispositif médical. La présente Norme internationale ne spécifie pas les niveaux d'acceptabilité des risques. La présente Norme internationale n'exige pas du fabricant qu'il mette en place un système qualité formalisé. Toutefois, la gestion des risques peut faire partie intégrante d'un système qualité (voir, par exemple, le Tableau G.1).
Технические детали
- Технический комитет
- ISO/TC 210 - Quality management and corresponding general aspects for medical devices
- SKU
- ISO 14971:2000
Похожие стандарты
Другие стандарты ISO
ISO 8689-1:2000
ДействующийWater quality — Biological classification of rivers — Part 1: Guidance on the interpretation of biological qu…
Overview ISO 8689-1:2000, titled Water quality - Biological classification of rivers - Part 1: Guidance on the interpretation of biological quality data from surveys of benthic macroinvertebrates, is…
ISO/ASTM51540-04(2012)
ОтменёнStandard Practice for Use of a Radiochromic Liquid Dosimetry System (Withdrawn 2020)
Significance and Use4.1 The radiochromic liquid dosimetry system provides a means of measuring absorbed dose in materials (5-7). Under the influence of ionizing radiation, chemical reactions take pla…
ISO/ASTM51204-04
ДействующийStandard Practice for Dosimetry in Gamma Irradiation Facilities for Food Processing (Withdrawn 2013)
Significance and Use4.1 Food products may be treated with ionizing radiation, such as gamma-rays from 60Co or 137Cs sources, for numerous purposes, including control of parasites and pathogenic micro…
ISO/ASTM51431-05
ОтменёнStandard Practice for Dosimetry in Electron Beam and X-Ray (Bremsstrahlung) Irradiation Facilities for Food P…
Significance and Use4.1 Food products may be treated with acceleratorgenerated radiation (electrons and X-rays) for numerous purposes, including control of parasites and pathogenic microorganisms, in…
ISO/ASTM52628-20e1
ДействующийStandard Practice for Dosimetry in Radiation Processing
1.1 This practice describes the basic requirements that apply when making absorbed dose measurements in accordance with the ASTM E61 series of dosimetry standards. In addition, it provides guidance o…
ISO/ASTM52921-13(2019)
ДействующийStandard Terminology for Additive Manufacturing—Coordinate Systems and Test Methodologies
Significance and Use 3.1 Although many additive manufacturing systems are based heavily upon the principles of Computer Numerical Control (CNC), the coordinate systems and nomenclature specific to CN…
ISO/ASTMTR52917-EB
ДействующийAdditive Manufacturing — Round Robin Testing — General Guidelines
This document outlines the steps with regard to aspects of design to conduct and run a round robin study (RRS) to assess the degree of variability in an additive manufacturing material or process. Th…
ISO/ASTM52901-17(2023)
ДействующийStandard Guide for Additive Manufacturing – General Principles – Requirements for Purchased AM Parts
Scope 1.1 This document defines and specifies requirements for purchased parts made by additive manufacturing. 1.2 It gives guidelines for the elements to be exchanged between the customer and the pa…