ISO 14971-1:1998 PDF
Medical devices — Risk management — Part 1: Application of risk analysis
Medical devices — Risk management — Part 1: Application of risk analysis
- Статус документа:
- Отменён
- Формат:
- Электронный (PDF)
- Количество страниц:
- 17
- Дата публикации:
- 1 октября 1998 г.
- Издание:
- ISO IS 14971 edition 1 version 1
- ICS:
- 11.040.01
Технические детали
- Технический комитет
- ISO/TC 210 - Quality management and corresponding general aspects for medical devices
- SKU
- ISO 14971-1:1998
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ОтменёнStandard Practice for Use of a Radiochromic Liquid Dosimetry System (Withdrawn 2020)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ДействующийStandard Practice for Dosimetry in Gamma Irradiation Facilities for Food Processing (Withdrawn 2013)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…