Staðlaráð Íslands - Íslenskir staðlar

Staða:

Fellur úr gildi - 6.2.2026

Íslenskt heiti:

Líffræðilegt mat á lækningatækjum – Hluti 1: Mat og prófun innan áhættustjórnunarkerfis

Enskt heiti:

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-11)

Tengdur staðall:

ISO 10993-1:2018

Tækninefnd:

CEN/TC 206

ICS flokkur:

11.100

Auglýst:

5.2.2026

Umfang (scope):

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.

Hafðu samband í síma 520-7150 varðandi þennan staðal.

ÍST EN ISO 10993-1:2009

Líffræðilegt mat á lækningatækjum – Hluti 1: Mat og prófun innan áhættustjórnunarkerfis

Verð: 6.175 kr.

Sjá nánar

ÍST EN ISO 10993-1:2025

This document specifies the requirements and general principles governing the biological evaluation of medical devices within a risk management process according to ISO 14971. This document applies to the biological evaluation of medical devices that have direct contact or indirect contact with either:— a patient's body during intended use or reasonably foreseeable misuse; or— the body of other users who are not patients, if the medical device is intended for personal protection (e.g. medical gloves, surgical masks).Biological evaluation assesses the biological safety of the medical device by considering the biological risks associated with:— constituents of a medical device; and— tissue-device interactions (including physical effects).The biological evaluation specified in this document can address the biological safety of the medical device, considering the life cycle from design and development through initial use of the finished medical device to final decomm

Verð: 15.498 kr.