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STN EN ISO 10993-1

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Electronic version (pdc file)

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Name: STN EN ISO 10993-1
Validity: Valid
Number of pages: 52
Language:
EN
Paper: 21,40€
Electronic version a) Only read (without ability to print and copy) 19,26€
b) Without ability to print, with ability to copy (printscreen) 21,40€
c) With ability to print and copy (printscreen) 27,82€
Slovak title Biologické hodnotenie zdravotníckych pomôcok. Časť 1: Hodnotenie a skúšanie v systéme manažérstva rizika (ISO 10993-1: 2018, vrátane opravenej verzie 2018-10)
English title Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)
Release Date: 01. 06. 2021
Date of withdrawal:
ICS: 11.100.20
Sorting character/National clasification code 85 6510
Level of incorporation: idt EN ISO 10993-1:2020, idt ISO 10993-1 Corrected version 2018-10:2018
Official Journal 05/21
Amendments
Replaced by:
Repleces: STN EN ISO 10993-1:2010-05 (85 6510)
Note in Official Journal:
Subject of the standard: 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).
Preview: Náhľad normy (PDF)