SIST EN ISO 10993-1:2021

Oznaka standarda: SIST EN ISO 10993-1:2021
Koda projekta: 00206070
Organizacija: SIST
Naslov (angleški): Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-11)
Naslov (slovenski): Biološko ovrednotenje medicinskih pripomočkov - 1. del: Ocena in preskušanje znotraj procesa obvladovanja tveganja (ISO 10993-1:2018, vključno s popravkom verzije 2018-11)
Če kupite standardizacijski dokument v .pdf formatu prek spletne prodaje, vam nudimo 10% popust pri spodnji ceni brez DDV. Cenik SIST
Dokumenti
Ime Jezik Status Cena Dodaj v košarico
SIST EN ISO 10993-1:2021 angleški jezik Active SIST-I: 85.91 EUR
PDF
Papir
Tehnični odbor: VAZ - Varovanje zdravja
ICS: 11.100.20
Status: Objavljen
Objavljen: 01-Feb-2021
Refer. št. objave: Sporocila 2021-02
Referenčna oznaka: EN ISO 10993-1:2020
Področje projekta (angleško): 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. Devicespecific or product standards address mechanical testing. This document excludes hazards related to bacteria, moulds, yeasts, viruses, transmissible spongiform encephalopathy (TSE) agents and other pathogens.
Povezava na standarde
Povezava Ime Datum
Nadomešča SIST EN ISO 10993-1:2010 - Biološko ovrednotenje medicinskih pripomočkov - 1. del: Ocena in preskušanje znotraj procesa obvladovanja tveganja (ISO 10993-1:2009) 01-Feb-2021
Nadomešča SIST EN ISO 10993-1:2010/AC:2010 - Biološko ovrednotenje medicinskih pripomočkov - 1. del: Ocena in preskušanje znotraj procesa obvladovanja tveganja - Popravek 1 (ISO 10993-1:2009/Cor 1:2010) 01-Feb-2021


• Slovenski standardi SIST s cenovnim razredom AC so popravki standardov in so v večini primerov brezplačni.

• Slovenski standardi SIST s cenovnim razredom AP so privzeti tuji standardi, katerih sestavni del je izvirni standard, ki ga moramo pridobiti pri izdajatelju v tujini. Naročilo pošljite na: prodaja@sist.si.

Najbolje prodajani standardi