BS EN ISO 18562-1:2020 PDF

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Evaluation and testing within a risk management process

Название (английский):

BS EN ISO 18562-1:2020

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Evaluation and testing within a risk management process

Статус документа:: Отменён
Формат:: Электронный (PDF)
Дата публикации:: 29 февраля 2020 г.
ICS:: 11.040.10
Технический комитет:: CEN
SKU:: BS EN ISO 18562-1:2020

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Abstract

1 Scope This document specifies:

— the general principles governing the biological evaluation within a risk management process of the gas pathways of a medical device , its parts or accessories , which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments;

— the general categorization of gas pathways based on the nature and duration of their contact with the gas stream;

— 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 gas pathway ;

— the assessment of the biological safety of the

BS EN ISO 18562-1:2020 PDF

Abstract

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