Évaluation de la biocompatibilité des chemins de gaz respiratoire utilisés dans le domaine de la san...
Le présent document spécifie les essais concernant les émissions des matières particulaires provenant des chemins de gaz utilisés dans un dispositif médical, ses parties ou ses accessoires, qui sont destinés à dispenser des soins respiratoires ou à fournir des substances par les voies respiratoires à un patient dans tous les types d’environnements. Les essais contenus dans le présent document…
Évaluation de la biocompatibilité des chemins de gaz respiratoire utilisés dans le domaine de la san...
Le présent document spécifie:
— les principes généraux gouvernant l’évaluation biologique au sein d’un processus de gestion du risque des chemins de gaz utilisés dans un dispositif médical, ses parties ou ses accessoires, qui sont destinés à dispenser des soins respiratoires ou à fournir des substances par les voies respiratoires à un patient dans tous les types d’environnements;
— la…
Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluatio...
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…
Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for...
This document specifies tests for the emissions of particulate matter from 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 tests of this document are intended to quantify particles from 0,25 µm diameter to 10 µm diameter that are emitted by the…
Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for...
This document specifies tests for substances leached by liquid water condensing in 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 chemical characterization methods described in this document apply to chemical substances that could leach from the medical…
Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for...
This document specifies tests for the emissions of volatile organic substances from 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 tests of this document are intended to quantify emissions of volatile organic substances that are added to the…
Information technology - Use of biometrics in video surveillance systems - Part 1: System design and...
The ISO/IEC 30137 series is applicable to the use of biometrics in VSSs (also known as closed circuit television or CCTV systems) for a number of scenarios, including real-time operation against watchlists and in post-event analysis of video data. In most cases, the biometric mode of choice will be face recognition, but this document also provides guidance for other modalities, such as gait…
