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

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Biocompatibility evaluation of breathing gas pathways in healthcare applications - Evaluation and testing within a risk management process1 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

The EMC considerations of the final installation are the responsibility of the professional installer

ISO 18949 describes test methods to evaluate reflection colour photographic prints with regard to changes in image appearance resulting from exposure to low relative humidity

coding of the RT+

With BS EN 60695-11-3 you can be ensured that the products consistently meet and exceed quality assurance targets

Tests described in this document are type tests

PD CEN/TR 15316-6-2 covers energy performance calculation of heating systems and water-based cooling space emission sub-systems

up to 24 m

The equipment specified by BS EN 13081 is suitable for use with liquid petroleum products and other dangerous substances of Class 3 of ADR [2] which have a vapour pressure not exceeding 110 kPa

Note6: ISO 13617 does not purport to address all of the safety problems associated with its use

b)      Annex A concerning the additional tolerances for piling tubes was removed

BS EN 16798-13 aims at international harmonization of the methodology

For illustration

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