ISO 5361:2016 pdf free
ISO 5361:2016 pdf free.Anaesthetic and respiratory equipment一Tracheal tubes and connectors
This Annex provides a concise rationale for the important requirements of ISO 5361 and is intended for use by those who are familiar with the subject of ISO 5361, but who have not participated in its development. An understanding of the reasons for the main requirements is considered essential for its proper application. Furthermore, as clinical practices and technologies change, it is believed that rationales for the present requirements will facilitate any revisions of this International Standard necessitated by those developments.
The clauses in this Annex have been so numbered to correspond to the clauses in this International Standard to which they refer. The numbering is, therefore, not consecutive.
The scope has been expanded to include so-called speciality tracheal tubes because they share many of the same requirements.[8][2] Speciality tracheal tubes have increased in clinical use while the use of basic tracheal tubes has been reduced due to increased use of supralaryngeal airways, non-invasive ventilation masks, and other devices.[10][11] Clause 4一General requirements for tracheal tubes and tracheal tube connectors This clause has been revised to include essential performance and risk management principles associated with tracheal tubes.
The need for a risk management file is a well recognized process through which the manufacturer of a medical device can identify hazards associated with a medical device, estimate and evaluate the risks associated with these hazards, control these risks, and monitor the effectiveness of that control.
Clinical evaluation may also be necessary to confirm the adequacy of the controls. See ISO 14971 for additional information.
While many major clinical trials validate the use of current commercial cuffed paediatric tracheal tubes,[12][13][14] others reported adverse events and point to the lack of a convention among manufactured designs.[15][16] The dimension C in Table 1a for sizes 3,0 to 4,5 are those developed by consensus among participants in the systematic review of ISO 5361.
Although material biocompatibility is important for all tracheal tubes and other airways, it was considered of special importance for tubes that might remain in situ for weeks. Anaesthetic agents would not be in contact with the tube marking materials for such long periods of time, but these agents might be damaging to marking materials.[7].ISO 5361 pdf free.
