ANSI AAMI ISO 5367-2015 pdf download
ANSI AAMI ISO 5367-2015 pdf download.Anaesthetic and respiratory equipment — Breathing sets and connectors
4.1.2 Breathing tubes shall, when transported, stored, installed, operated in normal use and maintained according to the instructions of the manufacturer, present no risks that are not reduced to an acceptable level using risk management procedures in accordance with ISO 1 4971 and which are connected with their intended application, in normal and in single-fault condition. NOTE A situation in which a fault is not detected is considered a normal condition. Fault conditions/hazardous situations might remain undetected over a period of time and, as a consequence, might lead to an unacceptable risk. In that case, a subsequently detected fault condition needs to be considered as a single-fault condition. Specific risk control measures need to be determined within the risk management process to deal with such situations.
4.1.3 It is recognized that the manufacturer may not be able to follow all of the processes identified in this International Standard for each constituent component of the breathing tube, such as proprietary components, subsystems of non-medical origin, and legacy devices. In this case, the manufacturer should take special account of the need for additional risk control measures.
4.1.4 Where requirements of this International Standard refer to freedom from unacceptable risk, acceptability or unacceptability is determined by the manufacturer in accordance with the manufacturer’s policy for determining acceptable risk. Check compliance by inspection of the risk management file.
4.2 Usability
If required by a competent authority, the manufacturer shall address in a usability engineering process any risks resulting from poor usability (see IEC 60601 -1 -6 and IEC 62366). Check compliance by inspection of the usability engineering file.
4.3 Clinical evaluation
If required by a competent authority, a clinical evaluation shall be performed and documented in the technical documentation of the device. Check compliance by inspection of the technical documentation of the device.
4.4 Biophysical or modelling research
If required by a competent authority, and where appropriate, validated biophysical or modelling research shall be carried out. Check compliance by inspection of the technical file.
4.5 Test methods
The manufacturer may use type tests different from those detailed within this International Standard, if an equivalent degree of safety is obtained. However, in the event of dispute, the methods specified herein shall be used as the reference methods.
4.6 Recommended service life
Re-usable breathing sets and breathing tubes shall comply with the requirements of this International Standard throughout the recommended service life as required in 8.4.4. Check compliance by inspection of the manufacturer’s technical file.
8.4.4 Unless the breathing set or breathing tube is intended and marked as being for single use, the manufacturer shall provide details of recommended methods of cleaning and disinfection or sterilization, and the maximum number or period of reuses, if processing in accordance with the provided instructions leads to a degree of degradation that will limit the useful life of the medical device. Where such degradation is established, the manufacturer shall provide an indication of the number of reprocessing cycles that can normally be tolerated, or some other indication of the end of the medical device’s ability to safely fulfil its intended use. NOTE Manufacturers’ attention is drawn to the regulatory provision requiring that the indication of single use must be consistent across the European Community.
8.4.5 *For coaxial and double-lumen breathing sets, the manufacturer shall provide details of recommended user test methods to verify the integrity of the breathing set before use. Specialized equipment that is required to perform this user test shall be supplied with the breathing set or available from the manufacturer. NOTE Particular problems with coaxial tubing or double lumen breathing sets with internal components include leakage (to atmosphere and between inspiratory and expiratory tubes), separation, or blockage.
