ANSI AAMI ISO 5367:2015 pdf download – Anaesthetic and respiratory equipment – Breathing sets and connectors

03-12-2022 comment

ANSI AAMI ISO 5367:2015 pdf download – Anaesthetic and respiratory equipment – Breathing sets and connectors
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
NOTE See Annex A for information on the use of dated and undated normative references.
ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
ISO 7000, Graphical symbols for use on equipment — Registered symbols
ISO 1 0993-1 , Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
ISO 1 1 607-1 , Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 1 4971 , Medical devices — Application of risk management to medical devices
ISO 1 5223-1 :201 2, Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
IEC 6041 7, Graphical symbols for use on equipment
IEC 60601 -1 :2005, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance
IEC 60601 -1 -6, Medical electrical equipment — Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
IEC 62366, Medical devices — Application of usability engineering to medical devices
ISO 80601 -2-1 2:2011 , Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
ISO 80601 -2-1 3:2011 , Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
EN 556-1 :2001, Sterilization of medical devices — Requirements for medical devices to be designated “STERILE” —Part 1: Requirements for terminally sterilized medical devices
EN 1 041 , Information supplied by the manufacturer with medical devices
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.

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