BS ISO 21917:2021 pdf download – Anaesthetic and respiratory equipment — Voice prostheses This document specifies performance requirements for voice prostheses including requirements for marking, packaging and information to be provided by the manufacturer as well as test methods for the evaluation of physical characteristics of voice prostheses. NOTE There is guidance or rationale for this list item contained in A.2. 2 Normative references The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials,sterile barrier systems and packaging systems ISO 18190:2016, Anaesthetic and respiratory equipment — General requirements for airways and related equipment ISO 18562-1, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1:Evaluation and testing within a risk management process 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 18190 and the following apply. ISO and IEC maintain terminology databases for use in standardization at the following addresses: — ISO Online browsing platform: available at https://www.iso.org/obp — IEC Electropedia: available at https://www.electropedia.org/ 3.1 characteristic curve curve that defines the relationship between pressure and flow across the voice prosthesis 3.2 flange dimension main dimensions of the tracheal and oesophageal flanges EXAMPLE For a round flange, the outside diameter; for an oval flange, the major and minor dimensions. 3.3 in-situ service life time between insertion and removal of a voice prosthesis 3.4 leakage the rate at which the test media leaks from the oesophageal side to the tracheal side of the voice prosthesis 6.3 Valve opening pressure The average valve opening pressure , determined using the test method given in B.4, shall be declared by the manufacturer in the instructions for use, [see 9.2 g)]. Check compliance by inspection of the instructions for use and the technical file. NOTE There is guidance or rationale for this list item contained in A.4. 6.4 Characteristic curves Characteristic curves of voice prostheses , generated by the test method given in B.5, shall be declared by the manufacturer in the instructions for use, [see 9.2 h)]. Check compliance by inspection of the instructions for use and the technical file. NOTE There is guidance...
Download Address
Download