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 or rationale for this list item contained in A.5.
7 Requirements for voice prostheses supplied sterile
The requirements of ISO 18190:2016, Clause 7 shall apply.
See also Clause 8.
8 Packaging of voice prostheses supplied sterile
Packaging of voice prostheses supplied sterile shall conform with ISO 11607-1.
9 Information supplied by the manufacturer
9.1 General requirements
The applicable requirements of ISO 18190:2016, Clause 9 shall apply.
9.2 Marking
9.2.1 Voice prostheses shall be marked with the following:
a) shaft length in mm;
b) outer shaft diameter in mm or circumference in Charrière/French gauge (CH/Fr).
9.2.2 Individual packs shall be marked with the following:
a) shaft length in mm;
b) outer shaft diameter in mm or circumference in Charrière/French gauge (CH/Fr);
c) type and model of voice prosthesis;
d) tracheal flange dimension(s) in mm;
e) oesophageal flange dimension(s) in mm, if different from d).
9.3 Instructions for use
The manufacturer shall provide instructions for use that shall contain, in addition to the information specified in 9.2.1, the following:
a) instructions for the safe removal of the voice prosthesis including instructions for cleaning;
b) the maximum in-situ lifetime expressed in days;
c) information about radiographic identity (see ISO 18190:2016, 6.1.3);
d) information about the type of valve mechanism;
e.g. flap valve, duck bill valve, ball valve.
e) if applicable, a warning to the effect that the voice prosthesis is non-sterile and for replacement procedure only;
f) the valve leakage rate in ml/min and the media used for the test;
g) valve opening pressure in hPa;
h) the characteristic curve.
Flows should be indicated in l/min. Static pressure differences should be indicated in hPa.