BS ISO 21917 pdf free download

BS ISO 21917-2021 pdf free download.Anaesthetic and respiratory equipment -Voice prostheses.
6.3 Valve opening pressure
The average valve opening pressure, determined using the test method given in 4, shall be declared by the manufacturer in the instructions for use, Isee 92 g)I.
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 AA.
6.4 Characteristic curves
Characteristic curves of voice prostheses, generated by the test method given in B5. shall be declared by the manufacturer in the instructions for use, Isee 92 h)j.
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 &5.
7 Requirements for voice prostheses supplied sterile
The requirements of 150 1619021116, 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) trachealflange dimension(s) in mm;
e) oesophagealflange dimension(s) in mm, if dilterent tram 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;
1) the valve leakage rate in mI/mm and the media used for the test;
g) valve opening pressure in hPa;
h) the characteristic curve.
Flows should be indicated in I/mm. Static pressure differences should be indicated in hPa.BS ISO 21917 pdf download.