What is ISO 21917 about?
ISO 21917 addresses anaesthetic and respiratory equipment and outlines 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.
There are two groups of voice prostheses are indwelling voice prostheses and non-indwelling voice prostheses.
Note: There is guidance or rationale for this list item contained in A.2.
Who is ISO 21917 for?
ISO 21917 on anaesthetic and respiratory equipment is useful for-
- Manufacturers of anaesthetic and respiratory equipment
- Medical laboratories
- Developers and engineers of anaesthetic and respiratory equipment
Why should you use ISO 21917?
Voice prostheses are used to restore voice in patients after total laryngectomy. They are placed into a surgically created tracheoesophageal puncture (TEP). There exist different prosthesis specific placement tools to insert a voice prosthesis into the TEP. Placement of the voice prosthesis can be performed via the tracheostomy (anterograde), via the mouth (retrograde) and via the surgical wound (intraoperative) for which ISO 21917 layouts performance requirements.
ISO 21917 provides guidelines on minimum requirements like materials, design requirements, requirements for voice prostheses supplied sterile, packaging and instructions for use. ISO 21917 also provides test methods that determine leakage, valve opening pressure and characteristic curve which ensures a high-quality product is delivered to the end-user and is healthy and safe for the patient’s life.