AS/NZS 2696:1996
$33.80
Medical devices – Polymer urethral catheters for general medical use
Published By | Publication Date | Number of Pages |
AS | 1996-07-05 | 28 |
Specifies requirements for polymer urethral catheters, manufactured sterile and non-sterile, and intended to be introduced through the urethra into the urinary bladder. Appendices include methods for determining catheter balloon performance, flow rate, in-use compatibility and cytoxicity.
Scope
This Standard specifies requirements for polymer urethral catheters, manufactured sterile and non-sterile, and intended to be introduced through the urethra into the urinary bladder. Catheters supplied non-sterile shall meet the requirements of this Standard, after sterilization using the manufacturer's recommended method.
NOTE: Materials to be used for the construction of urethral catheters are not specified in detail as their selection will depend, to some extent, upon the design, process of manufacture and method of sterilization, where appropriate, employed by the individual manufacturers.