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Specifies requirements for vena cava filters, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. This part of ISO 25539 supplements ISO 14630, which specifies general requirements for the performance of non-active surgical implants.
Author | ANSI/AAMI/ISO |
---|---|
Editor | AAMI |
Document type | Standard |
Format | File |
Confirmation date | 2015-11-24 |
ICS | 11.040.40 : Implants for surgery, prosthetics and orthotics |
Cross references | ISO 25539-3 (2011-12), IDT |
Year | 2012 |
Document history | |
Country | USA |
Keyword | ANSI 25539;ANSI/AAMI/ISO 25539;25539;ANSI/AAMI/ISO 25539-3-2012 (R2015) |