ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
- Malaysia – MDA
- European Economic Community – CE Mark
- Japan – JGMP
- China – CFDA
- Korea – KFDA
- Gulf States- GHC
This performance specification establishes performance requirements for the short-term utilization of a single-use, balloon-retention catheter, French sizes 12 through 26 inclusive, used by the medical professions for providing a means of bladder drainage by means of the urethra.
Defines requirements for sterile, single-use urethral catheters with and without balloons.
- Flow Rate through Drainage Lumen
- Balloon Integrity; Resistance to Rupture
- Inflated Balloon Response to Traction
- Balloon Volume Maintenance
- Balloon Size and Shaft Size
- Deflation Reliability; Failure to Deflate
- Genotoxicity Test – ISO 10993 part 3
- Skin Sensitization Test – ISO 10993 part 10
- Skin Irrigation Test – ISO 10993 part 10
- Acute Systemic Toxicity Test – ISO 10993 part 11
- In Vitro Cytotoxicity Test – ISO 10993 part 5