DSF/prEN ISO 10555-4
Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO/DIS 10555-4:2011)
| Organization: | DS |
| Status: | inactive |
| Page Count: | 21 |
| ICS Code (Transfusion, infusion and injection equipment): | 11.040.20 |
| ICS Code (Syringes, needles and catheters): | 11.040.25 |
scope:
This part of ISO 10555 specifies requirements for balloon dilatation catheters supplied in the sterile condition, and intended for single use. NOTE Attention is drawn to ISO 11070, which specifies requirements for accessory devices for use with intravascular catheters, to ISO 25539-2 which specifies requirements to delivery systems if they comprise an integral component of the deployment of the vascular stent and to ISO 14630 Non-active surgical implants - General requirements and, ISO 12006 (secretariat's note: the standards are EN standards and 12006 parts 1-3- does WG9 still wish to refer to these?).
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