Overview

This standard specifies general requirements for epidural catheters and their connectors which are delivered in sterile condition and are intended for single use. Test methods for X-ray capability, the breaking force of the catheter and the tightness of the treatment system are specified, amongst others. Requirements for single-use catheter ends and suction catheters are specified in DIN EN ISO 8836. Additional specifications for urethral catheters are partially covered by DIN EN 1616. Requirements for single-use rectal catheters are in DIN EN 12439 and single-use intervascular catheters, central, as well as catheters for medical sectors and single-use intervascular catheters, peripheral, are specified in DIN EN ISO 10555-1. In terms of content, this standard is not yet covered by a European or an International Standard. Therefore it is intended - after expiry of the submission period - to introduce a corresponding "New Work Item Proposal" at ISO/TC 84 "Devices for administration of medicinal products and intravascular catheters". This standard has been prepared by Working Committee NA 063-01-02 AA "Katheter, Drainagen" ("Catheters, drainages") at the Medical Standards Committee (NAMed).

Document: references other documents

Responsible national committee

NA 176-04-01 AA - Catheters, drainages