General information
Sterile closing cone for all kinds of open IV accesses and pre-filled syringes.
Specifications
Universal double-function closing cone:
Male end (the rounded end part) for standard Luer IV connections.
Female end (protruding part) Luer lock IV connection:
Material: PE (polyethylene).
Does not permit injections.
Quality requirements:
Complies with European Medical Device Directive Council directive 93/42/EEC or equivalent.
Meet standard:
EN-ISO 20594-1: Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements (ISO 594-1:1986).
Unit presentation:
1 unit, sterile, individually peel packed, single-use
Primary packaging:
Labelling: Manufacture’s name and/or trademark, product description and reference number, "sterile" with method, lot number, expiry date by year and month, "for single use", and CE mark and reference number of notifying body. Must be multilingual: English, French and Spanish, others when available.
Secondary packaging:
Protected unit, one (1) box 100-unit presentation, labelling is the same as primary packaging.
Additional required information: Number of units per secondary packaging. Information for product-specific storage conditions (e.g., temperature, pressure, light, humidity, etc.).
Transport packaging:
Labelling is the same as secondary packaging with product-specific transport and storage instructions, and quantity of secondary packaging.
NOTE: Alternative option:
- closing cone with female end only, for a standard Luer IV connection.
- closing cone with male end only, for a Luer lock IV connection; it requires two types of closing cones.