Reference

SSKT 063

Designation

Dressing Kit

Description Dressing Kit

Usage

EASY KIT Dressing Kit is used for dressing procedures.

Packing

All components are packed in operational order so that efficiency is ensured.  Depending on the preference 2 options are available:

• Pouch Pack: All necessary components are placed inside pouch. Pouch has necessary peeling opening available.

• Blister Pack: All necessary components are packed inside a blister pack. Blister pack has a peeling side marked.

In both packing methods, packages show the information below either put inside or in printing:

• o Product series name & product name o Kit type (connection / disconnection) o Kit contents with quantities o Manufacturing date o Date of expiry o Lot number o Reference number
• o Sterilization indicator o Method of sterilization
• o Warnings (don’t use open packages, for single use only, latex free) o Manufacturer contact & company information

 

Sterility

Kits are sterilized with EO sterilizer in house. Sterilization is documented and monitored through necessary forms, biological indicators, chemical indicators, dosimeters and data loggers.

Shelf Life

Product has been tested for stability. Test reports show that sets have a shelf life of 3 years.

Quality Certification & Compliance

All process across SUBMED is run in compliance with EN ISO 9001 & EN ISO 13485.

Independent third party laboratories tested EASY KIT series for packing sealing strength is in compliance with EN ISO 868-5, stability according to ASTM F 1980 and package leak tests according to ASTM F 1929. Thermoforming line is validated for temperature and pressure settings according to EN ISO 17025.

Sterilization process has been validated according to EN ISO 11135-1, for sterilization by Ethylene Oxide. Sterilizer is also validated by IQ and OQ tests.

Our manufacturing plant and clean room is in compliance and been tested for EN ISO 11605, EN ISO 14644-1, EN ISO 14644-2, EN ISO 14698-1 and EN ISO 14698-2 tests for bio contamination levels in order to assure relevant safety levels in all products.

EASY KIT products are tested for bio-burden according to EN ISO 11737-1. To achieve highest quality EO residue is also tested according to EN ISO 10993-7.

Dressing Kit is a CE Class IS product.

Content

Description	Qty.
40 x 40 Cm Drape	1
7.5 x 7.5 Cm Swab Gauze	5
Large B.P.C. Cotton Ball	5
Disposable Forceps	4
Disposable Bag with Tie	1
Integral Gallipot	2
Metal Scissor	1
Disposable Artery Forceps	1

 

Storage

Store the product under normal conditions for healthcare material, in a cool and dry place protected from light. The use of medical grade paper and film guarantees its sterility for the duration of its shelf life under normal transport and storage conditions.

 

Comments

The product must be used by specialised personnel only. Check the container’s integrity before use. Do not use if the container is open or damaged.