STILLPUR SALF 5L

Non Sterile SALF Purified Water - Medical Device

Medical Device CLASS I.

The medical devices described in this technical data sheet have been classified as - non-invasive devices - of Class I according to rule 1 of the classification given in Annex IX of Directive 93/42 / EEC and subsequent amendments and additions.

Rule 1:
All non-invasive devices are in Class I, unless one of the following rules applies. The following rules mentioned are those that go from rule 2 to rule 18. The non-applicability of these rules confirms the belonging to Class I of the medical device STILLPUR SALF Non-sterile purified water.
STILLPUR SALF CLASS I NON-STERILE purified water described in this Technical File

• It does not incorporate, as an integral part, a derivative of human blood.
• It does not incorporate as an integral part, in relation to the type of device and its methods of use, substances which, if used separately, can be considered medicinal products pursuant to Article 1 of Directive 2001/83 / EC.
• It does not incorporate substances or animal tissues referred to in Legislative Decree No. 67 of 06 April 2005 concerning medical devices manufactured with tissues of animal origin.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredient: water for injections.

DEVICE TYPE

NON-sterile Class I liquid. Purified water is obtained from water for human use subjected to treatment by reverse osmosis and subsequent distillation. The purified water is then divided into hermetically sealed dipolyethylene drums with screw cap equipped with a guarantee ring.

SPECIFICATIONS

The purified water complies with the specifications set forth in monograph 0008 of the European Pharmacopoeia Purified water, in particular as indicated in the section Purified Water in Containers.

USE

STILLPUR SALF can be used to power medical devices intended for the production of steam and nebulised products, for the dilution of medical devices Concentrated Solutions for Hemodialysis, for multiple use in the laboratory, for rinsing instruments, in the preparation of solutions for washing automatic equipment, for the preparation of buffer solutions and as raw material for non-sterile productions. STILLPUR SALF must not be used as a raw material for the preparation of medicines and foods.

WARNINGS

• The device is NOT sterile and cannot be used as a raw material for the production of drugs and food.
• Do not use if the liquid is not clear and colorless, if the container is damaged or if it is not hermetically sealed.
• After the first opening of the drum, the specifications of the purified water vary over time. Contact with air can lead to changes in pH, Total Organic Carbon (TOC), conductivity and microorganism count.

INSTRUCTIONS FOR USE

• Open the drum making sure that the container is intact, hermetically sealed and that the guarantee ring has not been removed or tampered with.
• Make sure the liquid is clear and colorless.
• Use according to the intended use according to the relative protocols.

VALIDITY PERIOD

2 years in intact packaging.
After the first opening of the drum, the specifications of the purified water vary over time. Contact with air can lead to increased counts of microorganisms. In particular, contact with CO2 contained in the air implies changes in pH, Total Organic Carbon (TOC) and conductivity.

FORMAT

5 liter can.