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CEN Articles - Packaging Materials

(by Tim Galekop)

The first surgical operation took place in Babylon, Greece about 4000 years ago. In the 19^th century approximately 60% of the patients died of hospital fever.

In 1881 Robert Koch started sterilization by using steam.

± 1935 the introduction took place of single use packaging materials
(Sheets of paper, later the paper bags and pouches)

In the forties the aluminium containers started to replace the old Shimmel Bush drums (mainly in Germany) and back in 1970 the first Nonwoven sheets of packaging materials where introduced.

For steam sterilisation CEN (Comitée Européen De Normalisation) has developed and published standards for sterilization processes.

A lot of things have changed over the last couple of years. Sterilization has become much more important.

The Sterilization Department is the heart of the hospital, if that does not pump i.e. the operating room (theatre) can not operate.

The European council directive of the 14^th June 1993 concerning Medical Devices and the CEN standards were made to minimise the risks and optimise the security for user and the patient.

TC 102 WG 4, Packaging materials, started their work in Madrid on May 3^rd 1988. The aim was to harmonise all existing National European Standards.

The first finished document was EN 868 part 1.

EN 868-1 has been ratified and published in the official Journal in February 1997.

The title from this document is: Packaging Materials and systems for Medical Devices which are to be Sterilized - Part 1: General requirements and test methods.

EN 868-1 is in line with the Medical Device Directive and is a horizontal standard.

EN 868 2-8 series are vertical standards and are dealing with requirements and test methods.

The documents EN 868 parts 2 to 8 have been officially ratified and published in June 1999.

The titles for EN parts 868 2-8 are:

EN 868 - 2	Sterilization wrap. Requirements and test methods.
EN 868 - 3	Paper for use in the manufacture of paper bags and in the manufacture of pouches and reels. Requirements and test methods.
EN 868 - 4	Paper bags. Requirements and test methods.
EN 868 - 5	Heat and self-sealable pouches and reels of paper and plastic film construction. Requirements and test methods.
EN 868 - 6	Paper for the manufacture of packs for medical use for sterilization by ethylene oxide or irradiation. Requirements and test methods.
EN 868 - 7	Adhesive coated paper for the manufacture of heat sealable packs for medical use for sterilization by ethylene oxide or irradiation. Requirements and test methods.
EN 868 - 8	Re-usable sterilization containers for steam sterilizers conforming to EN 285. Requirements and test methods.

TC 102 WG 4 met in December 1998. At that meeting the comments received during the CEN Enquiry concerning prEN Parts 9 and 10 were discussed. The revised parts 9 and 10 have been issued for a Formal Vote. The documents prEN 868 parts 9 and 10 were approved during the Formal Vote procedure and will hopefully soon be ratified and published.

prEN 868 - 9	Nonwoven uncoated materials of high density polyethylene fibres (Nonwoven HDPE) for the use in manufacture of pouches, reels, and lids. Requirements and test methods.
prEN 868 -10	Adhesive coated Nonwoven materials of high density polyethylene fibres (HDPE) for the use in manufacture of pouches, reels and lids. Requirements and test methods

Working group 4 has finalised its work program but has not been disbanded.