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CEN Reports - Report for CEN TC102

March 2004
(by Tim Galekop)

CEN TC 102 WG 4 (Convenor Tim Galekop) was established on May 3rd 1988 to deal with European Standards concerning single use and reusable packaging, Document EN 868-1 has been ratified and was published in the official European Journal in February 1997. This document is in line with the Medical Device Directive and all packaging materials having to fulfill EN 868-1 "Packaging Materials and Systems for Medical Devices which are to be sterilized - Part 1 General Requirements and Test methods". Documents EN 868-2 and subsequent parts deal with the requirements and test methods for different kind of packaging materials and can be used to show compliance with these particular requirements (A tool to prove compliance to part 1) Non compliance to these parts of the standard does not mean or infer non-compliance to part 1. Parts 2-10 have been ratified and have been published in June 1999.

Within the ISO there is the Technical Committee 198 Working Group 7. This WG has published document ISO/11607 "Packaging for terminally sterilized medical devices". The big difference with the EN 868 documents is that the ISO document deals with forming and sealing and was not conform to the Medical Device Directive. EN 868-1 and subsequent parts are typically for materials and final packages like pouches / sheets and re-usable containers.

ISO/TC 198 WG 7 has agreed in Kyoto Japan May 2002 that a joint combined revision of ISO 11607 and EN 868-1 will be developed under the Vienna agreement, with an ISO lead, to create one global packaging standard.

EN standards have to be revised every 5 years. EN 868-1 is at that stage at this moment of time. It is very important that the future new packaging standard has to show compliance with the essential requirements or other provisions of the European directives. On October 29 and 30 2002 a task-group meeting was held in London. This group existed of 11 persons from different companies including the FDA and myself to prepare the draft document. These meetings are very intense and even with all the hard work, we did not manage to finalize the two documents. A new Task-group meeting was held at the AAMI on January 14 - 15 in Arlington / Washington. After this meeting a formal meeting took place between the CEN TC 102 WG 4 and ISO TC 198 WG 7 working group members in June 2003 in Frankfurt. The final joint documents (ISO/CD 11607-1 and ISO/CD 11607-2) have been discussed at the ISO TC 198 meeting in December 2003 held in New Orleans. As a result of these the documents will send out as DIS.

The new harmonized standards will exist of:

EN ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1:
Requirements for materials, sterile barrier systems and packaging systems.

Scope
This International Standard specifies the requirements and test methods for materials performed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of the terminally sterilized medical device to the point of use.

EN ISO 11607-2 Packaging for terminally sterilized medical devices - Part 2:
Validation and requirements for forming, sealing and assembly processes.

Scope
Part 2 specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized and maintain sterility to the point of use. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.

Parts 1 and 2 do not cover all requirements for packaging medical devices that are manufactured aseptically and additional requirements may be necessary.

These International Standards are applicable to industry, health care facilities, and wherever medical devices are packaged and sterilized.

CSSD in hospitals will as well be considered as industry, as far as I am concerned this is the right decisions. Where is the difference between hospitals and manufacturers? Let us not forget that we are talking about the safety of the patient.

Tim Galekop
Convenor TC 102 WG 4
March 2004

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