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Revised standards for sterilisation: the changes: the standards for the three main methods of sterilising medical devices, ethylene oxide, radiation and moist heat, have been revised. This article discusses the major changes in the requirements, which will need to be addressed to demonstrate compliance with the revised standards.

Article Excerpt
Reason for revision

The first European standards for sterilisation were published in 1994 and the first international standards in 1994 and 1995 (Table I).These European standards are harmonised and give a presumption of conformity with the European medical device Directives. The international standards have been adopted as a United States (US) standard and recognised by the Food and Drug Administration. The 1994 and 1995 European and international standards are technically equivalent and entirely compatible, but they are editorially different. This has meant added complexity [or manufacturers and sterilisation contractors who need to meet US and European requirements to market medical devices in both jurisdictions.

Under the normal practice of standards organisations, standards are reviewed after five years. It was agreed in 1999 that a joint revision should be prepared under the leadership of the International Organisation for Standardisation (ISO).This process is coming to an end and revised standards are now being published.

The revised standards will simplify the compliance requirements for manufacturers supplying multiple geographical markets. The radiation and moist heat standards are published; the ethylene oxide (EtO) standard is expected be published in the second quarter of 2007. They are available as national adoptions of the European standards from national standards bodies in all the European countries. For the moist heat standards it has been agreed to have an extended withdrawal period, thus both the new and older standards will remain in force for three years.

Numbering

Because the lead for the revision process was taken by ISO Technical Committee (TC) 198, the ISO numbering system was applied; the standards will ultimately be dual numbered as European standards with an EN ISO prefix. The standards for EtO and radiation sterilisation retain the original ISO numbers of 11135 and 11137, respectively. The new standard for moist heat sterilisation is applicable to industry and health care and has a new number: ISO 17665.

Structure of the revised standards

The review and revision of the sterilisation standards were undertaken in parallel. It was decided at the beginning of the revision process that the structure of the standards for the three methods of sterilisation should be the same. It was also agreed that the same definitions should apply where the same term is used in the three process standards.

Based on these early decisions, the title of the documents giving requirements and guidance was agreed to be: Sterilisation of Health Care Products, Ethylene Oxide/Radiation/Moist Heat, Part 1 : Requirements for the Development, Validation and Routine Control of a Sterilisation Process for Medical Devices. The main clauses of the standards are set out in Table II. The changes in each of the revised sterilisation standards are outlined below.

The Revised Standard For EtO Sterilisation

ISO 11135-1.2, Sterilisation of Health Care Products, Ethylene Oxide

This standard has been published as a Final Draft International Standard (FDIS) for comment and voting by ISO member bodies. FDIS status means that no further technical changes are expected to be made to this document. So that ISO TC 198 Working Group (WG) I would meet ISO publishing deadlines, it was decided to limit the informative guidance contained in the standard to only that which is...

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