Help for medical product conformity

Edited by the Electronicstalk editorial team Nov 5, 2004

EN 60601-1-2:2001 requires manufacturers to provide more information in the declaration of conformity and TUV can help organisations define the degree to which products will be affected.

The 1993 version of EN 60601-1-2 standard 'Medical electrical equipment - Part1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests' was regarded as insufficient by most EMC experts, to adequately assess equipment.

As a result, the standard was reviewed and more technical details and requirements were included in the 2001 version.

After November 1, 2004, EN 60601-1-2:1993 while still valid the standard can no longer be used to demonstrate conformity for new products under European and British legislation.

In contrast to the old version, the new edition pays more attention to details and clearly defines two product categories i.e non-life-supporting and life-supporting devices.

The latter ones, e.g patient monitors for intensive care, has now to fulfil stricter technical requirements.

In general, EN 60601-1-2:2001 requires manufacturers to provide more information in the declaration of conformity.

To assist companies to create this document so that it is in line with the standard, there are decision tables and several examples.

Under the reviewed standard, labelling, the manufacturers declaration and accompanying documents now comprise 19 pages, whereas before this used to be just half a page.

It is recommended that manufacturers review their existing declarations of conformity and ensure that the documentation provided for users is appropriate and sufficient.

As usual, before conducting compliance tests, a test plan should be developed to help to take account of the various tests to be performed.

A strong basis for compliance is to use approved components which will increase the likelihood of passing the tests successfully, though it does not represent a guarantee for compliance as the assembled unit of approved components as a whole needs to comply.

Due to the complexity of the 2001 version, it is strongly recommended to seek advice from a Notified Body, such as TUV Rheinland, to find out to which degree the changes affect your current and future products.