In-vitro

[Kim Boll Jensen]

This is a multi-part message in MIME format.

Hi all

I have a strange problem. I'm trying to find EMC requirements for an
in-vitro diagnostic equipment.

The directive 98/79/EEC states in Article 1 §7 that directive 89/336/EEC
(EMC) does not apply.

When looking in Harmonized standards lists under 98/79 there are no EMC
standards, BUT on this page;

http://europa.eu.int/comm/enterprise/ne
approach/standardization/harmstds/reflist/invimedd.html

it states that "OJ C 319 page 13 of 2001-11-14"  applies to both 98/79
and 93/42 (medical devices) and this list includes EN 60601-1-2 which
are EMC requirements BUT, BUT, BUT the document OJ C 319 does NOT
include 98/79 in its heading, and this list of standards is not included
on the list on the above web page.

What is the right approach ?

Best regards,

Kim Boll Jensen
Bolls Raadgivning

Title: In-vitro

Hi all

I have a strange problem. I'm trying to find EMC requirements for an
in-vitro diagnostic equipment.

The directive 98/79/EEC states in Article 1 §7 that directive 89/336/EEC
(EMC) does not apply.

When looking in Harmonized standards lists under 98/79 there are no EMC
standards, BUT on this page;

http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist/invimedd.html

it states that "OJ C 319 page 13 of 2001-11-14"  applies to both 98/79
and 93/42 (medical devices) and this list includes EN 60601-1-2 which
are EMC requirements BUT, BUT, BUT the document OJ C 319 does NOT
include 98/79 in its heading, and this list of standards is not included
on the list on the above web page.

What is the right approach ?

Best regards,

Kim Boll Jensen
Bolls Raadgivning

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