of any apparatus (including software!) intended for use on human beings
for the purpose of diagnosis, prevention, monitoring, treatment, or
alleviation of disease, or for compensation for an injury or handicap.
After the visual inspection has been completed, and before EMC testing
is started, the engineer should address safety issues, by testing to
IEC-601-1, and check for leakage, current, dielectric breakdown,
insulation resistance, and ground bond testing.
Note: products not covered include the following:
- In vitro diagnostic devices-IVDD
- active implantable units, ( pacemakers ) -directive 90/385/eec
- medicinal products-directive 65/65/eec
- cosmetic products-directive 76/768/eec
- personal protective equipment-directive 89/686/eec
Severe fines are being issued to manufacturers that have not complied
with these standards.
While a brief listing of these are given on this
page, you should buy a copy of these specifications and carefully read
them for yourself, to determine which specifications, and what levels of
threat that you need to comply with.
Published in the official journal of the European communities (OJ) June
Implemented January 1, 1995 with a three year transition period. This
became mandatory on June 14, 1998!
The MDD requires that:
- The medical device fulfills its essential requirements.
- The conformity assessment procedure is carried out before the device
is placed on the market.
- The CE marking is applied to the device.
- A new approach directive. 43 pages of material! With 23
articles - list mandatory procedures or requirements.
- 12 annexes in addition to listing the essential requirements and
device classification criteria, the annexes provide methods of
auditing the systems used by manufacturers to insure that the
procedures are being implemented and used properly.
How does the medical manufacturer comply with the MDD?
- Determine the class of product your product falls into.
- Comply with all the essential requirements defined in annex 1.
Compliance with EN60601-1:1990, the basic European standard based on
iec601 may be used to demonstrate conformance with the essential
requirements for safety and EMC.
- Issue a declaration of conformity.
- Implement the appropriate conformity assessment scheme described in
article 11 and annexes 2-7.
- Apply the CE marking to the product.
Specific EMC requirements
The essential requirements of the MDD cover performance and safety issues,
and safety issues will not be covered here. The following address
EMC safety. The EMC phenomena of concern, along with the
corresponding basic EMC standards and test levels are provided as well as
a list of recommended EMC test equipment. This section specifically
identifies the required EMC tests, and lists recommended test equipment to
conduct the tests.
The harmonized medical EMC standard that is used to demonstrate EMC
compliance is en60601-1-2:1993 titled, "medical electrical equipment;
part1:general requirements for safety, part2: collateral standard:
electromagnetic compatibility - requirements and tests."
This page summarizes the immunity tests
listed in en60601-1-2:1993, as well as the recommended test equipment.
Call us for more details.