ESSENTIAL REQUIREMENTS Checklist MDD 93/42/EEC, Annex I
Device:__________________________________
No.
Essential Requirements
Applicable
(yes/no)
Standard/Requirement/Guideline
Reference to Documentation
Fulfilled
(yes/no)
grundl_anf_mdd_e.doc
Rev.:
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mdc
2001-01-15
I.
GENERAL REQUIREMENTS
1.
The design must be designed and manufactured in such a
way that, when used under the coordination and for the pur-
poses intended, they will not compromise the clinical condi-
tion or the safety of patients, or the safety and health of users
or, when applicable, other persons, provided that any risks
which may be associated with their use constitute acceptable
risks when weighed against the benefits to the patient and
are compatible with a high level of protection of health and
safety.
2.
The solutions adapted by the manufacturer for the design and
construction of the devices must conform to safety principles,
taking account of the generally acknowledged state of the art.
In selecting the most appropriate solutions, the manufacturer
must apply the following principles in the following order:
• eliminate or reduce risks as far as possible (inherently
safe design and construction),
• where appropriate take adequate protection measures in-
cluding alarms if necessary, in relation to risks that cannot
be eliminated,
inform users of the residual risks due to any shortcomings of
the protection measures adopted.
3.
The devices must achieve the performances intended by the
manufacturer and be designed, manufactured and packaged
in such a way that they are suitable for one or more of the
functions referred to in Article 1 (2) (a), as specified by the
manufacturer.
4.
The characteristics and performances referred to in Sections
1, 2 and 3 must not be adversely affected to such a degree
that the clinical conditions and safety of the patients and,
where applicable, of the other persons are compromised
during the lifetime of the device as indicated by the manu-
facturer, when the device is subjected to the stresses which