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TECHNICAL
COMMITTEE
The SDMA has a
very active Technical Committee that addresses a wide variety of topics
important to the dressings industry. Our current activities include:
Standards
We are represented on numerous BSI and CEN committees and working groups
dealing with Quality Systems, Sterilization, Nomenclature, Performance
Testing etc.
We provide the
secretariat for BSI CH117/1 committee that reviews proposed Standards
for dressings and which provides the platform whereby new topics
can be raised as potential new standards work.
At European level,
several experts from SDMA member companies contribute to the work of CEN
TC205 WG9 which deals with Dressing Standards.
Quality
Systems for Medical Devices
SDMA has commented on recent drafts of ISO 9001:2000 in respect of the
needs of the industry for regulatory purposes. Currently, together with
our colleagues in ABHI, we are commenting on the possible revision of
ISO 13485 which relates to the specific quality system needs of the medical
devices industry.
Performance
Testing
The SDMA acts as the catalyst to facilitate the development of performance
tests for specific properties of dressing products. Ideally these test
methods will relate as closely as possible to the function of a product
in a clinical situation. The intention is not to determine a specific
performance level but to establish a method which will allow clinicians
to decide which product is most appropriate to the condition they are
treating.
When a method has
been accepted as being capable of giving reproducible results, it can
be fed through the standards network for adoption as an accepted means
of assessing a particular property in a dressing.
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