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COVID-19
预防相关医疗设备欧洲标准中英文
Brussels 20 March 2020 - In
response to the coronavirus outbreak, CEN,
the European Committee for
Standardization, and CENELEC, the
European Committee for Electrotechnical
Standardization, agreed, in
collaboration with all their Members
and after the urgent request from the
European Commission, to make freely
available a series of European
standards (ENs) for medical devices and
personal protective equipment
used in
the context of the COVID-19 exceptional decision
is motivated by the need to tackle the
severe shortage of protective masks
and
medical equipment experienced all around Europe
due to the
exponential growth of the
COVID-19 emergency. The standards will
enable a quicker and smoother access to
market of new fundamental
medical and
protection equipment. Providing free access to the
national
adoptions of this set of
European standards facilitates the work of the
many companies within the European
Economic Area which are
reconverting
their production lines to deliver tangible results
quickly and
ensure that healthcare
professionals and patients have access to the
equipment they urgently need. The 11
standards developed by CEN and
potentially 3 additional ones developed
jointly with ISO made available
cover
common filtering masks, medical gloves and
protective clothing.
They are the fruit
of a collective European effort. These European
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standards were developed and adopted by
different Technical Bodies,
taking into
account the contributions of hundreds of experts
and
stakeholders in the personal
protective equipment and medical field all
around Europe. The standards are
available for free download from the
websites of CEN national members.
Thierry Breton, European
Commissioner
for the Internal Market, saluted the
init
iative: “In our
battle
against the coronavirus we need to act with
urgency, solidarity and
in a
coordinated manner. We need audacity and
innovative ways of
producing the
equipment we need. I am encouraging manufacturers
to
evaluate the possibilities of
increasing and diversifying production,
building on positive examples such as
textile and shoe manufacturers
starting
to produce masks and gowns. I will do everything
possible to
support their efforts. I am
pleased to announce that following contacts
with the Commission, today CEN and
CENELEC agreed to make freely
available
the standards needed for such companies to be able
to produce
masks and other protective
equipment. This agreement has immediate
effect.”Vincent Laflèche, CEN
President, commented: “Due to
the
coronavirus pandemic, we are living
unprecedented circumstances which
require exceptional measures. By making
a set of standards available for
free,
the European standardization community is
committed to help the
European
Commission in its effort to build the first common
European
reserve of emergency medical
equipment (RescEU)”.
Dany Sturtewagen,
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