Bed heads
Suspended bed head beam for I.C.
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Safety Quality and compliance with
norms
The "Intensive Care" bed head
model is the most recent experience directly gained by Tekno-lit
in the electro-medical appliance field.
For this reason as well as for the company's constant pursuit
of Total Quality, the "Intensive Care" bed head
model was conceived and created in complete compliance with
safety and quality requirements provided for by the most recent
technical international and national regulations 1*:
EN 60601 - 1 (CEI 62 - 5)
UNI EN ISO 11197
And originating from European norm 2*:
DDM 93/42
Certification of company quality system:
UNI EN ISO 9001
UNI EN ISO 13485
Guarantee quality throughout the planning,
development, production and commercialisation phases and thus
the safety of Tekno-lit's products.
1* - at first 62/5 and 62/10 were
the reference norms concerning electric safety requirements
of electro-medical appliances. 62/10 was subsequently annulled
and at present the reference regulations are cointaned in
62/5 - the italian version of 60601 - and UNI EN ISO 11197 which are
the norms concerning "basic requirements" and "specific
requirements" respectively as regards safety and whose
enforcement allows the necessary requirements to be met as
laid down in 93/42 norm.
2* - 93/42: MEANING (it is a European
Community law concerning medical equipment and its accessories)
, IMPLICATIONS (it is essencial for free circulation of medical
appliances within the European Community), LEGAL OBBLIGATIONS
(undue CE marking results in a sanction imposing immediate
discontinuation of production and/or importation).
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