All medical devices manufactured by Spencer are manufactured and CE marked in full conformity with the specifications of the European Directive 93/42/CE and the specific technical norms applicable.
Considering the quantity of technical norms applicable to Spencer Medical devices, the following table underlines the less specific reference norms
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UNI CEI EN ISO 14971 :2004
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Standard for risk management of medical devices |
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UNI EN 980:2004 |
Graphical symbols for use in the labelling of medical devices |
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UNI 10893 |
Instruction manuals - layout and composition |
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MEDDEV 2.12-1 |
Guidelines on a Medical Devices Vigilance System |
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NB-MED/2.5.1/REC5 |
Technical Documentation (Medical Devices) |
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MEDDEV 2.7.1 |
Evaluation of clinical data |
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EK-MED 920/03 |
Conformity assessment. Auditing of Subcontractors. Certification of OEM Devices |
All certificate have been issued by TUV Product Service GMBH Germany.
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CERTIFICATE CE (N° G1 06 11 33230 010) |
Emergency Lung ventilators, Pulse oximeters, suction devices, vacuum systems, medical gas systems for ambulances, resuscitators |
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CERTIFICATE CE (N° G2 04 05 33230 008) |
Heat therapy medical devices: instant ice packs, instant heat packs, ice spray |
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CERTIFICATE CE (N° G2M 04 05 33230 009) |
Aneroid and mercry sfigmomanometers |
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