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Technical rule [CURRENT] 2017
Medical device software - Part 2: Validation of software for medical device quality systems
from 386.40 EUR VAT included
from 361.12 EUR VAT excluded
Standard [CURRENT] 2017
Radiation therapy readiness check
Free of charge
Systems used to forecast remaining pacemaker battery service life
from 333.80 EUR VAT included
from 311.96 EUR VAT excluded
Integrating human factors into design controls
from 274.40 EUR VAT included
from 256.45 EUR VAT excluded
Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms
Guidance for logging of alarm system data
from 179.20 EUR VAT included
from 167.48 EUR VAT excluded
Dialysis fluid chemical composition
Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
Processing of health care products - Quality management systems for processing in health care facilities
from 312.50 EUR VAT included
from 292.06 EUR VAT excluded
Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
from 647.40 EUR VAT included
from 605.05 EUR VAT excluded
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