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Standard [CURRENT] 2020
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
from 179.20 EUR VAT included
from 167.48 EUR VAT excluded
Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
from 599.20 EUR VAT included
from 560.00 EUR VAT excluded
Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment
from 524.20 EUR VAT included
from 489.91 EUR VAT excluded
Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
from 471.50 EUR VAT included
from 440.65 EUR VAT excluded
Medical devices - Part 1: Application of usability engineering to medical devices + Amendment 1
from 1262.20 EUR VAT included
from 1179.63 EUR VAT excluded
Technical rule [CURRENT] 2020
Risk management guidance for combination products
from 312.50 EUR VAT included
from 292.06 EUR VAT excluded
Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
from 333.80 EUR VAT included
from 311.96 EUR VAT excluded
Reprocessing of hemodialyzers
Comprehensive guide to steam sterilization and sterility assurance in health care facilities
from 560.00 EUR VAT included
from 523.36 EUR VAT excluded
Pre-standard 2019
Safety and effectiveness of health IT software and systems - Part 3: Application of risk management
from 25.80 EUR VAT included
from 24.11 EUR VAT excluded
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