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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
Technical rule [CURRENT] 2019
Medical device safety assurance case guidance
from 333.80 EUR VAT included
from 311.96 EUR VAT excluded
Factors to consider when multi-vendor devices interact via an electronic interface: Practical applications and examples
from 274.40 EUR VAT included
from 256.45 EUR VAT excluded
Principles for medical device security - Postmarket risk management for device manufacturers
Standard [CURRENT] 2019
Medical equipment management - Vocabulary used in medical equipment programs
from 156.80 EUR VAT included
from 146.54 EUR VAT excluded
Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile"
from 179.20 EUR VAT included
from 167.48 EUR VAT excluded
Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing
Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results
Technical rule [CURRENT] 2018
Guidance for uncertainty analysis regarding the application of ISO/TS 10974
Standard [CURRENT] 2018
Extracorporeal systems for blood purification - Part 3: Plasmafilters
from 221.80 EUR VAT included
from 207.29 EUR VAT excluded
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