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Standard [CURRENT] 2023
Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation item for a biological indicator
from 179.20 EUR VAT included
from 167.48 EUR VAT excluded
Technical rule [CURRENT] 2023
Microbiological aspects of ethylene oxide sterilization
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from 311.96 EUR VAT excluded
Water for the processing of medical devices
from 386.40 EUR VAT included
from 361.12 EUR VAT excluded
Application of ISO 14971 to machine learning in artificial intelligence - Guide
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Guidance on the use of AGILE practices in the development of medical device software
Sterilization of health care products - Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release
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Standard for medical device security - Security risk management for device manufacturers
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
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from 433.36 EUR VAT excluded
Standard [CURRENT] 2022
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices
Medical devices and medical systems - Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE): Part 2-1: Particular requirements for forensic data logging
from 312.50 EUR VAT included
from 292.06 EUR VAT excluded
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