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Standard [CURRENT] 2023
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes Amendment 1: Application of risk management
from 179.20 EUR VAT included
from 167.48 EUR VAT excluded
Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation item for a biological indicator
Water for the processing of medical devices
from 386.40 EUR VAT included
from 361.12 EUR VAT excluded
Technical rule [CURRENT] 2023
Microbiological aspects of ethylene oxide sterilization
from 333.80 EUR VAT included
from 311.96 EUR VAT excluded
Application of ISO 14971 to machine learning in artificial intelligence - Guide
from 274.40 EUR VAT included
from 256.45 EUR VAT excluded
Guidance on the use of AGILE practices in the development of medical device software
Standard for medical device security - Security risk management for device manufacturers
Sterilization of health care products - Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release
from 221.80 EUR VAT included
from 207.29 EUR VAT excluded
Technical rule [CURRENT] 2022
Sterilization of health care products - Radiation - Part 4: Guidance on process control
Standard [CURRENT] 2022
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques
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