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Standard [CURRENT] 2009
Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
from 333.80 EUR VAT included
from 311.96 EUR VAT excluded
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
from 179.20 EUR VAT included
from 167.48 EUR VAT excluded
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
from 285.60 EUR VAT included
from 266.92 EUR VAT excluded
Technical rule [CURRENT] 2009
Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
from 607.00 EUR VAT included
from 567.29 EUR VAT excluded
Considerations of Unaddressed Safety Aspects in the Second Edition of IEC 60601-1 and Proposals for New Requirements
Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices
Standard [CURRENT] 2008
Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results
from 274.40 EUR VAT included
from 256.45 EUR VAT excluded
Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pumps
from 312.50 EUR VAT included
from 292.06 EUR VAT excluded
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
from 362.90 EUR VAT included
from 339.16 EUR VAT excluded
Technical rule [CURRENT] 2008
Process challenge devices/test packs for use in health care facilities
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