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Standard [CURRENT] 2019
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
This document has been modified by: AAMI/ISO 11607-2/A1:2023
from 216.20 EUR VAT included
from 202.06 EUR VAT excluded
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
This document has been modified by: AAMI/ISO 11607-1/A1:2023
from 312.50 EUR VAT included
from 292.06 EUR VAT excluded
Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results
from 333.80 EUR VAT included
from 311.96 EUR VAT excluded
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
from 179.20 EUR VAT included
from 167.48 EUR VAT excluded
Technical rule [CURRENT] 2019
Guide to the development and inclusion of aspects of safety in International Standards for medical devices
from 265.40 EUR VAT included
from 248.04 EUR VAT excluded
Basic Introduction to the IEC 60601 Series
from 221.80 EUR VAT included
from 207.29 EUR VAT excluded
Medical device safety assurance case guidance
Principles for medical device security - Postmarket risk management for device manufacturers
Medical equipment management - Vocabulary used in medical equipment programs
from 156.80 EUR VAT included
from 146.54 EUR VAT excluded
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