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Technical rule [CURRENT] 2024
Quality Management System (QMS) guidance on compliance with FDA's Final Rule on combination products
from 312.50 EUR VAT included
from 292.06 EUR VAT excluded
Standard [CURRENT] 2024
General-purpose ethylene oxide sterilizers with automated process control and ethylene oxide sterilant sources intended for use in health care facilities
from 274.40 EUR VAT included
from 256.45 EUR VAT excluded
Guidance on radiation validation and routine maintenance for single-use systems used for pharmaceutical and biopharmaceutical manufacturing
from 179.20 EUR VAT included
from 167.48 EUR VAT excluded
Processing of dilators, transesophageal and ultrasound probes in health care facilities
from 333.80 EUR VAT included
from 311.96 EUR VAT excluded
Compatibility of materials subject to sterilization
from 386.40 EUR VAT included
from 361.12 EUR VAT excluded
Standard for a medical equipment management program
Alternate equipment management (AEM) program in healthcare delivery organizations (HDOs)
Technical rule [CURRENT] 2023
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
from 463.70 EUR VAT included
from 433.36 EUR VAT excluded
Standard [CURRENT] 2023
Aseptic processing of health care products - Part 1: General requirements
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems Amendment 1: Application of risk management
from 221.80 EUR VAT included
from 207.29 EUR VAT excluded
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