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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
Healthcare technology management (HTM) educational programs Corrigendum 1
Free of charge
Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
from 415.50 EUR VAT included
from 388.32 EUR VAT excluded
Compatibility of materials subject to sterilization
from 386.40 EUR VAT included
from 361.12 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
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes Amendment 1: Application of risk management
2
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