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Technical rule [CURRENT] 2024
Microbiological methods - Understanding and use of product bioburden data
from 274.40 EUR VAT included
from 256.45 EUR VAT excluded
Standard [CURRENT] 2024
Sterilization of health care products - Chemical indicators - Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers
from 333.80 EUR VAT included
from 311.96 EUR VAT excluded
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
General-purpose ethylene oxide sterilizers with automated process control and ethylene oxide sterilant sources intended for use in health care facilities
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
Healthcare technology management (HTM) educational programs Corrigendum 1
Free of charge
Standard [CURRENT] 2023
Standard for medical device security - Security risk management for device manufacturers
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
Aseptic processing of health care products - Part 1: General requirements
from 386.40 EUR VAT included
from 361.12 EUR VAT excluded
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