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Standard [CURRENT] 2021
Medical electrical equipment - Part 1-12: General requirements - Collateral standard: Requirements for medical electrical equipment and medical electrical systems intended for use in emergency medical services environment - Amendment 1
from 156.80 EUR VAT included
from 146.54 EUR VAT excluded
Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, Amendment 1
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, Amendment 2
from 535.40 EUR VAT included
from 500.37 EUR VAT excluded
Technical rule [CURRENT] 2021
Appropriate Use of Public Cloud Computing for Quality Systems and Medical Devices
End-to-end microbiological quality and sterility assurance
from 221.80 EUR VAT included
from 207.29 EUR VAT excluded
Evaluation of particulate associated with vascular medical devices
from 312.50 EUR VAT included
from 292.06 EUR VAT excluded
Ultrapure dialysis fluid for hemodialysis and related therapies
Water testing methodologies
Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose at a specified sterility assurance level: Method VDmax SD-S
General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications
from 274.40 EUR VAT included
from 256.45 EUR VAT excluded
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