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Standard [CURRENT] 2019
Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile"
from 179.20 EUR VAT included
from 167.48 EUR VAT excluded
Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing
from 333.80 EUR VAT included
from 311.96 EUR VAT excluded
Technical rule [CURRENT] 2019
Factors to consider when multi-vendor devices interact via an electronic interface: Practical applications and examples
from 274.40 EUR VAT included
from 256.45 EUR VAT excluded
Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1
U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems
from 386.40 EUR VAT included
from 361.12 EUR VAT excluded
Technical rule [CURRENT] 2018
Guidance for uncertainty analysis regarding the application of ISO/TS 10974
Standard [CURRENT] 2018
Extracorporeal systems for blood purification - Part 3: Plasmafilters
from 221.80 EUR VAT included
from 207.29 EUR VAT excluded
Extracorporeal systems for blood purification- Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
Aseptic processing of health care products - Part 2: Sterilizing filtration
from 254.20 EUR VAT included
from 237.57 EUR VAT excluded
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