CONF-17-Philippe-Destrez.pdf

1、ISO 22441 standard for validation of the H2O2sterilizersexplainedName:Philippe DESTREZAffiliation:ASPIntroduction2StandardsStandardsRegulationRegulationGuidelinesGuidelinesEducation and PracticesEducation and PracticesISO and EN sterilization standards3General requirementsISO 14937General requiremen

2、tsISO 11138-1Common requirementsISO/TS 22421General requirementsISO 11140-1BD Steam penetrationISO 11140-2Alternative to BDISO 11140-4BD Air removalISO 11140-5Type 2 BI and PCD for smallsteam sterilizersISO/DIS 11140-6PCD small steam sterilizersEN 867-5Ethylene oxideISO 11138-2MoistheatISO 11138-3Dr

3、y heatISO 11138-4LTSFISO 11138-5Hydrogen peroxideISO/AWI 11138-6MoistheatISO 17665-1,-2&-3Large Steam steriliersEN 285Small Steam steriliersEN 13060Dry heatISO 20857EthyleneoxideISO 11135 and ISO/TS 21387Ethylene oxideEN 1422HydrogenperoxideISO/DIS 22441Hydrogen peroxideprEN 17180LTSFISO 25424LTSFEN

4、 14180Critical devicesISO 17664-1Biological evaluationof medical devicesISO 10993-1,-7 and 17Requirementsfor packaging systemsISO 11607-1Validation of Packaging processesISO 11607-2WrapsEN 867-2Paper bags and paperEN 867-4&-3Sealable pouches and reels EN 867-5LTS/Paper and adhesivecoatingEN 867-6&7R

5、e-usable containersEN 867-8General requirementsISO 15883-1Surgical instruments,etc ISO 15883-2Human waste containers and non invasive itemsISO 15883-3&7Thermolabile endoscopesISO 15883-4Non-invasive itemsISO 15883-6Test methods for cleaningefficacyISO/TS 15883-5Sterilization ProcessSterilizersBiolog

6、ical indicatorsSteam type 2Chemical indicatorsTerminal Sterilization of healthcare products(radiation excepted)Non biologicalindicatorsSterilizers for medicalpurposes Requirements and testingPackaging requirementsand test methodsWasher-disinfectorsThermal disinfectionChemical disinfectionProcessing