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Details zur gewählten Norm

Normentyp:ASTM F
Name:ASTM F 1980
Bezeichnung:Standard-Leitfaden für die beschleunigte Alterung von Sterilbarrieresystemen für Medizinprodukte


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storage test/ accelerated aging in lab drying oven or refrigerator (controlled temperature)
Storage tests with or without filling good for estimating the long-term stability of materials and packages. The storage tests, depending on the requirements, could be carried out in lab drying oven (convection), refrigerator, explosion-protected heating chamber (e.g. solvent-based media,T1- T3 max 105 °C;T 4 max. 70 °C), climate chamber (humidity and temperature controlled, temperature and humidity cycles possible). Please select the appropriate method to avoid unnecessary costs. Tests by this method are common for accelerated assessment of material aging for long-term applications, also in terms of resistance against chemicals, foodstuffs or other filling goods. The assesment looks purely on technical aspects, for the assessment of compliance with food legislation is referred to relevant legal requuirements. Nevbermind, we strongly recommend parallel tests under real storage conditions to validate the meaningfulness of accelerated aging tests. To prepare an offer we need the following information: What type of packaging should be tested (size, filling volume)? How many packages should be stored? Are the packages empty or do they have to be emptied before testing? Which contents are involved (CAS no./ safety data sheet)? How long should the packages be stored? Under what ambient conditions should the packages be stored (temperature, controlled relative humidity)?


storage test/ accelerated aging in explosion protected heating chamber (controlled temperature)
Storage tests with or without filling good for estimating the long-term stability of materials and packages. The storage tests, depending on the requirements, could be carried out in lab drying oven (convection), refrigerator, explosion-protected heating chamber (e.g. solvent-based media,T1- T3 max 105 °C;T 4 max. 70 °C), climate chamber (humidity and temperature controlled, temperature and humidity cycles possible). Please select the appropriate method to avoid unnecessary costs. To prepare an offer we need the following information: What type of packaging should be tested (size, filling volume)? How many packages should be stored? Are the packages empty or do they have to be emptied before testing? Which contents are involved (CAS no./ safety data sheet)? How long should the packages be stored? Under what ambient conditions should the packages be stored (temperature, controlled relative humidity)?


storage test/ accelerated aging in climate chamber (controlled temperature and relative humidity)
Storage tests with or without filling good for estimating the long-term stability of materials and packages. The storage tests, depending on the requirements, could be carried out in lab drying oven (convection), refrigerator, explosion-protected heating chamber (e.g. solvent-based media,T1- T3 max 105 °C;T 4 max. 70 °C), climate chamber (humidity and temperature controlled, temperature and humidity cycles possible). Please select the appropriate method to avoid unnecessary costs. To prepare an offer we need the following information: What type of packaging should be tested (size, filling volume)? How many packages should be stored? Are the packages empty or do they have to be emptied before testing? Which contents are involved (CAS no./ safety data sheet)? How long should the packages be stored? Under what ambient conditions should the packages be stored (temperature, controlled relative humidity)?


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Heike Schwertke +49 441 94986-14
heike.schwertke@innoform.de