Reference Standard For Seal Verification of Sterilization Pouches For Medical Devices
With the increasing demand for sterilization pouches of medical devices, quality and safety inspection have become more and more stringent. sterilization pouches of medical devices (blister box + tyvek roll material, sterilization paper bag, etc.) as a form of packaging directly in contact with the device and used to block microorganisms. No matter what form of packaging, it has two characteristics, which can meet the sterilization operation and remain sterile until the transportation conditions are used. Therefore, relevant departments began to focus on the review requirements of sterile packaging and make specific requirements for its performance and quality.
As we all know, GB/ t19633-2005 "packaging of ultimately sterilized medical devices" is one of the authoritative standards in the current sterile packaging standards. It is equivalent to iso11607-2003 "packaging of ultimately sterilized medical devices". Clarify the basic performance requirements of sterile packaging: biocompatibility of raw materials, chemical toxicity, microbial barrier, sealing closure, aging, etc. The mentioned tightness is a key factor affecting the whole aseptic barrier system, and its failure will mean that the aseptic state is destroyed, which will largely lead to medical errors.
Reference standard for seal verification of sterilization pouches for medical devices
GB/ t19633-2005 packaging of final sterilized medical devices clearly stipulates that the sealing strength is one of the safety verification items that cannot be ignored. The two test methods proposed are tensile seal strength test and bursting/creep test. The tensile seal test of sterilized package is mainly to test its sealing strength by pulling force. The bursting/creep test evaluates the overall minimum seal strength of the sterile packaging by pressurizing the package to the point of rupture or to the critical point and holding it for a period of time. Since this method is not described in detail in the standard, it is necessary to refer to ASTM F 1140, YY/T 0681 and ASTM F 8806.