跳至主要内容

National Standard Requirements for BD Test Packages


a) Produce method of BD test pack: BD test packs are folded from 100% defatted cotton cloth or 100% cotton surgical towel to grow 30cm±2cm, width 25cm±2cm, height 25cm-28cm. The BD test paper is placed in the middle of the above-mentioned cloth bag; the weight requirement of the manufactured BD test bag is 4 kg±2 kg, or the BD test bag is used once or repeatedly.
b) BD test method: preheat the sterilizer before testing, place the BD test package horizontally in front of the bottom layer of the sterilizer in the sterilizer, near the front of the cabinet door and the exhaust port. Any item time does not exceed 3.5 minutes at 134 degrees, remove the test pack, observe the color change of the BD test paper.
c) Judgment of results: BD test paper is uniformly and uniformly discolored, indicating that the BD test passes and the sterilizer can be used; discoloration inequality indicates that the BD test has failed and BD test can be repeated. Qualified, the sterilizer can be used. Unqualified, required check the cause of the BD test failure until the sterilizer can be used after the BD test passes.
http://www.kmnbz.com/Article/nationalst.html

评论

发表评论

此博客中的热门博文

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 req...
10 条评论
阅读全文

What is Self Seal Sterilization Pouches

  self seal sterilization pouches  is carried out in hospitals and medical or surgical sterilization manufacturing plants. Most packaging must be sterile when delivered to the end user. Medical self seal sterilization pouches provides protective envelopes for sterilization to protect against sterilization during disinfection, transportation, storage and delivery to the final home. Medical self seal sterilization pouches can assemble and secure several sterilization items required for a given surgical procedure and be ready for operation.   The term "sterilization" covers a wide range of products. A cotton ball, a cotton swab, and a tongue spatula are examples of "treatable products." Use them once and throw them away." Use once is not a synonym for cheap. Some very expensive sterilizations, such as dialysis filters, are themselves too fragile to be cleaned and reused after sterilization. To save costs, reuse is desirable. Most medical sterilization, such as sci...
2 条评论
阅读全文

If You Think Your Pouch is Just a Pouch, Wait Until You Read This

  Do you know what self sealing sterilization pouches are? If not, then read on to learn more about these amazing products. A self-sealing sterilization pouch is a bag that can be sealed and opened with one hand and contains an atmosphere that will destroy bacteria and other microorganisms in the bag's contents.   Self seal sterilization pouches   have been used for decades in hospitals worldwide because they offer excellent protection against contamination of medical instruments, surgical equipment, or pharmaceuticals during transport or storage. When self sealing sterilization pouches are used to package medical devices or pharmaceuticals, the self seal sterilization pouch provides a barrier that protects these products against moisture and contamination during shipping. This helps ensure that when your customers use them in their procedures, they will be safe for patient care. What do you truly understand about the sterilization pouches you use? What should you be awar...
发表评论
阅读全文