As the harmonization of ISO 10993 standards and FDA requirements proceeds, the methods described above will be used by the device industry to a greater and greater extent to aid in the selection of optimal materials and to control the uniformity of medical products. This clearly establishes ...
Nordson MEDICAL luer tapers are made to the ISO 594-1 standard, and may be connected to other luers meeting ISO standards. Please test your application to verify the performance of the interconnection. Where can I get more information on resin? Click here for resin information. What is the...
Storage method and shelf life Comparison with similar medical devices 4 Overview of design verification and validation documents General Information Declaration of Conformity to Standards Overview of validation of design Test to support device safety Physical and chemical properties Electrical safety and...
此指南为发展中的加速老化方案提供信息以便快速测定其有效性,并且, 适用于 ANSI/AAMI/ISO11607-1:2006 中定义的无菌屏障系统及其组成成分的物理性质的时 间影响。 1.2 Information obtained using this guide may be used to support expiration date claims for medical device sterile barrier systems. 此指南提供的...
With a clear understanding of the market, regulations, and challenges, Element delivers certainty as a single source supplier of medical device testing services.
It has established quality management systems according to the requirements of GB, ISO and CE standards. The management systems are applied to all of the management, R & D and manufacturing divisions. It has already got the Medical Device Manufacturing Enterprise License, the Hygience Licence, the...
2. Safety interlocking device 3.With BD test, HELIX TEST, Vacuum test. 4.LCD display and touch buttons 5.With standard test interface 6.Open top water tank 7.Europe CLASS B standard. 8.With automatic protection function: over temperature protection, over pressu...
This product is a medical device complied with ISO standards. Produced in accordance with ISO standard; Products certified by CE0197, ISO13485, FDA 510K, KGMP, INMETRO and CFDA; E.O Gas Sterilization; Shelf life: ...
Shelf Life 24 Months Transport Package Cartons Specification 25 tests/box, 40tests/box Trademark Dewei Origin China HS Code 3822190090 Production Capacity 100, 000 Tests/Day Product Description Intended Use These tests are simple, fast reliable, and accurate tests that ...
* Dural side handle to release of backpart with damping device which can let the back rest fall down slowly to ensure the safety of the patient, single hand operation. * One button trendelenburg, release Abdominal pressure and prevent shoc...