The review of the main performance indicators of disposable medical products can be evaluated by the inspection report to see if they meet the requirements, and the content of the inspection report can be reviewed by the content of the registered product standard. Therefore, the examination of registered product standard is one of the most important parts in the examination of product main performance.
Whether the performance requirements meet the requirements can be evaluated by the following main contents:
1. Sterility requirements
The product should be sterile. It is carried out in accordance with the "sterility test law" of the Pharmacopoeia of the people's Republic of China (2005 Edition)
2. Limit of ethylene oxide residue:
If the product is sterilized by ethylene oxide, the residual amount of ethylene oxide shall not be more than 10 ug/g.
3. General performance requirements for surgical gowns, surgical drapes and fenestrated surgical drapes :
(1) Impermeability: the impermeability of the product shall be evaluated according to YY/T4744-1997 test (a hydrostatic test method for determining the impermeability of fabrics).
(2) Resistance to dry microbial penetration: test according to YY/T0506.5 standard (operation sheets, sterile surgical gowns and clean clothes standard for patients and medical staff Part 5: resistance to dry microbial penetration test method).
Moisture resistant microbe penetration: test according to YY/T0506.6 standard (operation sheets, operation clothes and clean clothes standard for patients and medical staff Part 6: moisture resistant microbe penetration test method).
4. General performance requirements of respirator:
It shall meet the requirements of YY0469-2004 standard (this standard specifies the technical requirements, test methods, marks and instructions for use, packaging, transportation and storage of medical surgical masks).
5. General performance requirements for rubber medical gloves:
It shall meet the requirements of GB7543-1996 (this standard specifies the technical requirements and sampling methods of rubber gloves for medical operation).
6. General performance requirements for medical absorbent gauze accessories:
It shall conform to YY0594-2006 standard (this standard specifies the general requirements, packaging and marking requirements of surgical gauze dressing made of absorbent cotton gauze or absorbent cotton and viscose blended gauze).
7. Physical properties:
(1) The breaking strength shall meet the requirements of FZ/T60005-1991 standard (determination of breaking strength and breaking elongation of nonwovens).
(2) The quality requirements of nonwovens should meet the requirements of FZ/T60003-1991 (quality measurement of nonwovens per unit area).
(1) It shall be flat and clean without stains, holes and serious wrinkles;
(2) There should be sewing requirements, such as: the seam should be firm and flat, how many stitches should be in each unit, and the stitches should be even without thread loss, and the sewing thread head should be cut off, etc;
(3) There should be no abnormal smell.
9. Requirements for external components:
The performance requirements of the external components shall be written in the standard, but the test methods can be provided by two ways: one is that the enterprise can conduct full inspection according to the requirements; the other is to provide the qualification certificate of the supplier and the inspection report within the validity period issued by the qualified inspection organization as the basis for verification.