YY/T 0618-2017 Translated English of Chinese Standard (YY/T 0618-2017, YYT0618-2017): Test methods for bacterial endotoxins of medical devices¡ªRoutine monitoring and alternatives to batch testinghttps://www.chinesestandard.net, 6 déc. 2022 - 53 pages This standard specifies basic guidelines for test methods for bacterial endotoxins, which are applicable to the determination of medical devices, components or raw materials. Note: Although the scope of this standard is limited to medical devices, the requirements specified in this standard and the guidelines given may also apply to other medical products. This standard does not apply to the evaluation of pyrogens, other than bacterial endotoxin. |
Table des matières
| 3 | |
Use of technique | 20 |
Informative Outofspecification OOS and failure investigation guide | 50 |
Expressions et termes fréquents
alternatives to batch amebocyte lysate manufacturer analysis and/or Appendix bacterial endotoxin test batch testing calculated calibrated cerebrospinal fluid Chromogenic and turbidity components control points Depyrogenation detected determine Diluents dilution series documented endotoxin concentration endotoxin contamination Endotoxin dosage endotoxin levels endpoint method equipment EU/mL evaluated failure investigation FMEA formula GB/T Gel-clot technique geometric mean guidelines identification identification/validation inhibition/enhancement inspection instruments interference investigation test kinetic label laboratory LAL-RM lambda leaching Limulus amebocyte lysate Limulus test linear maximum validated dilution medical device medical products non-pyrogenic products Note Out-of-specification Pharmacopoeia preparation primary package procedures product endotoxin limit product positive control product units production process production run qualification quality management system Rabbit tests raw materials reagents regression analysis risk assessment sample extract Sample solution selected serial dilution specified Standard control series standard curve temperature Test endotoxin limit test methods test results test sample test solution turbidity techniques