YY 1293.5-2017 Translated English of Chinese Standard. YY1293.5-2017: Contacting wound dressing - Part 5: Alginate dressingThis Part of YY 1293 specifies the performance requirements and test methods for alginate dressing. This Part is applicable to aseptically supplied alginate dressing that consists only of alginate fibres. This Part does not include requirements for alginate dressing containing silver and other bacteriostatic agents. |
Contents
| 3 | |
Introduction | 4 |
Scope | 5 |
Classification | 6 |
Biocompatibility | 7 |
Marks | 10 |
Annex A informative Infrared identification map of alginate | 12 |
Common terms and phrases
1.0g of alginate 5mL of hydrochloric 5mL of water according to Annex acid and 23mL Add 5mL alginate dressing containing alginate fiber alginate G guluronic Annex VIII aseptically blank solution British Pharmacopoeia broken packaging Cadmium Calcium content China Edition 2010 China Food complete carbonization Contacting wound dressing content test Take EDTA exceed fabrics and cut GB/T guluronic acid Heavy metal hydrochloric acid Ignition residue II of Pharmacopoeia infrared absorption spectrum Infrared identification Inspection Center Let it cool Loss on drying map of alginate Medical Device Quality meet the requirements month of failure non-woven fabrics number or date People's Republic Perform according Pharmacopoeia of People's potassium bromide production lot number referenced document Republic of China salt inspection method sample Shandong Shelf packaging single packaging Slowly bake specified sterility and sterilization sterilized medical devices terminally sterilized medical Test methods test solution test Take 1.0g testing according volumetric flask wound exudate YY/T