YY/T 1470-2016 Translated English of Chinese Standard. (YYT 1470-2016, YY/T1470-2016, YYT1470-2016): Disposable cut of the umbilical cordhttps://www.chinesestandard.net, 2018 M05 5 - 13 pages This Standard specifies the structural styles, requirements, test methods, inspection rules, marking and operation instructions, packaging, transportation and storage for disposable cut of the umbilical cord. This Standard applies to disposable cut of the umbilical cord. The product is used to clamp and cut the newborn umbilical cord during obstetrical delivery. |
Contents
| 3 | |
Scope | 4 |
Structural styles | 5 |
Requirements | 6 |
Test methods | 8 |
Inspection rules | 10 |
Marking and operation instructions | 11 |
Packaging transportation and storage | 13 |
Common terms and phrases
100 product units 15 N static 4.2 Inspection level acuity to check batch number Batch-by-batch inspection Biological evaluation Category A Category Category B Category Category C classification clamp the infusion Clamping performance classification Inspection group Conduct test Corrosion resistance Cutting blade cutting knife Cutting performance Delayed-type hypersensitivity Dimension of umbilical Ethylene oxide residue evaluation of medical Fitting performance group I I I Inspection I I I Inspection items infusion tube specified Inspection group I I I Inspection items 4.5 inspection Nonconformity Category Intradermal reaction Knife rest limit All pass medical devices method GB/T method specified nonconforming product number nonconformity classification operation instructions performance Disposable cut Periodic inspection Pharmacopoeia product changes product name Republic of China Revaluation of biological sampling program Shanghai specified in 5.4.1 specified in GB/T specified in Table stainless steel Standard sterile structural styles Surface roughness terms of nonconforming Test methods umbilical cord clamp vitro cytotoxicity YY/T