YY/T 0979-2016 Translated English of Chinese Standard. (YYT 0979-2016, YY/T0979-2016, YYT0979-2016): Intra-uterine suction curettes for single usehttps://www.chinesestandard.net, 2018. 4. 23. - 15페이지 This standard specifies the structural type and material, requirements, test methods, inspection rules, marking and instructions for use, packaging, transportation and storage of intra-uterine suction curettes. This standard is applicable to single-use intra-uterine suction curettes (hereinafter referred to as suction curette) which is connected to a suction device for performing negative pressure suction operation on early pregnant women. |
목차
| 3 | |
Scope | 4 |
Structural type and material | 5 |
Requirements | 7 |
Test methods | 8 |
Inspection rules | 10 |
Markings and instructions for use | 11 |
Packaging transportation and storage | 12 |
Appendix A Normative Marking Packaging | 14 |
자주 나오는 단어 및 구문
acceptance quality limit accessory tube adopts one-time sampling Basic dimension Limit Batch inspection Biological evaluation cavity suction curette Class B Class conform contain the following curette body curette shall contain Cytotoxicity Delayed type hypersensitivity deviation Basic dimension dimension Limit deviation double cavity suction Ethylene oxide residue following markings groups I I I Inspection I I I Inspection items implemented standard number Inspection groups I I I Inspection items 4.7 inspection Nonconforming classification intra-uterine suction curettes Intradermal stimulation test joint Limit deviation Basic manufacturer medical devices method in GB/T methods and sterilization millimeters Note Negative pressure resistance Nonconforming classification Class number and production number of nonconforming Periodic inspection Pharmacopoeia Product registration number Production batch number production date production enterprise license quality level RQL quality limit AQL Republic of China requirements of 4.6 sampling scheme Single cavity suction single-use intra-uterine suction sterilization expiry period Structural type suction curette Take syringe Test according test method