YY/T 0979-2016 Translated English of Chinese Standard. (YYT 0979-2016, YY/T0979-2016, YYT0979-2016): Intra-uterine suction curettes for single use [Buy--download True-PDF in 3-second: https://play.google.com/books > Sign in > This BOOK > "3-dots" > Export > Save as "*.pdf"]https://www.chinesestandard.net, 23 apr 2018 - 15 pagine 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. |
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acceptance quality limit accessory tube adopts one-time sampling basic dimensions Basic Limit Basic Batch inspection Biological evaluation Cavity smoothness cavity suction curette conform contain the following curette body curette shall comply curette shall contain Cytotoxicity Delayed type hypersensitivity deviation dimension deviation dimension deviation dimension double cavity suction enterprise license number Ethylene oxide residue following markings implemented standard number Inspect by visual Inspection groups Inspection items intra-uterine suction curettes Intradermal stimulation test joint Limit Basic Limit manufacturer medical devices medium package method in GB/T methods and sterilization millimeters Negative pressure resistance Nonconforming classification 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 Rejection quality level 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 suction mouth syringe Test according test method