YY 0091-2013 PDF EnglishUS$185.00 · In stock · Download in 9 seconds
YY 0091-2013: Cervix dilator Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Obsolete YY 0091: Historical versions
Similar standardsYY 0091-2013: Cervix dilator---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YY0091-2013YY PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040.30 C 36 Replacing YY 0091-1992 Cervix dilator ISSUED ON: OCTOBER 21, 2013 IMPLEMENTED ON: OCTOBER 1, 2014 Issued by: China Food and Drug Administration According to the medical device industry standard announcement of National Medical Products Administration (No. 76 of 2022), starting from September 7, 2022, this Standard becomes a recommended standard and will no longer be mandatory. Table of ContentsForeword ... 3 1 Scope ... 4 2 Normative references ... 4 3 Structural type and material ... 5 4 Technical requirements ... 7 5 Test methods ... 8 6 Inspection rules ... 9 7 Marking and packaging ... 10 8 Transportation and storage ... 11 Cervix dilator1 ScopeThis Standard specifies the structural type and material, technical requirements, test methods, inspection rules, marking, packaging, transportation, and storage of cervix dilator. This Standard applies to cervix dilator (hereinafter referred to as dilator). This product is used in obstetrics and gynecology to dilate the cervix. This Standard does not apply to disposable cervix dilator.2 Normative referencesThe following documents are indispensable for the application of this document. For the dated references, only the editions with the dates indicated are applicable to this document. For the undated references, the latest edition (including all the amendments) are applicable to this document. GB/T 1220 Stainless steel rod GB/T 1527 Drawn tube of copper and copper alloys GB/T 2828.1 Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection GB/T 2829 Sampling procedures and tables for periodic inspection by attributes (apply to inspection of process stability) GB/T 6463 Metallic and other inorganic coatings - Review of methods of measurement of thickness GB/T 10610 Geometrical product specifications (GPS) - Surface texture: Profile method - Rules and procedures for the assessment of surface texture YY 0076-1992 Coating classifications for metal product - Technical conditions YY/T 0149-2006 Medical instruments of stainless steel - Test methods of corrosion resistance YY/T 0171-2008 Surgical instruments - Packaging, Marking and Instructions YY/T 1052 Marking requirements for surgical instruments as cracks, sharp edges, burrs, and dents. 4.1.2 The markings on the dilator shall be clear and obvious. 4.1.3 The head of the dilator shall be round and smooth. After using absorbent cotton to wipe it, no fibers shall be pulled out. 4.2 Dimensions The diameter dimension D of dilator rod AND the overall length dimension L shall comply with the provisions of Table 1 and Table 2. 4.3 Surface roughness The surface roughness Ra of the dilator shall not be greater than 0.4 μm. 4.4 Coating The coating of copper dilator shall not be lower than the D · L3Ni7/Cr0.3 requirements specified in YY 0076-1992. 4.5 Corrosion resistance 4.5.1 The copper dilator shall not be damaged after a saturated steam test at 134 °C~138 °C for 20 min. After wiping, there shall be no irremovable traces of corrosion. 4.5.2 If the dilator is made of stainless steel, its corrosion resistance shall not be lower than the requirements of level 5.4 b in YY/T 0149-2006.5 Test methods5.1 Appearance Use absorbent cotton to wipe the head of the dilator. Observe the other parts visually and use hands to touch them. It shall comply with the provisions of 4.1.1, 4.1.2, and 4.1.3. 5.2 Dimensions Use special and general measuring tools to measure. It shall comply with the provisions of 4.2. 5.3 Surface roughness Use the sample comparison method OR the profile method specified in GB/T 10610 to conduct the test. The profile method shall be used for arbitration. It shall comply with the provisions of 4.3. 5.4 Coating Determine according to the method specified in GB/T 6463. It shall comply with the provisions of 4.4. 5.5 Corrosion resistance 5.5.1 Use saturated steam at a temperature of 134 °C~138 °C to carry out the test for 20 min; repeat the test 20 times (The interval is based on the specimen cooling to room temperature). It shall comply with the provisions of 4.5.1. 5.5.2 It shall be carried out according to the boiling water test method specified in YY/T 0149-2006. It shall comply with the provisions of 4.5.2.6 Inspection rules6.1 Acceptance The dilator shall be inspected by the quality inspection department of the manufacturer. Only after passing the inspection, can it be submitted to the buyer for acceptance. 6.2 Inspection method Dilators shall be submitted for inspection in lots. The inspection is divided into lot-by- lot inspection (exit-factory inspection) and periodic inspection (type inspection). 6.3 Lot-by-lot inspection 6.3.1 Lot-by-lot inspection shall be in accordance with the provisions of GB/T 2828.1. 6.3.2 Lot-by-lot inspection shall adopt the single sampling plan for normal inspection. Its nonconformity classification, inspection group, inspection items, inspection level, and acceptance quality limit (AQL) shall be in accordance with Table 3 (calculated based on the number of nonconformity products per 100 units of product). ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of English version of YY 0091-2013 be delivered?Answer: The full copy PDF of English version of YY 0091-2013 can be downloaded in 9 seconds, and it will also be emailed to you in 9 seconds (double mechanisms to ensure the delivery reliably), with PDF-invoice.Question 2: Can I share the purchased PDF of YY 0091-2013_English with my colleagues?Answer: Yes. 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