標準編號:	YY 0091-2013
中文名稱:	子宮頸擴張器
英文名稱:	Cervix dilator
中標分類:	C36    其他專科器械
行業(yè)分類:	YY    醫(yī)藥行業(yè)標準
ICS分類:	11.040.30 11.040.30    外科器械和材料 11.040.30
發(fā)布機構(gòu):	國家食品藥品監(jiān)督管理總局
發(fā)布日期:	2013-10-21
實施日期:	2014-10-1
標準狀態(tài):	valid
替代舊標準:	YY 0091-1992 子宮頸擴張器
翻譯語言:	英文
文件格式:	PDF
中文字符數(shù):	11000 字
翻譯價格(元):	660.0
交付時間:	付款后 1 個工作日

YY 0091-2013 Cervix dilator 1 Scope This standard specifies the structural types and materials, technical requirements, test methods, inspection rules, marking and packaging, and transportation and storage of cervix dilators. This standard is applicable to cervix dilators (hereinafter referred to as dilators), which are used for dilating the cervix in obstetrics and gynecology. This standard is not applicable to disposable cervix dilators. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB/T 1220 Stainless steel bars 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 3 Structural types and materials 3.1 The types, basic dimensions, and limit deviations of dilators shall meet the requirements of Figure 1 and Tables 1 and 2. 3.2 The dilators shall be made of copper materials as specified in GB/T 1527 or stainless steel materials as specified in GB/T 1220. Note: The handle may also have no holes. Figure 1 Cervix dilator ? Table 1 Basic dimensions of cervix dilators (round head) In: mm

Foreword I 1 Scope 2 Normative references 3 Structural types and materials 4 Technical requirements 5 Test methods 6 Inspection rules 7 Marking and packaging 8 Transportation and storage

子宮頸擴張器 1 范圍 本標準規(guī)定了子宮頸擴張器的結(jié)構(gòu)型式與材料、技術(shù)要求、試驗方法、檢驗規(guī)則、標志、包裝、運輸、貯存。 本標準適用于子宮頸擴張器(以下簡稱擴張器)，該產(chǎn)品供婦產(chǎn)科擴張子宮頸口用。 本標準不適用于一次性子宮頸擴張器。 2 規(guī)范性引用文件 下列文件對于本文件的應(yīng)用是必不可少的。凡是注日期的引用文件，僅注日期的版本適用于本文件。凡是不注日期的引用文件，其最新版本(包括所有的修改單)適用于本文件。 GB/T 1220不銹鋼棒 GB/T 1527銅及銅合金拉制管 GB/T 2828.1 計數(shù)抽樣檢驗程序 第1部分：按接收質(zhì)量限(AQL)檢索的逐批檢驗抽樣計劃 GB/T 2829 周期檢驗計數(shù)抽樣程序及表(適用于對過程穩(wěn)定的檢驗) GB/T 6463 金屬和其他無機物覆蓋層 厚度測量方法評述 GB/T 10610 產(chǎn)品幾何技術(shù)規(guī)范(GPS)表面結(jié)構(gòu) 輪廓法 評定表面結(jié)構(gòu)的規(guī)則和方法 YY 0076—1992 金屬制件的鍍層分類 技術(shù)條件 YY/T 0149-2006 不銹鋼醫(yī)用器械 耐腐蝕性能試驗方法 YY/T 0171—2008 外科器械 包裝、標志和使用說明書 YY/T 1052 手術(shù)器械標志 3 結(jié)構(gòu)型式與材料 3.1 擴張器的型式、基本尺寸及極限偏差應(yīng)符合圖1及表1、表2的規(guī)定。 3.2 擴張器應(yīng)選用GB/T 1527中規(guī)定的銅材料或選用GB/T 1220規(guī)定的不銹鋼材料制造。 標線 注：柄部也可無孔。 圖1 子宮頸擴張器 表1 子宮頸擴張器(圓頭)基本尺寸 單位為毫米 型式 規(guī)格 L L1 L2 b D SR R≈ H