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1、ICS11.040.40C35YY中華人民共和國(guó)醫(yī)藥行業(yè)標(biāo)準(zhǔn)YY0117.3-2005代替YY0117.3-1993外科植入物骨關(guān)節(jié)假體鍛、鑄件鉆鉻鑰合金鑄件Implantsforsurgery-Forgings,castingsforbonejointprostheses-Cobaltchromiummolybdenumalloycastings2005-12-07發(fā)布2006-12-01實(shí)施國(guó)家食品藥品監(jiān)督管理局發(fā)布YY0117.3-2005目次月U舀········································
2、··········································································??皿1范圍···············································································································??12規(guī)范性引用文件··········································.·........................
3、......·....·..........??13要求···············································································································??14試驗(yàn)方法····················??八··········································································??25檢驗(yàn)規(guī)則··················
4、······················，····························································??26質(zhì)量證明·········································································································??37標(biāo)志、包裝、運(yùn)輸、貯存···························································
5、·······························??4附錄A(規(guī)范性附錄)關(guān)于外科植人物—骨關(guān)節(jié)假體鉆鉻鑰合金鑄件缺陷補(bǔ)焊的專項(xiàng)要求?5YY0117.3-2005nil舌YY0117的總標(biāo)題為《外科植人物骨關(guān)節(jié)假體鍛、鑄件》，由下列幾部分組成:—第1部分:Ti6A14V欽合金鍛件;—第2部分:ZTi6A14V欽合金鑄件;—第3部分:鉆鉻鑰合金鑄件。本部分在原YY0117.3-1993(外科植人物骨關(guān)節(jié)假體鍛、鑄件鉆鉻鋁合金鑄件)}行業(yè)標(biāo)準(zhǔn)基礎(chǔ)上進(jìn)行修訂。本部分對(duì)YY0117.3-1993所做的修改包括:—?jiǎng)h除“鍛件分類”
6、章節(jié);—材料的化學(xué)成分和力學(xué)性能的要求及其實(shí)驗(yàn)方法執(zhí)行新版的國(guó)際標(biāo)準(zhǔn)和國(guó)家標(biāo)準(zhǔn);—檢驗(yàn)規(guī)則更加細(xì)化;—對(duì)某些章節(jié)的編排做了相應(yīng)調(diào)整。本部分主要根據(jù)國(guó)際標(biāo)準(zhǔn)ISO5832-4;1996(外科植人物—金屬材料—第4部分:鑄造鉆鉻鋁合金》進(jìn)行修訂，在化學(xué)成分、力學(xué)性能、技術(shù)指標(biāo)上等同該國(guó)際標(biāo)準(zhǔn)。本部分附錄A為規(guī)范性附錄。本部分代替YY0117.3-1993《外科植人物骨關(guān)節(jié)假體鍛、鑄件鉆鉻鑰合金鑄件》。本部分由國(guó)家食品藥品監(jiān)督管理局提出。本部分由全國(guó)外科植人物和矯形器械標(biāo)準(zhǔn)化技術(shù)委員會(huì)(SAC/TC110)歸口。本部分起草單位:北京百慕航材
7、高科技股份有限公司。本部分主要起草人:周學(xué)玉、劉忠良、江霞、丁致平Y(jié)Y0117.3-2005外科植入物骨關(guān)節(jié)假體鍛、鑄件鉆鉻鑰合金鑄件范圍本部分規(guī)定了外科植人物用鉆一鉻一鋁合金材料制造外科植人物骨關(guān)節(jié)假體鑄件的要求、試驗(yàn)方法、檢驗(yàn)規(guī)則、質(zhì)量證明、標(biāo)志和包裝等。本部分適用于骨關(guān)節(jié)假體鉆鉻鑰合金鑄件的生產(chǎn)和驗(yàn)收。2規(guī)范性引用文件下列文件中的條款通過(guò)本部分的引用而成為本部分的條款。凡是注明日期的引用文件，其隨后所有的修改單(不包括勘誤的內(nèi)容)或修訂版均不適于本部分，然而，鼓勵(lì)根據(jù)本部分達(dá)成協(xié)議的各方研究是否可使用這些文件的最新版本。凡是不注
8、明日期的引用文件，其最新版本適用于本部分。GB/T223鋼鐵及合金化學(xué)分析方法GB/T228金屬材料室溫拉伸試驗(yàn)方法(GB/T228-2002,egvISO6892;1998)GB17100外科植人物用鑄造鉆鉻鋁合金(G
