JIS T3304-2006 Sterile epidural needles for single use.pdf

T 3304：2006 （1） 目 次 1 適用範囲 適用範囲··········································································································································································1 2 引用規格 引用規格··········································································································································································1 3 用語及定義 用語及定義·································································································································································1 4 構成 構成··················································································································································································2 5 物理的要求事項 物理的要求事項·····························································································································································3 5.1 材料 材料···············································································································································································3 5.2 外観及清浄度 外観及清浄度··························································································································································4 5.3 潤滑剤量 潤滑剤量··································································································································································4 5.4 刃先 刃先···············································································································································································4 5.5 外針寸法許容差 外針寸法許容差··················································································································································4 5.6 外針針基合致 外針針基合致·········································································································································4 5.7 引抜強 引抜強··································································································································································5 5.8 漏 漏···············································································································································································5 5.9 弾性 弾性···············································································································································································6 5.10 曲強 曲強····································································································································································6 5.11 刃面 刃面································································································································································6 5.12 通過性 通過性 ···············································································································································6 5.13 （脊）髄膜下麻酔針 （脊）髄膜下麻酔針·······························································································································6 6 化学的要求事項 化学的要求事項·····························································································································································6 6.1 試験液調製 試験液調製······························································································································································6 6.2 抽出物酸限度 抽出物酸限度·································································································································7 6.3 溶出金属制限 溶出金属制限··························································································································································7 7 無菌性保証 無菌性保証·································································································································································7 8 生物学的安全性 生物学的安全性·····························································································································································7 9 試験 試験·····················································································································································7 9.1 硬膜外針 硬膜外針 ······································································································································································7 9.2 （脊）髄膜下麻酔針 （脊）髄膜下麻酔針·································································································································7 10 製造販売業者情報提供 製造販売業者情報提供··································································································································7 11 包装 包装················································································································································································8 11.1 一次包装 一次包装·····································································································································································8 11.2 二次包装 二次包装·····································································································································································8 12 表示 表示················································································································································································8 12.1 一次包装 一次包装····································································································································································8 12.2 二次包装 二次包装····································································································································································8 13 記号使用 記号使用···································································································································································8 免费标准下载网( w w w . f r e e b z . n e t ) 免费标准下载网( w w w . f r e e b z . n e t ) 无需注册, 即可下载 T 3304：2006 （2） 規格，工業標準化法第 12 条第 1 項規定基，日本医療器材工業会(JMED)及財団法人日 本規格協会(JSA)，工業標準原案具日本工業規格制定申出，日本工業標準調 査会審議経，厚生労働大臣制定日本工業規格。規格，著作権法保護対象 著作物。 規格一部，技術的性質特許権，出願公開後特許出願，実用新案権，又出願公開後 実用新案登録出願抵触可能性注意喚起。厚生労働大臣及日本工業標準調査会 ，技術的性質特許権，出願公開後特許出願，実用新案権，又出願公開後実用新 案登録出願確認，責任。 免费标准下载网( w w w . f r e e b z . n e t ) 免费标准下载网( w w w . f r e e b z . n e t ) 无需注册, 即可下载 日本工業規格 JIS T 3304：2006 硬膜外針 Sterile epidural needles for single use 1 適用範囲適用範囲 規格，留置又麻酔薬若鎮痛薬投与用鋭利先端滅菌済 器具，直使用，1 回限使用使捨（脊）髄膜下硬膜外針 （以下，硬膜外針。 ）規定。 2 引用規格引用規格 次掲規格，規格引用，規格規定一部構成。 引用規格， 西暦年付記， 記載年版適用， 後改正版 （追 補含。 ）適用。西暦年付記引用規格，最新版（追補含。 ）適用。 JIS G 4305 冷間圧延鋼板及鋼帯 JIS G 4314 用鋼線 JIS T 0307 医療機器医療機器，及供給情報用図記号 JIS T 0993-1 医療機器生物学的評価第 1 部：評価及試験 JIS T 3308 （脊）髄膜下麻酔針 JIS T 3210 滅菌済注射筒 ISO 594-1, Conical fitting with a 6%(Luer)taper for syringes,needles and certain other medical equipment Part1:General requirements ISO 594-2, Conical fitting with 6%(Luer) taper for syringes, needles and certain other medical equipment Part2:Lock fittings ISO 9626, Stainless steel needle tubing for manufacture of medical devices 3 用語及定義用語及定義 規格用主用語及定義，次。 3.1 外針外針 持続的麻酔薬鎮痛薬投与硬膜外（腔）留置又硬膜外（腔） ， 膜下（腔） ，若仙骨管麻酔薬鎮痛薬投与目的（穿）刺挿入設計 ，単（腔）針管。針管表面目安目盛付。 3.2 免费标准下载网( w w w . f r e e b z . n e t ) 免费标准下载网( w w w . f r e e b z . n e t ) 无需注册, 即可下载 2 T 3304：2006 （穿） 刺挿入時， 外針内 （腔） 体組織侵入防止目的， 外針内（腔） 挿入，硬膜外（腔）達，外針簡単引抜器具。， 硬膜外針備必要。 3.3 外針針基外針針基 外針刃先反対側，注射筒等接続接合若接着金属製又樹脂製部 品。 3.4 引抜目的， 刃先反対側取付指部品。 3.5 翼翼（） （穿）刺挿入外針押進部品。外針針基一体性取外 。 3.6 公称外径公称外径 硬膜外針包装又容器表示外針外径寸法。 3.7 公称長公称長 硬膜外針包装又容器表示外針長寸法。 3.8 精製水精製水 日本薬局方第二部医薬品各条規定“精製水”，又同等以上水。 3.9 試験用水試験用水 日本薬局方第二部医薬品各条規定“注射用水”又他方法製造水， 試験用(LAL)試薬検出限界反応示。 3.10 一次包装一次包装 硬膜外針直接覆包装，硬膜外針無菌性保持，更，二次包装 場合，“内袋”該当。 3.11 二次包装二次包装 一次包装直接覆包装，通常，複数一次包装硬膜外針，例，50 本入包装。 4 構成構成 硬膜外針，主外針，外針針基，翼，及構成（図図 1 参照） 。， （脊）髄膜下麻酔針附属，又（脊）髄膜下麻酔針組込 。，硬膜外針先端（脊）髄膜下麻酔針出専用穴（図図 3 参照） 。 免费标准下载网( w w w . f r e e b z . n e t ) 免费标准下载网( w w w . f r e e b z . n e t ) 无需注册, 即可下载 3 T 3304：2006 図図 1，2，3 一般的硬膜外針一例，図図 4，5 一般的（脊）髄膜下麻酔針一例示。 ，針（鞘）附属。針（鞘），使用前後術者刃先身体誤刺保護 ，外針針基（嵌）合。 翼 目盛外針 外針針基 針（鞘） 図図 1硬膜外針各部名称硬膜外針各部名称 刃面 先端 図図 2硬膜外針刃先例硬膜外針刃先例 専用穴 図図 3専用穴例（硬膜外針刃先断面）専用穴例（硬膜外針刃先断面） 外針針基 内針 針（鞘） 外針 図図 4（脊）髄膜下麻酔針例（脊）髄膜下麻酔針例 免费标准下载网( w w w . f r e e b z . n e t ) 免费标准下载网( w w w . f r e e b z . n e t ) 无需注册, 即可下载 4 T 3304：2006 図図 5（脊）髄膜下麻酔針刃先形状例（脊）髄膜下麻酔針刃先形状例 5 物理的要求事項物理的要求事項 5.1 材料材料 外針材料，JIS G 4305 規定 SUS304，SUS304L 若 SUS321，又 ISO 9626 材料項 適合鋼。，材料，JIS G 4314 規定 SUS304， SUS304N1 若 SUS316，JIS G 4305 規定 SUS304，SUS304L，SUS321，又 ISO 9626 材料 項適合鋼合成樹脂接合。，合成樹脂。 外針潤滑剤油用場合，油，油基準（）， 油基準（）又同等以上基準適合。 注記注記 油基準， 平成 7 年 12 月 20 日薬機第 327 号厚生省薬務局医療機器開発課長通知 “注 射針及注射筒等潤滑剤用油基準”。 5.2 外観及清浄度外観及清浄度 外観及清浄度，次。 a) 目視検査，外針，外針針基，翼及外面，凹凸及， 仕上面滑，表面微粒子又異物付着。 b) 目視検査，外針内面，有害酸化物，切粉微粒子又異物付着， 欠点。，針基内面微粒子又異物付着 。 c) 目視検査，外針目盛又付，明確目盛又識別 。 d) 目視検査，外針真，正常切断面及厚。 5.3 潤滑剤量潤滑剤量 潤滑剤量，外針表面液滴認，内面認量。 5.4 刃先刃先 刃先，次。 a) 刃先，鋭利研磨，目視分欠点。， （脊）髄膜下麻酔針附属，又（脊）髄膜下麻酔針組込 ，（脊）髄膜下麻酔針先端刃面又専用穴出入 。 b) 刃先，外針合防止構造。 注記注記 留置，刃先出，方向 刃先形作。 5.5 外針寸法許容差外針寸法許容差 外針寸法許容差，次。 a) 外針公称外径対許容差， 8 3 + 。 b) 外針公称長対許容差， 10 mm 以下±20 ， 20 mm 未満±8 ， 20 mm 免费标准下载网( w w w . f r e e b z . n e t ) 免费标准下载网( w w w . f r e e b z . n e t ) 无需注册, 即可下载 5 T 3304：2006 以上 40 mm 未満±7 ，40 mm 以上 60 mm 未満±5 ，及 60 mm 以上 ±3 。 5.6 外針針基合致外針針基合致 図図 6 ISO 594-1 規定（雄）検査使用構造硬膜外針，外 針針基 5 N 力入，外針針基穴（雌）合 致，外針針基先端，限度内。，図図 6 示検査使用構 造硬膜外針（接合），ISO 594-2 規定検査用。 単位 mm 4.270 0 0.005 4.315 0.01 0 0.75 0 0.01 7.25 0.005 0 3.880 6/100 図図 6（雄） 検査（雄） 検査 5.7 引抜強引抜強 外針公称外径応，外針中心軸方向表表 1 力引張，外針外針針基引抜 。 表表 1引抜強引抜強 外針公称外径 （mm） 力 （N） 0.3 0.33 0.36 0.4 0.45 0.5 0.55 0.6 0.65 0.7 0.8 0.9 1.1 1.2 超 22 22 22 22 22 22 34 34 34 40 44 54 69 69 5.8 漏漏 次方法試験，適合。 免费标准下载网( w w w . f r e e b z . n e t ) 免费标准下载网( w w w . f r e e b z . n e t ) 无需注册, 即可下载 6 T 3304：2006 a) 第第 1 法 法 取外硬膜外針 JIS T 3210 適合注射筒筒先 27.5 N 力 合。少。吸子 5 mL 目盛合，針先端栓刺 ，刃先空気漏後，刃先針基水中没。吸子 2 mL 目盛 押，15 秒間観察，針針基接合部，又針基試験用注射筒筒先合部 連続気泡発生認。 b) 第第 2 法 法 取外硬膜外針針基，水圧試験装置取付 ，27.5 N 力合。少。次針先端栓刺，刃先 水漏後，0.2 MPa 圧水送込，15 秒間観察，針針基 合部，水滴落水漏認。 5.9 弾性弾性 外針公称外径（図図 7 D） 1.0 mm 以下，図図 7 外針先端一点 A 25 D2 離 外針上点 B 固定，A 力加，8 度曲 1 分間保後，放目視，外針， 元位置戻。 ° 図図 7弾性弾性 5.10 曲強曲強 外針公称外径 1.0 mm 以下，公称長 12 mm 以上，図図 8 外針 5 mm 曲率 半径 90 度曲，折。 図図 8曲強曲強 5.11 刃面刃面 外針，体内（穿）刺状態，外針刃面向分外針針基，若翼形 状，構造又外針針基，若翼印付。 5.12 通過性通過性 外針内（腔）通，外針内（腔）通 。 5.13 （脊）髄膜下麻酔針（脊）髄膜下麻酔針 （脊）髄膜下麻酔針 JIS T 3308 箇条 5（物理的要求事項） 5.1（材料） ，5.2（外観及清 針 基 外 針 免费标准下载网( w w w . f r e e b z . n e t ) 免费标准下载网( w w w . f r e e b z . n e t ) 无需注册, 即可下载 7 T 3304：2006 浄度） ，5.3（刃先） ，5.4（内針） ，5.5（外針寸法許容差） ，5.6（外針針基合致） ，5.7（引抜 強） ，5.8（漏） ，5.9（弾性） ，5.10（曲強）及 5.11（刃面）適合。 6 化学的要求事項化学的要求事項 6.1 試験液調製試験液調製 6.1.1 硬膜外針用試験液硬膜外針用試験液 25 本硬膜外針，及取除状態，酸適切容 器入，250 mL 精製水浸漬。針全表面針管内側含，水接触。 3 0 37+ 60±2分間保後，針取除，針内外面水容器戻試験液 。針入同様操作対照溶液調製。 6.1.2 （脊）髄膜下麻酔針用試験液（脊）髄膜下麻酔針用試験液 （脊）髄膜下麻酔針附属又組込，JIS T 3308 箇条 6（化学的要求事 項） 6.1.1（脊）髄膜下麻酔針用試験液従試験液及対照溶液調製。 6.2 抽出物酸限度抽出物酸限度 試験液pH値，pH電極用測定，対照溶液pH値差1以内 。 6.3 溶出金属制限溶出金属制限 試験液及対照溶液原子吸光光度法一般的認微量分析法分析，対照溶液 分析値差引補正試験液鉛，亜鉛，及鉄合計含量5 mg/L以下， 含量，0.1 mg/L以下。 7 無菌性保証無菌性保証 滅菌基準又同等以上基準基，無菌性担保行。 注記注記 滅菌基準，平成17年3月30日付薬食監麻発第0330001号“薬事法及採 血及供血業取締法一部改正法律施行伴医薬品，医療機器等製造管 理及品質管理（GMP/QMS）係省令及告示制定及改廃 第四章第滅 菌基準”。 8 生物学的安全性生物学的安全性 JIS T 0993-1 規定生物学的安全性評価行。 9 試験試験 9.1 硬膜外針硬膜外針 硬膜外針10本，引抜，外針及同硬質容器入， 試験用水30 mL加，融封又適切栓密封振混後，室温1時間放 置，液試験液。試験液調製方法検体全体試験用水浸漬場合，硬膜 外針10本，引抜，各管内試験用水40 mL1分間約10 mL 速流，液外針及洗，洗液合試験液。試験液 ，日本薬局方試験法試験行，0.5 EU/mL未満。 9.2 （脊）髄膜下麻酔針（脊）髄膜下麻酔針 免费标准下载网( w w w . f r e e b z . n e t ) 免费标准下载网( w w w . f r e e b z . n e t ) 无需注册, 即可下载 8 T 3304：2006 （脊）髄膜下麻酔針附属又組込，（脊）髄膜下麻酔針，JIS T 3308 箇条 9（） 9.1（脊）髄膜下麻酔針適合。 10 製造販売業者情報提供製造販売業者情報提供 製造販売業者，外針内（腔）通，適切情報添付文書 情報提供。 11 包装包装 11.1 一次包装一次包装 一次包装，微生物侵入防止，通常取扱，輸送及保管中内容製品損傷 包装。一次包装，一度開封再，開封明確分 。 11.2 二次包装二次包装 二次包装，通常取扱，輸送及保管中内容製品保護強度。 12 表示表示 12.1 一次包装一次包装 一次包装，次事項表示。 a) 外針外径(mm)及長(mm) b) “滅菌済”旨 c) 製造番号又製造記号 1) 12.2 二次包装二次包装 二次包装，次事項表示。，二次包装用，一次包装最小販売単位包装 用場合，次事項一次包装表示。 a) 製造販売業者氏名又名称，及住所 b) 承認番号 c) 販売名 d) 外針外径(mm)及長（mm） e) 数量（入数） f) “滅菌済”旨 g) “再使用禁止”旨（“”表現除。） h) 製造番号又製造記号 1) i) 滅菌年月 1) 注注 1) 製造番号又製造記号滅菌年月表場合， 改滅菌年月表示必要。 ，滅菌年月代使用期限表示。 13 記号使用記号使用 12.1 及 12.2 要件， JIS T 0307 規定適切記号使用替。 注記注記 JIS T 0307 規定主記号例，参考表参考表 1 示。 免费标准下载网( w w w . f r e e