DB43-T 2622-2023 醫(yī)療導(dǎo)管標(biāo)識管理規(guī)范

ICS

01.070CCS

C

43湖 南 省 地 方 標(biāo)準(zhǔn)DB43/T

2622—2023醫(yī)療導(dǎo)管標(biāo)識管理規(guī)范Managementspecificationformarkingmedicalcatheters2023

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05

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29

發(fā)布

2023

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實施湖南省市場監(jiān)督管理局

發(fā)

布DB43/T

—前言························································································································

Ⅲ1

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12

規(guī)范性引用文件······································································································13

術(shù)語和定義············································································································14

縮略語··················································································································

25

醫(yī)療導(dǎo)管標(biāo)識要求···································································································25.1導(dǎo)管標(biāo)識分類與醫(yī)療導(dǎo)管安全分級

···········································································35.2 導(dǎo)管標(biāo)簽紙·········································································································46

··························································································

4附錄

A（資料性） 醫(yī)療導(dǎo)管風(fēng)險分級專家推薦建議···························································

5參考文獻····················································································································

7DB43/T

—本文件按照

GB/T

—《標(biāo)準(zhǔn)化工作導(dǎo)則第

1

部分：標(biāo)準(zhǔn)化文件的結(jié)構(gòu)和起草規(guī)則》的規(guī)定起草。請注意本文件的某些內(nèi)容可能涉及專利。本文件的發(fā)布機構(gòu)不承擔(dān)識別專利的責(zé)任。本文件由湖南省衛(wèi)生健康委員會提出并歸口。醫(yī)院、中南大學(xué)湘雅三醫(yī)院本文件主要起草人：張靜平、李映蘭、李樂之、孫向明、黃艷萍、向琴、何勁、岳麗趙婷。IIIDB43/T

—1

本文件規(guī)定了醫(yī)療導(dǎo)管標(biāo)識、使用及管理要求。本文件適用于各級各類醫(yī)療機構(gòu)的醫(yī)療導(dǎo)管臨床使用或管理活動。2

規(guī)范性引用文件本文件沒有規(guī)范性引用文件。3

術(shù)語和定義下列術(shù)語和定義適用于本文件。3.1醫(yī)療導(dǎo)管

或輸出作用，屬于醫(yī)療器械。3.2醫(yī)療導(dǎo)管標(biāo)識

catheter

identification置導(dǎo)管風(fēng)險管理做的標(biāo)記識別。3.3醫(yī)療導(dǎo)管安全分級

catheter

security

際情況進行分級。3.4安全識別字符

characters3.5基本色 fundamental

區(qū)分醫(yī)療導(dǎo)管附屬物標(biāo)識基本底色，顏色為白色。3.6分類色

區(qū)分醫(yī)療導(dǎo)管類別的顏色，包括紅、藍(lán)、黃、綠四色（見圖

1吸類、黃色代表排泄類、綠色代表引流類。DB43/T

—圖

1分類色4

縮略語下列縮略語適用于本文件。CVC：中心靜脈導(dǎo)管（

Venous

Catheter）PICC：經(jīng)外周靜脈置入中心靜脈導(dǎo)管（

Inserted

Central

Catheter）IABP:主動脈內(nèi)球囊反搏（Intra-Aortic

）ECMO:體外膜肺氧合（Extracorporeal

Membrane

）5

醫(yī)療導(dǎo)管標(biāo)識要求5.1 導(dǎo)管標(biāo)識分類與醫(yī)療導(dǎo)管安全分級5.1.1 動、靜脈類導(dǎo)管動、靜脈類導(dǎo)管標(biāo)識采用紅框白底黑字。動、靜脈類導(dǎo)管一般包括氣囊漂浮導(dǎo)管、動脈導(dǎo)管、IABP

導(dǎo)管、

導(dǎo)管、ECMO

導(dǎo)管、靜脈留置針、動脈留置針、臨時起搏器導(dǎo)管等。動、靜脈類導(dǎo)管具體安全分級根據(jù)患者實際情況進行（可參考資料性附錄

A

2

所示。圖

2 動、靜脈類導(dǎo)管標(biāo)識示例圖5.1.2 呼吸類導(dǎo)管呼吸類導(dǎo)管采用藍(lán)框白底黑字。呼吸類導(dǎo)管一般包括氣管導(dǎo)管、呼吸機管路、吸氧管等。呼吸類導(dǎo)管具體安全分級根據(jù)患者實際情況進行（可參考資料性附錄

A

3

所示。DB43/T

—圖

3呼吸類導(dǎo)管標(biāo)識示例圖5.1.3 排泄類導(dǎo)管排泄類導(dǎo)管采用黃框白底黑字。排泄類導(dǎo)管一般包括導(dǎo)尿管、膀胱造瘺管、腸造瘺管等。排泄類導(dǎo)管具體安全分級根據(jù)患者實際情況進行（可參考資料性附錄

A“高”、“中”、“低”表示，如圖

4

所示。圖

4 排泄類導(dǎo)管標(biāo)識示例圖5.1.4 引流類導(dǎo)管引流類導(dǎo)管采用綠色邊框白底黑字。引流類導(dǎo)管一般包括蛛網(wǎng)膜下隙持續(xù)引流管、腦室引流管、硬膜外/下引流管、鼻胃管、鼻腸管、T

/下引流管、肝斷面引流管、文氏引流管、膈下引流管、盆腔引流管、腰大池引流管、切口引流管、傷口引流管、皮下引流管等。引流類導(dǎo)管具體安全分級根據(jù)患者實際情況進行（可參考資料性附錄

A“高”、“中”、“低”表示，如圖

5

所示。DB43/T

—圖

5 引流類導(dǎo)管標(biāo)識示例圖5.1.5 導(dǎo)管附屬物導(dǎo)管附屬物采用白底黑字，導(dǎo)管附屬物包含引流瓶、引流袋、敷貼等，如圖

6

所示。圖

6 導(dǎo)管附屬物標(biāo)識示例圖5.2 導(dǎo)管標(biāo)簽紙5.2.1 紙張要求紙張應(yīng)符合以下要求：a）

不易卷邊，不易破損和磨損；b）

防水、防油、防酒精。5.2.2 標(biāo)識信息為厘米（cm）。6

6.1 應(yīng)按照分類標(biāo)準(zhǔn)進行標(biāo)識，正確使用對應(yīng)顏色的標(biāo)識貼及安全識別字符。6.2

嚴(yán)格執(zhí)行查對制度，對標(biāo)識內(nèi)容進行核查，標(biāo)識信息內(nèi)容須完整無誤，導(dǎo)管標(biāo)識出現(xiàn)破損或字