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中华人民共和国医药行业标准

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医用缝合针

1991-08-19发布 1991-10-01实施

国家医药管理局 发布

中华人民共和国医药行业标准

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医用缝合针

1 主题内容与适用范围

本标准规定了医用缝合针(以下简称缝合针)的产品分类、技术要求、试验方法、检验规则、标志、包装、运输、贮存等要求。

本标准适用于医用圆、三角普通孔及弹机孔缝合针，该产品供缝合内脏、软组织、皮肤等用。

2 引用标准

GB 191 包装储运图示标志

GB 2828 逐批检查计数抽样程序及抽样表(适用于连续批的检查)

GB 4342 金属显微维氏硬度试验方法

GB 10563 医用缝合针钢丝

3 产品分类

缝合针的型式和基本尺寸及极限偏差应符合下列图样及表1和表2的规定。

[图片]

圆直                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                &

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[图片]

圆 3/8 弧

三角 3/8 弧

[图片]

短刃三角 1/2 弧

短刃三角 3/8 弧

[图片]

反三角 3/8 弧

三角半弯

[图片]

普通孔(A)

弹机孔(B)

续图

型式、规格代号示例：

a. D=0.4 mm, L=12 mm, 圆 3/8 弧

普通孔缝合针型式规格代号为：圆 3/8A · 4×12

弹机孔缝合针型式规格代号为：圆 3/8B · 4×12

b. D=0.4 mm, L=10 mm, 三角 1/2 弧