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UNE EN ISO 8537:2008被替代

Sterile Single-use Syringes, With Or Without Needle, For Insulin

出版：Asociacion Espanola de Normalizacion

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基本信息

標(biāo)準(zhǔn)編號(hào)： UNE EN ISO 8537:2008

發(fā)布時(shí)間：2008/12/22 0:00:00

標(biāo)準(zhǔn)類(lèi)別：Standard

出版單位：Asociacion Espanola de Normalizacion

標(biāo)準(zhǔn)頁(yè)數(shù)：32

標(biāo)準(zhǔn)簡(jiǎn)介

Describes requirements and test methods for sterile syringes with or without needles for single use solely for the injection of insulin in humans. Covers syringes for use with 40 units of insulin/ml and 100 units of insulin/ml. Intended for use soon after filling as they are not suitable for containing insulin over extended periods of time. Covers normative references, definitions and nomenclature, types of syringe, freedom from extraneous matter, limits for extractable matter, lubrication of syringes and needles, range of sizes, graduated scale, barrel, piston/plunger assembly, nozzle, needles, performance of assembled syringe packaging and marking.

標(biāo)準(zhǔn)備注

Supersedes UNE 53372. (09/2003)

本標(biāo)準(zhǔn)替代的舊標(biāo)準(zhǔn)

UNE 53372:1990

UNE EN ISO 8537:1995

替代本標(biāo)準(zhǔn)的新標(biāo)準(zhǔn)

UNE EN ISO 8537:2016

等同采用的國(guó)際標(biāo)準(zhǔn)

I.S. EN ISO 8537:2008 - Identical

BS EN ISO 8537:2008 - Identical

DIN EN ISO 8537 (2008-10) - Identical

NF EN ISO 8537:2008 - Identical