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NF EN ISO 8537:2008现行

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

出版：Association Francaise de Normalisation

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基本信息

标准编号： NF EN ISO 8537:2008

发布时间：2008/10/1 0:00:00

标准类别：Standard

出版单位：Association Francaise de Normalisation

标准页数：31

标准简介

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.

标准备注

Indice de classement: S93-005. Supersedes NFS 93 005. (03/2004) PR NF EN ISO 8537 April 2008. (04/2008)

本标准替代的旧标准

NFS 90 019:1981

NF EN ISO 8537:1994

等同采用的国际标准

SN EN ISO 8537:1995 - Identical

I.S. EN ISO 8537:2008 - Identical

EN ISO 8537:2008 - Identical

NEN EN ISO 8537:2008 - Identical

ONORM EN ISO 8537:2008 - Identical

SS EN ISO 8537 Ed. 2 (2008) - Identical