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UNI EN ISO 8537:1995被替代

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

出版：Italian Standards

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基本信息

标准编号： UNI EN ISO 8537:1995

标准类别：Standard

出版单位：Italian Standards

标准页数：0

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

1995 Edition re-issued in April 2001 and incorporates AMD 1 2001. (10/2008)

替代本标准的新标准

UNI EN ISO 8537:2008

等同采用的国际标准

NEN EN ISO 8537:1994 - Identical

DIN EN ISO 8537 (2008-10) - Identical

NF EN ISO 8537:2008 - Identical

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

ONORM EN ISO 8537:2008 - Identical

NEN EN ISO 8537:2008 - Identical

EN ISO 8537:2008 - Identical