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National standards and national normative documents

Publication date

October 1994

Number of pages

30 p.

Reference

NF EN ISO 8537

ICS Codes

11.040.25 Syringes, needles and catheters

Classification index

S93-005

Print number

1 - 01/10/1994

International kinship

ISO 8537:1991

European kinship

EN ISO 8537:1994

Replaced standards (1)

NF S90-019

January 1981

Standard Cancelled

Medical and surgical equipment. Plastic disposable sterile insulin syringes.

Standard replaced by (1)

NF EN ISO 8537

October 2008

Standard Cancelled

Sterile single-use syringes, with or without needle, for insulin

<p>ISO 8537:2007 specifies requirements and test methods for sterile syringes, with or without needles, solely for the injection of insulin. The syringes are single-use only, primarily for use in humans. It covers syringes for use with 40 units of insulin/ml (U-40) and 100 units of insulin/ml (U-100).</p> <p>Sterile syringes specified in ISO 8537:2007 are intended for use soon after filling as they are not suitable for containing insulin over extended periods of time.</p>

Table of contents

View the extract

1 Domaine d'application
1
2 Références normatives
1
3 Définitions et nomenclature
1
4 Types de seringues
3
5 Absence de matières étrangères
3
6 Teneurs limites en matières extractibles
3
7 Lubrification des seringues et des aiguilles
3
8 Gamme de dimensions
3
9 Échelle graduée
4
10 Corps
5
11 Ensemble tête du piston/piston
5
12 Embout
5
13 Aiguilles
5
14 Performances de la seringue montée
5
15 Emballage
6
16 Marquage
6
Annexe A Liquide pour la détermination de "l'acidité" ou de "l'alcalinité" et des métaux extractibles
9
Annexe B Méthode d'essai de détection, à l'aspiration, de fuites d'air au niveau de la tête du piston de la seringue
10
Annexe C Méthode d'essai pour la détermination de la force requise pour actionner le piston
12
Annexe D Propriétés des aiguilles dont le diamètre extérieur est inférieur à 0,45 mm
13
Annexe E Méthode d'essai pour la détermination de l'espace mort
14
Annexe F Vérification de l'absence de fuite de liquide lors de la compression au niveau du piston, des jonctions entre l'embout de la seringue et l'embase ou entre l'aiguille et le corps
15
Annexe G Méthode d'essai de détection, à l'aspiration, de fuites d'air au niveau des jonctions embout/embase ou aiguille/corps
17
Annexe H Préparation de la solution d'essai pour la vérification de l'absence de substances pyrogènes et de toxicité
18
Annexe J Symbole graphique "non réutilisable"
19

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