ISO 8537

Sterile single-use syringes, with or without needle, for insulin
Sterile Single-Use Syringes, with or without Needle, for Insulin
Sterile Single-Use Syringes, with or without Needle, for Insulin
STERILE SINGLE-USE SYRINGES, WITH OR WITHOUT NEEDLE, FOR INSULIN
Sterile Single-Use Syringes, with or without Needle, for Insulin First Edition; (CEN EN ISO 8537: 1994)

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Publication Date: 03/15/2016 - Complete Document *

Description :

This International Standard specifies requirements and test methods for empty, sterile, single-use syringes, with or without needles, made of plastic materials and intended solely for the injection of insulin, with which the syringes are filled by the end user. This International Standard covers syringes intended for single-use only in humans and with insulins of various concentrations.

The insulin syringes specified in this International Standard are intended for use (i.e. insulin injection) immediately after filling and are not intended to contain insulin for extended periods of time.

This International Standard excludes single-use syringes made of glass, syringes for use with powerdriven syringe pumps, syringes that are pre-filled by the manufacturer, and syringes intended to be stored after filling (e.g. in a kit intended for filling by a pharmacist).

Document Type : Complete Document

Edition : Third Edition

Language : English

Page Count : 34

Publication Date : 03/15/2016

Revision : 3RD

Status : Current

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

Publication Date: 10/01/2007 - Complete Document *

Description :

This International Standard 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).

Sterile syringes specified in this International Standard are intended for use soon after filling as they are not suitable for containing insulin over extended periods of time.

Document Type : Complete Document

Edition : Second Edition

Language : English

Page Count : 33

Publication Date : 10/01/2007

Revision : 2ND

Status : Historical

Title : Sterile Single-Use Syringes, with or without Needle, for Insulin

Publication Date: 05/01/1991 - Complete Document *

Description :

This International Standard specifies requirements and test methods for sterile syringes with or without needles intended for single use solely for the injection of insulin and primarily in humans. It covers syringes for use with 40 units of insulin/ml (U-40) and 100 units of insulin/ml (U-100).

Sterile syringes specified in this International Standard are intended for use soon after filling as they are not suitable for containing insulin over extended periods of time.

Document Type : Complete Document

Edition : First Edition; Amendment 1: 11/01/2000

Language : English

Page Count : 33

Publication Date : 05/01/1991

Revision : 1ST

Status : Historical

Title : Sterile Single-Use Syringes, with or without Needle, for Insulin

Publication Date: 11/01/2000 - Amendment

Document Type : Amendment

Page Count : 7

Publication Date : 11/01/2000

Revision : 1ST

Status : Historical

Title : STERILE SINGLE-USE SYRINGES, WITH OR WITHOUT NEEDLE, FOR INSULIN

Publication Date: 01/01/1991 - Base Document

Document Type : Base Document

Language : English

Page Count : 27

Publication Date : 01/01/1991

Revision : 1ST

Status : Historical

Title : Sterile Single-Use Syringes, with or without Needle, for Insulin First Edition; (CEN EN ISO 8537: 1994)