ISO 7886-1:2017

Sterile hypodermic syringes for single use — Part 1: Syringes for manual use

Sterile hypodermic syringes for single use — Part 1: Syringes for manual use

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Referenced standards

IEC 62366-1:2015ISO 10993-1:2009ISO 11607-1:2006ISO 11607-2:2006ISO 14971:2007ISO 15223-1:2016ISO 15223-2:2010ISO 23908:2011ISO 384:2015ISO 7864:2016ISO 80369-20:2015ISO 80369-7:2016ISO 8537:2016ISO 8601:2004
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ISO 7886-1:2017

Sterile hypodermic syringes for single use — Part 1: Syringes for manual use

Sterile hypodermic syringes for single use — Part 1: Syringes for manual use

ISO 7886-1:2017 specifies requirements and test methods for verifying the design of empty sterile single-use hypodermic syringes, with or without needle, made of plastic or other materials and intended for the aspiration and injection of fluids after filling by the end-users. This document does not provide requirements for lot release. The syringes are primarily for use in humans.

Sterile syringes specified in this document are intended for use immediately after filling and are not intended to contain the medicament for extended periods of time.

It excludes syringes for use with insulin (see ISO 8537), single-use syringes made of glass, syringes for use with power-driven syringe pumps, syringes pre-filled by the manufacturer, and syringes intended to be stored after filling (e.g. in a kit for filling by a pharmacist).

Hypodermic syringes without a needle specified in this document are intended for use with hypodermic needles specified in ISO 7864.

Edition2017
Standard Part No1
Published Date2017
Published ByInternational Standardization Organisation
Page Count28