BS EN ISO 7886-1:2018 ✓ Most Recent

BS EN ISO 7886-1:2018 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 .


Cross References:
ISO 23908:2011 Ed 1
ISO 15223-1:2016
ISO 80369-7:2016
ISO 14971:2007
ISO 8601:2004 Ed 3
ISO 384:2015
ISO 11607-2:2006 (R10) Ed 1
IEC 62366-1:2015
ISO 11607-1:2006 (R10) Ed 1
ISO 80369-20:2015
ISO 15223-2:2010 Ed 1
ISO 8537:2016
ISO 10993-1:2009
ISO 7864:2016


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