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ISO 8537:2016
Sterile single-use syringes, with or without needle, for insulin
General information
Buying
Published
Scope
ISO 8537:2016 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.
ISO 8537:2016 excludes single-use syringes made of glass, syringes for use with power-driven 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).
Life cycle
PREVIOUSLY
WITHDRAWN
ISO 8537:2007
NOW
PUBLISHED
ISO 8537:2016
90.93
Standard confirmed
Jun 11, 2021
REVISED BY
PROJECT
ISO/PWI 8537
National adoptions
Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)
60.60 Standard published