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Glavni meni

ISO 8537:2016

Sterile single-use syringes, with or without needle, for insulin
21. 3. 2016.

Опште информације

90.93     11. 6. 2021.

ISO

ISO/TC 84

Međunarodni standard

11.040.25  

engleski   francuski  

Kupovina

Objavljen

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Apstrakt

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).

Životni ciklus

PRETHODNO

POVUČEN
ISO 8537:2007

TRENUTNO

OBJAVLJEN
ISO 8537:2016
90.93 Odluka o potvrđivanju standarda
11. 6. 2021.

REVIDIRAN OD

PROJEKAT
ISO/PWI 8537

Nacionalna preuzimanja

Sterilni špricevi za jednokratnu upotrebu, za insulin, sa iglom ili bez igle

60.60 Standard objavljen