Standard Svensk standard · SS-EN ISO 8537:2016

Sterila insulinsprutor för engångsbruk, med eller utan kanyl (ISO 8537:2016)

Status: Gällande

Omfattning
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 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).

Ämnesområden

Utrustning för transfusion, infusion och injektion (11.040.20) Sprutor, kanyler och katetrar (11.040.25)


Produktinformation

Språk: Engelska

Framtagen av: Förbrukningsmaterial inom sjukvården, SIS/TK 330

Internationell titel: Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)

Artikelnummer: STD-8020033

Utgåva: 3

Fastställd: 2016-04-18

Antal sidor: 48

Ersätter: SS-EN ISO 8537:2008