Nezařazeno

Oblast zaměření: Nezařazeno
Komise : CEN/TC 205 (Non-active medical devices)
Původce: CEN
K připomínkám do: 9.07.2019
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This document specifies the properties and performance of sterile single-use hypodermic syringes with or without needle, made of plastic, rubber or other materials and intended for the filling and the injection of vaccines immediately after filling. Upon delivering a fixed dose of vaccine, the syringe is automatically rendered unusable.

This document does not specify the design of the auto-disable feature, which is left to the discretion of the manufacturer.

This document is not applicable to syringes for use with insulin (specified in ISO 8537), syringes for use with power-driven syringe pumps (specified in ISO 7886‑2), reuse prevention syringes (specified in ISO 7886‑4) and syringes designed to be prefilled. It does not address compatibility with injection fluids/vaccines.

NOTE          Prefilled syringes are covered in the ISO 11040‑ series.

Oblast zaměření: Nezařazeno
Komise : CEN/TC 205 (Non-active medical devices)
Původce: CEN
K připomínkám do: 9.07.2019
Zobraz více Zobraz méně
 

This document specifies requirements for sterile single-use hypodermic syringes of nominal capacity 1 ml and above, made of plastic materials and intended for use with power-driven syringe pumps.

This document does not apply to syringes for use with insulin (specified in ISO 8537[2]), single-use syringes made of glass, syringes prefilled with the injection by the manufacturer and syringes supplied with the injection as a kit for filling by a pharmacist. It does not address compatibility with injection fluids.