Sprutor, kanyler och katetrar

Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 27 jul 2019
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This part of ISO 10555 specifies requirements, performance, and user safety issues related to

subcutaneous implanted ports and catheters for intravascular long-term use supplied in sterile condition

and intended for single use.

This part of ISO 10555 does not specify requirements, performance, and user safety issues related to

non-coring needles.

NOTE Subcutaneous implanted ports are known to be used for indications other than intravascular such as

intra-peritoneal, intra-thecal, intra-pleural, and epidural access.

Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 31 jul 2019
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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.

Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 31 jul 2019
Se merSe mindre
 

This part of ISO 7886 specifies the properties and performance of sterile single-use hypodermic syringes with or without needle, made of plastic or other materials and intended for the filling and the injection of vaccines immediately after filling. Upon commencement of injection of a nominal fixed dose of vaccine, the auto-disable feature of the syringe is passively activated so that the syringe cannot be reused.

This part of ISO 7886 does not specify the design of the auto-disable feature, which is left to the discretion of the manufacturer.

This part of ISO 7886 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 under ISO 11040- series.