Utrustning för transfusion, infusion och injektion

Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 31 jan 2023
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This document specifies minimum requirements for concentrates used for haemodialysis and related therapies. This document is addressed to the manufacturer of such concentrates. In several instances in this document, the dialysis fluid is addressed, which is made by the end user, to help clarify the requirements for manufacturing concentrates. Because the manufacturer of the concentrate does not have control over the final dialysis fluid, any reference to dialysis fluid is for clarification and is not a requirement of the manufacturer. This document includes concentrates in both liquid and powder forms. It also includes additives, also called spikes, which are chemicals that can be added to the concentrate to supplement or increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid. This document also specifies requirements for equipment used to mix acid and bicarbonate powders into concentrate at the user's facility. Concentrates prepared from pre-packaged salts and water at a dialysis facility for use in that facility are excluded from the scope of this document. Although references to dialysis fluid appear herein, this document does not address dialysis fluid as made by the end user. This document also excludes requirements for the surveillance frequency of water purity used for the making of dialysis fluid by the dialysis facility. This document does not address bags of sterile dialysis fluid or sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid. This document does not cover the dialysis fluid that is used to clinically dialyse patients. Dialysis fluid is covered in ISO 23500-5. The making of dialysis fluid involves the proportioning of concentrate and water at the bedside or in a central dialysis fluid delivery system. Although the label requirements for dialysis fluid are placed on the labelling of the concentrate, it is the user's responsibility to ensure proper use. This document does not cover haemodialysis equipment, which is addressed in IEC 60601-2-16:2012.

Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 31 jan 2023
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This document specifies requirements and test methods for automated functions in needle-based injection systems with automated functions (NIS-AUTO).
General requirements are provided for all automated functions. In addition, specific requirements are provided for the following automated functions:
a) medicinal product preparation (e.g. reconstitution);
b) needle preparation;
c) needle hiding;
d) priming;
e) dose setting;
f) needle insertion;
g) injection depth control;
h) injection of the medicinal product;
i) recording of device functions;
NOTE This document does not cover remote communication from the NIS-AUTO (pertains to wired and wireless communication transfer from the NIS auto).
j) disabling the NIS-AUTO;
k) needle retraction;
l) needle shielding;
m) needle removal.
All references to "function" in this document are by definition construed as automated functions (see 3.2). This document does not apply to functions that are performed manually by the user.
 

Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 5 feb 2023
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This document specifies general requirements for intravascular catheters, supplied sterile and intended for single use, for any application.
This document is not applicable to intravascular catheter accessories, e.g. those covered by ISO 11070.

Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 5 feb 2023
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This document specifies requirements for balloon dilatation catheters supplied sterile and intended for single use.
This document does not specify requirements for vascular stents (see ISO 25539-2).
NOTE Guidance on the selection of balloon materials is given in Annex G.