Medicinsk utrustning

Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 31 jan 2023
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1.1 General This document is the base standard for a number of other standards dealing with water treatment equipment, water, dialysis water, concentrates, and dialysis fluid (ISO 23500 series) and provides dialysis practitioners with guidance on the preparation of dialysis fluid for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration. As such, this document functions as a recommended practice. This document does not address clinical issues that might be associated with inappropriate usage of the water, dialysis water, concentrates, or dialysis fluid. Healthcare professionals involved in the provision of treatment for kidney failure should make the final decision regarding the applications with which these fluids are used, for example, haemodialysis, haemodiafiltration, high-flux haemodialysis, and the reprocessing of dialysers, and need to be aware of the issues that the use of inappropriate fluid quality raises in each of the therapies. The concepts incorporated in this document should not be considered inflexible or static. The recommendations presented here should be reviewed periodically in order to assimilate increased understanding of the role of dialysis fluid purity in patient outcomes and technological developments. 1.2 Inclusions This document addresses the user's responsibility for dialysis fluid once the equipment used in its preparation has been delivered and installed. For the purposes of this document, dialysis fluid includes: a) dialysis water (see 3.17 for definition) used for the preparation of dialysis fluid and substitution fluid, b) dialysis water used for the preparation of concentrates at the user's facility, c) concentrates, d) the final dialysis fluid and substitution fluid. The scope of this document includes a) the quality management of equipment used to treat and distribute water used for the preparation of dialysis fluid and substitution fluid, from the point at which municipal water enters the dialysis facility to the point at which the final dialysis fluid enters the dialyser or the point at which substitution fluid is infused, b) equipment used to prepare concentrate from powder or other highly concentrated media at a dialysis facility, and c) preparation of the final dialysis fluid or substitution fluid from dialysis water and concentrates. NOTE Because water used to prepare dialysis fluid can also be used to reprocess dialysers not marked intended for single use, this aspect of water use is also covered by this document. 1.3 Exclusions This document does not apply to sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid, systems for continuous renal replacement therapy that use pre-packaged solutions, and systems and solutions for peritoneal dialysis.

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 1 feb 2023
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1.1 General This document is addressed to the manufacturer and/or supplier of water treatment systems and/or devices used for the express purpose of providing water for haemodialysis or related therapies. 1.2 Inclusions This document covers devices used to treat potable water intended for use in the delivery of haemodialysis and related therapies, including water used for: a) the preparation of concentrates from powder or other highly concentrated media at a dialysis facility; b) the preparation of dialysis fluid, including dialysis fluid that can be used for the preparation of substitution fluid; c) the reprocessing of dialysers intended for single use where permitted for multiple uses, d) the reprocessing of dialysers not specifically marked as intended for single use. This document includes all devices, piping and fittings between the point at which potable water is delivered to the water treatment system, and the point of use of the dialysis water. Examples of the devices are water purification devices, online water quality monitors (such as conductivity monitors), and piping systems for the distribution of dialysis water. 1.3 Exclusions This document excludes dialysis fluid supply systems that proportion water and concentrates to produce dialysis fluid, sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid, dialysis concentrates, haemodiafiltration systems, haemofiltration systems, systems that process dialysers for multiple uses, and peritoneal dialysis systems. Some of these devices, such as dialysis fluid delivery systems and concentrates, are addressed in other documents such as ISO 23500-4 and ISO 23500‑5, This document also excludes the on-going surveillance of the purity of water used for dialysis fluid, concentrate preparation, or dialyser reprocessing which is addressed in ISO 23500‑1.

Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 1 feb 2023
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This document specifies minimum requirements for water to be used in haemodialysis and related therapies. This document includes water to be used in the preparation of concentrates, dialysis fluids for haemodialysis, haemodiafiltration and haemofiltration, and for the reprocessing of haemodialysers. This document excludes the operation of water treatment equipment and the final mixing of treated water with concentrates to produce dialysis fluid. Those operations are the sole responsibility of dialysis professionals. This document does not apply to dialysis fluid regenerating systems.

Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 1 feb 2023
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This document specifies minimum quality requirements for dialysis fluids used in haemodialysis and related therapies. This document includes dialysis fluids used for haemodialysis and haemodiafiltration, including substitution fluid for haemodiafiltration and haemofiltration. This document excludes the water and concentrates used to prepare dialysis fluid or the equipment used in its preparation. Those areas are covered by other International Standards. Sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid, systems for continuous renal replacement therapy that use pre-packaged solutions, and systems and solutions for peritoneal dialysis are excluded from this document.

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.

Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 28 mar 2023
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This document specifies requirements and gives the test method for medical gloves for single use in order to determine freedom from holes.

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
Källa: CEN
Svarsdatum: den 29 mar 2023
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