Medicinsk utrustning

Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 29 maj 2018
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This document specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment.

Secondary aims of this document are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components.

NOTE In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this document.

Kommittébeteckning: SIS/TK 340 (Implantat och biologisk säkerhet)
Källa: CEN
Svarsdatum: den 4 jun 2018
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This part of ISO 14708 specifies requirements that are applicable to those ACTIVE IMPLANTABLE MEDICAL DEVICES that are intended to treat hearing impairment via electrical stimulation of the auditory pathways. Devices which treat hearing impairment via means other than electrical stimulation are not covered by this part of ISO 14708.

The tests that are specified in this part of ISO 14708 are type tests and are to be carried out on samples of a device to show compliance.

This part of ISO 14708 is also applicable to NON-IMPLANTABLE PARTS and accessories of the devices (see NOTE).

The electrical characteristics of the IMPLANTABLE PART are determined by either the appropriate method detailed in this part of ISO 14708 or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this part of ISO 14708 applies.

NOTE A device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, this standard specifies those requirements of NON-IMPLANTABLE PARTS and accessories which could affect the safety or performance of the implantable part.

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
Källa: CEN
Svarsdatum: den 9 jun 2018
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IEC 60601-1:2005+A1:2012, 1.1 is replaced by:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL SUPPLY UNITS, hereafter also referred to as ME EQUIPMENT.

This International Standard applies to MEDICAL SUPPLY UNITS manufactured within a factory or assembled on site, including cabinetry and other ENCLOSURES, which incorporate PATIENT care services.

NOTE 1 A party that assembles on site various components intended for PATIENT care services into an ENCLOSURE is considered the MANUFACTURER of the MEDICAL SUPPLY UNIT.

HAZARDS inherent in the intended function of ME EQUIPMENT or ME SYSTEMS within the scope of this International Standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of IEC 60601-1:2005+A1:2012 (see 201.1.4).

NOTE 2 See also IEC 60601-1:2005+A1:2012, 4.2.

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
Källa: CEN
Svarsdatum: den 9 jun 2018
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Clause 1 of ISO 18190:2016 applies.
In addition:
This International, device‐specific, Standard specifies requirements for laryngoscopes with non‐flexible BLADES and HANDLES, with internal battery‐operated power sources, used for illuminating the larynx during intubation. It also specifies critical dimensions for those HANDLES and BLADES with interchangeable HOOK‐ON FITTINGS.
It is not applicable to:
- flexible laryngoscopes;
- laryngoscopes designed for surgery;
- laryngoscopes powered from mains electricity supply;
- laryngoscopes connected by light‐transmitting cables to external light sources;
or
- video laryngoscopes designed to work with an external, integral or attached video system.

Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 11 jun 2018
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This document specifies requirements, including performance requirements, for plastics collapsible, non-vented, sterile containers complete with collecting tube outlet port(s), integral needle, and with optional transfer tube(s), for the collection, storage, processing, transport, separation, and administration of blood and blood components. The plastics containers may contain anticoagulant and/or preservative solutions, depending on the application envisaged.

This document is also applicable to multiple units of plastics containers, e.g. to double, triple, quadruple, or multiple units.

Unless otherwise specified, all tests specified in this document apply to the plastics container as prepared ready for use.

This document is not applicable to plastics containers with an integrated filter.

NOTE In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this document.

Kommittébeteckning: SIS/TK 435 (Livsmedel och foder)
Källa: CEN
Svarsdatum: den 13 jul 2018
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This document describes a procedure for the determination of ochratoxin A (OTA) in chilli, paprika, black and white pepper, nutmeg, spice mix, liquorice (root and extracts), cocoa and cocoa products by high performance liquid chromatography (HPLC) with immunoaffinity column clean-up and fluorescence detection.

This method has been validated in interlaboratory studies via the analysis of both naturally contaminated and spiked samples ranging from 1,0 μg/kg to 84,9 μg/kg for spices (paprika and chili [5], black and white pepper, nutmeg and spice mix [6]), ranging from 7,7 μg/kg to 96,8 μg/kg for liquorice [7] and ranging from 2,1 μg/kg to 26,3 μg/kg for cocoa and cocoa products [6].

For further information on the validation see Clause 9 and Annex B.