Utrustning för anestesi, respiration och återupplivning

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 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.