Hälso- och sjukvård

Ämnesområden: Utrustning för ögonoptik
Kommittébeteckning: SIS/TK 336 (Ögonoptik)
Källa: CEN
Svarsdatum: den 24 aug 2022
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This part of ISO 9342 specifies requirements for reference lenses for the calibration and verification of focimeters that are used for the measurement of spectacle form lenses. It also gives a method for the determination of the back vertex power of the reference lenses.
NOTE It is accepted that other reference lenses can also be used with powers within the given range, manufactured to the same standard of accuracy and form, but different back vertex powers. However, only lenses with integer nominal powers, as described in paragraph 4.1, can be used for the calibration of digitally-rounding focimeters.

Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 30 aug 2022
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This document specifies requirements, including performance requirements, for plastics collapsible, non-vented, sterile containers (known as plastics 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 can 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.

Kommittébeteckning: SIS/TK 211 (Hissar och rulltrappor)
Källa: CEN
Svarsdatum: den 1 sep 2022
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1.1 This document specifies safety requirements for construction, manufacturing, installation, maintenance, inspection and dismantling of permanently installed electrically powered vertical lifting appliances affixed to a building structure intended for use by persons, including persons with disability:
— travelling vertically between predefined levels along a guided path whose inclination to the vertical does not exceed 15°;
— supported or sustained by rack and pinion, rope traction drive, noncircular elastomeric-coated suspension means (hereafter called traction belts) traction drive, rope positive drive, chains, toothed belts, screw and nut, guided chain, scissors mechanism or hydraulic jack (direct or indirect);
— with enclosed wells;
— with a rated speed not greater than 0,15 m/s;
— with the carrier completely enclosed.
1.2 This document does not cover:
— hydraulic lifting appliances where the setting of the pressure relief valve ( exceeds 50 MPa;
— operation in severe conditions (e.g. extreme climates, strong magnetic fields);
— lightning protection;
— operation subject to special rules (e.g. potentially explosive atmospheres);
— handling of materials, the nature of which could lead to dangerous situations;
— lifting appliances whose primary function is the transportation of goods;
— lifting appliances prone to vandalism;
— earthquakes, flooding;
— firefighting and evacuation;
— noise and vibrations;
— the design of concrete, hard core, timber or other foundation or building arrangement;
— the design of anchorage bolts to the supporting structure;
— the transport of type-C wheelchairs as defined in EN 12183:2014 and/or EN 12184:2014;
— vertically sliding doors.
NOTE Noise and vibration are not considered significant nor relevant hazards.
1.3 This document deals with all significant hazards, hazardous situations or hazardous events relevant to lifting appliance, when it is used as intended and under conditions of misuse which are reasonably foreseeable by the manufacturer. They have been identified by risk assessment; see Annex I.

Kommittébeteckning: SIS/TK 344 (Hjälpmedel)
Källa: ISO
Svarsdatum: den 12 sep 2022
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This part of ISO 7176 specifies requirements and test methods for lithium batteries and battery systems intended for use in electrically powered wheelchairs, and their charging systems.

Ämnesområden: Medicinska material
Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 13 sep 2022
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This document specifies minimum requirements and a test method for the antimicrobial (microbicidal or microbistatic) activity of wound dressing products. It applies to all wound dressing products that specifically claim antimicrobial activity according to this document.

Kommittébeteckning: SIS/TK 527 (Renhet i operationsrum)
Källa: ISO
Svarsdatum: den 15 sep 2022
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This International Standard specifies functional requirements for a self-initiated disease symptom checker app to be used for early screening and control of pandemics such as COVID-19.
There are four functional components specified in the standard: 1) self-registration; 2) symptom checking; 3) guidance on screening stations; and 4) health consultation.

Ämnesområden: Tandvårdsutrustning
Kommittébeteckning: SIS/TK 327 (Tandvård)
Källa: CEN
Svarsdatum: den 16 sep 2022
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This document specifies requirements and test methods common to all non-hinged hand instruments used in dentistry, including materials, hardness, surface finish, resistance to reprocessing and information for marking, though some may have specific additional requirements and test methods.
It does not specify terms and definitions or classification of specific types of hand instruments. This document excludes powered instruments. The classification and the shape of working ends of nonhinged hand instruments are excluded from this document.

Kommittébeteckning: SIS/TK 440 (Laboratorieutrustning)
Källa: CEN
Svarsdatum: den 19 sep 2022
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This document specifies requirements and tests for glass Petri dishes intended for general laboratory purposes and microbiological work.

Kommittébeteckning: SIS/TK 334 (Hälso- och sjukvårdsinformatik)
Källa: CEN
Svarsdatum: den 17 okt 2022
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Within the context of the ISO/IEEE 11073 family of standards for device communication, ISO/IEEE 11073-10420:2012 establishes a normative definition of the communication between personal body composition analyzing devices and managers (e.g. cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology and IEEE 11073-20601 information models. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. ISO/IEEE 11073-10420:2012 defines a common core of communication functionality for personal telehealth body composition analyzer devices. In this context, body composition analyzer devices are being used broadly to cover body composition analyzer devices that measure body impedances, and compute the various body components including body fat from the impedance.