Hälso- och sjukvård

Kommittébeteckning: SIS/TK 504 (e-Tillgänglighet)
Källa: CEN
Svarsdatum: den 1 maj 2018
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The present document specifies the functional accessibility requirements applicable to ICT products and services, together with a description of the test procedures and evaluation methodology for each accessibility requirement in a form that is suitable for use in public procurement within Europe. The present document might be useful for other purposes such as procurement in the private sector.

The relationship between the present document and the essential requirements of Directive 2016/2102 on the accessibility of the websites and mobile applications of public sector bodies [i.28] is given in Annex A.

The present document contains the necessary functional requirements and provides a reference document such that if procedures are followed by different actors, the results of testing are similar and the interpretation of those results is clear. The test descriptions and evaluation methodology included in the present document are elaborated to a level of detail compliant with ISO/IEC 17007:2009 [i.14], so that conformance testing can give conclusive results.

All clauses except those in clause 12, related to documentation and support services, are self-scoping. This means they are introduced with the phrase 'Where ICT <pre-condition>'. Compliance is achieved either when the pre-condition is true and the corresponding test (in Annex C) is passed, or when the pre-condition is false (i.e. the pre-condition is not met or not valid).

NOTE 1: Compliance issues are covered in normative clause C.1.

The inherent nature of certain situations makes it impossible to make reliable and definitive statements that accessibility requirements have been met. In those situations therefore, the requirements in the present document are not applicable:

• when the product is in a failure, repair or maintenance state where the ordinary set of input or output functions are not available;

• during those parts of start-up, shutdown, and other state transitions that can be completed without user interaction.

NOTE 2: Even in the above situations, it

Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 9 maj 2018
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Amendment (replace the third paragraph):

Me equipment that measures a body temperature is inside the scope of this document.

EXAMPLE 1 Me equipment using accessories such as a pulmonary artery catheter for the determination of cardiac output by thermodilution is in the scope of this document if it displays a body temperature.

EXAMPLE 2 Me equipment using accessories such as a Foley catheter that includes a temperature probe is in the scope of this document.

Amendment (correct misspelling of output temperature in definition 201.3.215):

Amendment (replace existing example of definition 201.3.222 with the following):

EXAMPLE Blackbody, fluid bath.

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.

Ämnesområden: Tandvårdsmaterial
Kommittébeteckning: SIS/TK 327 (Tandvård)
Källa: CEN
Svarsdatum: den 1 jun 2018
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This International Standard specifies requirements for dental polymer-based restorative materials supplied in a form suitable for mechanical mixing, hand-mixing, or intra-oral and extra-oral external energy activation, and intended for use primarily for the direct or indirect restoration of the teeth and for luting.

The polymer-based luting materials covered by this standard are intended for use in the cementation or fixation of restorations and appliances such as inlays, onlays, veneers, crowns and bridges. This standard does not cover those polymer-based luting materials that have an adhesive component within the structure of the material (see ISO/TS 16506).

The standard does not cover polymer-based materials intended to prevent caries (see ISO 6874), core materials or those used for veneering metal sub-frames (see ISO 10477).

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 331 (Laboratoriemedicin)
Källa: CEN
Svarsdatum: den 24 jun 2018
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This International Standard specifies the requirements for competence to carry out reference measurement procedures in laboratory medicine, using the requirements of ISO/IEC 17025:2017 as a normative reference and listing additional requirements for calibration laboratories to perform their tasks adequately.

The relationship between clauses in this international standard and ISO/IEC 17025:2017 are summarized in Annex A.

Examinations of properties with results reported on a nominal or ordinal scale are not included.

This International Standard is not applicable to medical laboratories.

NOTE 1 It is the laboratory’s responsibility to comply with the relevant legal health and safety requirements.

NOTE 2 Requirements for medical laboratories are specified in ISO 15189.