Hälso- och sjukvård

Kommittébeteckning: SIS/TK 344 (Hjälpmedel)
Källa: CEN
Svarsdatum: den 13 okt 2020
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This document specifies requirements and test methods for manual wheelchairs intended to carry one person of mass not greater than 250 kg, including:

— stand-up manual wheelchairs, and

— manual wheelchairs for showering and/or toileting.

This document does not apply to custom-made manual wheelchairs or manual wheelchairs intended for use in sports.

This document also specifies requirements and test methods for manual wheelchairs with electrically powered ancillary equipment.

Ämnesområden:
Kommittébeteckning: SIS/TK 331 (Laboratoriemedicin)
Källa: CEN
Svarsdatum: den 17 okt 2020
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This document gives requirements and recommendations for the handling, storage, processing, and documentation of frozen tissue specimens intended for DNA examination during the pre-examination phase before a molecular examination is performed.

This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories that evaluate DNA isolated from frozen tissue. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.

Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in this document.

NOTE International, national, or regional regulations or requirements can also apply to specific topics covered in this document.

Kommittébeteckning: SIS/TK 344 (Hjälpmedel)
Källa: ISO
Svarsdatum: den 9 nov 2020
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This document specifies apparatus, test methods, and disclosure requirements for determination of lateral stability properties of wheelchair seat cushions by measuring the response from the cushion to a shift in the centre of mass. It provides a method of determining changes in a particular physical and mechanical property of the cushion. It does not provide information specific to cushion performance for a particular individual user. It does not provide information related to anterior-posterior stability, nor to stability contributions from cushion edges.

NOTE 1 Test conditions simulate a symmetric anatomy.

NOTE 2 Loads are intended to represent those seen under the pelvis of a 40-60th percentile wheelchair user.

NOTE 3 This document may be applicable to seat cushions in other applications.

Kommittébeteckning: SIS/TK 331 (Laboratoriemedicin)
Källa: CEN
Svarsdatum: den 15 nov 2020
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This standard specifies requirements and test methods for single-use evacuated and non-evacuated receptacles, intended by their manufacturers, for the primary containment and preservation of specimens, other than blood specimens, derived from the human body, for the purposes of in vitro diagnostic examination. NOTE 1 Requirements and test methods for evacuated and non-evacuated single-use venous blood specimen containers are specified in EN ISO 6710. NOTE 2 While it is desirable that specimen receptacles should be designed to avoid spontaneous discharge of the contents, when being opened, this standard does not specify a test procedure for this because it has not been possible to devise an objective and reproducible test. This standard does not specify requirements for collection needles or needle holders or other accessories used in conjunction with specimen receptacles.