Helsevesen, teknikk

This document gives recommendations for the handling, documentation, storage and processing of frozen tissue specimens intended for the examination of isolated DNA during the pre-examination phase before a molecular examination is performed. This document is applicable to any molecular in vitro diagnostic examination 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.

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.

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.

TThis document specifies requirements and test methods for electrically powered wheelchairs, with a maximum speed not exceeding 20 km/h, intended to carry one person of mass not greater than 300 kg, including: - electrically powered scooters with three or more wheels, - manual wheelchairs with an add-on drive system, - handrim-activated power-assisted wheelchairs, - electrically powered stand-up wheelchairs, - balancing wheelchairs, - wheelchairs with a pivot drive wheel unit, and - assistant-guided wheelchairs. This document does not apply to custom-made electrically powered wheelchairs or electrically powered wheelchairs intended for use in sports. This document also specifies requirements and test methods for manual wheelchairs with electrically powered ancillary equipment.