Yhteinen Toimialaliitto

This document defines good study practice for the planning, design, conduct, recording and reporting of clinical performance studies carried out to assess the clinical performance and safety of in vitro diagnostic (IVD) medical devices for regulatory purposes.NOTE 1 The purpose of these studies is to assess the ability of an IVD medical device in the hands of the intended user, to yield results pertaining to a particular medical condition or physiological/pathological state, in the intended population. The document is not intended to describe whether the technical specifications of the IVD medical device in question are adequately addressed by the clinical performance study.This document identifies the principles that underpin clinical performance studies and specifies general requirements intended to— ensure the conduct of the clinical performance study will lead to reliable and robust study results,— define the responsibilities of the sponsor and principal investigator,— assist sponsors, clinical research organization, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of IVD medical devices, and— protect the rights, safety, dignity and well-being of the subjects providing specimens for use in clinical performance studies.Analytical performance studies are out of the scope of this document. NOTE 2 When the collection of specimens specifically for the analytical performance study creates an additional collection risk for subjects, some of the elements of this document (particularly the annexes) can be useful for ensuring subject safety.Clinical performance studies that are performed for reasons other than pre- and post-market regulatory purposes, such as for re-imbursement purposes, are out of the scope of this document.NOTE 3 Some of the elements of this document can be useful for the design of such studies, including subject safety and data integrity.This document does not include safety information for laboratory workers or other personnel collecting the study specimens.NOTE 4 Such information is included in other publications[1][12][13].NOTE 5 Users of this document can consider whether other standards and/or requirements also apply to the IVD medical device which is the subject of the clinical performance study, for instance, in the situation for which there is an IVD medical device and a medical device used in an integrated system (e.g. a lancet, an IVD test strip, and a glucose meter), aspects of both this document and ISO 14155 can be considered.

Revised Annex ZA

Revised Annex ZA

This European Standard applies to trampoline parks and their components.This European Standard specifies safety requirements for the design, construction, inspection and maintenance of trampoline parks and their components.This European Standard also specifies minimum operational requirements to ensure an appropriate level of safety and service when used for recreational, training, educational or therapeutic purposes.This European Standard does not apply to-trampolines defined as gymnastic equipment according to EN 13219:2001,-trampolines for domestic use according to EN 7114:2014+A1:2017, and-children's playgrounds (see EN 1176 all parts).

This document applies only to Dimethyl Ether refuelling connectors hereinafter referred to as devices, constructed entirely of new, unused parts and materials. Dimethyl Ether refuelling connectors consist of the following components, as applicable:a) Nozzle (mounted on dispenser side).b) Receptacle (mounted on vehicle).This document applies to devices which use Dimethyl Ether as fuel, hereinafter referred to in this document as D15 [see 9.1 c)].This document applies to devices with standardised mating components.This document applies to connectors which prevent Dimethyl Ether vehicles from being fuelled by fuel station dispensers for other gaseous fuels.This document is applicable to: Dimethyl Ether in accordance with ISO 16861.NOTE All references to pressures (kPa) throughout this document are considered gauge pressures unless otherwise specified.