EN ISO 14155 definition

EN ISO 14155 means EN ISO 14155: Parts 1 and 2: the harmonised International and European standard entitled “Clinical investigation of medical devices for human subjects” which provides voluntary guidance on good clinical practice for medical device clinical investigations.
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Examples of EN ISO 14155 in a sentence

  • This includes every step in the clinical investigation from first consideration of the need and justification of the study to publication of the results.” As a general principle, “the rights, safety and wellbeing of clinical investigation subjects shall be protected consistent with the ethical principles laid down in the Declaration of Helsinki” (EN ISO 14155).

  • Guidance is available in MedDev 2.7.1, GHTF SG5 N2R8 and EN ISO 14155.

  • Appendix 4: Specify and insert the sponsor’s investigation-related duties and functions under EN ISO 14155 or ICH GCP to be performed by the CRO.

  • Expected contents of a CIP are listed in Annex XV of the MDR, and in the Annex to EN ISO 14155.

  • Monitoring functions will be performed in compliance with Good Clinical Practices, EN ISO 14155, and as outlined in 21CRF§812.43(d) and 21CRF§812.46.

  • It is NOT intended that it will reproduce EN ISO 14155 or ICH GCP, but it will summarise for the benefit of staff of all parties administering the investigation site, issues over which the NHS body will liaise with the CRO.

  • Statement specifying that the investigator is not allowed to deviate from the CIP, except as specified in EN ISO 14155 4.5.4 b: Requests for deviations, and reports of deviations, if the deviation affects subject's rights, safety and wellbeing, or the scientific integrity of the clinical investigation; Under emergency circumstances, deviations from the CIP to protect the rights, safety and well-being of human subjects may proceed without prior approval of the sponsor and the EC.

  • Ultimately, under EN ISO 14155 or ICH GCP, the sponsor is accountable for the execution of sponsor duties, even if they are delegated to a CRO.

  • If a CRA becomes aware that an Investigator is not complying with the signed Investigator’s Agreement, the CIP, the requirements of EN ISO 14155 or other applicable regulations, or any conditions of approval imposed by the reviewing EC, the Sponsor or Designee will immediately either secure compliance or discontinue shipments of the investigational device to the Investigator and terminate the Investigator’s participation in the investigation.

  • The PI's file will contain the CIP/amendments, IB/Instructions for use, CRFs, sites’ standard operation procedures (SOPs) or reference to it, EC and CA approval with correspondence, informed consent, device records, staff curriculum vitae and authorization forms, screening and enrolment logs, site- specific subject identification code logs, and other appropriate documents/ correspondence as required by EN ISO 14155 and local regulations.

Related to EN ISO 14155

  • Biological safety cabinet means a containment unit suitable for the preparation of low to moderate risk agents where there is a need for protection of the product, personnel, and environment, according to National Sanitation Foundation (NSF) Standard 49.

  • CMOs means notes or other instruments secured by collateral consisting primarily of mortgages, mortgage-backed securities and/or other types of mortgage-related obligations.

  • Medical marijuana concentrate means a specific subset of Medical Marijuana that was produced by extracting cannabinoids from Medical Marijuana. Categories of Medical Marijuana Concentrate include Water-Based Medical Marijuana Concentrate, Food-Based Medical Marijuana Concentrate and Solvent-Based Medical Marijuana Concentrate.

  • Clean coal technology demonstration project means a project using funds appropriated under the heading “Department of Energy—Clean Coal Technology,” up to a total amount of $2,500,000,000 for commercial demonstration of clean coal technology, or similar projects funded through appropriations for the Environmental Protection Agency. The federal contribution for a qualifying project shall be at least 20 percent of the total cost of the demonstration project.

  • Licensure means the status of a licensee when OCCL issued a child care license when the applicant demonstrated compliance with these regulations and applicable codes, regulations, and laws.

  • business vertical means a distinguishable component of an enterprise that is engaged in the supply of individual goods or services or a group of related goods or services which is subject to risks and returns that are different from those of the other business verticals.

  • Fluoroscopic imaging assembly means a subsystem in which X-ray photons produce a visual image. It includes the image receptor(s) such as the image intensifier and spot-film device, electrical interlocks, if any, and structural material providing linkage between the image receptor and diagnostic source assembly.

  • Medical marijuana waste or "waste" means unused,

  • combustible waste means non-biodegradable, non- recyclable, non-reusable, non-hazardous solid waste having minimum calorific value exceeding 1500 kcal/kg and excluding chlorinated materials like plastic, wood pulp, etc.;

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

  • Cannabidiol means a finished preparation containing, of its total cannabinoid content, at least 98 percent cannabidiol and not more than 0.90 percent tetrahydrocannabinol by volume that has been extracted from marijuana or synthesized in a laboratory.

  • Oxides of nitrogen means the sum of the volume mixing ratio (ppbv) of nitrogen monoxide (nitric oxide) and nitrogen dioxide expressed in units of mass concentration of nitrogen dioxide (µg/m3);

  • Design torso angle means the angle measures between a vertical line through the "R" point and the torso line in a position which corresponds to the design position of the seat-back established by the vehicle manufacturer;

  • Marijuana product means marijuana as defined in 50-32-101 and marijuana-infused products

  • CAISO-Approved Meter means any revenue quality, electric energy measurement meter furnished by Seller, that (a) is designed, manufactured and installed in accordance with the CAISO’s metering requirements, or, to the extent that the CAISO’s metering requirements do not apply, Prudent Electrical Practices, and (b) includes all of the associated metering transformers and related appurtenances that are required in order to measure the net electric energy output from the Generating Facility.

  • Pharmacist preceptor or “preceptor” means a pharmacist licensed to practice pharmacy whose license is current and in good standing. Preceptors shall meet the conditions and requirements of rule 657—4.9(155A). No pharmacist shall serve as a preceptor while the pharmacist’s license to practice pharmacy is the subject of disciplinary sanction by a pharmacist licensing authority.

  • Cosmetology means any one and/or combination of practices generally and usually performed by and known as the occupation of beauty culturalist, cosmeticians, cosmetologists or hairdressers or any person holding him or herself out as practicing cosmetology in or upon a place or premises. Cosmetology shall include, but otherwise not be limited to, the following: embellishing, arranging, dressing, curling, waving, cleansing, beautifying, cutting, singeing, bleaching, coloring, or similar work upon the hair of any person by any means and with hands or mechanical or electrical apparatuses, devices or appliances or by use of cosmetic preparations, antiseptics, tonics, lotions, creams or otherwise, massaging, cleansing, stimulating, manipulating, exercising, beautifying or similar work, the scalp, face, neck, arms, hands, bust or upper part of the body, or manicuring, pedicuring or sculpting the nails of any person.

  • Comprehensive resource analysis means an analysis including,

  • Technology startup company means a for profit business that

  • Impulsive sound means either a single pressure peak or a single burst (multiple pressure peaks) that has a duration of less than one second.

  • Cannabis waste means waste that is not hazardous waste, as defined in Public Resources Code section 40141, that contains cannabis and that has been made unusable and unrecognizable in the manner prescribed in sections 5054 and 5055 of this division.

  • MGD means million gallons per day. "mg/l" means milligrams per liter. "ug/l" means micrograms per liter. "ng/l" means nanograms per liter. "S.U." means standard pH unit. "kg/day" means kilograms per day.

  • Single tomogram system means a CT x-ray system which obtains x-ray transmission data during a scan to produce a single tomogram.

  • Pre-Licensed Therapist means an individual who has obtained a Master’s Degree in Social Work or Marriage and Family Therapy and is registered with the BBS as an Associate CSW or MFT Intern acquiring hours for licensing. An individual’s registration is subject to regulations adopted by the BBS.

  • Chinese Medicine Practitioner means a Chinese medicine practitioner who is duly registered with the Chinese Medicine Council of Hong Kong pursuant to the Chinese Medicine Ordinance (Cap. 549) of the laws of Hong Kong, but excluding the Insured Person, the Policyholder, an insurance intermediary, an employer, employee, Immediate Family Member or business partner of the Policyholder and/or Insured Person.

  • Civil Aeronautical Product means any civil aircraft, aircraft engine, or propeller or subassembly, appliance, material, part, or component to be installed thereon.