ISO 14155 definition

ISO 14155. 2011 means the version in force from time to time, or its replacement, of the International Standard ISO14155:2011 'Clinical investigation of medical devices for human subjects -Good clinical practice’ developed by the International Organisation for Standardisation. Medical Device means the same as in the Therapeutic Goods Xxx 0000. Multi-centre Study is a Study conducted by several investigators according to a single Clinical Investigation Plan at more than one study site. NHMRC means the National Health and Medical Research Council of the Commonwealth of Australia. Personal Information has the same meaning as in the Privacy Xxx 0000 (Cth) Personnel means employees, agents and/or authorised representatives, and includes in the case of the Institution, the Principal Investigator. Principal Investigator is the person responsible for the conduct of the Study at the Study Site as described in Schedule 1.
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ISO 14155. 2020 means the version in force from time to time, or its replacement, of the International Standard ISO14155:2020 'Clinical investigation of medical devices for human subjects -Good clinical practice’ developed by the International Organisation for Standardisation.
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ISO 14155. 2020 means the version in force from time to time, or its replacement, of the International Standard ISO14155:2020 'Clinical investigation of medical devices for human subjects -Good clinical practice’ developed by the International Organisation for Standardisation. Medical Device means the same as in the Therapeutic Goods Act 1989. Multi-centre Study is a Study conducted by several investigators according to a single Clinical Investigation Plan at more than one study site. NHMRC means the National Health and Medical Research Council of the Commonwealth of Australia. Personal Information has the same meaning as in the Privacy Act 1988 (Cth) Personnel means employees, agents and/or authorised representatives, and includes in the case of the Institution, the Principal Investigator. Principal Investigator is the person responsible for the conduct of the Study at the Study Site as described in Schedule 1.
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Examples of ISO 14155 in a sentence

  • The Investigator is responsible for ensuring that Informed Consent is obtained prior to the use of any investigational devices, study-required procedures and/or testing, or data collection.The obtaining and documentation of Informed Consent must be in accordance with the principles of the Declaration of Helsinki, ISO 14155, any applicable national regulations, and local Ethics Committee and/or Regulatory authority body, as applicable.

  • A device deficiency is defined in accordance with ISO 14155 as “inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety, or performance.” Device deficiencies include malfunctions, use errors, and inadequate labeling.

  • The study will be performed in accordance with the relevant parts of the Code of Federal Regulations, ICH Guidelines for Good Clinical Practices, the European Standard ISO 14155, the Declaration of Helsinki, and any regional and/or national regulations.

  • The applicant shall ensure that medical devices for clinical investigational use is designed, conducted and reported in accordance to ISO 14155, Clinical research of Medical Devices for Human Subjects – Good Clinical Practice.

  • An adverse event is defined (following ISO 14155) as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the study device.

  • Description of the intended clinical performance (refer ISO 14155).

  • Training will also be provided to ensure appropriate storage and handling of data, and all study staff will be required to be trained on Good Clinical Practice (GCP) guidelines per ISO 14155: 2011.A record of all formal training will be stored in the Site Regulatory Binder and provided to the Sponsor for inclusion in the Sponsor’s CHF.

  • 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).

  • These technical descriptions are translated by the software and hardware vendors who support the specifications in their tools.

  • This study will be conducted in accordance with this protocol and the ethical principles that have their origin in the Declaration of Helsinki, ISO 14155: 2011 and :2020.


More Definitions of ISO 14155

ISO 14155 means, with regard to device and diagnostic studies, the international standard 14155 of the International Organization for Standardization together with such other good clinical practice requirements as are specified in local national law where the Study is being performed.
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ISO 14155 means the guideline for clinical trials of medical devices which is valid as harmonized standard in the European Union.
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Related to ISO 14155

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