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.

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.

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.

Examples of ISO 14155 in a sentence

• Other protocol deviations to be considered include non-adherence to the protocol that results in a significant additional risk to the patient, or non-adherence to FDA regulations and/or ISO 14155.

• The parties will conduct each Study in accordance with all applicable laws, regulations and international standards, including but not limited to International Conference on Harmonization, Good Clinical Practice (ICH-GCP), the Declaration of Helsinki, ISO 14155, the regulations of the United States Food and Drug Administration or its foreign equivalent governing clinical investigations and the protection of human subjects (“Applicable Law”).

• ISO 14155 - means the version in force from time to time, or its replacement, of the International Standard ISO14155 - 'Clinical Investigation of medical devices for human subjects'.

• 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.

• Further the study will be run in compliance with ISO 14155 (2nd ed) 2011, CRF Title 21, Part 50 and generally accepted standards of good clinical practice.

• The Study will follow the guidelines relevant to the conducting of a Clinical Investigation as outlined in the Medical Device Directive, ISO 14155 parts 1 & 2, applicable standards of Good Clinical Practice, and other applicable laws, regulations and regulatory requirements.

• The specific human patient experiments of neuroprosthetic retinal implant is conducted in compliance with the international guidelines of the declaration of Helsinki for Good Clinical Practice and ISO 14155.

• ISO 14155 - means the version in force from time to time, or its replacement, of the International Standard ISO14155- 'Clinical Investigation of medical devices for human subjects.

• Studie bude dodržovat pokyny, které jsou relevantní pro provádění klinického výzkumu, uvedené ve směrnici o zdravotnických prostředcích, v normě ISO 14155, část 1 a 2, v platných standardech správné klinické praxe, a v dalších platných zákonech, nařízeních a regulačních požadavcích.

• The investigator(s) and all parties involved in this study should conduct the study in adherence to the ethical principles based on the Declaration of Helsinki, Good Clinical Practice (GCP), ICH Guidelines (GCP standard ISO 14155, Clinical investigations of medical devices for human subjects – Good clinical practice, version SS-EN ISO 14155:2020).

More Definitions of ISO 14155

ISO 14155 si intende, per quanto riguarda i dispositivi e gli studi diagnostici, lo standard internazionale 14155 dell’Organizzazione internazionale per la standardizzazione, unitamente ad altri requisiti di buona pratica clinica specificati nella legge nazionale locale in cui viene condotto lo Studio.

ISO 14155 means the guideline for clinical trials of medical devices which is valid as harmonized standard in the European Union.