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fda on clinical

fda on clinical, Total:26 items.

In the international standard classification, fda on clinical involves: Medical sciences and health care facilities in general, Medical equipment, Veterinary medicine, Radiation measurements, Laboratory medicine, Applications of information technology, Aids for disabled or handicapped persons.


Korean Agency for Technology and Standards (KATS), fda on clinical

  • KS P ISO 14155:2019 Clinical investigation of medical devices for human subjects — Good clinical practice

KR-KS, fda on clinical

  • KS P ISO 14155-2019 Clinical investigation of medical devices for human subjects — Good clinical practice
  • KS P ISO 15198-2017(2022) Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer

International Organization for Standardization (ISO), fda on clinical

  • ISO 14155:2020 Clinical investigation of medical devices for human subjects — Good clinical practice
  • ISO 5841-2:1986 Implants for surgery; Cardiac pacemakers; Part 2 : Reporting of the clinical performance of populations of pulse generators

未注明发布机构, fda on clinical

Group Standards of the People's Republic of China, fda on clinical

  • T/CACM 015.1-2017 Specifications for formulation of randomized controlled clinical research protocols of traditional Chinese medicine
  • T/CGCPU 013-2020 Ethical Considerations for Subject Pain Management in Clinical Trials
  • T/CACM 1353-2021 Technical guidelines for clinical trial design and evaluation of traditional Chinese medicine in the treatment of carotid atherosclerosis

US-CFR-file, fda on clinical

  • CFR 42-405.203-2013 Public Health. Part405:Federal health insurance for the aged and disabled. Section405.203:FDA categorization of investigational devices.

Professional Standard - Hygiene , fda on clinical

  • WS/T 420-2013 Verification of analytical performance of quantitative kits by clinical laboratory

American Society for Testing and Materials (ASTM), fda on clinical

  • ASTM E2080-14 Standard Guide for Clinical Psychophysiological Detection of Deception &40;PDD&41; Examinations for Sex Offenders
  • ASTM E2045-22 Standard Practice for Detailed Clinical Observations of Test Animals
  • ASTM E2045-99(2014) Standard Practice for Detailed Clinical Observations of Test Animals
  • ASTM E2080-06 Standard Guide for Clinical Psychophysiological Detection of Deception (PDD) Examinations for Sex Offenders
  • ASTM F2978-13 Guide to Optimize Scan Sequences for Clinical Diagnostic Evaluation of Metal-on-Metal Hip Arthroplasty Devices using Magnetic Resonance Imaging
  • ASTM F2978-20 Standards Guide to Optimize Scan Sequences for Clinical Diagnostic Evaluation of Metal-on-Metal Hip Arthroplasty Devices using Magnetic Resonance Imaging

German Institute for Standardization, fda on clinical

  • DIN 6809-7:2003 Clinical dosimetry - Part 7: Method for determination of patient dose in X-ray diagnostics

GOSTR, fda on clinical

  • GOST R ISO 15198-2009 Clinical laboratory medicine. In vitro diagnostic medical devices. Validation of user control procedures by the manufacturer

British Standards Institution (BSI), fda on clinical

  • BS ISO 5841-2:2000 Implants for surgery - Cardiac pacemakers - Reporting of clinical performance of populations of pulse generators or leads
  • BS ISO 5841-2:2001 Implants for surgery - Cardiac pacemakers - Reporting of clinical performance of populations of pulse generators or leads
  • BS ISO 5841-2:2014 Implants for surgery. Cardiac pacemakers. Reporting of clinical performance of populations of pulse generators or leads

American National Standards Institute (ANSI), fda on clinical

Indonesia Standards, fda on clinical

  • SNI ISO 15198:2009 Clinical laboratory medicine - In vitro diagnostic medical devices - validation of user quality control procedures by the manufacturer

RU-GOST R, fda on clinical

  • GOST R ISO 8551-2010 Prosthetics and orthotics. Functional deficiencies. Description of the person to be treated with an orthosis, clinical objectives of treatment, and functional requirements of the orthosis




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