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medical equipment

medical equipment, Total:31 items.

In the international standard classification, medical equipment involves: Laboratory medicine, Medical equipment, Information sciences. Publishing, Applications of information technology.

Association Francaise de Normalisation, medical equipment

NF EN 1642:2013 Médecine bucco-dentaire - Dispositifs médicaux pour la médecine bucco-dentaire - Implants dentaires

CZ-CSN, medical equipment

CSN 84 7106-1983 Medlcal eguipment. Methods, means and processes of sterllization and desinfection of items for medical use. Terms and definitions.

British Standards Institution (BSI), medical equipment

DD ISO/TS 10993-20:2006 Biological evaluation of medical devices. Principles and methods for immunotoxicology testing of medical devices
BS EN ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Clinical investigation plans
BS EN ISO 14155:2011 Clinical investigation of medical devices for human subjects. Good clinical practice

International Organization for Standardization (ISO), medical equipment

ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plants

Korean Agency for Technology and Standards (KATS), medical equipment

KS P ISO 14155-2:2007 Clinical investigation of medical devices for human subjects－Part 2：Clinical investigation plans

GOSTR, medical equipment

GOST R ISO 15198-2009 Clinical laboratory medicine. In vitro diagnostic medical devices. Validation of user control procedures by the manufacturer
GOST ISO/TR 10993-22-2020 Medical devices. Biological evaluation of medical devices. Part 22. Guidance on nanomaterials

KR-KS, medical equipment

KS P ISO 15198-2017 Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer

European Committee for Standardization (CEN), medical equipment

EN ISO 14155-2:2003 Clinical Investigation of Medical Devices for Human Subjects - Part 2: Clinical Investigation Plans ISO 14155-2:2003
EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
EN ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)

RU-GOST R, medical equipment

GOST ISO 10993-1-2011 Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing
GOST ISO 10993-18-2011 Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials
GOST ISO 10993-11-2011 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
GOST R ISO 10993-11-1999 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic to xicity
GOST R ISO 10993-10-1999 Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and sensitization
GOST ISO/TS 10993-20-2011 Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicology testing of medical devices
GOST ISO 10993-5-2011 Medical devices. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity
GOST ISO 10993-7-2016 Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals
GOST ISO 10993-6-2011 Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation
GOST ISO 10993-12-2011 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and control materials
GOST ISO 10993-7-2011 Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals
GOST R ISO 10993-6-1999 Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation
GOST R ISO 10993-12-1999 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and reference materials
GOST ISO 10993-13-2011 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
GOST ISO 10993-13-2016 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, medical equipment

GB/T 42218-2022 Clinical laboratory medicine—In vitro diagnostic medical devices—Validation of user quality control procedures by the manufacturer

Indonesia Standards, medical equipment

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

American National Standards Institute （ANSI), medical equipment

ANSI/IEEE 11073-00101:2008 Guide for Health Informatics - Point-of-Care Medical Device Communication - Technical Report - Guidelines for the Use