Standards and regulations
The standards behind medical technology, in plain words.
54 standards and regulations from the BMEssentia library: what each one covers, and the devices, simulations and Essentia studios that use it. Summaries are written by BMEssentia; always work from the current official edition.
General
Safety, risk, quality, buildings and regulation.
- IEC 60601-1Medical electrical equipment, Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2Medical electrical equipment, Part 1-2: Electromagnetic disturbances, requirements and tests
- IEC 60601-1-8Medical electrical equipment, Part 1-8: Alarm systems, general requirements, tests and guidance
- IEC 60601-2-24Medical electrical equipment, Part 2-24: Particular requirements for infusion pumps and controllers
- ISO 80601-2-12Medical electrical equipment, Part 2-12: Particular requirements for critical care ventilators
- ISO 80601-2-61Medical electrical equipment, Part 2-61: Particular requirements for pulse oximeter equipment
- IEC 62353Medical electrical equipment, Recurrent test and test after repair of medical electrical equipment
- ISO 14971Medical devices, Application of risk management to medical devices
- IEC 62366-1Medical devices, Part 1: Application of usability engineering to medical devices
- IEC 62304Medical device software, Software life cycle processes
- ISO 13485Medical devices, Quality management systems, Requirements for regulatory purposes
- ISO 10993-1Biological evaluation of medical devices, Part 1: Evaluation and testing within a risk management process
- EU MDR 2017/745Regulation (EU) 2017/745 on medical devices
- UK MDR 2002 / UKCAUK Medical Devices Regulations 2002 and the UKCA and CE marks
- FDA 21 CFR 820 (QMSR)US Quality Management System Regulation for medical devices
- FDA 510(k) / De Novo / PMAUS premarket pathways for medical devices
- HTM 06-01Health Technical Memorandum 06-01: Electrical services supply and distribution
- HTM 02-01Health Technical Memorandum 02-01: Medical gas pipeline systems
- HTM 03-01Health Technical Memorandum 03-01: Specialised ventilation for healthcare premises
- HTM 01-06 / ISO 15883Decontamination of flexible endoscopes, and washer-disinfector requirements
- HBN 00-01 (and FGI Guidelines)Health Building Note 00-01: General design guidance for healthcare buildings
- ISO 7396-1Medical gas pipeline systems, Part 1: Pipeline systems for compressed medical gases and vacuum
- IEC 60364-7-710 (BS 7671 Section 710)Low-voltage electrical installations, Requirements for special installations: medical locations
- IEC 80001-1Application of risk management for IT networks incorporating medical devices, safety, effectiveness and security
- IEC 61010-1Safety requirements for electrical equipment for measurement, control and laboratory use
- ANSI/AAMI EQ89 (formerly EQ56)Guidance for the use of medical equipment maintenance strategies and procedures
- NFPA 99Health Care Facilities Code
- IRR17 and IR(ME)R 2017Ionising Radiations Regulations 2017 and Ionising Radiation (Medical Exposure) Regulations 2017
- MHRA Yellow Card and FSN systemUK reporting of adverse incidents with medical devices
- WHO medical device guidanceWorld Health Organization guidance on medical device management and regulation
Particular
Standards for particular devices.
- IEC 60601-2-4defibrillators
- IEC 60601-2-2electrosurgical (HF surgical) equipment
- IEC 60601-2-22surgical, cosmetic, therapeutic and diagnostic lasers
- IEC 60601-2-27ECG monitoring equipment
- IEC 60601-2-34invasive blood pressure monitoring
- ISO 80601-2-30 and ISO 81060-2automated non-invasive blood pressure
- ISO 80601-2-56clinical thermometers
- ISO 15197blood glucose meters (self-testing)
- IEC 60601-2-19 and IEC 60601-2-21infant incubators and radiant warmers
- IEC 60601-2-50infant phototherapy equipment
- IEC 60601-2-16haemodialysis, haemodiafiltration and haemofiltration equipment
- ISO 80601-2-13anaesthetic workstations
- IEC 60601-2-33MR equipment for medical diagnosis
- IEC 60601-2-44X-ray equipment for computed tomography
- IEC 60601-2-54radiography and radioscopy (X-ray)
- IEC 60601-2-37ultrasonic diagnostic and monitoring equipment
- IEC 60601-2-18endoscopic equipment
- IEC 60601-2-36extracorporeally induced lithotripsy
- IEC 60601-2-10nerve and muscle stimulators
- IEC 60601-2-26 and IEC 60601-2-40EEG and EMG equipment
- ISO 15883washer-disinfectors
- EN 285 and ISO 17665steam sterilization
- IEC 60825-1laser product safety and classes
- ISO 23500water and fluids for haemodialysis