ICS 11.040.01
Medical equipment in general
Standards in This Category
26/30551819 DC
BSI
BS EN IEC 60601-2-62 Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
This standard establishes specialized safety and performance requirements specifically designed for high-intensity therapeutic ultrasound equipment used in medical settings. It addresses the unique
LVS EN ISO 13485:2016
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
This document outlines specific regulatory requirements for quality management systems within the medical device industry. It establishes a framework designed to ensure consistent safety and
LVS EN 13718-1+A1:2020
Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
This document outlines the specific requirements for medical equipment utilized within airborne rescue transport units. It establishes a framework to ensure that all devices employed in emergency air
LVS EN ISO 14971:2020
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
This document establishes a framework for managing risks associated with medical devices, focusing on identifying potential hazards and evaluating the significance of associated risks throughout the
LVS EN ISO 15223-1:2021
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
This technical specification establishes comprehensive requirements for symbols intended for use in information provided by manufacturers of medical devices. It focuses on the general principles
LVS EN ISO 15378:2018
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)
This document specifies additional requirements for the application of ISO 9001:2015 to pharmaceutical primary packaging materials within the context of Good Manufacturing Practice. It addresses the
LVS EN ISO 20417:2021
Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021,Corrected version 2021-12)
This technical specification outlines the requirements for information that manufacturers of medical devices must provide to users, users of single-use devices, patients, and other parties involved
LVS CEN ISO/TR 20416:2020
Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020)
This document serves as a technical report addressing post-market surveillance activities conducted by manufacturers within the medical device sector. It offers comprehensive guidance on establishing
LVS CEN ISO/TR 24971:2020
Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
This document serves as a guidance reference specifically designed for the application of risk management principles within the medical device sector. It provides a comprehensive framework to assist
LVS EN 45502-1:2015
Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
This document establishes comprehensive general safety requirements and provisions regarding labeling and information for active implantable medical devices. It serves as the foundational part of a
LVS EN 60601-1-10:2008
Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
This document outlines the essential safety and performance requirements for electrical medical equipment, specifically addressing devices equipped with feedback controllers for physiological
LVS EN 60601-1-2:2016
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
This standard establishes specific requirements for electromagnetic compatibility (EMC) concerning medical electrical equipment, serving as a special standard that complements the fundamental safety
LVS EN IEC 60601-2-31:2020
Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
This document establishes specific safety and performance requirements for external power supplies used with implantable cardiac pacemakers. It serves as a specialized subset within the broader
LVS EN 60601-2-36:2015
Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy
This document establishes specific safety and essential performance requirements for a specialized class of medical electrical equipment. It focuses on extracorporeal shock wave lithotripsy systems,
LVS EN 60601-1-8:2008
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems...
This technical specification establishes essential safety and performance requirements for medical electrical equipment and medical electrical systems, with a specific focus on the general
LVS EN IEC 60601-2-22:2021
Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
This document specifies the special basic safety and essential performance requirements for laser equipment used in surgery, cosmetics, therapy, and diagnosis, which falls under the broader category
LVS EN IEC 60601-2-75:2020
Medical Electrical Equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment
This technical document establishes specific requirements for the basic safety and essential performance of medical electrical equipment dedicated to photodynamic therapy and photodynamic diagnosis.
LVS EN IEC 61847:2025
Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics
This standard establishes the fundamental characteristics for measuring output power in ultrasound surgical systems and defines the requirements for manufacturer declarations regarding these
LVS EN IEC 80601-2-78:2020
Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
This technical specification establishes essential safety and essential performance requirements for medical robots used in rehabilitation, examination, alternative therapy, or palliative care.
LVS EN IEC 80601-2-60:2020
Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
This document specifies the fundamental safety and essential performance requirements specifically tailored for dental equipment used within electrical medical devices. As a specialized part of a