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ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.
ISO 14971 Medical devices — Application of risk management to medical devices is a voluntary consensus standard, [1] published by International Organization for Standardization (ISO) for the first time in 1998, and specifies terminology, principles, and a process for risk management of medical devices.
IEC 62366 is a process-based standard that aims to help manufacturers of medical devices to design for high usability. It does not address clinical decision-making related to use of the device. The standard will replace ISO/IEC 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability.
ISO 15223 Medical devices – Symbols to be used with medical device labels, labelling, and information to be supplied ISO 15223-1:2016 Part 1: General requirements; ISO 15223-2:2010 Part 2: Symbol development, selection and validation; ISO 15225:2016 Medical devices – Quality management – Medical device nomenclature data structure
The ISO 10993 set entails a series of standards for evaluating the biocompatibility of medical devices to manage biological risk. These documents were preceded by the Tripartite agreement and is a part of the international harmonisation of the safe use evaluation of medical devices. [1]
ISO/TS 19218 Medical devices – Hierarchical coding structure for adverse events ISO/TS 19218-1:2011 Part 1: Event-type codes; ISO/TS 19218-2:2012 Part 2: Evaluation codes; ISO/TR 19231:2014 Health informatics – Survey of mHealth projects in low and middle income countries (LMIC) ISO 19233 Implants for surgery – Orthopaedic joint prosthesis
Harmonization of regulatory standards is seen by economists as a key component in reducing trade costs and increasing interstate trade. [9] Where importing-market standards are harmonized with international standards, such as those from ISO or IEC, the negative effect on developing-country exporters is substantially lessened, or even reversed. [10]
Download as PDF; Printable version; In other projects ... (monitoring and control equipment, and medical devices) ... (Harmonised Standards list for RoHS2, OJEU C363 ...