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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 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 Annex ZA harmonized ISO 14971:2012 with the Medical Devices Directive 93/42/EEC of 1993. [8] The Annex ZB harmonized ISO 14971:2012 with the Active Implantable Medical Device Directive 90/385/EEC of 1990. [9] The Annex ZC harmonized ISO 14971:2012 with the In-vitro Diagnostic Medical Device Directive 98/79/EC of 1998. [10]
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]
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
Global Medical Device Nomenclature (GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. This nomenclature is a naming system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
The tariff schedule has 99 chapters under 22 sections, and various appendices for chemicals, pharmaceuticals, and intermediate chemicals for dye.Raw materials or basic substances generally appear in the early chapters and in earlier headings within a chapter, whereas highly processed goods and manufactured articles appear in later chapters and headings.
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