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Harmonized Standards, Elaboration
A standard is a document that suggests a set of rules and guidelines on how one can obtain a result comparable to others who engage in the same kind of activities.
The standards are based on optional agreements established by relevant organs. Standards can be national or international, however most standards directing how companies should work are based on European or international standards.
The development within standards can be followed by the organs publishing these. You can buy the ISO standards from various websites e.g. http://www.global.iso.com. In Denmark you can purchase the standards from “Dansk Standard”, http://www.ds.dk/252.
Some of the harmonized standards most relevant for the development of medical devices are:
EN ISO 13485. Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes (ISO 13485:2003)
DS/EN ISO 19011. Guideline for Quality and/or Environmental Management Systems Auditing (ISO 19011:2002)
DS/EN ISO 14971. Medical Devices – Application of risk Management to Medical Devices (ISO 14971:2000)
DS/EN ISO 10005. Quality Management Systems – Guidelines for Quality Plans (ISO 10005:2005)
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