Iso Medical Device Standards
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The article uses iso 13485 2003 and iso 14971 2007 as illustrations p.
Iso medical device standards. Whereas iso 9001 emphasizes continual improvement and customer satisfaction 13485 encompasses the requirements that medical device manufacturers must incorporate into their management systems. Iso 10651 3 1997 lung ventilators for medical use. Iso 13485 2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. A medical device is a product such as an instrument machine implant or in vitro reagent that is intended for use in the diagnosis prevention and treatment of diseases or other medical conditions.
Risk analysis must be performed for each med device produced and includes the documentation of. Read on for a brief overview of the most relevant as well as information about the role nqa can play in getting your organization certified. Iso medical device standards provide a collective framework for managing various types of risk to your company. For information about the content and availability of european standards please contact the european standardisation organisations.
Several management standards are applicable to medical device manufacturing. Directorate general for health and food safety medical devices email webpage on medical devices. Iso 374 5 2016 protective gloves against dangerous chemicals and micro organisms part 5. The iso 13485 standard was entitled quality systems medical devices supplementary requirements to iso 9001.
Terminology and performance requirements for micro organisms risk. Iso 13485 medical devices quality management systems requirements for regulatory purposes is an international organization for standardization iso standard published for the first time in 1996. P one common source of misunderstanding in the medical device industry is the method the various national regulatory systems use to identify standards. Iec 60601 is a series of technical standards for the safety and essential performance of medical electrical equipment published by the international electrotechnical commission first published in 1977 and regularly updated and restructured as of 2011 it consists of a general standard about 10 collateral standards and about 80 particular standards.
The standards are available in read only format and you can find the links here. It represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices this standard supersedes earlier documents such as en 46001 1993. Iso 13485 is designed to be used by organizations involved in the design production installation and servicing of medical. Medical device standards supported by nqa.
Guidelines related to medical devices directives. Essential to this endeavor is the practice of risk analysis which establishes a process for managing and controlling product risk. Who is iso 13485 for. The most common medical device manufacturing standards include.
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