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This European Standard specifies, in conjunction with EN 29002, the quality system requirements for the production and, where relevant, installation of medical devices.
ICS 03.120.10 Quality management and quality assurance
ICS 11.040.01 Medical equipment in general
Language:
English
Subject Keywords:
Process control; Renovation; Quality assurance; Packaging; Management; Medical equipment; Quality control; Quality assurance systems; Quality auditing; Records (documents); Marking; Medical instruments; Instructions for use; Documents