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The sub-clause 4.2.3 of ISO 13485:2016 requires a manufacturer of medical device to establish a Technical file, similar to a device master record. The EU medical device regulation requires a manufacturer of a medical device to maintain a Technical documentation.
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.
The Annex SL is a section of the ISO/IEC Directives part 1 that prescribes how ISO Management System Standard (MSS) standards should be written. The aim of Annex SL is to enhance the consistency and alignment of MSS by providing a unifying and agreed-upon high level structure, identical core text and common terms and core definitions.
ISO/TS 13399-307:2016 Part 307: Creation and exchange of 3D models - End mills for indexable inserts; ISO/TS 13399-308:2016 Part 308: Creation and exchange of 3D models - Milling cutters with arbor hole for indexable inserts; ISO/TS 13399-309:2016 Part 309: Creation and exchange of 3D models - Tool holders for indexable inserts
A design history file is a compilation of documentation that describes the design history of a finished medical device.The design history file, or DHF, is part of regulation introduced in 1990 when the U.S. Congress passed the Safe Medical Devices Act, which established new standards for medical devices that can cause or contribute to the death, serious illness, or injury of a patient.
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; ISO 15226:1999 Technical product documentation – Life cycle model and allocation of documents