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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 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 5971:1981, 2017, Size designation of clothes: Pantyhose; ISO 7070:1982, Size designation of clothes - Hosiery; ISO 8559:1989, Garment construction and anthropometric surveys: Body dimensions (withdrawn, replaced by ISO 8559-1) ISO 8559-1:2017, Size designation of clothes: Part 1: Anthropometric definitions for body measurement
The joint European standard for size labelling of clothes, formally known as the EN 13402 Size designation of clothes, is a European standard for labelling clothes sizes. The standard is based on body dimensions measured in centimetres , and as such, and its aim is to make it easier for people to find clothes in sizes that fit them.
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.
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