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  2. ISO 13485 - Wikipedia

    en.wikipedia.org/wiki/ISO_13485

    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.

  3. Device Master Record - Wikipedia

    en.wikipedia.org/wiki/Device_Master_Record

    Design History File (DHF) 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.

  4. List of ISO standards 12000–13999 - Wikipedia

    en.wikipedia.org/wiki/List_of_ISO_standards_12000...

    ISO 13473-1:1997 Part 1: Determination of Mean Profile Depth; ISO 13473-2:2002 Part 2: Terminology and basic requirements related to pavement texture profile analysis; ISO 13473-3:2002 Part 3: Specification and classification of profilometers; ISO/TS 13473-4:2008 Part 4: Spectral analysis of surface profiles

  5. PDF - Wikipedia

    en.wikipedia.org/wiki/PDF

    ISO published version 2.0 of PDF, ISO 32000-2 in 2017, available for purchase, replacing the free specification provided by Adobe. [14] In December 2020, the second edition of PDF 2.0, ISO 32000-2:2020, was published, with clarifications, corrections, and critical updates to normative references [ 15 ] (ISO 32000-2 does not include any ...

  6. Japanese Industrial Standards - Wikipedia

    en.wikipedia.org/wiki/Japanese_Industrial_Standards

    JIS X 0213:2004 – 7-bit and 8-bit double byte coded extended Kanji sets for information interchange; JIS X 0221-1:2001 – Japanese national standard which corresponds to ISO 10646; JIS X 0401:1973 – Todofuken (prefecture) identification code; JIS X 0402:2003 – Identification code for cities, towns and villages

  7. ISO 14971 - Wikipedia

    en.wikipedia.org/wiki/ISO_14971

    ISO 14971 Medical devices — Application of risk management to medical devices is a voluntary consensus standard, [1] published by International Organization for Standardization (ISO) for the first time in 1998, and specifies terminology, principles, and a process for risk management of medical devices.

  8. List of style guides - Wikipedia

    en.wikipedia.org/wiki/List_of_style_guides

    The Chicago Manual of Style, Chicago: University of Chicago Press. A Manual for Writers of Research Papers, Theses, and Dissertations, Chicago Style for Students and Researchers, by Kate L. Turabian. Often referred to as "Turabian." MLA Handbook for Writers of Research Papers, by Joseph Gibaldi. Often referred to as "MLA".

  9. ISO 15189 - Wikipedia

    en.wikipedia.org/wiki/ISO_15189

    ISO 15189 Medical laboratories — Requirements for quality and competence is an international standard that specifies the quality management system requirements particular to medical laboratories. The standard was developed by the International Organisation for Standardization 's Technical Committee 212 (ISO/TC 212).

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