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  2. 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.

  3. List of ISO standards 14000–15999 - Wikipedia

    en.wikipedia.org/wiki/List_of_ISO_standards_14000...

    ISO 15784-2:2015 Part 2: Centre to field device communications using SNMP; ISO 15784-3:2008 Part 3: Application profile-data exchange (AP-DATEX) ISO 15785:2002 Technical drawings – Symbolic presentation and indication of adhesive, fold and pressed joints; ISO 15786:2008 Technical drawings – Simplified representation and dimensioning of holes

  4. List of ISO standards - Wikipedia

    en.wikipedia.org/wiki/List_of_ISO_standards

    Download as PDF; Printable version; In other projects Wikimedia Commons; Wikidata item; ... ISO 16000 – ISO 17999; ISO 18000 – ISO 19999; ISO 20000 – ISO 99999.

  5. 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.

  6. IEC 62304 - Wikipedia

    en.wikipedia.org/wiki/IEC_62304

    IEC 62304 – medical device software – software life cycle processes [1] is an international standard published by the International Electrotechnical Commission (IEC). The standard specifies life cycle requirements for the development of medical software and software within medical devices.

  7. PDF/A - Wikipedia

    en.wikipedia.org/wiki/PDF/A

    PDF is a standard for encoding documents in an "as printed" form that is portable between systems. However, the suitability of a PDF file for archival preservation depends on options chosen when the PDF is created: most notably, whether to embed the necessary fonts for rendering the document; whether to use encryption; and whether to preserve additional information from the original document ...

  8. PDF/E - Wikipedia

    en.wikipedia.org/wiki/PDF/E

    ISO 24517-1:2008 is an ISO Standard published in 2008.. Document management—Engineering document format using PDF—Part 1: Use of PDF 1.6 (PDF/E-1) This standard defines a format (PDF/E) for the creation of documents used in geospatial, construction and manufacturing workflows [1] and is based on the PDF Reference version 1.6 from Adobe Systems.

  9. CE marking - Wikipedia

    en.wikipedia.org/wiki/CE_marking

    CE marking example on a mobile phone charger. The presence of the logo (from French, "conformité européenne" meaning "European conformity") [2] on commercial products indicates that the manufacturer or importer affirms the goods' conformity with European health, safety, and environmental protection standards.