Your search resulted in 105 documents for "BS BS EN ISO 13485" amongst all current BS documents.

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  1. MOST RECENT

    2233561

    BS EN ISO 13485:2016+A11:2021

    Medical devices. Quality management systems. Requirements for regulatory purposes

    standard by British Standard / European Standard / International Organization for Standardization, 09/08/2021.

    Languages: English

    Historical Editions: BS EN ISO 13485:2016BS EN ISO 13485:2012BS EN ISO 13485:2003BS EN ISO 13488:2001BS EN ISO 13485:2001BS EN 46003:1999BS EN 46002:1997BS EN 46001:1997BS EN 46002:1994BS EN 46001:1994

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  2. MOST RECENT

    2185404

    BS EN ISO 14155:2020

    Clinical investigation of medical devices for human subjects. Good clinical practice

    standard by British Standard / European Standard / International Organization for Standardization, 08/19/2020.

    Languages: English

    Historical Editions: BS EN ISO 14155:2011BS EN ISO 14155-1:2009BS EN ISO 14155-2:2009BS 08/30116059 DCBS EN ISO 14155-2:2003BS EN ISO 14155-1:2003BS EN 540:1993

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  3. MOST RECENT

    1916888

    BS PD IEC/TR 62366-2:2016

    Medical devices-Guidance on the application of usability engineering to medical devices

    standard by BSI Group, 04/27/2016.

    Languages: English

    Historical Editions: BS EN 62366:2008+A1:2015BS EN 62366:2008

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  4. MOST RECENT

    2094163

    BS EN ISO 11137-1:2015+A2:2019

    Sterilization of health care products. Radiation-Requirements for development, validation and routine control of a sterilization process for medical devices

    standard by British Standard / European Standard / International Organization for Standardization, 11/27/2019.

    Languages: English

    Historical Editions: BS EN ISO 11137-1:2015BS EN ISO 11137-1:2006+A1:2013BS EN ISO 11137-1:2006BS EN 552:1994

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  5. MOST RECENT

    1115590

    BS EN 556-1:2001

    Sterilization of medical devices. Requirements for medical devices to be designated "STERILE"-Part 1. Requirements for terminally sterilized medical devices

    standard by British-Adopted European Standard, 11/30/2006.

    Languages: English

    Historical Editions: BS EN 556:1995

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  6. MOST RECENT

    2009253

    BS PD CEN/TR 17223:2018

    Guidance on the relationship between EN ISO 13485:2016 (Medical devices. Quality management systems. Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation

    standard by BSI Group, 03/21/2018.

    Languages: English

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  7. MOST RECENT

    2122912

    BS EN ISO 11737-2:2020

    Sterilization of health care products. Microbiological methods-Tests of sterility performed in the definition, validation and maintenance of a sterilization process

    standard by British Standard / European Standard / International Organization for Standardization, 05/19/2020.

    Languages: English

    Historical Editions: BS EN ISO 11737-2:2009BS 07/30157769 DCBS EN ISO 11737-2:2000

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  8. MOST RECENT

    1905961

    BS EN 62304:2006+A1:2015

    Medical device software. Software life-cycle processes

    standard by British-Adopted European Standard, 11/30/2015.

    Languages: English

    Historical Editions: BS EN 62304:2006

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  9. MOST RECENT

    1112538

    BS EN 13612:2002

    Performance evaluation of in vitro diagnostic medical devices

    standard by British-Adopted European Standard, 02/27/2003.

    Languages: English

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  10. MOST RECENT

    1186874

    BS PD ISO/TR 14969:2004 [ Withdrawn ]

    Medical devices. Quality management systems. Guidance on the application of ISO 13485:2003

    standard by BSI Group, 11/03/2004.

    Languages: English

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