Your search resulted in 100 documents for "BS BS EN ISO 13485" amongst all current BS documents.
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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 13485:2016, BS EN ISO 13485:2012, BS EN ISO 13485:2003, BS EN ISO 13488:2001, BS EN ISO 13485:2001, BS EN 46003:1999, BS EN 46002:1997, BS EN 46001:1997, BS EN 46002:1994, BS EN 46001:1994
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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, 11/26/2020.
Languages: English
Historical Editions: BS EN ISO 14155:2011, BS EN ISO 14155-1:2009, BS EN ISO 14155-2:2009, BS 08/30116059 DC, BS EN ISO 14155-2:2003, BS EN ISO 14155-1:2003, BS EN 540:1993
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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+A1:2015, BS EN 62366:2008
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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 11137-1:2015, BS EN ISO 11137-1:2006+A1:2013, BS EN ISO 11137-1:2006, BS EN 552:1994
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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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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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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 11737-2:2009, BS 07/30157769 DC, BS EN ISO 11737-2:2000
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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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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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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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