ISO 13485:2016
Medical devices - Quality management systems - Requirements for regulatory purposes

Standard No.

ISO 13485:2016

Release Date

2016

Published By

International Organization for Standardization (ISO)

Latest

ISO 13485:2016

ISO 13485:2016 Referenced Document

• ISO 10012:2003 Measurement management systems - Requirements for measurement processes and measuring equipment
• ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
• ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
• ISO 146 Metallic materials; Hardness test; Verification of Vickers hardness testing machines HV 0,2 to HV 100
• ISO 14644-10:2013 Cleanrooms and associated controlled environments - Part 10: Classification of surface cleanliness by chemical concentration
• ISO 14644-1:2015 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration
• ISO 14644-2:2015 Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
• ISO 14644-3:2005 Cleanrooms and associated controlled environments - Part 3: Test methods
• ISO 14644-4:2001 Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up
• ISO 14644-5:2004 Cleanrooms and associated controlled environments - Part 5: Operations
• ISO 14644-7:2004 Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
• ISO 14644-8:2013 Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by chemical concentration (ACC)
• ISO 14644-9:2012 Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration
• ISO 14698-1:2003 Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods
• ISO 9000:2015 Quality management systems - Fundamentals and vocabulary
• ISO 9001:2015 Quality management systems - Requirements

ISO 13485:2016 history

• 2016 ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
• 2009 ISO 13485:2003/Cor 1:2009 Medical devices - Quality management systems - Requirements for regulatory purposes; Technical Corrigendum 1
• 2003 ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
• 1996 ISO 13485:1996 Quality systems - Medical devices - Particular requirements for the application of ISO 9001