ISO 19227:2018
Implants for surgery - Cleanliness of orthopedic implants - General requirements
- Standard No.
- ISO 19227:2018
- Release Date
- 2018
- Published By
- International Organization for Standardization (ISO)
- Latest
- ISO 19227:2018
ISO 19227:2018 Referenced Document
- ASTM D7066-04 Standard Test Method for dimer/trimer of chlorotrifluoroethylene (S-316) Recoverable Oil and Grease and Nonpolar Material by Infrared Determination*， 2023-12-23 Update
- ASTM F2459-12 Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis*， 2023-12-23 Update
- ASTM F3127-16 Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices*， 2023-12-23 Update
- EN 13018:2016 Non-destructive testing - Visual testing - General principles
- EN 1484:1997 Water analysis - Guidelines for the determination of total organic carbon (TOC) and dissolved organic carbon (DOC)
- ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
- ISO 10993-17:2002 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
- ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods
- ISO 11737-1:2018 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
- ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
- ISO 14644-10:2013 Cleanrooms and associated controlled environments - Part 10: Classification of surface cleanliness by chemical concentration
- ISO 14644-13:2017 Cleanrooms and associated controlled environments — Part 13: Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classifications
- ISO 14644-14:2016 Cleanrooms and associated controlled environments - Part 14: Assessment of suitability for use of equipment by airborne particle concentration
- ISO 14644-15:2017 Cleanrooms and associated controlled environments - Part 15: Assessment of suitability for use of equipment and materials by airborne 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 14971:2007 Medical devices - Application of risk management to medical devices
- ISO 2859-1:1999 Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection
- ISO 3951-1:2013 Sampling procedures for inspection by variables.Part 1: Specification for single sampling plans indexed by acceptance quality limit (AQL) for lot-by-lot inspection for a single quality characteristic and a single AQL
- ISO 3951-2:2013 Sampling procedures for inspection by variables. Part 2: General specification for single sampling plans indexed by acceptance quality limit (AQL) for lot-by-lot inspection of independent quality characteristics
- ISO 9377-2:2000 Water quality - Determination of hydrocarbon oil index - Part 2: Method using solvent extraction and gas chromatography
- ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories
ISO 19227:2018 history
- 2018 ISO 19227:2018 Implants for surgery - Cleanliness of orthopedic implants - General requirements
