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ISO 19227:2018

Implants for surgery — Cleanliness of orthopedic implants — General requirements

Implants for surgery — Cleanliness of orthopedic implants — General requirements

Pages
24
Latest Standard
ISO 19227:2018
Digital Document2018 edition2018Purchase Options

Referenced standards

ASTM D7066-04ASTM F2459-12ASTM F3127-16EN 13018:2016EN 1484:1997ISO 10993-12:2012ISO 10993-17:2002ISO 10993-1:2009ISO 10993-5:2009ISO 11737-1:2018ISO 13485:2016ISO 14644-10:2013ISO 14644-13:2017ISO 14644-14:2016ISO 14644-15:2017ISO 14644-1:2015ISO 14644-2:2015ISO 14644-3:2005ISO 14644-4:2001ISO 14644-5:2004ISO 14644-7:2004ISO 14644-8:2013ISO 14644-9:2012ISO 14971:2007ISO 2859-1:1999ISO 3951-1:2013ISO 3951-2:2013ISO 9377-2:2000ISO/IEC 17025
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ISO 19227:2018

Implants for surgery — Cleanliness of orthopedic implants — General requirements

Implants for surgery — Cleanliness of orthopedic implants — General requirements

ISO 19227:2018 specifies requirements for the cleanliness of orthopaedic implants, hereafter referred to as implants, and test methods for the cleaning process validation and controls, which are based on a risk management process.

ISO 19227:2018 does not specify requirements for packaging or sterilization which are covered by other International Standards.

ISO 19227:2018 applies to in-process cleaning and final cleaning.

ISO 19227:2018 does not apply to liquid or gaseous implants.

ISO 19227:2018 does not apply to cleaning processes performed by the user or under the responsibility of the user.

Edition2018
Published Date2018
Published ByInternational Standardization Organisation
Page Count17