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ISO 19227:2018

Current Date published:

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.

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Related Information

Similar Standards

  • AS/NZS 2817:1997

    Implants for surgery - Care and handling of orthopaedic implants

  • BS 2574-1:1991

    Lower limb orthoses, Guide to the design and manufacture of lower limb orthoses, excluding foot orthoses

  • BS 2574-2:1994

    Lower limb orthoses, Specification for hip, knee and ankle joints for lower limb orthoses

  • BS 3531-11:1991

    Implants for osteosynthesis, Implants for osteosynthesis. Specification for staples with parallel legs

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ISO 19227:2018

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