ISO 19227:2018
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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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Quality management system
4.2 Risk management
4.3 Design of cleaning process
4.4 Validation
4.5 Sampling
4.6 Manufacturing of test specimens
4.7 Testing methods
5 Cleanliness evaluation: Test methods and cleanliness acceptance criteria after final cleaning
5.1 General
5.2 Visual inspection
5.3 Bioburden
5.4 Bacterial endotoxins
5.5 Organic contaminants
5.5.1 General
5.5.2 Extraction
5.5.3 Detection
5.6 Inorganic contaminants
5.7 Particulate contamination
5.8 Cytotoxicity
6 Continued process verification
7 Documentation
Annex A (informative) Potential sources of harm in a cleaning process
Annex B (informative) Relation between cleaning process design, validation and risk management
Annex C (informative) Relation between cleaning validation, biological evaluation and sterilization validation
Bibliography
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Related Information
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AS/NZS 2817:1997
Implants for surgery - Care and handling of orthopaedic implants
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BS 2574-1:1991
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BS 2574-2:1994
Lower limb orthoses, Specification for hip, knee and ankle joints for lower limb orthoses
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BS 3531-11:1991
Implants for osteosynthesis, Implants for osteosynthesis. Specification for staples with parallel legs
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Quality management system
4.2 Risk management
4.3 Design of cleaning process
4.4 Validation
4.5 Sampling
4.6 Manufacturing of test specimens
4.7 Testing methods
5 Cleanliness evaluation: Test methods and cleanliness acceptance criteria after final cleaning
5.1 General
5.2 Visual inspection
5.3 Bioburden
5.4 Bacterial endotoxins
5.5 Organic contaminants
5.5.1 General
5.5.2 Extraction
5.5.3 Detection
5.6 Inorganic contaminants
5.7 Particulate contamination
5.8 Cytotoxicity
6 Continued process verification
7 Documentation
Annex A (informative) Potential sources of harm in a cleaning process
Annex B (informative) Relation between cleaning process design, validation and risk management
Annex C (informative) Relation between cleaning validation, biological evaluation and sterilization validation
Bibliography