ISO 22442-4-2010 Medical devices utilizing animal tissues – Principles for elimination inactivation. Requirements and application.

Categories: Regulations, Standards

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Course Content

Acknowledgements and Attestation

Submit Acknowledgements and Attestation

Introduction

1 Scope

2 Normative references

3 Terms and definitions

4 Elimination of TSE agents: basic considerations

5 Potential methods to eliminate TSE agents

6 Experimental validation of methods for eliminating TSE agents from medical devices utilizing non-viable animal tissues

6.1 General
6.2 Defining of product families for purposes of designing TSE process validation studies
6.3 Selection and testing of product for establishing and verifying the infecting dose of TSE agent
6.4 TSE agent spiking materials
6.5 Availability of bioassay animals (conventional and transgenic mice, other rodents, farm animals)
6.6 Potential development of cell culture assays for infectivity
6.7 Correlations between transmissible spongiform encephalopathy–associated prion protein and infectivity assays
6.8 Reductions in infectivity compared with failure to detect at limits of detection
6.9 Determining numbers of replicate validations needed to support inferences of reduction in infectivity rather than variations in assay performance
6.10 Requirements for step-wise reductions in transmissible spongiform encephalopathy–associated prion protein and infectivity verses whole-process validation
Experimental validation of methods Quiz

Final Exam
This final exam is administered to demonstrate the participant’s understanding and comprehension of the course materials. A score of 80% or greater is required to receive a Certificate of Completion.

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What Will You Learn?

Course Content

Acknowledgements and Attestation

Submit Acknowledgements and Attestation

Introduction

Introduction

1 Scope

1 Scope

2 Normative references

2 Normative references

3 Terms and definitions

3 Terms and definitions

Terms and Definitions Quiz

4 Elimination of TSE agents: basic considerations

4.1.1 TSEs of concern

4.1.2 Animal tissues of concern

4.1.3 Tissues infected with TSE agents

Elimination of TSE Agents Quiz

5 Potential methods to eliminate TSE agents

5.1 Methods for inactivating infectivity

5.2 Methods for removing TSE infectivity without inactivating infectivity

Potential Methods Quiz

6 Experimental validation of methods for eliminating TSE agents from medical devices utilizing non-viable animal tissues

6.1 General

6.2 Defining of product families for purposes of designing TSE process validation studies

6.3 Selection and testing of product for establishing and verifying the infecting dose of TSE agent

6.4 TSE agent spiking materials

6.5 Availability of bioassay animals (conventional and transgenic mice, other rodents, farm animals)

6.6 Potential development of cell culture assays for infectivity

6.7 Correlations between transmissible spongiform encephalopathy–associated prion protein and infectivity assays

6.8 Reductions in infectivity compared with failure to detect at limits of detection

6.9 Determining numbers of replicate validations needed to support inferences of reduction in infectivity rather than variations in assay performance

6.10 Requirements for step-wise reductions in transmissible spongiform encephalopathy–associated prion protein and infectivity verses whole-process validation

Experimental validation of methods Quiz

Final Exam
This final exam is administered to demonstrate the participant’s understanding and comprehension of the course materials. A score of 80% or greater is required to receive a Certificate of Completion.

Final ExamTerms and Definitions Quiz

Earn a Certificate

What Will You Learn?

Course Content

Acknowledgements and Attestation

Submit Acknowledgements and Attestation

Introduction

Introduction

1 Scope

1 Scope

2 Normative references

2 Normative references

3 Terms and definitions

3 Terms and definitions

Terms and Definitions Quiz

4 Elimination of TSE agents: basic considerations

4.1.1 TSEs of concern

4.1.2 Animal tissues of concern

4.1.3 Tissues infected with TSE agents

Elimination of TSE Agents Quiz

5 Potential methods to eliminate TSE agents

5.1 Methods for inactivating infectivity

5.2 Methods for removing TSE infectivity without inactivating infectivity

Potential Methods Quiz

6 Experimental validation of methods for eliminating TSE agents from medical devices utilizing non-viable animal tissues

6.1 General

6.2 Defining of product families for purposes of designing TSE process validation studies

6.3 Selection and testing of product for establishing and verifying the infecting dose of TSE agent

6.4 TSE agent spiking materials

6.5 Availability of bioassay animals (conventional and transgenic mice, other rodents, farm animals)

6.6 Potential development of cell culture assays for infectivity

6.7 Correlations between transmissible spongiform encephalopathy–associated prion protein and infectivity assays

6.8 Reductions in infectivity compared with failure to detect at limits of detection

6.9 Determining numbers of replicate validations needed to support inferences of reduction in infectivity rather than variations in assay performance

6.10 Requirements for step-wise reductions in transmissible spongiform encephalopathy–associated prion protein and infectivity verses whole-process validation

Experimental validation of methods Quiz

Final Exam This final exam is administered to demonstrate the participant’s understanding and comprehension of the course materials. A score of 80% or greater is required to receive a Certificate of Completion.

Final ExamTerms and Definitions Quiz

Earn a Certificate

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Final Exam
This final exam is administered to demonstrate the participant’s understanding and comprehension of the course materials. A score of 80% or greater is required to receive a Certificate of Completion.