ISO 11137 — Sterilization by Radiation — Certification Brochure

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London Academy of Professional Training
Certificate
ISO 11137 — Sterilization by Radiation
ISO Certification Programme
REF: HL-EQP-11137  •  ISO Health  •  Equipment
6Subjects 15Chapters 60Classes 430Total Marks 60%Pass Mark LifetimeValidity
At a Glance
ReferenceHL-EQP-11137
AwardCertificate
Assessment430 marks — 258 to pass (60%)
PrerequisitesNone
ValidityLifetime
Awarding BodyLAPT — London Academy of Professional Training
Curriculum
1 Continuous Improvement in Sterilisation 0 chapters  45 marks
2 Fundamentals of Radiation Sterilisation 5 chapters · 30 classes  85 marks
• 1 Understanding Radiation and Its Types — 6 classes
› 1.1 Define Radiation and Its Importance in Sterilization
› 1.2 Identify Different Types of Radiation Used in Sterilisation
› 1.3 Explain the Mechanism of Ionizing Radiation in Microbial Kill
› 1.4 Compare and Contrast Key Features of Gamma, X-ray, and Electron Beam Radiation
› 1.5 Analyze Safety Measures Related to Radiation Exposure in Sterilization
› 1.6 Evaluate the Effectiveness of Radiation Sterilisation in Various Applications
• 2 Principles of Sterilization and Microbial Control — 6 classes
› 2.1 Define Sterilization and Its Importance in Microbial Control
› 2.2 Identify Different Methods of Sterilization Used in Healthcare
› 2.3 Explain the Mechanism of Action for Radiation Sterilization
› 2.4 Compare Radiation Sterilization with Other Sterilization Techniques
› 2.5 Evaluate Factors Affecting the Efficacy of Radiation Sterilization
› 2.6 Apply Best Practices for Implementing Radiation Sterilization in Facilities
• 3 ISO 11137 Standards and Requirements — 6 classes
› 3.1 Understand ISO 11137 Standards and their Importance
› 3.2 Identify Key Terminology in Radiation Sterilisation
› 3.3 Outline the Radiation Sterilisation Process Steps
› 3.4 Analyze Equipment Requirements for Radiation Sterilisation
› 3.5 Assess Safety Protocols in Radiation Sterilisation
› 3.6 Implement Quality Control Measures Following ISO 11137
• 4 Radiation Dosimetry and Measurement Techniques — 6 classes
› 4.1 Understand Basic Principles of Radiation Dosimetry
› 4.2 Explore Different Types of Radiation Measurement Techniques
› 4.3 Identify Key Factors Affecting Radiation Dosimetry Accuracy
› 4.4 Analyze the Role of Calibration in Radiation Measurement
› 4.5 Implement Assessment Methods for Radiation Dose Distribution
› 4.6 Evaluate Real-World Applications of Radiation Dosimetry in Sterilization
• 5 Quality Assurance in Radiation Sterilization — 6 classes
› 5.1 Identify Key Components of Quality Assurance in Radiation Sterilization
› 5.2 Analyze the Role of Validation in Radiation Sterilization Processes
› 5.3 Evaluate Risk Management Strategies for Radiation Sterilization
› 5.4 Develop Standard Operating Procedures for Radiation Sterilization
› 5.5 Implement Quality Control Measures in Radiation Sterilization
› 5.6 Assess the Impact of Quality Assurance on Sterilization Outcomes
3 ISO 11137 Standards and Compliance 5 chapters · 30 classes  105 marks
• 1 Understanding ISO 11137 Standards: An Overview — 6 classes
› 1.1 Explore the Basics of ISO 11137 Standards
› 1.2 Identify Key Components of Radiation Sterilization
› 1.3 Analyze the Importance of Compliance in Sterilization Processes
› 1.4 Examine Radiation Types and Their Applications in Sterilization
› 1.5 Assess Risk Management Strategies within ISO 11137 Framework
› 1.6 Implement Best Practices for Maintaining ISO 11137 Compliance
• 2 Fundamentals of Radiation Sterilization Processes — 6 classes
› 2.1 Define Radiation Sterilization and Its Importance in Healthcare
› 2.2 Explain the Principles of Radiation Types Used in Sterilization
› 2.3 Identify Key ISO 11137 Standards Relevant to Radiation Sterilization
› 2.4 Discuss the Various Radiation Sterilization Processes and Their Applications
› 2.5 Analyze the Compliance Requirements for ISO 11137 Certification
› 2.6 Evaluate Case Studies on Successful Implementation of Radiation Sterilization
• 3 ISO 11137 Compliance Requirements and Documentation — 6 classes
› 3.1 Understand ISO 11137: Overview of Sterilization Standards
› 3.2 Identify Compliance Requirements for ISO 11137
› 3.3 Analyze Documentation Standards in ISO 11137 Compliance
› 3.4 Evaluate the Role of Validation in Radiation Sterilization
› 3.5 Implement Best Practices for Maintaining Compliance Records
› 3.6 Review Case Studies Illustrating ISO 11137 Compliance
• 4 Risk Management and Quality Assurance in Sterilization — 6 classes
› 4.1 Identify Key Risks in Radiation Sterilization Processes
› 4.2 Analyze the Impact of Risks on Quality Assurance
› 4.3 Develop Strategies for Risk Mitigation in Sterilization
› 4.4 Implement Quality Assurance Techniques for Effective Sterilization
› 4.5 Evaluate Compliance with ISO 11137 Standards
› 4.6 Create a Continuous Improvement Plan for Sterilization Quality Management
• 5 Auditing and Continuous Improvement of ISO 11137 Practices — 6 classes
› 5.1 Understand ISO 11137 Compliance Requirements
› 5.2 Identify Key Audit Processes for ISO 11137
› 5.3 Evaluate Current Practices Against ISO 11137 Standards
› 5.4 Implement Effective Corrective Actions for Non-Compliance
› 5.5 Develop an Internal Audit Checklist for ISO 11137
› 5.6 Create a Continuous Improvement Plan Based on Audit Findings
4 Quality Assurance and Control 5 chapters  85 marks
• 1 Understanding ISO 11137 Standards and Their Importance in Sterilization
• 2 Principles of Radiation Sterilization and Quality Assurance
• 3 Quality Control Measures for Radiation Sterilization Processes
• 4 Risk Management and Compliance in Radiation Sterilization
• 5 Continuous Improvement and Innovation in Quality Assurance Practices
5 Risk Management in Sterilisation Practices 0 chapters  45 marks
6 Strategic Leadership in Sterilisation 0 chapters  65 marks
LAPT — 85 Great Portland Street, W1W 7LT, London, United Kingdom
info@lapt.org  •  +44 7513 283044  •  lapt.org		 UKPRN 10067351  •  Company 4984798
Curriculum current at the date of issue.