ISO 11135 — Sterilization of Health-Care Products Ethylene Oxide — Certification Brochure

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London Academy of Professional Training
Certificate
ISO 11135 — Sterilization of Health-Care Products Ethylene Oxide
ISO Certification Programme
REF: HL-EQP-11135  •  ISO Health  •  Equipment
6Subjects 10Chapters 60Classes 430Total Marks 60%Pass Mark LifetimeValidity
At a Glance
ReferenceHL-EQP-11135
AwardCertificate
Assessment430 marks — 258 to pass (60%)
PrerequisitesNone
ValidityLifetime
Awarding BodyLAPT — London Academy of Professional Training
Curriculum
1 Ethylene Oxide Sterilization Principles 5 chapters · 30 classes  85 marks
• 1 Introduction to Ethylene Oxide Sterilization Fundamentals — 6 classes
› 1.1 Define Ethylene Oxide and its Role in Sterilization
› 1.2 Explain the Mechanism of Action of Ethylene Oxide on Microorganisms
› 1.3 Identify the Key Advantages of Using Ethylene Oxide for Sterilization
› 1.4 Discuss the Health and Safety Considerations of Ethylene Oxide Usage
› 1.5 Outline the Regulatory Standards Governing Ethylene Oxide Sterilization
› 1.6 Apply Ethylene Oxide Sterilization Principles to Case Studies
• 2 ISO 11135 Standards and Regulatory Framework — 6 classes
› 2.1 Understand ISO 11135 Standard Overview
› 2.2 Explore the Regulatory Framework for Ethylene Oxide Sterilization
› 2.3 Identify Key Terminology in Ethylene Oxide Sterilization
› 2.4 Examine the Principles of Ethylene Oxide as a Sterilant
› 2.5 Analyze Compliance Requirements for ISO 11135 Certification
› 2.6 Apply ISO 11135 Standards to Real-World Sterilization Scenarios
• 3 Ethylene Oxide Sterilization Process and Equipment — 6 classes
› 3.1 Explain the Fundamentals of Ethylene Oxide Sterilization
› 3.2 Identify the Key Components of Ethylene Oxide Sterilization Equipment
› 3.3 Describe the Ethylene Oxide Sterilization Cycle Phases
› 3.4 Analyze Factors Influencing Ethylene Oxide Sterilization Efficacy
› 3.5 Demonstrate Proper Techniques for Loading Sterilization Chambers
› 3.6 Evaluate Safety Protocols and Environmental Considerations in Ethylene Oxide Use
• 4 Validation and Monitoring of Sterilization Processes — 6 classes
› 4.1 Define Key Concepts of Sterilization Validation
› 4.2 Identify the Stages of Ethylene Oxide Sterilization Process
› 4.3 Explain the Importance of Monitoring Sterilization Parameters
› 4.4 Demonstrate Validation Techniques for Ethylene Oxide Systems
› 4.5 Analyze Data from Sterilization Cycle Reports
› 4.6 Apply Corrective Actions Based on Monitoring Results
• 5 Risk Management and Safety Measures in Ethylene Oxide Use — 6 classes
› 5.1 Assessing Risks in Ethylene Oxide Sterilization Processes
› 5.2 Identifying Safety Hazards Associated with Ethylene Oxide
› 5.3 Implementing Control Measures for Ethylene Oxide Safety
› 5.4 Developing Emergency Response Plans for Ethylene Oxide Exposure
› 5.5 Evaluating Effectiveness of Safety Protocols in Ethylene Oxide Use
› 5.6 Training Staff on Risk Management and Safety for Ethylene Oxide Operations
2 Evaluation of Sterilization Practices 0 chapters  65 marks
3 Leadership in Healthcare Operations 0 chapters  65 marks
4 Regulatory Compliance and Standards 5 chapters · 30 classes  85 marks
• 1 Understanding ISO 11135: Fundamentals of Ethylene Oxide Sterilization — 6 classes
› 1.1 Explore the Fundamentals of ISO 11135
› 1.2 Identify Key Benefits of Ethylene Oxide Sterilization
› 1.3 Understand the Ethylene Oxide Sterilization Process
› 1.4 Discuss Safety Considerations and Risks Related to Ethylene Oxide
› 1.5 Evaluate Compliance Standards in Ethylene Oxide Sterilization
› 1.6 Apply ISO 11135 Standards to Real-world Scenarios
• 2 Regulatory Framework: Compliance Requirements for Health-Care Products — 6 classes
› 2.1 Understand Regulatory Frameworks for Health-Care Products
› 2.2 Identify Key Standards for Sterilization Processes
› 2.3 Analyze the Role of ISO 11135 in Compliance
› 2.4 Evaluate Risk Management Strategies for Ethylene Oxide Sterilization
› 2.5 Implement Documentation Practices for Regulatory Compliance
› 2.6 Assess Continuous Improvement in Sterilization Practices
• 3 Quality Management Systems: Integration with ISO 11135 — 6 classes
› 3.1 Understand Key Principles of ISO 11135 for Effective Quality Management
› 3.2 Analyze the Relationship Between ISO 11135 and Regulatory Compliance
› 3.3 Identify Essential Components of Quality Management Systems in Healthcare
› 3.4 Evaluate the Role of Risk Management in ISO 11135 Implementation
› 3.5 Develop Strategies for Integrating ISO 11135 into Existing Quality Systems
› 3.6 Assess the Impact of Ethylene Oxide Sterilization on Product Quality and Safety
• 4 Risk Management in Ethylene Oxide Sterilization: A Deep Dive — 6 classes
› 4.1 Identify key risks in Ethylene Oxide sterilization processes
› 4.2 Analyze regulatory requirements for Ethylene Oxide sterilization
› 4.3 Evaluate risk assessment methodologies for healthcare sterilization
› 4.4 Develop a risk management plan for Ethylene Oxide sterilization
› 4.5 Implement monitoring strategies to mitigate risks in sterilization
› 4.6 Review case studies on risk management failures in sterilization
• 5 Audit and Continuous Improvement: Ensuring Ongoing Compliance — 6 classes
› 5.1 Understand the Basics of ISO 11135 Standards
› 5.2 Identify Key Audit Requirements for Sterilization Processes
› 5.3 Develop Effective Audit Checklists for Compliance
› 5.4 Analyze Audit Findings for Continuous Improvement
› 5.5 Implement Corrective Actions Following Audit Reviews
› 5.6 Establish a Culture of Continuous Compliance Monitoring
5 Risk Management in Sterilization 0 chapters  65 marks
6 Training and Staff Development 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.