Sterilization by steam course
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Sterilisation by the Steam Course
Validation of Sterilisation by Steam per EN ISO 17665-1
Training Overview
This is a one-day training course to help participants understand the requirements of EN ISO 17665-1 for sterile medical devices and their relevance to MDR and UK MDR 2002. The course delivers an in-depth analysis of the sterilisation validation process for steam, with various practical study cases, it will explore the key criteria in EN ISO 17665-1 to -3.
- Understand the link between UK MDR 2002/MDR and EN ISO 17665-1, -2, -3.
- Define the requirements for validation of sterilisation.
- Recognise the different types of indicators used, and ISO 11138-1 and -3 compliance.
- Describe the requirements for sterilisation in routine use and release of batch
- Understand what the essential contents of a validation report for sterilisation should contain.
Learning Objectives / Outcomes
At the end of this training, participants will be able to:
Who Will Benefit?
This training is for:
Regulatory/Quality Assurance (QA) Managers and personnel
Design and Development Managers and personnel
Quality Control(QC) professionals
Course Syllabus
- I. Introduction
- II. Characterisation of the material in the device and its interaction with irradiation
- III. Selection of dosimeters
- IV. Validation - IQ (Installation Qualification)
- V. Validation – OQ (Operational Qualification)
- VI. Validation – PQ (Performance Qualification)
- VII. Requalification and Maintenance
- VIII. Routine Controls
- IX. Impact of device modifications on the sterilization process and extension of range
- X. Bioburden and Sterility Testing
Pre-requisites
The participant should have an introductory knowledge of:
- Microbiology
- Packaging requirements
Learning Process
We utilise interactive learning methodologies to provide an engaging and practical course. The participants will take part in study cases, applications and exercises to ensure comprehension. Courses can be conducted online or on-site as required, with modifications for business learning needs
Pricing
- Online Course: £450 per person based on class size
- Student Discount: special prices available on request (admin@mdsspro.com)
- On-Site Training: Personalise approach to meet business specification - (admin@mdsspro.com)
Why Choose MDSSPRO
Expert-Led Training on MDR Compliant Training, Made for You
MDSSPRO combines decades of experience working in the industry with a desire to be the best at medical device compliance. MDSSPRO was founded in 2016 by Patricia Vest, and consists of experienced auditors, consultants, and technical assessors that have worked with world-leading notified bodies like TÜV SÜD, SGS, UL, and Intertek.
Our training is more than a course – it is a strategic educational partnership. We ensure that our training focuses on practical and current regulatory knowledge so that your team is confident and efficient in meeting compliance. Regardless of whether the training is delivered online or in person, every training course is developed specifically to take account of your operating and regulatory environment.
Together, let's build compliance confidence.
Utilize MDSSPRO to help with your medical device compliance and assurance that meets the highest standards of regulatory and quality. Our team will be there to assist you throughout your compliance journey, with training programmes developed around your organizational needs to expert auditing and consultancy.
