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Requirements of constant product quality and quality assurance have became more and more important. As the liability issue is now also raised in hospitals about the production of medical products and therefore also of sterile products, the necessity for a well evaluated and documented production process is apparent.
In this new chapter of Jan Huys’ book „Sterilization of Medical Supplies by Steam“, directives and standards for products to be sterilized are described.
• New European legislation (MDR)