ISO 11607-1 PDF

Product Details The process of designing and developing a packaging system for terminally sterilized medical devices is a complicated and critical endeavour. The device components and the packaging system should be combined to create a product that performs efficiently, safely and effectively in the hands of the user. The goal of a terminally sterilized medical device packaging system is to allow sterilization, provide physical protection, maintain sterility up to the point of use and allow aseptic presentation. BS EN ISO specifies the basic attributes required of materials and pre-formed systems intended for use in packaging systems for terminally sterilized medical devices, while considering the wide range of potential materials, medical devices, packaging system designs and sterilization methods.

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Product Details The process of designing and developing a packaging system for terminally sterilized medical devices is a complicated and critical endeavour.

The device components and the packaging system should be combined to create a product that performs efficiently, safely and effectively in the hands of the user.

The goal of a terminally sterilized medical device packaging system is to allow sterilization, provide physical protection, maintain sterility up to the point of use and allow aseptic presentation. BS EN ISO specifies the basic attributes required of materials and pre-formed systems intended for use in packaging systems for terminally sterilized medical devices, while considering the wide range of potential materials, medical devices, packaging system designs and sterilization methods.

The standard describes the validation requirements for forming, sealing and assembly processes. European standards that provide requirements for particular materials and preformed sterile barrier systems are available and known as the BS EN series.

The specific nature of the medical device, the intended sterilization methods s , the intended use, expiry date, transport and storage all influence the packaging system design and choice of materials.

One significant barrier to harmonization was terminology. The sterile barrier system is essential to ensure the safety of terminally sterilized medical devices. Regulatory authorities recognize the critical nature of sterile barrier systems by considering them as an accessory or a component of a medical device. Preformed sterile barrier systems sold to healthcare facilities for use in internal sterilization are considered as medical devices in many parts of the world.

BS EN ISO specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use. An overview of sterile barrier systems can be found in Annex A. It is applicable to industry, health care facilities and wherever medical devices are placed in sterile barrier systems and sterilized.

It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Nor does it describe a quality assurance system for control of all stages of manufacture. Standard Number.

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BS EN ISO 11607-1

This is the first of two international standards written to ensure that terminally sterilized medical device packaging allows sterilization, provides physical protection and maintains sterility to the point of use. BS EN ISO looks at requirements for packaging materials, as well as sterile barrier systems and packaging systems. Manufacturers of medical devices, including IVDs Manufacturers of packaging materials and packaging systems for sterile devices Healthcare facilities with in-house or contracted sterilization services Why should you use BS EN ISO ? The development and construction of packaging systems for terminally sterilized medical devices is complicated and critical to patient safety. BS EN ISO specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems intended to maintain the sterility of terminally sterilized medical devices until the point of use. Use of the standard: Supports compliance with the General Safety and Performance Requirements GSPR contained in the EU MDR [WT1] Supports increased focus internationally on requirements for sterile barrier systems for sterile medical devices Tackles the usability of packaging as well as its physical and microbiological performance Promotes state of the art procedures NOTE: BS EN ISO does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. It does not describe a quality assurance system for control of all stages of manufacture.

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BS EN ISO 11607-1:2009+A1:2014

Brad Kelechava 2 Comments Both standards in the international series for the packaging for terminally sterilized medical devices have been revised: ISO , which addresses materials, sterile barrier systems, and packaging systems, and ISO , which covers the validation for forming, sealing and assembly processes. The shared focus of these two standards is the packaging for terminally sterilized medical devices. The term sterile barrier system was introduced in ISO to describe the minimum packaging needed to perform the unique functions crucial to proper medical packaging. This includes allowing for sterilization, providing an acceptable microbial barrier, and allowing for aseptic presentation, and it, unsurprisingly, is an incredibly complicated endeavor.

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