🔥🔥 Don’t Miss Out on Our End of Autumn Sale. If you have any questions, feel free to click the bottom right corner to contact our customer service..

Concat us[email protected]
Shopping Cart

No products in the cart.

🔍
BS EN ISO 11607-1:2020

BS EN ISO 11607-1:2020

$198.66

Packaging for terminally sterilized medical devices – Requirements for materials, sterile barrier systems and packaging systems

Published By Publication Date Number of Pages
BSI 2020 56
PDF Format Searchable Printable Preview Now
Guaranteed Safe Checkout
Categories: ,

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

PDF Catalog

PDF Pages PDF Title
2 undefined
4 European foreword
Endorsement notice
8 Foreword
9 Introduction
11 1 Scope
2 Normative references
3 Terms and definitions
16 4 General requirements
4.1 Quality systems
4.2 Risk management
4.3 Sampling
4.4 Test methods
17 4.5 Documentation
5 Materials, preformed sterile barrier systems and sterile barrier systems
5.1 General requirements
20 5.2 Microbial barrier properties
21 5.3 Compatibility with the sterilization process
5.4 Labelling system
5.5 Storage and transport of materials and preformed sterile barrier systems
22 6 Design and development for packaging systems
6.1 General
6.2 Design
23 7 Usability evaluation for aseptic presentation
24 8 Packaging system performance and stability
8.1 General
8.2 Packaging system performance testing
25 8.3 Stability testing
9 Packaging system validation and changes
26 10 Inspection immediately prior to aseptic presentation
11 Information to be provided
27 Annex A (informative) Guidance on medical packaging
30 Annex B (informative) Standardized test methods, guides and procedures that can be used to demonstrate conformity with the requirements of this document
41 Annex C (normative) Test method for resistance of impermeable materials to the passage of air
42 Annex D (informative) Environmental aspects
43 Annex E (informative) Draft guidance on ways to differentiate a sterile barrier system from protective packaging
48 Bibliography

Related products

BS EN ISO 11607-1:2020
$198.66