Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
Also Known As:
SKU184977935
Published by
Deutsches Institut für Normung
DIN
Publication Date2020-05
Pages CountPages22
This part of ISO 11607 specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems. It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized. It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
Details
| Descriptors | Applications, Biocompatibility, Biological hazards, CE marking, Closures, Compatibility, Conditioning, Covers, Definitions, Density, Design, Disposables, Forming, General conditions, Germs, Hygiene, Information, Inspection, Marking, Materials specification, Medical devices, Medical equipment, Medical products, Medical sciences, Medical technology, Methods, Packages, Packaging material, Packaging tests, Performance, Permability, Physical testing, Products, Public health, Qualifications, Quality, Quality assurance, Quality management, Rating tests, Reagents, Reuse, Safety, Safety requirements, Sampling methods, Sealing, Sequence of operations, Shaping, Specification, Specification (approval), Stability, Sterile barrier systems, Sterility, Sterilization (birth control), Sterilization (hygiene), Sterilized goods, Sterilizers, Storage, Systems, Testing, Toxicity, Transport, Use, Validation, Visual inspection (testing), Processes, Procedures, Bearings, Impermeability, Freedom from holes, Tightness, Implementation |
| ICS Codes | 11.080.30 - Sterilized packaging |
| Language(s) | English |
| File Size | 1.3 MB |
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