ISO 11607:2003
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Packaging for terminally sterilized medical devices
PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users , Hardcopy
English, French
10-02-2003
02-11-2025
1 Scope
2 Normative references
3 Definitions
4 Packaging materials
5 Package forming and sealing
6 Final (product) package
Annex A (normative) Test method for resistance of impermeable
materials to the passage of air
Annex B (informative) Evaluating package performance in
distribution, storage and handling systems
Annex C (informative) Dye penetration test
Bibliography
This International Standard specifies the requirements for single-use materials and reusable containers used for packaging of terminally sterilized medical devices, whether produced industrially or in health care facilities.
This International Standard outlines principal requirements for packaging process development and validation for the manufacturer of terminally sterilized medical devices. Forming and sealing are considered to be the most critical processes. Other process operations that can affect the final package are addressed also. Guidelines are provided for the most common practices and techniques.
This International Standard specifies essential criteria used to evaluate the performance of packages for sterile medical devices. The intent is to provide designers and manufacturers of medical devices with a framework of laboratory tests and evaluations that can be used to qualify the overall performance of the package used to protect device components during handling, distribution and storage.
This International Standard does not cover all requirements for packaging for products manufactured aseptically; in such cases, additional requirements are necessary to ensure that the packaging and packaging process do not present a source of contamination of the product.
This International Standard is not applicable to protocols for sampling plans or the number and duration of replicate runs.
NOTE For the purposes of this International Standard, hospitals or other organizations that package medical devices are considered to be manufacturers.
| Committee |
ISO/TC 198
|
| DevelopmentNote |
Supersedes ISO/FDIS 11607 (02/2003)
|
| DocumentType |
Standard
|
| Pages |
23
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NEN ISO 11607 : 2003 | Identical |
| GOST ISO 11607 : 2011 | Identical |
| GOST R ISO 11607 : 2003 | Identical |
| AAMI ISO 11607 : 2ED 2000 | Identical |
A newer version of this standard is available.
Please Login or Create an Account so you can add users to your Multi user PDF Later.
Important note : All end users must be registered with an Account prior to user licenses being assigned.
Users cannot be edited or removed once added to your Multi user PDF.