The consortium responsible for drawing up the draft of this guideline has also participated as a national working group in compiling the first public edition of the ISO 16232 series. Among other things, the final report differs in the fact that the contents are more detailed and that examples have been included, usually listed either as “Comment” or “Example” or with the addition of “Informative”. With a view to the ISO 16232 series, the following subjects have been dealt with either additionally or in more detail.
- Scope of application and validity
- Agreement on cleanliness inspection (informative)
- Simplified cleanliness inspection – monitoring variations (informative)
- Selection of inspection method (informative)
- Appropriate clean handling of test components
- Extraction procedure set up and validation and blank test
- Case examples.
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