Sterilization of health care products. Radiation - Requirements for development, validation and routine control of a sterilization process for medical devices

Sterilization of health care products. Radiation - Requirements for development, validation and routine control of a sterilization process for medical devices

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Changes introduced by Amendment 1 (A1:2013)

2 Normative references (MODIFIED)

It is important to note that when another standard is referenced within this document and that reference is undated, it directs the reader to the current version of the standard. This was done so that if the referenced standard is revised, this entire document will not require revision. An example of this is seen in Clause 2, 'Normative References'. As we can see, the reference to ISO 11137-2 is now undated. Additionally, some references to specific clauses within ISO 11137-2 have been removed in the eventuality that the document undergoes a structural change, thus making the clause references invalid.
Changes of this type are found in the following clauses:
  • • 7.4 – reference date removed
  • • 8.2.2 and 'Note to a)' – reference date and clause references removed
  • • 8.2.2 and 'Note to b)' – reference date and clause references removed
  • • 12.1.3.5 b) – reference date and clause references removed
  • • A.7.4 – reference date and clause references removed
  • • A.8.2.2 (Clauses 7, 8, and 9) - reference date and clause references removed.