The new BS EN ISO 11137-2 2013 Edition has been released and is available now. The new revision, titled “Sterilization of health care products. Radiation. Establishing the sterilization dose,” is an adoption of the ISO 11137-2 2013 Edition, without any modification. However, there are changes to the informative Annexes that cover the relationship between the standard and the essential requirements of various EU Directives.
In the previous BS EN ISO 11137-2 2012 Edition (which included Corrigendum 1 and is now obsolete), the information was contained in just 1 Annex, Annex ZA. Now, there are 3 Annexes:
- Annex ZA, for EU Directive 90/385/EEC on active implantable medical devices,
- Annex ZB, for EU Directive 93/42/EEC on medical devices, and
- Annex ZC, for EU Directive 98/79/EC on in vitro diagnostic medical devices.
Each Annex has a table showing the relationship between this adoption of ISO 11137-2 and the specific Directive. The table is divided into 3 columns, one for the clauses of the ISO standard, one for the essential requirements (ERs) of the Directive, and one with qualifying remarks or notes.
These BS EN ISO 11137-2 Annexes show you how the standard confers the presumption of conformity for the Directive and associated EFTA (European Free Trade Association) regulations.
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