EVS-EN ISO 11135:2014/A1:2019

EN ISO 11135:2014/A1:2019 modifies the European standard EN ISO 11135:2014.

EN ISO 11135 describes requirements for ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings. Compliance with EN ISO 11135 ensures products that meet the defined requirements for sterile products with a high degree of confidence.

The main text and the amendment can be found in the standard’s history.

In this amendment you can find:

— Relationship between EN ISO 11135 and the Essential Requirements of EU Directive 90/385/EEC on active implantable medical devices,
— Relationship between EN ISO 11135 and the Essential Requirements of EU Directive 93/42/EEC on medical devices,
— Relationship between EN ISO 11135 and the Essential Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices,
— Relationship between EN ISO 11135 and the General Safety and Performance Requirements of Regulation (EU) 2017/745,
— Relationship between EN ISO 11135 and the General Safety and Performance Requirements of Regulation (EU) 2017/746,
— Annex E (which specifies the release of a product from a single batch sterilization process).