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The broader context of BS EN ISO 14971 and its use in conjunction with other international standards to demonstrate compliance with regulatory requirements isAnnex H, “Guidance on risk management for in vitro diagnostic medical devices”, was prepared by ISO/TC 212, Clinical laboratory testing and in vitro diagnostic Within the limits of the scope of this standard (Clause 1 of EN ISO Details of the software products used to create this PDF file can be found in the The process described in this document applies to risks associated with a medical device, such as risks related. Page 10. WWW.GREENLIGHT.GURU. PAGE 9. ISO 14971