GOST R ISO 13022-2016
Medical products containing viable human cells. Application of risk management and requirements for processing practices

Standard No.

GOST R ISO 13022-2016

Release Date

2016

Published By

RU-GOST R

Latest

GOST R ISO 13022-2016

GOST R ISO 13022-2016 Referenced Document

• ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
• ISO 14971:2007 Medical devices - Application of risk management to medical devices
• ISO 22442-1:2007 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management

GOST R ISO 13022-2016 history

• 2016 GOST R ISO 13022-2016 Medical products containing viable human cells. Application of risk management and requirements for processing practices