GOST R 52999.2-2009
Cardiac valve prostheses. Part 2. Risk management

Standard No.

GOST R 52999.2-2009

Release Date

2009

Published By

RU-GOST R

Status

Withdraw 2015-01

Latest

GOST R 52999.2-2009

GOST R 52999.2-2009 Referenced Document

• GOST R 52999.1-2008 Cardiac valve prostheses. Part 1. General technical requirements and test methods
• GOST R 52999.3-2009 Cardiac valve prostheses. Part 3. Guidance on clinical investigation
• GOST R ISO 13485-2004 Medical devices. Quality management systems. System requirements for requlatory purposes
• GOST R ISO 14971-2009 Medical devices. Application of risk management to medical devices
• ISO 5840:2005 Cardiovascular implants - Cardiac valve prostheses

GOST R 52999.2-2009 history

• 2009 GOST R 52999.2-2009 Cardiac valve prostheses. Part 2. Risk management