JIS Q 14971-1:2001
Medical devices -- Risk management -- Part 1: Application of risk analysis

Standard No.

JIS Q 14971-1:2001

Release Date

2001

Published By

Japanese Industrial Standards Committee (JISC)

Latest

JIS Q 14971-1:2001

Scope

This International Standard specifies procedures for investigating, using available information, the safety of medical devices, including in vitro diagnostic devices or accessories, by identifying hazards and estimating risks associated with the device.

JIS Q 14971-1:2001 history

• 2001 JIS Q 14971-1:2001 Medical devices -- Risk management -- Part 1: Application of risk analysis