ANSI/AAMI/ISO 22442-1:2007
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management

Standard No.

ANSI/AAMI/ISO 22442-1:2007

Release Date

2008

Published By

American National Standards Institute （ANSI)

Status

Be replaced

Replace By

ANSI/AAMI/ISO 22442-1:2016

Latest

ANSI/AAMI/ISO 22442-1:2016

Scope

Applies to medical devices other than in-vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. Specifies, in conjunction with ISO 14971, a procedure to investigate, using available information, the safety of such devices by estimating and evaluating the resulting risks, controlling these risks and monitoring the effectiveness of that control.

ANSI/AAMI/ISO 22442-1:2007 history

• 1970 ANSI/AAMI/ISO 22442-1:2016 Medical devices utilizing animal tissues and their derivatives—Part 1: Application of risk management
• 2008 ANSI/AAMI/ISO 22442-1:2007 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management