AAMI/ISO 22442-1:2016 ✓ Most Recent

2002169 Preview

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management

standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization , 11/17/2016

Track This

Identical Versions Available

Full Description

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 ANSI/AAMI/ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. Outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk, as defined in ANSI/AAMI/ISO 14971, and expected medical benefit as compared to available alternatives. This part of ANSI/AAMI/ISO 22442 is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing animal tissues or derivatives. See more

Also Bought By Customers

 

Document History

  1. AAMI/ISO 22442-1:2016

    👀 currently
    viewing


    Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management

    • Most Recent

  2. AAMI/ISO 22442-1:2007/(R)2011


    Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management

    • Historical Version

Order Options

Delivery Options
Price: $270.00
Available for Immediate Download

Product Details

Published:

11/17/2016

ISBN(s):

9781570206658

ANSI:

ANSI Approved

Number of Pages:

35

File Size:

1 file

Same As:

ISO 22442-1:2015, BS EN ISO 22442-1:2015

Note:

This product is restricted and cannot be purchased in the following countries Ukraine, Russia, Belarus