magnifying icon Basket
1 item ^

Basket is empty
Login

Login

LOGGED AS

Help

Satisfaction enquiry

SATISFACTION ENQUIRY

Newsletter

Free of charge lifelong learning "Standardization"

FREE OF CHARGE LIFELONG LEARNING "STANDARDIZATION"

Standardisation

Draft standards in public enquiry

DRAFT STANDARDS IN PUBLIC ENQUIRY

Standards organizations

STANDARDS ORGANIZATIONS

  • National standards

  • European standards

  • International standards


Deliverable

 
Free preview
Price
Language
 
ISO/TR 24971 Ed.1.0 Edition 06/2013
Medical devices -- Guidance on the application of ISO 14971
  •  
  •  
  •  
 

Abstract

ISO TR 24971:2013 provides guidance in addressing specific areas of ISO 14971 when implementing risk management. This guidance is intended to assist manufacturers and other users of the standard to understand the role of international product safety and process standards in risk management, develop the policy for determining the criteria for risk acceptability, incorporate production and post-production feedback loop into risk management, differentiate between "information for safety" and "disclosure of residual risk", and evaluate overall residual risk.

Status

Standard - Inactive

Origin

Technical Committee :
62A : Common aspects of electrical equipment used in medical practice

Implementation

start of the vote on the project      date of ratification (dor)   
end of the vote on the project      date of anouncement (doa)   
start of the vote on the final project      date of publication (dop)   
end of the vote on the final project      date of withdrawal (dow)   


Publication Official Journal
of the Grand-Duchy of Luxembourg
Reference

Relations

Evolutions
IEC 60951-3 Ed.3.0 RLV
IEC 60951-3 Ed.3.0 RLV
ISO/TR 24971 Ed.2.0
ISO/TR 24971 Ed.2.0

International Classification for Standards (ICS codes) :

11.040.01 : Medical equipment in general

magnifying icon Basket
1 item ^

Basket is empty


Warning:
DIN standards can be downloaded only once! After downloading, they are no longer available in the eLibrary.
Begin download?