UNLIMITED FREE
ACCESS TO THE WORLD'S BEST IDEAS

SUBMIT
Already a GlobalSpec user? Log in.

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

Customize Your GlobalSpec Experience

Select Your Free Newsletters

Industry Newsletters

Select Your Free Product Alerts

Finish!
Privacy Policy

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

New! AI Engineering Assistant 
- Trained on our vast library of engineering resources.

DIN EN ISO 14971

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

active, Most Current
Buy Now
Organization: DIN
Publication Date: 1 July 2020
Status: active
Page Count: 47
ICS Code (Medical equipment in general): 11.040.01

Document History

DIN EN ISO 14971
April 1, 2022
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
A description is not available for this item.
DIN EN ISO 14971
July 1, 2020
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
A description is not available for this item.
DIN EN ISO 14971
August 1, 2018
Medical devices - Application of risk management to medical devices (ISO/DIS 14971:2018); German and English version prEN ISO 14971:2018
A description is not available for this item.
DIN EN ISO 14971
April 1, 2013
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
This International Standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and...
DIN EN ISO 14971/A1
April 1, 2009
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01); English version FprEN ISO 14971:2009, Amendment 1
A description is not available for this item.
DIN EN ISO 14971
October 1, 2007
Medical devices - Application of risk management to medical devices (ISO 14971:2007) Corrigendum 1 to English version of DIN EN ISO 14971:2007-07
A description is not available for this item.
DIN EN ISO 14971
July 1, 2007
Medical devices - Application of risk management to medical devices (ISO 14971:2007)
A description is not available for this item.
DIN EN ISO 14971/A1
October 1, 2003
Medical devices - Application of risk management to medical devices - Amendment 1: Rationale for requirements (ISO 14971:2000/AMD 1:2003)
A description is not available for this item.
DIN EN ISO 14971
March 1, 2001
Medical devices - Application of risk management to medical devices (ISO 14971:2000); English version of DIN EN ISO 14971
A description is not available for this item.
View Less
View All

References

This document references:
ISO 18153 - In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials
Published by ISO on August 15, 2003
A description is not available for this item.
This document references:
ISO 19001 - In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
Published by ISO on March 15, 2013
This International Standard specifies requirements for information supplied by the manufacturer with reagents used in staining in biology. It applies to producers, suppliers and vendors of dyes,...
This document references:
ISO 10993-2 - Biological evaluation of medical devices Part 2: Animal welfare requirements
Published by ISO on July 15, 2006
This part of ISO 10993 is aimed at those who commission, design and perform tests or evaluate data from animal tests undertaken to assess the biocompatibility of materials intended for use in medical...
This document references:
ISO 15197 - In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
Published by ISO on May 15, 2013
This International Standard specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples, for specific design verification procedures...
This document references:
ISO 22442-3 - Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
Published by ISO on December 15, 2007
A description is not available for this item.
View Less
View All
Advertisement