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DIN EN 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 (ISO 22442-3:2007)

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Organization: DIN
Publication Date: 1 March 2008
Status: active
Page Count: 29
ICS Code (Other standards related to laboratory medicine): 11.100.99

Document History

DIN EN ISO 22442-3
March 1, 2008
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 (ISO 22442-3:2007)
A description is not available for this item.

References

This document is referenced by:
DIN EN ISO 15798 - Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2013 + Amd.1:2017) (includes Amendment :2017)
Published by DIN on February 1, 2018
This International Standard is applicable to ophthalmic viscosurgical devices (OVDs), a class of nonactive surgical implants with viscous and/or viscoelastic properties, intended for use during...
This document is referenced by:
DIN EN ISO 11135 - Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014 + Amd.1:2018) (includes Amendment :2019)
Published by DIN on April 1, 2020
A description is not available for this item.
This document is referenced by:
DIN EN ISO 14534 - Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
Published by DIN on August 1, 2015
This International Standard specifies safety and performance requirements for contact lenses, contact lens care products, and other accessories for contact lenses. This International Standard does...
This document is referenced by:
DIN EN ISO 11137-1 - Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd.1:2013 + Amd.2:2018) (includes Amendment A2:2019)
Published by DIN on April 1, 2020
A description is not available for this item.
This document is referenced by:
DIN EN ISO 5840-2 - Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015)
Published by DIN on May 1, 2016
This part of ISO 5840 is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization. This part...
This document is referenced by:
DIN EN ISO 14630 - Non-active surgical implants - General requirements (ISO 14630:2012)
Published by DIN on March 1, 2013
A description is not available for this item.
This document is referenced by:
DIN EN ISO 20857 - Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
Published by DIN on August 1, 2013
Inclusions This International Standard specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devices. NOTE Although the scope of...
This document is referenced by:
DIN EN ISO 5840-3 - Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013)
Published by DIN on June 1, 2013
This part of ISO 5840 outlines an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk management. The selection of appropriate...
This document is referenced by:
DIN EN ISO 11737-1 - Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)
Published by DIN on November 1, 2018
This document specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw...
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