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CEN - EN ISO 10993-6

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation

active, Most Current
Organization: CEN
Publication Date: 1 December 2016
Status: active
Page Count: 46
ICS Code (Biological evaluation of medical devices): 11.100.20

Document History

EN ISO 10993-6
December 1, 2016
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
A description is not available for this item.
EN ISO 10993-6
May 1, 2009
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
This part of ISO 10993 specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices. This part of ISO 10993 applies to...
EN ISO 10993-6
April 1, 2007
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
A description is not available for this item.

References

This document references:
ISO 10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Published by ISO on August 1, 2018
This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization of medical devices based on the...
This document references:
ISO 10993-11 - Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
Published by ISO on September 1, 2017
This document specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.
This document references:
ISO 10993-16 - Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
Published by ISO on May 1, 2017
This document provides principles on designing and performing toxicokinetic studies relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic studies in the...
This document references:
ISO 5832-1 - Implants for surgery - Metallic materials - Part 1: Wrought stainless steel
Published by ISO on July 15, 2016
This part of ISO 5832 specifies the characteristics of, and corresponding test methods for, wrought stainless steel for use in the manufacture of surgical implants. NOTE 1 The mechanical properties...
This document references:
ISO 5832-7 - IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 7: FORGEABLE AND COLD-FORMED COBALT-CHROMIUM-NICKEL-MOLYBDENUM-IRON ALLOY
Published by ISO on November 15, 2016
This document specifies the characteristics of, and corresponding test methods for, forgeable and coldformed cobalt-chromium-nickel-molybdenum-iron alloy for use in the manufacture of surgical...
This document is referenced by:
BS EN ISO 7198 - Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches
Published by BSI on March 31, 2017
A description is not available for this item.
This document is referenced by:
CSA Z17510-2 - Sleep apnoea breathing therapy - Part 2: Masks and application accessories
Published by CSA on January 1, 2010
This part of ISO 17510 applies to masks, their fixing and to the accessories used to connect a sleep apnoea breathing therapy equipment to the patient. It specifies requirements for masks and...
This document is referenced by:
EN 14683 - Medical face masks - Requirements and test methods
Published by CEN on March 1, 2019
This document specifies construction, design, performance requirements and test methods for medical face masks intended to limit the transmission of infective agents from staff to patients during...
This document is referenced by:
SN EN 14683+AC - Medical face masks - Requirements and test methods
Published by SNV on February 1, 2020
This document specifies construction, design, performance requirements and test methods for medical face masks intended to limit the transmission of infective agents from staff to patients during...
This document is referenced by:
NEN-EN 13060+A1 - Small steam sterilizers
Published by NEN on November 1, 2018
This European Standard specifies the performance requirements and test methods for small steam sterilizers and sterilization cycles which are used for medical purposes or for materials that are...
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