FD ISO/TR 37137

FD ISO/TR 37137

September 2014
Published document Current

Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants

The objective of ISO/TR 37137:2014 is to provide interim Part-by-Part guidance on potential adjustments to various test methods within the 10993 series to account for the intentional release of soluble components or degradation products from absorbable medical devices. The content is intended to add clarity and present potentially acceptable approaches for reducing the possibility of erroneous or misleading results due to the nature of the absorbable material. All suggestions should be considered as preliminary and subject to change, with final dispositions implemented through direct modification to the respective parts of ISO 10993. Thus, interim adoption of any of the described adjustments requires an accompanying written justification.

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Main informations

Collections

National standards and national normative documents

Publication date

September 2014

Number of pages

21 p.

Reference

FD ISO/TR 37137

ICS Codes

11.040.40   Implants for surgery, prosthetics and orthotics

Classification index

S99-516

Print number

1

International kinship

ISO/TR 37137:2014
Sumary
Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants

The objective of ISO/TR 37137:2014 is to provide interim Part-by-Part guidance on potential adjustments to various test methods within the 10993 series to account for the intentional release of soluble components or degradation products from absorbable medical devices. The content is intended to add clarity and present potentially acceptable approaches for reducing the possibility of erroneous or misleading results due to the nature of the absorbable material. All suggestions should be considered as preliminary and subject to change, with final dispositions implemented through direct modification to the respective parts of ISO 10993. Thus, interim adoption of any of the described adjustments requires an accompanying written justification.

Table of contents
  • Avant-propos
    iv
  • 1 Domaine d'application
    1
  • 2 Termes et définitions
    1
  • 3 Considérations générales
    1
  • 4 Considérations relatives à la stérilisation
    3
  • 5 Considérations relatives aux produits combinés associant un médicament au dispositif
    3
  • 6 Liste des parties et description des questions relatives aux produits absorbables en supplément des parties pertinentes de la série ISO 10993 "Évaluation biologique des dispositifs médicaux"
    4
  • Annexe A (informative) Nomenclature des termes absorber, dégrader et des termes associés
    16
  • Bibliographie
    17
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