BS ISO 13019:2018

Действует

Tissue-engineered medical products. Quantification of sulfated glycosaminoglycans (sGAG) for evaluation of chondrogenesis — 24 стр.

Описание Изменения Ссылки Версии

Ссылочные документы

ASTM F2027-00

Заменен

Standard Guide for Characterization and Testing of Substrate Materials for Tissue-Engineered Medical Products — 3 стр.

ASTM F2212-02

Заменен

Standard Guide for Characterization of Type I Collagen as a Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) — 10 стр.

BS ISO 12891-1:2015

Действует

Retrieval and analysis of surgical implants. Retrieval and handling — 34 стр.

ISO/TS 10993-19:2006

Действует

Biological evaluation of medical devices -- Part 19: Physicochemical, morphological and topographical characterization of materials — 22 стр.

ISO 10993-1:2009

Заменен

Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process — 28 стр.

ISO 14971:2007

Действует

Medical devices -- Application of risk management to medical devices — 90 стр.

ISO 13022:2012

Действует

Medical products containing viable human cells -- Application of risk management and requirements for processing practices — 56 стр.

ISO 20391-1:2018

Действует

Biotechnology -- Cell counting -- Part 1: General guidance on cell counting methods — 24 стр.