This International Standard specifies requirements and guidance for processing practices and managing risk
associated with viable cellular components of products regulated as medicinal products, biologics, medical
devices and active implantable medical devices, or combinations thereof. It covers viable human materials of
autologous as well as allogeneic human origin, obtained from living or deceased donors.
For manufacturers of medical products containing viable cells of human origin, this International Standard
specifies procedures to be used in processing and handling, as well as those to be used in identifying the
hazards and hazardous situations associated with such cells, in order to estimate and evaluate the resulting
risks, to control these risks, and to monitor the effectiveness of that control. Furthermore, this International
Standard outlines the decision process for the residual risk acceptability, taking into account the balance of
residual risk and expected medical benefit as compared to available alternatives.
This International Standard provides requirements and guidance on risk management related to the hazards
typical of medical products manufactured utilizing viable human materials, such as:
a) contamination by bacteria, moulds, yeasts or parasites;
b) contamination by viruses;
c) contamination by agents causing Transmissible Spongiform Encephalopathies (TSE);
d) contaminating material responsible for undesired pyrogenic, immunological or toxicological reactions;
e) decomposition of the product and degradation products caused by inadequate handling;
f) hazards related to the tumorigenic potential of the cell types used;
g) complications resulting from unintended physiological and anatomical consequences (this includes
unintended migration of cells, unwanted release of biologically active substances such as hormones and
cytokines, and unintended interactions between cellular and non‑cellular components of the product);
h) failure of traceability;
i) complications resulting from the material eliciting an unintended immunogenic reaction.
For the evaluation of contamination with other unclassified pathogenic entities, similar principles might be applicable.
Hazards related to genetic modification are outside the scope of this International Standard and are
NOTE 1 A definition of "genetically modified" can be found in ASTM F2312.
NOTE 2 This International Standard does not specify a quality management system for the control of all stages of
production of medical products as described above.
If additional national or regional criteria beyond what is defined in this International Standard exist in the
country where the medical product will be used, they are also applicable.
NOTE 3 Regional requirements can be more stringent than requirements referenced in this International Standard,
especially with regard to donor eligibility criteria.
This International Standard is not applicable to:
— non‑viable materials of human origin;
— viable cells of non‑human origin;
— blood and its components used for transfusion, germ cells, organs and bone marrow used for transplantation,
and other tissues that do not meet the definition of "medical product";
— in vitro diagnostic devices.
NOTE 4 For guidance on the application of this International Standard, see Annex A.
Status: PublishedPublication date: 2012-04
Edition: 1Number of pages: 48
Technical Committee: ISO/TC 194 Biological and clinical evaluation of medical devices
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