This International Standard specifies requirements and guidance for processing practices and managing risk<\/p>\n
associated with viable cellular components of products regulated as medicinal products, biologics, medical<\/p>\n
devices and active implantable medical devices, or combinations thereof. It covers viable human materials of<\/p>\n
autologous as well as allogeneic human origin, obtained from living or deceased donors.<\/p>\n
For manufacturers of medical products containing viable cells of human origin, this International Standard<\/p>\n
specifies procedures to be used in processing and handling, as well as those to be used in identifying the<\/p>\n
hazards and hazardous situations associated with such cells, in order to estimate and evaluate the resulting<\/p>\n
risks, to control these risks, and to monitor the effectiveness of that control. Furthermore, this International<\/p>\n
Standard outlines the decision process for the residual risk acceptability, taking into account the balance of<\/p>\n
residual risk and expected medical benefit as compared to available alternatives.<\/p>\n
This International Standard provides requirements and guidance on risk management related to the hazards<\/p>\n
typical of medical products manufactured utilizing viable human materials, such as:<\/p>\n
a) contamination by bacteria, moulds, yeasts or parasites;<\/p>\n
b) contamination by viruses;<\/p>\n
c) contamination by agents causing Transmissible Spongiform Encephalopathies (TSE);<\/p>\n
d) contaminating material responsible for undesired pyrogenic, immunological or toxicological reactions;<\/p>\n
e) decomposition of the product and degradation products caused by inadequate handling;<\/p>\n
f) hazards related to the tumorigenic potential of the cell types used;<\/p>\n
g) complications resulting from unintended physiological and anatomical consequences (this includes<\/p>\n
unintended migration of cells, unwanted release of biologically active substances such as hormones and<\/p>\n
cytokines, and unintended interactions between cellular and non-cellular components of the product);<\/p>\n
h) failure of traceability;<\/p>\n
i) complications resulting from the material eliciting an unintended immunogenic reaction.<\/p>\n
For the evaluation of contamination with other unclassified pathogenic entities, similar principles might be applicable.<\/p>\n
Hazards related to genetic modification are outside the scope of this International Standard and are<\/p>\n
addressed elsewhere.<\/p>\n
NOTE 1 A definition of "genetically modified" can be found in ASTM F2312.<\/p>\n
NOTE 2 This International Standard does not specify a quality management system for the control of all stages of<\/p>\n
production of medical products as described above.<\/p>\n
If additional national or regional criteria beyond what is defined in this International Standard exist in the<\/p>\n
country where the medical product will be used, they are also applicable.<\/p>\n
NOTE 3 Regional requirements can be more stringent than requirements referenced in this International Standard,<\/p>\n
especially with regard to donor eligibility criteria.<\/p>\n
This International Standard is not applicable to:<\/p>\n
\u2014 non-viable materials of human origin;<\/p>\n
\u2014 viable cells of non-human origin;<\/p>\n
\u2014 blood and its components used for transfusion, germ cells, organs and bone marrow used for transplantation,<\/p>\n
and other tissues that do not meet the definition of "medical product";<\/p>\n
\u2014 in vitro <\/i>diagnostic devices.<\/p>\n
NOTE 4 For guidance on the application of this International Standard, see Annex A.<\/p>\n","protected":false},"excerpt":{"rendered":"
Medical products containing viable human cells \u2014 Application of risk management and requirements for processing practices<\/b><\/p>\n\n\n
\n Published By<\/td>\n Publication Date<\/td>\n Number of Pages<\/td>\n<\/tr>\n \n ISO<\/b><\/a><\/td>\n 2012-04<\/td>\n 56<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":589537,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[162,2634],"product_tag":[],"class_list":{"0":"post-589524","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-100-20","7":"product_cat-iso","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/589524","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/589537"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=589524"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=589524"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=589524"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}