With the recent changes to the resource, the following updates need to be made to the supporting documentation: 

The scope and usage, and the boundaries and relationships need updating to reflect the text we adopted in the resource proposal.  I have copied these here:

Scope and Usage

A material substance originating from a biological entity intended to be clinically applied (e.g., transplanted, infused, grafted) to another (possibly the same) biological entity.

Examples include:

hematopoietic stem cells (bone marrow, peripheral blood, or cord blood extraction)

mesenchymal stromal cells

blood products (whole blood, red blood cells, platelets, plasma, etc)

organs (kidney, lung, heart, liver etc)

tissues, human (cornea, heart valves, blood vessels, skin, tendons, cartilage, bone)

tissues, non-human (porcine valves, porcine skin, bovine cardiac tissue, etc.)

ART tissue (sperm, oocyte, embryo)

manipulated cells (e.g. CAR T-cells)

human milk for immunological properties

topical products (serum eye drops, fibrin sealant)

fecal microbiota

regenerated tissue products (regenerated epidermis, regenerated corneal epithelium, regenerated trachea)

Boundaries and Relationships

The following boundaries need to be considered:

Medication - If the product is derived from an individual or small pool, or within the same blood group, it is a BiologicallyDerivedProduct, otherwise it is to be considered a Medication.

NutritionProduct - If the product is for normal human dietary consumption it is a NutritionProduct, while if the product is for transplant, infusion, or injection it is a  BiologicallyDerivedProduct.  We note that this is remains a grey area, particularly around certain uses of human milk, that specific implementations can more specifically resolve.

Device - Some biologically derived products are considered a device within certain jurisdictions.

Specimen - A biologically derived product may involve the same material (e.g., tissue, blood, organ, etc.) as a specimen where the intended use determines whether to use Specimen, BiologicallyDerivedProduct, or transition from a Specimen to a BiologicallyDerivedProduct.  The focus of the Specimen is to conduct a diagnostic test, while the BiologicallyDerivedProduct is to use for a clinical therapy or procedure on the same or different patient.  E.g., blood used for a test is represented by a Specimen, while blood for transfusion is represented as a BiologicallyDerivedProduct.  A specimen can be obtained from a BiologicallyDerivedProduct thus creating a Specimen instance where Specimen.subject needs is a BiologicallyDerivedProduct as a source.  Note that a specimen or biologically derived product can be obtained through similar procedures such as sampling, harvesting, biopsy, or other techniques.

Substance: A substance is a homogeneous material with a definite composition that can be reproduced in the same way consistently.  Certain substances may include or originate from biologically derived product, but from the point forward where we do not care about the relationship with the originating donor(s) it is now considered and managed as a substance.

 productCode definition: A code that identifies the kind of this biologically derived product (SNOMED Ctcode; ISBT 128 Product Description Code).

identifier definition: This records identifiers associated with this biologically derived product instance that are defined by business processes. 

Add a comment: At least one identifier should be a globally unique identifier managed by a recognized Issuing Agency.

sourceIdentifier definition: This records source identifiers associated with this biologically derived product instance that are defined by business processes. 

Add a comment: Provides traceability to allow linking all the product instances that were derived from the same source.  At least one identifier should be a globally unique identifier managed by a recognized Issuing Agency.