| POCP_HD020100UV01 R_ProductInstance |
(Link to Excel View) Derived from RMIM: POCP_RM020100UV01 |
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| InstanceOfKind1 |
Design Comments: Used as an entry point to connect a product kind with a particular instance of that product. Refered to within the product kind model. |
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| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassInstance, root= "INST"} |
Design Comments: Fixed to INST (instance) |
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| quantity [0..1] Role (RTO<PQ,PQ>) |
Design Comments: The amount of the product instance being further described. |
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| productOrDeviceLotOrInstanceInstance [1..1] (ProductOrDeviceLotOrInstance) |
Design Comments: A choice of product or device. The instance model distinguishes the two because the class Device has certain attributes which are currently still being used in some cases. |
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| subjectOf [0..*] (Subject) | |||||||||
| ProductOrDeviceLotOrInstance |
Design Comments: A choice of product or device. The instance model distinguishes the two because the class Device has certain attributes which are currently still being used in some cases. |
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| asIdentifiedItem [0..*] (IdentifiedItem) |
Design Comments: Specifies alternative identifiers for a product instance. The organization scoping the role, is the organization responsible for issuing the identifier. Note, the use of this class is discouraged in the instance model. Initially the intent was to allow users to specify identifiers without needing to understand what these identifiers are. This might be the remaining use case. However, most identifiers have well-defined places such as product kind code (item code), product instance id (serial number), product instance id of a product lot for lot numbers. |
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| asContent [0..1] (Content2) |
Design Comments: Specifies the container instance of the product instance. |
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| asMember [0..1] (Member) |
Design Comments: Relates a product instance to its lot of which it is an individual member, subset or portion. A product instance can only relate to one lot. In case where a product is a mix of multiple lots use the ingredient role instead to constitute a mixed lot. This mixed lot can then be further portioned into sub-lots. Either way, a member or portion of a lot still only has one parent lot. |
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| asInstanceOfKind [0..1] (InstanceOfKind2) | |||||||||
| part [0..*] (Part) |
Design Comments: Relates a multiple-component product instance (scoper) to one of its component instances (player) consistent with the definition of Part linking the product (kind) with its part-product (kinds). |
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| ingredient [0..*] (Ingredient1) |
Design Comments: Relates an ingredient instance (player) to the product instance (scoper). See the Ingredient class (from Product) about the general meaning. Specifically for product instances, ingredients may be the constituents of a mixed lot, even if the ingredients are of the same kind. |
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| member [0..*] (Member1) |
Design Comments: Relates a product lot (or batch) to an instance or portion of it. This role would typically appear more than once to list all the members of a product lot. These members of a product lot may be individual serialized portions filled into a container (e.g., bottle or ampoule) for retail, or larger batches shipped to other manufacturers, wholesalers or repackers. Either way, each portion can be individually identified, such as with the serial number which may or may not be printed on the package. |
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| choice of ProductInstance |
Design Comments: A product instance is (a) an individual product instance, i.e., an individually identified thing with a serial number; (b) a product lot, i.e., a set of things of the same kind (e.g., 1000 for expressing a number of tablets) or an amorphous mass (e.g., 100 L of a liquid raw material), or (c) any subset, member, or portion of a product lot. The distinction between an individual thing and a lot is made in the quantity attribute, which is set to 1 (one) for individual items, or any number e.g., 1000 or amount 100 L for sets of things or amorphous masses respectively. |
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| or DeviceInstance |
Design Comments: An individually ("serialized") device of the labeled kind, and/or a production lot for multiple equal products, considered devices, even if they are not individually distinguished. This is used for the purpose of listing and tracking individual device instance. The main distinction between DeviceInstance and the more generic ProductInstance is that the DeviceInstance allows specifying manufacturer model name/number and software version number. |
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| IdentifiedItem |
Design Comments: Specifies alternative identifiers for a product instance. The organization scoping the role, is the organization responsible for issuing the identifier. Note, the use of this class is discouraged in the instance model. Initially the intent was to allow users to specify identifiers without needing to understand what these identifiers are. This might be the remaining use case. However, most identifiers have well-defined places such as product kind code (item code), product instance id (serial number), product instance id of a product lot for lot numbers. |
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| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassIdentifiedEntity, root= "IDENT"} |
Design Comments: Fixed to IDENT (identified entity), as naming is one way of identifying an entity. |
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| id [0..*] Role (DSET<II>) |
Design Comments: An identifier that has been assigned to a product by a particular identifier issuer. |
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| code [0..1] Role (CD) {CWE:D:IdentifiedEntityType} |
Design Comments: Indicates the type of identifier that has been assigned. |
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| assigningOrganization1 [0..1] (Organization) |
Design Comments: Any organization that plays a role in the product life-cycle in any way. The role that this organization plays and how it performs with regards to other organizations and the product is specified by the relationships (roles, participations) with other organizations and acts respectively. |
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| Organization |
Design Comments: Any organization that plays a role in the product life-cycle in any way. The role that this organization plays and how it performs with regards to other organizations and the product is specified by the relationships (roles, participations) with other organizations and acts respectively. |
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| choice of ProductIdentifierIssuer |
Design Comments: DEPRECATED. For backward compatibility only. Use the product organization instead. UsageNotes: DEPRECATED this is the same as the Establishment CMET. |
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| or E_ProductEstablishmentUniversal | |||||||||
| ProductIdentifierIssuer |
Design Comments: DEPRECATED. For backward compatibility only. Use the product organization instead. UsageNotes: DEPRECATED this is the same as the Establishment CMET. |
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| classCode [1..1] (M) Organization (CS) {CNE:V:EntityClassOrganization, root= "ORG"} |
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| determinerCode [1..1] (M) Organization (CS) {CNE:V:EntityDeterminerSpecific, root= "INSTANCE"} |
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| id [0..*] Organization (DSET<II>) |
Design Comments: An identifier for the organization that has issued the identifier. |
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| name [0..1] Organization (ON) |
Design Comments: The name of the organization issuing the identifier. |
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| Content2 |
Design Comments: Specifies the container instance of the product instance. |
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| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassContent, root= "CONT"} |
Design Comments: Fixed to CONT (content). |
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| quantity [0..1] Role (RTO<PQ,PQ>) |
Design Comments: The amount of the product instance (numerator) in the package instance (denominator). |
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| container [1..1] (Container) |
Design Comments: A package instance. Most data on the product instance should be in the ProductInstance class, even if it is a packaged product. The Container class is used only to represent data about the container instance as separate from the product instance. |
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| subjectOf [0..*] (Subject) | |||||||||
| Container |
Design Comments: A package instance. Most data on the product instance should be in the ProductInstance class, even if it is a packaged product. The Container class is used only to represent data about the container instance as separate from the product instance. |
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| classCode [1..1] (M) Container (CS) {CNE:V:EntityClassContainer, root= "CONT"} |
Design Comments: Fixed to CONT (container). |
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| determinerCode [1..1] (M) Container (CS) {CNE:V:EntityDeterminerSpecific, root= "INSTANCE"} |
Design Comments: Fixed to INSTANCE. |
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| id [0..1] Container (II) |
Design Comments: An id for the container distinct from the content within it. Normally serial numbers for packaged products should be on the ProductInstance. The Container class is used only to track containers as separate from the product. |
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| code [0..1] Container (CD) {CWE:D:ContainerEntityType} |
Design Comments: A code for the package. |
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| desc [0..1] Container (ED) |
Design Comments: A text description of the packaged product. |
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| formCode [0..1] Container (CD) {CWE:D:MaterialForm} |
Design Comments: A coded indicator of the type of packaging. |
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| capacityQuantity [0..1] Container (PQ) |
Design Comments: The maximum quantity of the product that the package can hold. |
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| asContent [0..1] (Content3) |
Design Comments: A role representing the relationship between an (inner) package instance and its larger (outer) package instance. |
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| asInstanceOfKind [0..1] (InstanceOfKind2) |
Design Comments: Connects a product instance with a MaterialKind specifying what kind of product it is. This is used when listing a ProductInstance along with its part or Ingredient instances. The MaterialKind.code will then cite the code of the product which this part or ingredient material is an instance. |
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| Content3 |
Design Comments: A role representing the relationship between an (inner) package instance and its larger (outer) package instance. |
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| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassContent, root= "CONT"} |
Design Comments: Fixed to CONT (content). |
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| container [1..1] (Container) | |||||||||
| subjectOf [0..*] (Subject) |
Design Comments: Links the product instance with a product event. |
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| Subject |
Design Comments: Links the product instance with a product event. |
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| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationTargetSubject, root= "SBJ"} |
Design Comments: Fixed to SUBJ (subject) |
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| quantity [0..1] Participation (PQ) |
Design Comments: The amount of items processed affected by the product event. |
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| productActChoice [1..1] (A_ProductEventUniversal) | |||||||||
| InstanceOfKind2 |
Design Comments: Connects a product instance with a MaterialKind specifying what kind of product it is. This is used when listing a ProductInstance along with its part or Ingredient instances. The MaterialKind.code will then cite the code of the product which this part or ingredient material is an instance. |
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| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassInstance, root= "INST"} |
Design Comments: Fixed to INST (instance) |
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| kindOfMaterialKind [1..1] (E_ProductMaterialKindUniversal) | |||||||||
| Member |
Design Comments: Relates a product instance to its lot of which it is an individual member, subset or portion. A product instance can only relate to one lot. In case where a product is a mix of multiple lots use the ingredient role instead to constitute a mixed lot. This mixed lot can then be further portioned into sub-lots. Either way, a member or portion of a lot still only has one parent lot. |
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| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassMember, root= "MBR"} |
Design Comments: Fixed to MBR (member) which is synonymous with portion, i.e., a sub-amount of the product (lot's) total amount, where one sub-amount is essentially equal in kind from any other sub-amount. |
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| groupProductOrDeviceLotOrInstance [1..1] (ProductOrDeviceLotOrInstance) | |||||||||
| subjectOf [0..*] (Subject) | |||||||||
| Part |
Design Comments: Relates a multiple-component product instance (scoper) to one of its component instances (player) consistent with the definition of Part linking the product (kind) with its part-product (kinds). |
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| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassPart, root= "PART"} |
Design Comments: Fixed to PART. |
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| partProductOrDeviceLotOrInstance [1..1] (ProductOrDeviceLotOrInstance) | |||||||||
| subjectOf [0..*] (Subject) | |||||||||
| Ingredient1 |
Design Comments: Relates an ingredient instance (player) to the product instance (scoper). See the Ingredient class (from Product) about the general meaning. Specifically for product instances, ingredients may be the constituents of a mixed lot, even if the ingredients are of the same kind. |
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| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassIngredientEntity, root= "INGR"} |
Design Comments: Fixed to INGR. Specializations (ACTI, etc.) might be used, but usually it is not the purpose of this class to specify different kind of ingredients, rather merely specifying that these ingredient instances are in the product. Notably, multiple ingredient instances may be of the exact same kind, but merely from different production lots. |
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| quantity [0..1] Role (RTO<PQ,PQ>) |
Design Comments: A ratio specifying how much of the ingredient product instance is in scoping product instance. If this ingredient instance role relates to the Ingredient role specifying the Product (kind), the ratio would normally be the same as the strength. However, if a product lot is created by using multiple ingredient lots for the same kind of ingredient, the ratios of each ingredient role would be compounded as follows: SUM(scoper productInstance's quantity / ingredient.quantity.numerator * ingredient.quantity.denominator) over all ingredients of the same kind divided by scoper productInstance's quantity should be equivalent to the specified ingredient strength. For example, 100 L of amoxicillin syrup with specified strength 500 mg in 5 mL is created. The raw amoxicillin originates from 2 ingredient lots. From the first lot, 2 kg of amoxicillin (moiety) were taken until it was used up, and from the second lot 8 kg were taken to make the required 10 kg of amoxicillin (moiety). This would be specified as productInstance.quantity = 100 L; ingredient1.quantity.numerator = 2 kg; ingredient1.quantity.denominator = 100 L; ingredien2.quantity.numerator = 8 kg, ingredient2.quantity.denominator = 100 L. Now: The sum (100 L / 100 L * 2 kg + 100 L / 100 L * 8 kg) / 100 L makes 10 kg / 100 L, which is equivalent to 500 mg / 5 mL. If a mixed lot of 3000 tablets is created by mixing together equal amounts of tablets from lot A and lot B, we can specify: scoping productInstance.quantity = 1; ingredientA.quantity.numerator = 2; ingredientA.quantity.denominator = 1; ingredientA.quantity.denominator = 2; now 3000 / 2 * 1 come from lot A and 3000 / 2 * 1 come from lot B. Constraint: the dimension of the denominator must be the same as the dimension of the scoping productInstance's quantity and all of the quantity numerators of the scoper's (i.e., the product instance's) played roles (e.g., member or portion of lot, part of kit, etc.). [from SPL] |
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| ingredientProductOrDeviceLotOrInstance [1..1] (ProductOrDeviceLotOrInstance) | |||||||||
| subjectOf [0..*] (Subject) | |||||||||
| Member1 |
Design Comments: Relates a product lot (or batch) to an instance or portion of it. This role would typically appear more than once to list all the members of a product lot. These members of a product lot may be individual serialized portions filled into a container (e.g., bottle or ampoule) for retail, or larger batches shipped to other manufacturers, wholesalers or repackers. Either way, each portion can be individually identified, such as with the serial number which may or may not be printed on the package. |
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| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassMember, root= "MBR"} |
Design Comments: Fixed to MBR (member) which is synonymous with portion, i.e., a sub-amount of the product (lot's) total amount, where one sub-amount is essentially equal in kind from any other sub-amount. |
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| memberProductOrDeviceLotOrInstance [1..1] (ProductOrDeviceLotOrInstance) | |||||||||
| subjectOf [0..*] (Subject) | |||||||||
| ProductInstance |
Design Comments: A product instance is (a) an individual product instance, i.e., an individually identified thing with a serial number; (b) a product lot, i.e., a set of things of the same kind (e.g., 1000 for expressing a number of tablets) or an amorphous mass (e.g., 100 L of a liquid raw material), or (c) any subset, member, or portion of a product lot. The distinction between an individual thing and a lot is made in the quantity attribute, which is set to 1 (one) for individual items, or any number e.g., 1000 or amount 100 L for sets of things or amorphous masses respectively. |
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| classCode [1..1] (M) ManufacturedMaterial (CS) {CNE:V:EntityClassManufacturedMaterial, root= "MMAT"} |
Design Comments: Fixed to MMAT (manufactured material, "material" meaning simply "thing".) |
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| determinerCode [1..1] (M) ManufacturedMaterial (CS) {CNE:V:EntityDeterminerSpecific, root= "INSTANCE"} |
Design Comments: Fixed to INSTANCE as this is a particular instance of a product (even if a large lot) actually created rather than a mere product description. |
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| id [0..1] ManufacturedMaterial (II) |
Design Comments: A unique identifier for this instance. If the product instance represents a single individual product (quantity = 1) then this id is also called the "serial number". If the product instance represents a product lot, the id is also called the "lot number". |
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| quantity [0..1] ManufacturedMaterial (PQ) |
Design Comments: The amount of product comprised by this product instance. An individually identified thing with a serial number always has quantity set to 1 (one). A product lot, i.e., a set of things of the same kind has quantity set to the lot size. E.g., 1000 tablets or 100 L of a liquid raw material. Constraint: the dimension of this attribute must be the same as the dimension of the package quantity numerator and of the ingredient quantity denominator. |
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| desc [0..1] ManufacturedMaterial (ED) |
Design Comments: A text description of the product instance. |
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| existenceTime [0..1] ManufacturedMaterial (IVL<TS>) |
Design Comments: The interval of time during which the product has been in existence. The low bound of the interval captures the date of production. |
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| expirationTime [0..1] ManufacturedMaterial (IVL<TS>) |
Design Comments: An interval of time specifying the beginning and end of the time range in which the product is considered suitable for its stated purpose. If only an expiration date is known, this is represented in the high boundary of the interval. |
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| stabilityTime [0..1] ManufacturedMaterial (IVL<TS>) |
Design Comments: The period of time during which the material item is considered usable after it is activated (e.g., use within 24 hours after opening, while the closed bottle may have a shelf-life of 2 years.) |
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| Inherits associations from ProductOrDeviceLotOrInstance |
Design Comments: A choice of product or device. The instance model distinguishes the two because the class Device has certain attributes which are currently still being used in some cases. |
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| DeviceInstance |
Design Comments: An individually ("serialized") device of the labeled kind, and/or a production lot for multiple equal products, considered devices, even if they are not individually distinguished. This is used for the purpose of listing and tracking individual device instance. The main distinction between DeviceInstance and the more generic ProductInstance is that the DeviceInstance allows specifying manufacturer model name/number and software version number. |
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| classCode [1..1] (M) Device (CS) {CNE:V:EntityClassDevice, root= "DEV"} |
Design Comments: Fixed to MMAT (manufactured material, "material" meaning simply "thing".) |
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| determinerCode [1..1] (M) Device (CS) {CNE:V:EntityDeterminerSpecific, root= "INSTANCE"} |
Design Comments: Fixed to INSTANCE. |
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| id [0..1] Device (II) |
Design Comments: The serial number if applicable to a unique device. |
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| quantity [0..1] Device (PQ){default= "1"} |
Design Comments: The amount of the product present within a particular device instance. Typically fixed to 1 or not specified. |
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| desc [0..1] Device (ED) |
Design Comments: A text description of the device. |
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| existenceTime [0..1] Device (IVL<TS>) |
Design Comments: The interval of time during which the product has been in existence. The low bound of the interval captures the date of production. |
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| expirationTime [0..1] Device (IVL<TS>) |
Design Comments: An interval of time specifying the beginning and end of the time range in which the product is considered suitable for its stated purpose. If only an expiration date is known, this is represented in the high boundary of the interval. |
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| manufacturerModelName [0..1] Device (SC) {CWE:D:ManufacturerModelName} |
Design Comments: DEPRECATED: The model number or designation of minor production variants which do not affect the properties of the device as labeled. For example, the same device might come with silver or black bezel and may have different model number designations by the manufacturer. This number is not a controlled identifier but has meaning in the context of the product and its manufacturer. This should NOT be used any more but instead, |
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| softwareName [0..1] Device (SC) {CWE:D:SoftwareName} |
Design Comments: The software or firmware version number installed in this product instance. This is specified as a "name", i.e., text string, which may be made up of numbers and letters. |
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| Inherits associations from ProductOrDeviceLotOrInstance |
Design Comments: A choice of product or device. The instance model distinguishes the two because the class Device has certain attributes which are currently still being used in some cases. |
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