This standard specifies the requirements and guidelines for the naming of medical devices in order to promote the exchange of management information and cooperation between interested parties on an international scale. YY/T 0468-2003 Medical device naming system specification for the exchange of management information YY/T0468-2003 Standard download decompression password: www.bzxz.net

YY/T 0468--2003/ISO15225:2000—Specification for the naming system of medical devices used for the management of information exchange” (English version of this standard is equivalent to ISO15225:2000 “Nomenclature” Appendix A of this standard is normative, and Appendix B and Appendix C are informative. This standard is proposed by the Medical Device Division of the State Food and Drug Administration. This standard is under the jurisdiction of the SAC/TC221 Technical Committee on Quality Management and General Requirements for Medical Devices. The drafting units of this standard are: Technical Committee on Quality Management and General Requirements for Medical Devices, Beijing Guoyixi Huaguang Certification Co., Ltd. (formerly China Medical Device Quality Certification Center). The main drafters of this standard are: Wu Junhua, Qin Shuhua, Zhang Mingzhu, Zheng Yihan, Wang Huifang, Chen Zhigang. Y Y/T0468—2003/IS015225:2000 Introduction
This standard provides the rules and guidelines for the construction of the medical device naming system so that competent authorities, certification bodies and manufacturers can meet the naming requirements for medical devices. This standard also helps to implement medical device regulations and promote international cooperation and information exchange. It is expected that such assistance and promotion can be extended to other aspects, such as regulatory authorities and healthcare providers. This standard also provides minimum data sets and requirements for the composition of data systems. The above requirements can be used by system designers to establish a database using the naming system described in the standard. The information covered by this standard is also used in the public domain. The requirements included in this standard can be used to develop and update the naming of medical devices. This standard specifies the naming The rules and guidelines for naming design ensure that the naming established in accordance with this standard is simple, practical, reasonable, and suitable for users of various professions and levels, and is suitable for both computerized systems and publishing work. In order to avoid the rapid expansion of naming systems that meet the requirements of this standard, it is hoped that a monitoring department will be established to manage and maintain such naming systems. The formulation of this standard takes into account the needs of the above departments, making it cost-effective and easy to manage. It is expected that the supervisory agencies and other departments responsible for maintaining the naming will collaborate in the management environment to achieve appropriate international coordination. 1 Scope
YY/T0468—2003/IS015225:2000 Naming for management of information exchange
Medical device naming system specifications
This standard specifies requirements and guidance for the construction of medical device nomenclature in order to facilitate the exchange of regulatory information and cooperation between interested parties (such as competent authorities, manufacturers, suppliers, healthcare providers and end users) on an international scale. Note 1: This standard includes guidance on the minimum data set and its construction. This guidance is provided to enable system designers to establish databases using the nomenclature system described hereafter.
The requirements contained in this standard can be used to establish and maintain nomenclature used to identify medical devices. Note 2: This standard does not include the name compilation itself. The name compilation is provided in a separate document. Note 3: In the original international standard, in order to supplement the specific requirements of the European Medical Devices Directive, a method for achieving common identification between organizations that exchange information in accordance with the requirements of the directive was specified.
2 Referenced Standards
The provisions of the following documents become provisions of this standard through reference in this standard. For dated referenced documents, all subsequent amendments (excluding errata) or revisions do not apply to this standard, however, parties to agreements based on this standard are encouraged to investigate whether the latest versions of these documents can be used. For undated referenced documents, the latest versions of the documents apply to this standard. ISO 1087:1990 Terminology — Vocabulary ISO/IEC 8859-1:1998 Information processing — 8-bit single-byte coded graphic character set ISO/IEC 2382-1: 1993 Information technology — Vocabulary — Part 1: Basic terminology ISO 2382-4:1987 Information processing systems — Vocabulary — Part 4: Organization of data ISO/IEC 2382-17:1996 Information technology — Vocabulary — Part 17: Databases NOTE Other documents that may be helpful in understanding this standard are listed in the bibliography. 3 Terms and definitions The following terms and definitions apply to this standard. NOTE Many of the terms used in this standard have their basis in regulatory regulations. Examples of these terms are "medical device", "customized medical device" and "manufacturer". These terms have been defined in the respective jurisdictions and will be used in the nomenclature. Due to the potential for confusion with the statutory definitions in the respective jurisdictions, these terms are not defined in this document. This standard was developed to transcend and avoid substantial confusion arising from different definitions of these terms. 3.1
character
An element in a group of elements used to form, control or represent data. [ISO/IEC 8859-1:1998]
concept
A unit of thought formed by abstraction based on the common characteristics of a group of objects. [ISO 1087:1990]
device category
No definition available.
NOTE: 4.2 includes a description of the term "device category". 1
YY/T0468—2003/IS015225:20003.4
Device type
device type
No definition available.
NOTE: 4.4 includes a description of the term "device type". 3.5
Filefile
A named group of records stored and processed as a unit. 3.6
Foreign keyforeignkey
An attribute or group of attributes in one relation that corresponds to the primary key in another relation. [ISO/IEC2382-17:1996]
Generic device group
I generic device group.
No definition available.
NOTE: 4.3 includes a description of the term "generic device group". 3.8
identifier
One or more characters used to identify or name a data element and possibly to indicate a characteristic of that data element. [ISO 2382-4:1987]
name
A verbal representation of an object.
[ISO 1087:1990]
nomenclature
A system of terms based on a pre-defined naming convention. [ISO 1087:1990]
preferred term
A term recommended by a governing body.
[ISO 1087:1990]
primary key
a key used to uniquely identify a record. [ISO/IEC 2382-17:1996]
relational structure
relational structure
data structure arranged in a relation.
ISO/IEC 2382-17:1996
secondary key.
secondary key
a key other than the primary key but for which an identifier is maintained by which one or more records can be identified. [ISO/IEC 2382-17:1996]
synonyms
different terms for the same entity.
[ISO/IEC 2382-17:1996]
template term
a basic concept derived from two or more preferred terms. 3. 17
term
a name in a language for a specified concept in a particular language. [ISO 1087:1990]
control body
monitoring body
YY/T 0468--2003/ISO 15225:2000 represents the interests of regulatory authorities, manufacturers and healthcare providers to ensure the continued applicability and effectiveness of global medical device nomenclature. 3.19
custom made device
custom made device
means a device that is specially made for a specific patient based on a written prescription given by a legally licensed physician that specifies the design characteristics and is the responsibility of the physician
Note: See Council Directive 93/42/EEC on Medical Devices. 3.20
Device intended for clinical investigationDevice intended for investigation in a suitable human clinical setting by a legally qualified medical practitioner in accordance with Article 2.1 of Annex X of Council Directive 93/42/EEC.
Note: See Council Directive 93/42/EEC on medical devices. 3.21
Supervisory authority
gatekeeper
An organization responsible for the supervisory authority and for maintaining and issuing the global nomenclature for medical devices. 3.22
Manufacturer
A natural or legal person who is responsible for the design, manufacture, packaging and labeling of a device before it is placed on the market under his own name, whether these tasks are completed by him personally or by a third party. Note: See Council Directive 93/42/EEC on medical devices. 3.23
Medical device; medical device Instruments, equipment, appliances, materials or other articles, including software required for application, intended by the manufacturer for the following purposes for human beings, used alone or in combination; their effects on the human body and in the body are not obtained by pharmacological, immunological or metabolic means, but these means may be involved and play a certain auxiliary role. These purposes are: prevention, diagnosis, treatment, monitoring, relief of diseases; diagnosis, treatment, monitoring, relief, compensation of injuries or disabilities; study, replacement, regulation of anatomical or physiological processes; pregnancy control.
YY/T0468—2003/IS015225.20004 Composition principles
4.1 General
The nomenclature consists of three levels, as shown in Figure 1. The difference between these levels lies in the different breadth of the device groups represented by the specified terms in each level. All medical devices can be classified in each level. Each level has a set of related structures (3.13) in the following order:
Device category (see 4.2)
Group of similar devices (see 4.3);
Device type (see 4.4).
Number of terms similar
10 to 20
>500000
Device category
Group of similar devices
Device type
Figure 1 General structure used for nomenclature
Anesthetic breathing equipment
Anesthetic work table
Specific manufacturer model
Note: The difference between the "product category" used in the EU Medical Devices Directive and the "device category" used in this standard should be noted. The former represents a small group of closely related devices. The latter represents a broader group of basic devices. 4.2 Device categories
Each category has a general definition of use and represents different devices with a common intended use range or common technology. A device class has the maximum number of devices covered by each stored term (3.17). For the purpose of data composition, a device class consists of records containing the device class term (3.17) and related data (such as coding and other attributes). NOTE 5.1 ​​specifies the requirements for device classes. 4.3 Homogeneous device group
A homogeneous device group consists of a group of devices with the same or similar intended use or common technology. The purpose of grouping devices together is to group together device vigilance reports or to bring together groups of essentially similar devices from different sources. Where possible, any device characteristic (e.g. implantable, non-implantable, sterile, non-sterile) can be used as a means of grouping related data. For the purpose of data composition, a homogeneous device group consists of records containing the device group term (3.17). The terminology of a device group (3.17) may include the following:
preferred term (3.11);
b) attribute term (3.16 and 5.2.4);
synonyms (3.15);
and the following related information:
d) code;
e) definition;
f) for synonyms, the code of the record of the device group containing the preferred term or attribute term; g) for attributes, the qualifier of the attribute.
Note: 5.2 specifies the requirements for the device group, and Appendix B gives examples of the device group. 4
4.4 Device type
YY/T0468—2003/IS015225:2000 Device types include various medical devices, including devices for clinical research (3.20) and customized devices (3.19) or groups of medical devices that may be produced in various models. Device types include sufficient common features to allow the manufacturer to assign a "brand" and model number. Device types have the minimum number of devices covered by each stored term (3.17). For data composition, the device type includes a record containing the device type identification and related information such as its code and other identification. The stored name is taken from the manufacturer's (3.22) documentation. NOTE 5.3 specifies the requirements for device types. 5 Requirements
5.1 Device categories
Device categories shall be selected from the appropriate terms listed in Annex A. NOTE The present list is not exhaustive and a small number of device categories may need to be added. 5.2 Groups of similar devices
NOTE: See Annex B for examples of the generation of terms for groups of similar devices. 5.2.1 General
NOTE: Each group of similar devices may be a component of more than one device category. The nomenclature shall consist of appropriate preferred terms (3.11), attribute terms and synonyms (3.15). All terms shall be given in the singular. The base text for preferred terms and attribute terms in the homogeneous device group data file shall be in English. 5.2.2 Abbreviations and acronyms
Abbreviations and acronyms, which are not symbols of units but are used as a term or part of a term, shall be in capital letters. Abbreviations used in preferred terms and attribute terms shall be expanded within the definition specified. Abbreviations used as synonyms or parts of a term shall be expanded within the term after the abbreviation is given. 5.2.3 Preferred Terms
Preferred terms shall represent a group of device types with similar or identical functions or with common characteristics. Preferred terms shall be clear and include:
a) a basic concept; followed by:
b) one or more qualifiers, separated from the basic concept by commas, as appropriate. NOTE 1: Adding more qualifiers can result in a more specific classification, and the basic concept should be the primary basis for the listing. Precise qualifiers should be used.
NOTE 2: Ambiguous qualifiers include the phrases "various", "other", "device", "various", "different". "Unclassified\ preferred terms should also be applied. Note 3: Such preliminary classification is allowed when no suitable terms are available. Commercial names should not be used as preferred terms.
Preferred terms should be defined in no more than 700 characters. 5.2.4 Attribute terms
Attribute terms should be used when more than two preferred terms are formed from the same basic concept. Attribute terms should be composed of the same basic concept plus the qualifier <qualify>. Attribute terms should not be used as synonyms.
Attribute terms should be identified by definitions of no more than 700 characters. 5.2.5 Synonyms
Synonyms should be connected to one of the following terms; 5
YY/T 0468—2003/ISO15225:2000a) preferred term; or
b) attribute term
Note: Synonyms are an auxiliary means of setting appropriate preferred terms. Synonyms should not be connected to other synonyms. 5.3 Device type
The name should consist of one of the following information: a) Information contained in the manufacturer's declaration of conformity for affixing the CE mark. Or b) Information provided to the competent authority in relation to custom-made devices or devices for clinical investigation. The device type designator should include:
a) The name of the device given by the manufacturer in the information provided. b) The name of the manufacturer or equivalent responsible person. A device type should not be part of more than one device group. The device type should be listed in one device group according to its primary intended use as specified by the manufacturer. 6 Data file requirements table
6.1 General
This part of this standard is intended for information system designers who implement naming in databases. It specifies the minimum requirements for data fields required to maintain the naming system. Each level in the data structure is represented by a data file. The requirements for data files are shown in 6.2 to 6.4. Future data fields will be added to all data files according to the requirements of the end user of the database system. In systems where the same data file has more than one natural language text, the primary key should be marked with a unique code for different languages. Note: To maintain its clarity.
The character set used for transmission should be the Latin alphabet No. 1 specified in ISO/IEC8859-1:1998. 6.2 The minimum number of digits for the device category data file fields shall be as specified in Table 1. bzxZ.net
Table 1 Requirements for device category data files
Identifiers
Data categories and formats
Numeric, 2 digits
Alphanumeric, 60 characters
Alphanumeric, 18X70 characters
Primary key
Primary key
Note 1: The reason for having two primary keys is that the codes will be used for automatic conversion between natural language texts storing terms in this data file. Note 2: The data for this data file is given in Annex A (normative). Note 3: When information is exchanged and the records in the data file described in Table 1 are part of this information, only the code of the relevant record needs to be transmitted.
6.3 Data files for groups of similar devices
Data field codes should be assigned an increasing sequence base starting from 10000. After adding a new record to the data file, the code should also be incremented by 1. - A record with a zero (blank) code and the term "unclassified" or its equivalent in another language should always appear in the data file. The "unclassified" record should have the data field synonym code and attribute qualifier set to zero (see Table 2). The data file for a group of similar devices should be as shown in Table 2:
Identifier
Synonym code
Attribute qualifier
YY/T 0468--2003/IS0 15225:2000 Table 2 Requirements for data files for similar device groups
Data categories and formats
Numbers, 5 digits
Alphanumeric code, 60 characters
Numbers, 5 digits
Numbers, 2 digits
Alphanumeric code, up to 10×70 characters Note: Appendix C gives an example of a device group record. Primary key
Primary key
If not equal to zero, the device group is a synonym, and its value is the code of the preferred term or attribute term
If not equal to zero, the device group is an attribute term. The value represents how many characters are taken from the term to be searched Basic concepts for reading (listing) corresponding preferred terms
See 5.2 of this standard
Note 1: The reason for having two primary keys is to make the codes convenient for automatic conversion between natural language texts of terms stored in data files. Note 2: In these data files involving device classification data files, there are no external keys because there is a many-to-many relationship between the two data files. System designers should use methods available in database tools to achieve this many-to-many relationship. The most common method is a data file containing codes (as external keys) for device categories and records of similar device groups. In synonym codes or attribute limits When the qualifier is not zero, the code of the record of the same device group should not be used as an external key associated with the data file.
Note 3: These records may not be available in the entire natural language text of the naming system, in which case there is no corresponding relationship (see Appendix C). Note 4: Codes of the same device group in the range of 1 to 9999 cannot be used for data transmission in accordance with this standard. This requires that the official list of the same device group shall not contain records with such code values. Codes of the same device group in the range of 1~ to 9999 are reserved for use by end users. These codes are intended for the convenience of end users to store terms outside the scope of this standard. 6.4 Device type The minimum number of fields in the data file shall be as specified in Table 3:
Table 3 Device Type Data File Requirements
Identifier
Similar Device Group
Data Category and Format
Numeric, 5 digits
Alphanumeric, 60 characters
Alphanumeric, 60 characters
External Key, representing the relationship to the Similar Device Group Record (preferred term in the naming)
Secondary Key, also used as an external key to represent the primary key when the brand and model are consecutive (see Table 3) The data fields "Brand" and "Model" shall be unique. NOTE 1: The data field "Brand" is used to identify the manufacturer on the device label. Where appropriate, it may identify the authorized representative. Abbreviated text such as a recognizable trade name or letter-to-letter trademark may be used. NOTE 2: The data field model shall be the name used by the manufacturer to identify the particular type of device. Where appropriate, other forms of information may be used, such as brand, European Article Number (EAN), Health Industry Bar Code (HIBC). These data fields should not be confused with the individual serial number of the device or the batch number of the device. Note 3: The reason for using two data fields to represent the primary key number is that the model name used by one manufacturer (or when the same manufacturer uses several brand names to represent his name) may be used by other manufacturers and therefore is not appropriate to use as the primary key. Note 4: System designers may find it useful to designate a single (numeric) data field as a more manageable primary key in the database system of the data file.
YY/T 0468—2003/ISO 15225:2000 Code: 01 Term: Active implantable devices
Appendix A
(Normative Appendix)
Description of device categories
This category includes devices that rely on energy not directly generated by the human body or gravity, and are intended to be inserted into the human body by surgical or medical means, or introduced into a natural cavity by medical means and intended to remain in the body. Note 1: Examples of devices in this category are: pacemakers, implantable infusion pumps, cochlea implants and their accessories. Note 2: See the Active Implant or Medical Devices Directive. Code: 02 Term: Anesthesia and respiratory devices This category includes devices used to supply, regulate, monitor, distribute and deliver respiratory , medical and anesthetic gases and aerosols, for the supply and/or control of breathing and/or anesthesia.
Note 3: Examples of devices in this category are: anesthesia workstations, breathing circuits, ventilators and accessories. Code: 03 Term: Dental instruments
This class includes devices used for the diagnosis, prevention, monitoring, treatment or relief of oral, maxillofacial and dental diseases. Note 4: Examples of devices in this class are: dental appliances, impression materials, dental amalgam, dental tools and their accessories. Code: 04 Term: Electromechanical medical devices
This class includes devices that operate on electrical energy (electromedical) or on energy not generated by the patient's body or gravity, and use this energy to produce an effect or action (mechanical ).
Note 5: Examples of devices in this category: EEG machines, infusion pumps, hemodialysis monitors, ECG monitors, spring-driven and elastomeric pumps. Code: 05 Term: Hospital Hardware Equipment
This category includes devices that are not directly used for diagnosis or examination, nor do they directly affect the clinical evaluation of patient status, test results or further treatment.
Note 6: Examples of devices in this category are: sterilizers, patient transport equipment, and disinfection devices. Code: 06 Term: In vitro diagnostic devices
This category includes devices used for in vitro examination of samples taken from the human body to determine physiological or pathological conditions. Note 7: Examples of devices in this category are: blood glucose monitors, bilirubin assays Instruments, microbiological sensitivity systems and their accessories. Code: 07 Term: Passive implantable devices
Note 8: This category includes devices other than active implantable devices that are implanted for more than 30 days. Examples of devices in this category are: intrauterine devices, heart valves, orthopedic prostheses and their accessories. Code: 08 Term: Ophthalmic and optical instruments This category includes devices used to diagnose, prevent, monitor, treat, correct or alleviate eye diseases and visual impairments. Note 9: Examples of devices in this category are: tonometers, intraocular lenses, slit lamps and their accessories. Code: 09 Term: Reusable instruments This category includes instruments that are reused after cleaning and sterilization after use in surgery or other occasions. Note 10: Examples of devices in this category are: retractors, hemostats, drills, saws and their accessories. Code: 10 Term: Single-use instruments This category includes instruments that are intended to be used only once. Note 11: Examples of devices in this category are: intravenous infusion sets, condoms and laparotomy sponges. Code: 11 Term: Technical assistive devices for the disabled This category includes special or general-purpose devices used to compensate, alleviate, prevent or offset injuries, disabilities or handicaps. 8
Note 12: Examples of devices in this category: crutches, prostheses, hearing aids, wheelchairs and their accessories. Code: 12 Term: Radiation devices for diagnosis and treatment YY/T0468--2003/ISO15225:2000 This category includes devices that use diagnostic and (or) treatment devices such as X-rays, magnetic resonance imaging, ultrasound imaging, in vivo isotope imaging and linear accelerators.
Note 13: Examples of devices in this category include: X-ray equipment, computed tomography devices and their accessories. 9
YY/T0468—2003/IS015225:2000 Appendix B
(Informative Appendix)
Examples of the Generation of Terms and Synonyms for Similar Devices This informative appendix provides examples of the generation of terms and the updating of names for similar device groups. B.1 Formation of Terms for Similar Device Groups
Preferred terms shall be characters that give the name a functional structure that represents the user and purpose of the device. Qualifiers, especially those common to many terms, may be based on device performance or characteristics or, where appropriate, on recognized areas of use. The general structure of preferred terms is a basic concept (single noun or noun group) followed by one or more qualifiers (adjectives or adjective groups), with the qualifiers delimited or separated by commas. The basic concept is the broadest representation of the medical device group and is further described by the qualifiers. The order of qualifiers is from broad (less restrictive) to narrow (more restrictive) when moving from left to right. B.2 Examples of terms for groups of similar devices
B.2.1 A preferred term should be structured in the following form:Basic concept
Noun or noun group
Qualifier
Adjective or adjective group
Note: The terms used in the examples are for illustration only. B.2.2 Preferred terms, hierarchical structure
Alarm, enuresis1)
Circulatory assist device, ventricular2)
Not written as
Not written as
Qualifier
Adjective or adjective group
Enuresis, alarm
Ventricular circulatory assist device
B.2.3 Preferred terms using qualifiers that reflect the nature or characteristics (principle, method) of the device named by the term. Suture, nylon
Suture, polyethylene
Suture, polyglycolic acid
B.2.4 Preferred terms using qualifiers that reflect the “field of use” of the device named in the term: Dialysis machine, extraction
Dialysis machine, bicarbonate
Dialysis machine, serum, urine
Dialysis machine, hemodialysis
B.2.5 When there are two or more preferred terms with the same basic concept, an attribute term should be introduced: Audiometer, qualifier)
Audiometer, BeKesy
Audiometer, clinical
Audiometer, impedance
Audiometer,.
B.2.6 Synonyms:
Dinamap
1) Examples starting with nouns.
Related to
2) Examples starting with a noun phrase.
Blood pressure monitor, electronic
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