ANNEX VIII
CLASSIFICATION RULES 分類規則
CHAPTER I
DEFINITIONS SPECIFIC TO CLASSIFICATION RULES 分類規則的特定定義
1. DURATION OF USE使用期限
1.1. ‘Transient’ means normally intended for continuous use for less than 60 minutes.
瞬態”是指通常連續使用不到60分鐘的時間。
1.2. ‘Short term’ means normally intended for continuous use for between 60 minutes and 30 days.
“短期”是指通常打算連續使用60分鐘到30天。
1.3. ‘Long term’ means normally intended for continuous use for more than 30 days.
“長期”是指通常打算連續使用30天以上。
2. INVASIVE AND ACTIVE DEVICES侵入式和主動式設備
2.1. ‘Body orifice’ means any natural opening in the body, as well as the external surface of the eyeball, or any permanent artificial opening, such as a stoma.“身體孔口”是指身體以及眼球外表面的任何自然開口，或任何永久性的人工開口，例如造口。
2.2. ‘Surgically invasive device’ means:“外科手術設備”是指：
| (a) | an invasive device which penetrates inside the body through the surface of the body, including through mucous membranes of body orifices with the aid or in the context of a surgical operation; and在身體的幫助下或在外科手術的情況下，通過身體的表面（包括通過體孔的粘膜）穿透體內的侵入性裝置；和 |
| (b) | a device which produces penetration other than through a body orifice.產生通過身體孔口以外的穿透的裝置。 |
2.3. ‘Reusable surgical instrument’ means an instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out.“可重複使用的手術器械”是指旨在用於外科手術中的切割，鑽孔，鋸切，刮擦，刮擦，夾緊，縮回，剪裁或類似操作的器械，無需連接有源設備，製造商打算在使用後再使用已經執行了適當的程序，例如清潔，消毒和滅菌。
2.4. ‘Active therapeutic device’ means any active device used, whether alone or in combination with other devices, to support, modify, replace or restore biological functions or structures with a view to treatment or alleviation of an illness, injury or disability.“主動治療裝置”是指為治療，減輕疾病，傷害或殘疾而使用的任何主動裝置，無論是單獨使用還是與其他裝置結合使用，以支持，修改，替換或恢復生物學功能或結構。
2.5. ‘Active device intended for diagnosis and monitoring’ means any active device used, whether alone or in combination with other devices, to supply information for detecting, diagnosing, monitoring or treating physiological conditions, states of health, illnesses or congenital deformities.“用於診斷和監視的有源設備”是指任何用於單獨提供信息以檢測，診斷，監視或治療生理狀況，健康狀況，疾病或先天性畸形的信息的有源設備，無論是單獨使用還是與其他設備結合使用。
2.6. ‘Central circulatory system’ means the following blood vessels: arteriae pulmonales, aorta ascendens, arcus aortae, aorta descendens to the bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales, vena cava superior and vena cava inferior.“中央循環系統”是指以下血管：肺動脈，升主動脈，主動脈弓，主動脈下降到分叉主動脈，冠狀動脈，冠狀動脈，冠狀動脈內動脈，腕間動脈，腦幹，腦動脈， ，維納肺，上腔靜脈和下腔靜脈。
2.7. ‘Central nervous system’ means the brain, meninges and spinal cord.“中樞神經系統”是指大腦，腦膜和脊髓。
2.8. ‘Injured skin or mucous membrane’ means an area of skin or a mucous membrane presenting a pathological change or change following disease or a wound.“受傷的皮膚或粘膜”是指出現疾病或傷口後發生病理變化或變化的皮膚或粘膜區域。
CHAPTER II
IMPLEMENTING RULES 實施細則
3.1. Application of the classification rules shall be governed by the intended purpose of the devices.分類規則的應用應受設備的預期用途支配。
3.2. If the device in question is intended to be used in combination with another device, the classification rules shall apply separately to each of the devices. Accessories for a medical device and for a product listed in Annex XVI shall be classified in their own right separately from the device with which they are used.如果要將該設備與其他設備組合使用，則分類規則應分別適用於每個設備。醫療器械附件和附件XVI中所列產品的附件應獨立於其使用的器械而單獨分類。
3.3. Software, which drives a device or influences the use of a device, shall fall within the same class as the device.
If the software is independent of any other device, it shall be classified in its own right.驅動設備或影響設備使用的軟件應與設備屬於同一類。
如果軟件獨立於任何其他設備，則應按其自身權利進行分類。
3.4. If the device is not intended to be used solely or principally in a specific part of the body, it shall be considered and classified on the basis of the most critical specified use.如果不打算將設備單獨或主要用於人體的特定部位，則應根據最嚴格的指定用途對設備進行考慮和分類。
3.5. If several rules, or if, within the same rule, several sub-rules, apply to the same device based on the device's intended purpose, the strictest rule and sub-rule resulting in the higher classification shall apply.如果根據設備的預期用途將多個規則或同一規則中的多個子規則應用於同一設備，則應採用最嚴格的規則和導致更高分類的子規則。
3.6. In calculating the duration referred to in Section 1, continuous use shall mean:在計算第1節中提到的持續時間時，連續使用應表示：
| (a) | the entire duration of use of the same device without regard to temporary interruption of use during a procedure or temporary removal for purposes such as cleaning or disinfection of the device. Whether the interruption of use or the removal is temporary shall be established in relation to the duration of the use prior to and after the period when the use is interrupted or the device removed; and
整個設備的整個使用期間，而無視程序期間的臨時使用中斷或出於清潔或消毒目的而臨時拆除的情況。應根據使用中斷或移除設備之前和之後的使用持續時間來確定中斷使用或移除是暫時的；和 |
(b) |
the accumulated use of a device that is intended by the manufacturer to be replaced immediately with another of the same type.製造商打算立即用另一種相同類型的設備替換累積使用的設備。 |
3.7. A device is considered to allow direct diagnosis when it provides the diagnosis of the disease or condition in question by itself or when it provides decisive information for the diagnosis.當設備本身提供有關疾病或狀況的診斷或為診斷提供決定性信息時，就認為該設備可以直接診斷。
CHAPTER III
CLASSIFICATION RULES 分類規則
4. NON-INVASIVE DEVICES非侵入性設備
4.1. Rule 1
All non-invasive devices are classified as class I, unless one of the rules set out hereinafter applies.除非適用以下規則之一，否則所有非侵入性設備均被歸為I類。
4.2. Rule 2
All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa:所有旨在最終輸注，給藥或引入人體的旨在引導或存儲血液，體液，細胞或組織，液體或氣體的非侵入性設備均歸為IIa類：
| — | if they may be connected to a class IIa, class IIb or class III active device; or如果它們可以連接到IIa類，IIb類或III類有源設備；或者 |
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if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.如果用於輸送或儲存血液或其他體液或用於儲存器官，器官的一部分或人體細胞和組織（除血袋外）；血袋被歸類為IIb類。 |
In all other cases, such devices are classified as class I.在所有其他情況下，此類設備被歸類為I類。
4.3. Rule 3
All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa.
All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III.所有旨在改變人體組織或細胞，血液，其他體液或打算植入體內或向體內施用的其他液體的生物學或化學組成的非侵入性器械均歸為IIb類，除非使用該器械進行的治療由過濾，離心或氣體，熱交換組成，在這種情況下，它們被分類為IIa類。
所有非侵入性器械，由一種或多種物質組成，旨在在體外與取自人體的人類細胞，組織或器官直接接觸，或在植入或給藥至人體之前與人類胚胎體外接觸歸類為III類。
4.4. Rule 4
All non-invasive devices which come into contact with injured skin or mucous membrane are classified as:所有與受傷的皮膚或粘膜接觸的非侵入性設備均分類為：
| — | class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;如果打算用作機械屏障，壓縮或吸收滲出物，則為I類； |
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class IIb if they are intended to be used principally for injuries to skin which have breached the dermis or mucous membrane and can only heal by secondary intent;如果打算將其主要用於皮膚破損的真皮或粘膜損傷，並且只能通過次級意圖治愈，則為IIb級； |
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class IIa if they are principally intended to manage the micro-environment of injured skin or mucous membrane; and如果主要是為了管理受傷的皮膚或粘膜的微環境，則為IIa類；和 |
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class IIa in all other cases.在所有其他情況下，均為IIa類。 |
This rule applies also to the invasive devices that come into contact with injured mucous membrane.該規則也適用於與受傷的粘膜接觸的侵入性設備。
5. INVASIVE DEVICES侵入性設備
5.1. Rule 5
All invasive devices with respect to body orifices, other than surgically invasive devices, which are not intended for connection to an active device or which are intended for connection to a class I active device are classified as:除外科手術侵入性裝置以外，不打算與有源裝置連接或與I類有源裝置連接的所有與體孔有關的侵入性裝置均分類為：
| — | class I if they are intended for transient use;如果是打算暫時使用的，則為I類； |
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class IIa if they are intended for short-term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in the nasal cavity, in which case they are classified as class I; and如果打算短期使用，則為IIa類；除非用於遠至咽部的口腔，直至耳鼓的耳道或鼻腔中，否則將其歸類為IIa類。Class I;和 |
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class IIb if they are intended for long-term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in the nasal cavity and are not liable to be absorbed by the mucous membrane, in which case they are classified as class IIa.如果它們打算長期使用，則為IIb級，除非它們用於遠至咽部的口腔中，直至耳鼓的耳道或鼻腔中，並且不易被皮膚吸收粘膜，在這種情況下，它們被分類為IIa類。 |
All invasive devices with respect to body orifices, other than surgically invasive devices, intended for connection to a class IIa, class IIb or class III active device, are classified as class IIa.除外科手術侵入性器械外，所有與體孔有關的侵入性器械（旨在與IIa，IIb或III類有源器械連接）均歸為IIa類。
5.2. Rule 6
All surgically invasive devices intended for transient use are classified as class IIa unless they:所有打算暫時使用的外科手術器械均被分類為IIa類，除非它們：
| — | are intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with those parts of the body, in which case they are classified as class III;旨在通過直接接觸身體的那些部位來控制，診斷，監測或糾正心臟或中央循環系統的缺陷，在這種情況下，它們被分類為III類； |
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are reusable surgical instruments, in which case they are classified as class I;是可重複使用的手術器械，在這種情況下，它們被歸為I類； |
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are intended specifically for use in direct contact with the heart or central circulatory system or the central nervous system, in which case they are classified as class III;專門用於與心臟或中央循環系統或中樞神經系統直接接觸，在這種情況下，它們被分類為III類； |
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are intended to supply energy in the form of ionising radiation in which case they are classified as class IIb;旨在以電離輻射的形式提供能量，在這種情況下，它們被歸類為IIb級； |
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have a biological effect or are wholly or mainly absorbed in which case they are classified as class IIb; or具有生物學效應或被全部或主要吸收，在這種情況下，它們被歸類為IIb類；或者 |
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are intended to administer medicinal products by means of a delivery system, if such administration of a medicinal product is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are classified as class IIb.“藥品”旨在通過輸送系統來管理藥品，如果這種藥品的給藥方式在考慮到施用方式的情況下可能具有潛在的危險，在這種情況下，它們被歸為IIb類。 |
5.3. Rule 7
All surgically invasive devices intended for short-term use are classified as class IIa unless they:所有打算短期使用的外科手術器械均被分類為IIa類，除非它們：
| — | are intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with those parts of the body, in which case they are classified as class III;旨在通過直接接觸身體的那些部位來控制，診斷，監測或糾正心臟或中央循環系統的缺陷，在這種情況下，它們被分類為III類； |
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are intended specifically for use in direct contact with the heart or central circulatory system or the central nervous system, in which case they are classified as class III;專門用於與心臟或中央循環系統或中樞神經系統直接接觸，在這種情況下，它們被分類為III類； |
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are intended to supply energy in the form of ionizing radiation in which case they are classified as class IIb;旨在以電離輻射的形式提供能量，在這種情況下，它們被歸類為IIb級； |
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have a biological effect or are wholly or mainly absorbed in which case they are classified as class III;具有生物學效應或被全部或主要吸收，在這種情況下，它們被歸類為III類； |
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are intended to undergo chemical change in the body in which case they are classified as class IIb, except if the devices are placed in the teeth; or打算在體內進行化學變化，在這種情況下，它們被分類為IIb類，除非將器械放置在牙齒中；或者 |
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are intended to administer medicines, in which case they are classified as class IIb.用於管理藥物，在這種情況下，它們被歸類為IIb類。 |
5.4. Rule 8
All implantable devices and long-term surgically invasive devices are classified as class IIb unless they:所有可植入設備和長期外科手術侵入設備均歸為IIb類，除非它們：
| — | are intended to be placed in the teeth, in which case they are classified as class IIa;打算放置在牙齒中，在這種情況下，它們被分類為IIa類； |
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are intended to be used in direct contact with the heart, the central circulatory system or the central nervous system, in which case they are classified as class III;旨在與心臟，中央循環系統或中樞神經系統直接接觸使用，在這種情況下，它們被分類為III類； |
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have a biological effect or are wholly or mainly absorbed, in which case they are classified as class III;具有生物學效應或被全部或主要吸收，在這種情況下，它們被分類為III類； |
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are intended to undergo chemical change in the body in which case they are classified as class III, except if the devices are placed in the teeth;打算在體內進行化學變化，在這種情況下，它們被歸類為III類，除非器械放置在牙齒中； |
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are intended to administer medicinal products, in which case they are classified as class III;用於管理藥品，在這種情況下，它們被歸類為III類； |
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are active implantable devices or their accessories, in which cases they are classified as class III;是有源植入設備或其附件，在這種情況下，它們被分類為III類； |
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are breast implants or surgical meshes, in which cases they are classified as class III;是乳房植入物或手術網，在這種情況下，它們被分類為III類； |
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are total or partial joint replacements, in which case they are classified as class III, with the exception of ancillary components such as screws, wedges, plates and instruments; or是全部或部分關節置換，在這種情況下，它們被分類為III類，但螺釘，楔子，平板和器械等輔助部件除外；或者 |
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are spinal disc replacement implants or are implantable devices that come into contact with the spinal column, in which case they are classified as class III with the exception of components such as screws, wedges, plates and instruments.是脊椎盤置換植入物或與脊柱接觸的可植入設備，在這種情況下，它們被分類為III類，但螺釘，楔形物，板和器械等組件除外。 |
6. ACTIVE DEVICES活動設備
6.1. Rule 9
All active therapeutic devices intended to administer or exchange energy are classified as class IIa unless their characteristics are such that they may administer energy to or exchange energy with the human body in a potentially hazardous way, taking account of the nature, the density and site of application of the energy, in which case they are classified as class IIb.
All active devices intended to control or monitor the performance of active therapeutic class IIb devices, or intended directly to influence the performance of such devices are classified as class IIb.
All active devices intended to emit ionizing radiation for therapeutic purposes, including devices which control or monitor such devices, or which directly influence their performance, are classified as class IIb.
All active devices that are intended for controlling, monitoring or directly influencing the performance of active implantable devices are classified as class III.所有打算用於管理或交換能量的有源治療設備，除非其特性是考慮到其性質，密度和部位，以可能以潛在危險的方式向人體提供能量或與人體交換能量，否則均分類為IIa類。能量的應用，在這種情況下，它們被歸為IIb類。
所有旨在控製或監視有源IIb類治療設備性能或直接影響此類設備性能的有源設備均歸為IIb類。
為了治療目的而打算發射電離輻射的所有有源設備，包括控製或監視此類設備或直接影響其性能的設備，均歸為IIb類。
所有旨在控制，監視或直接影響有源可植入設備性能的有源設備均歸為III類。
6.2. Rule 10
Active devices intended for diagnosis and monitoring are classified as class IIa:用於診斷和監視的有源設備被歸類為IIa類：
| — | if they are intended to supply energy which will be absorbed by the human body, except for devices intended to illuminate the patient's body, in the visible spectrum, in which case they are classified as class I;如果它們旨在提供可被人體吸收的能量，除了用於在可見光譜中照亮患者身體的設備之外，在這種情況下，它們被歸為I類； |
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if they are intended to image in vivo distribution of radiopharmaceuticals; or如果它們旨在對放射性藥物的體內分佈進行成像；或者 |
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if they are intended to allow direct diagnosis or monitoring of vital physiological processes, unless they are specifically intended for monitoring of vital physiological parameters and the nature of variations of those parameters is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration, activity of the central nervous system, or they are intended for diagnosis in clinical situations where the patient is in immediate danger, in which cases they are classified as class IIb.如果它們旨在直接診斷或監測重要的生理過程，除非它們專門用於監測重要的生理參數，並且這些參數的變化性質可能會導致對患者的直接危險，例如變化在心臟功能，呼吸，中樞神經系統活動方面，或者打算在患者處於緊急危險的臨床情況下進行診斷，在這種情況下，它們被分類為IIb類。 |
Active devices intended to emit ionizing radiation and intended for diagnostic or therapeutic radiology, including interventional radiology devices and devices which control or monitor such devices, or which directly influence their performance, are classified as class IIb.旨在發射電離輻射並用於診斷或治療放射學的有源設備，包括介入放射學設備和控製或監視此類設備或直接影響其性能的設備，均歸為IIb類。
6.3. Rule 11
Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause:旨在提供用於做出具有診斷或治療目的的決定的信息的軟件被歸類為IIa類，除非此類決定可能會導致以下影響：
| — | death or an irreversible deterioration of a person's state of health, in which case it is in class III; or死亡或人的健康狀況不可逆轉的惡化，在這種情況下，屬於第三類；或者 |
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a serious deterioration of a person's state of health or a surgical intervention, in which case it is classified as class IIb.人的健康狀況嚴重惡化或手術干預，在這種情況下，其分類為IIb級。 |
Software intended to monitor physiological processes is classified as class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb.
All other software is classified as class I.
旨在監視生理過程的軟件被分類為IIa類，除非該軟件旨在監視重要的生理參數，否則這些參數的變化會導致對患者的直接危險，在這種情況下，歸類為IIb類。
所有其他軟件均歸為I類。
6.4. Rule 12
All active devices intended to administer and/or remove medicinal products, body liquids or other substances to or from the body are classified as class IIa, unless this is done in a manner that is potentially hazardous, taking account of the nature of the substances involved, of the part of the body concerned and of the mode of application in which case they are classified as class IIb.除非考慮到所涉及物質的性質，以危險的方式進行操作，否則所有用於向體內或從體內施用和/或去除藥物，體液或其他物質的有源設備均被列為IIa類。 ，有關機構的部分以及適用的方式，在這種情況下，它們被歸為IIb類。
6.5. Rule 13
All other active devices are classified as class I.所有其他有源設備被歸類為I類。
7. SPECIAL RULES特別規則
7.1. Rule 14
All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, as defined in point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma, as defined in point 10 of Article 1 of that Directive, and that has an action ancillary to that of the devices, are classified as class III.所有包含作為整體組成部分的物質的設備，如果單獨使用，則可以視為指令2001/83 / EC第1條第2點所定義的藥用產品，包括源自人血的藥用產品或該指令第1條第10點所定義的人體血漿，並且具有與設備的行為相輔相成的作用，被歸類為III類。
7.2. Rule 15
All devices used for contraception or prevention of the transmission of sexually transmitted diseases are classified as class IIb, unless they are implantable or long term invasive devices, in which case they are classified as class III.用於避孕或預防性傳播疾病傳播的所有設備均歸類為IIb類，除非它們是可植入或長期侵入性設備，在這種情況下，它們均歸類為III類。
7.3. Rule 16
All devices intended specifically to be used for disinfecting, cleaning, rinsing or, where appropriate, hydrating contact lenses are classified as class IIb.
All devices intended specifically to be used for disinfecting or sterilising medical devices are classified as class IIa, unless they are disinfecting solutions or washer-disinfectors intended specifically to be used for disinfecting invasive devices, as the end point of processing, in which case they are classified as class IIb.
This rule does not apply to devices that are intended to clean devices other than contact lenses by means of physical action only.
所有專門用於消毒，清潔，沖洗或在適當情況下使用水合隱形眼鏡的設備均歸為IIb級。
所有專門用於對醫療器械進行消毒或滅菌的器械均歸類為IIa類，除非它們是專門用於對侵入性器械進行消毒的消毒溶液或清洗消毒器，作為處理的終點，在這種情況下，它們是歸類為IIb類。
該規則不適用於僅通過物理動作清潔隱形眼鏡以外的設備的設備。
7.4. Rule 17
Devices specifically intended for recording of diagnostic images generated by X-ray radiation are classified as class IIa.專門用於記錄由X射線輻射生成的診斷圖像的設備歸為IIa類。
7.5. Rule 18
All devices manufactured utilising tissues or cells of human or animal origin, or their derivatives, which are non-viable or rendered non-viable, are classified as class III, unless such devices are manufactured utilising tissues or cells of animal origin, or their derivatives, which are non-viable or rendered non-viable and are devices intended to come into contact with intact skin only.除非是利用人類或動物來源的組織或細胞或其衍生物製造的所有設備，否則它們都是不能生存的或變得不可行的，這些設備均被歸類為III類。 ，它們是不可行的或變得不可行的，並且是旨在僅與完整皮膚接觸的設備。
7.6. Rule 19
All devices incorporating or consisting of nanomaterial are classified as:所有包含納米材料或由納米材料組成的設備均分類為：
| — | class III if they present a high or medium potential for internal exposure;如果它們具有高或中等的內部暴露潛能，則為III類； |
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class IIa if they present a negligible potential for internal exposure.如果它們呈現出的內部暴露潛力可忽略不計，則為IIa類。 |
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class IIa if they present a negligible potential for internal exposure.如果它們呈現出的內部暴露潛力可忽略不計，則為IIa類。 |
7.7. Rule 20
All invasive devices with respect to body orifices, other than surgically invasive devices, which are intended to administer medicinal products by inhalation are classified as class IIa, unless their mode of action has an essential impact on the efficacy and safety of the administered medicinal product or they are intended to treat life-threatening conditions, in which case they are classified as class IIb.除外科手術侵入性器械外，所有旨在通過吸入方式給藥的與體孔有關的侵入性器械均被歸類為IIa類，除非其作用方式對所給藥的藥物的功效和安全性具有實質性影響，或它們旨在治療危及生命的疾病，在這種情況下，它們被歸類為IIb類。
7.8. Rule 21
Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body are classified as:打算由人體孔口或皮膚上使用的，由人體吸收或局部分散在人體中的由物質或物質組合組成的設備分類為：
| — | class III if they, or their products of metabolism, are systemically absorbed by the human body in order to achieve the intended purpose;如果它們或其代謝產物被人體全身吸收以達到預期目的，則為III類； |
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class III if they achieve their intended purpose in the stomach or lower gastrointestinal tract and they, or their products of metabolism, are systemically absorbed by the human body;如果它們在胃或下胃腸道中達到了預期的目的，並且它們或其代謝產物被人體全身吸收，則為III類； |
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class IIa if they are applied to the skin or if they are applied in the nasal or oral cavity as far as the pharynx, and achieve their intended purpose on those cavities; and如果將它們塗抹在皮膚上，或者如果將它們塗抹在鼻腔或口腔直至咽部，並達到在這些腔體上的預期目的，則為IIa級；和 |
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class IIb in all other cases.在所有其他情況下為IIb類。 |
7.9. Rule 22
Active therapeutic devices with an integrated or incorporated diagnostic function which significantly determines the patient management by the device, such as closed loop systems or automated external defibrillators, are classified as class III.具有集成的或併入的診斷功能的主動治療設備（例如閉環系統或自動體外除顫器）可顯著確定設備對患者的管理，分類為III類。