2021年1月23日发(作者：攥)
SCHEDULE 1
(Section 6)
CLASSIFICATION RULES FOR MEDICAL DEVICES
PART 1
MEDICAL DEVICES OTHER THAN
IN VITRO
DIAGNOSTIC DEVICES

Invasive Devices
侵入式器械

Rule 1
:
(1) Subject to subrules (2) and (3), all surgically invasive devices are classified
as Class II
。服从于子规则（
2
）（< br>3
），全部的手术侵入性器械归为为
II
类

(2) A surgically invasive device that is intended to diagnose, monitor, control
or correct a defect of the central cardiovascular system or the central nervous
system or of a fetus in utero is classified as Class IV.
用于中心心血管系统、中枢神
经系统 或是体内胎儿的问题的诊断、监视、控制或纠正的手术侵入性器械归为
IV
类。

(3) A surgically invasive device that is intended to be absorbed by the body, or
that is normally intended to remain in the body for at least 30 consecutive days,
is classified as Class III.
吸收进入人体内的手术侵入性器械，或通常植入进入体内最少
持续
30
日归为
III
类

Rule 2
:
(1) Subject to subrules (2) to (4), all invasive devices that penetrate the body
through a body orifice or that come into contact with the surface of the eye are
classified as Class II.
服从于子 规则（
2
）到（
4
），全部侵入性器械通过身体腔道穿透人
体，或者 是进入与接触眼睛表面的属于
II
类

(2) A device described in subrule (1) that is intended to be placed in the oral or
nasal cavities as far as the pharynx or in the ear canal up to the ear drum is
classified as Class I.
（
1
）中所描述的器 械用于口腔或鼻腔直至咽部，或者进入耳道向上
到鼓膜的归为
I
类

(3) A device described in subrule (1) that is normally intended to remain in the
body or in contact with the surface of the eye for at least 30 consecutive days is
classified as Class III .
（
1
）中所描述的器械通常计划放置在体内或与眼睛表面有接触至
少持续< br>30
日的，归为
III
类

(4) A device described in subrule (1) that is intended to be represented as
preventing the transmission of infectious agents during sexual activities or
reducing the risk thereof is classified as Class III.
（
1
）类中所描述的用于性活动中
传染源传播的预防或 者减少这个过程中的风险归为
III
类。

Rule 3
:
Despite rules 1 and 2
不考虑规则
1
和
2
(
a
) all denture materials and orthodontic appliances, and their accessories, are
classified as Class II;
所有牙齿材料和矫齿的电气用具，它们的附件，归为
II
类。

(
b
) all surgical or dental instruments are classified as Class I; and
所有的手术或
牙科器械归为
I
类。

(
c
) all latex condoms are classified as Class II.
所有乳胶避孕套归为
II
类

Non- invasive Devices
非侵入式器械

Rule 4
:
(1) Subject to subrule (2), all non-invasive devices that are intended to come
into contact with injured skin are classified as Class II.
服 从于子规则（
2
），所以
非侵入式器械用于与创面皮肤接触的归为
II
类

(2) A device described in subrule (1) that is intended to be used as a
mechanical barrier, for compression or for absorption of exudations, is classified
as Class I.
（
1
）中所描述的器械用于去用作机械屏障，为了压迫或者为了吸收分泌物，归
为
I类

Rule 5
:
A non-invasive device intended for channelling or storing gases, liquids,
tissues or body fluids for the purpose of introduction into the body by means of
infusion or other means of administration is classified as Class II.
非侵入式器械用于输送或贮存气体、液体、组织、 体液，目的是为了引入体内，依靠输注
或者其它的实施方式归为
II
类。

Rule 6
:
(1) Subject to subrules (2) and (3), a non-invasive device intended for
modifying the biological or chemical composition of blood or other body fluids,
or liquids, for the purpose of introduction into the body by means of infusion or
other means of administration is classified as Class III.
服从于子 规则（
2
）和（
3
），
为了引入到体内采用输注或者其它实施方式用 于改变体内血液的或者体液的、
液体的生物或
化学成份的非侵入式器械归为
II
类

(2) A device described in subrule (1) whose characteristics are such that the
modification process may introduce a foreign substance into the body that is
potentially hazardous, taking into account the nature and quantity of the
substance, is classified as Class IV.
（
1
）中所描述的如此修改过程可能引入外来杂质
进入体 内发生可能的危险，要考虑这个物质的性质和数量，归为
IV
类。

(3) A device described in subrule (1) that accomplishes the modification by
centrifugation, gravity filtration or the exchange of gas or heat is classified as
Class II.1
）中所描述的器械，用离心分离、重力过滤或者气体的交换或加热方式去实现，
归为< br>II
类。

Rule 7
:
(1) Subject to subrule (2), all other non-invasive devices are classified as
Class I.
服从于子规则（
2
），全部其它非侵入性器械归为
I
类

(2) A device described in subrule (1) is classified as Class II if it is intended

（
1
）中所描述的器械如果用于下列情况，归为
II
类

(
a
) to act as a calibrator, tester or quality control support to another medical
device; or
用于进行校准、质量控制测试以支持其它医疗器械

(
b
) to be connected to an active device that is classified as Class II, III or IV.
与有源器械有关系的归为相应的
II
类、
III
类或
IV< br>类。


Active Devices
有源器械

Rule 8
:
(1) Subject to subrules (2) and (3), an active device intended to emit ionizing
radiation, including any device or software intended to control or monitor such
a device or directly influence its performance, is classified as Class III.
服从于子
规则（
2
）和 （
3
），用于发生电离辐射，包括其它的器械或软件用于控制或监视这样的器
械或者马 上影响它的性能的有源器械归为
III
类。

(2) A device described in subrule (1) that is intended to be used in
radiographic mode is classified as Class II.
（
1
）中所描述的器械用于射线模式的归
为
II
类。

(3) Despite subrule (2), an active device that is intended to be used for
mammographies is classified as Class III.
（
2
）中所描述的器械用于乳房
X
线成相的
归为
III
类。

Rule 9
:
(1) Subject to subrules (2) and (3), an active therapeutic device, including any
dedicated software, intended to be used to administer or withdraw energy to or
from the body is classified as Class II.
服从于子规则（
2
）和（
3
），有源治疗器械，
包含专用软件，用于作用于实施或者取消人体的能量，归为
II
类。

2) If the administration or withdrawal by a device described in subrule (1) is
potentially hazardous, taking into account the nature of the administration or
withdrawal, the intensity of the energy and the part of the body concerned, the
device is classified as Class III.
假如用这个器械去 管理和收回的在（
1
）中所描述的器
械是有潜在危险的，
要考虑这个管理和收 回，
能量的强度和与身体有关的部位，
这种器械归
为
III
类。
(3) A device described in subrule (2) that is intended to control the treatment
of a patient’s condition through a closed loop system is classified as Class IV.
（
2
）中所描述的器械用于 通过闭循环系统控制病人条件的治疗的器械归为
IV
类。

Rule 10
:
(1) Subject to subrule (2), an active diagnostic device, including any dedicated
software, that supplies energy for the purpose of imaging or monitoring
physiological processes is classified as Class II.
服从于子规则（
2
），一个有源治疗
器械，包含一些专用软件，为了成像、监视生理过程的这些物质能源归为
II
类。

(2) A device described in subrule (1) that is intended to be used to monitor,
assess or diagnose a disease, a disorder, an abnormal physical state or a
pregnancy, if erroneous readings could result in immediate danger, is classified
as Class II I.
（
1
）中所描述的器械用于监视、评定或者治疗一个疾病的、不良的、不规则的生理过程，或者怀孕，假如错误的阅读能导致直接危险的，归为
III
类

Rule 11
:
(1) Subject to subrules (2) and (3), an active device, including any dedicated
software, intended to administer drugs, body fluids or other substances to the
body or withdraw them from the body is classified as Class II.
服从于子规则（
2
）
和（
3
），一个有源器械，包括 一些专用软件，用于人体中实施或取消药物、体液、或其它
给予体内的物质，归为
II
类。

(2) If the administration or withdrawal by a device described in subrule (1) is
potentially hazardous, taking into account the nature of the administration or
withdrawal, the nature of the substance involved and the part of the body
concerned, the device is classified as Class III.
（
1
）中所描述的器械假如来自 这个
器械的实施或者取消会带来潜在的危险，
考虑实施或取消的所涉及物质的性质，
和 与身体有
关的部位，这种器械归为
III
类。

(3) A device described in subrule (2) that is intended to control the treatment
of a patient’s condition through a closed loop system is classified as Class IV.
（
2
）中所描述的器械用于通过闭 合循环系统去控制病人状况的治疗的器械归为
IV
类。

Rule 12
:
Any other active device is classified as Class I.
其它的有源器械归为
I
类。

Special Rules
Rule 13
:
A medical device that is intended to be used for
用于以下用途的医疗器械

(
a
) disinfecting or sterilizing blood, tissues or organs that are intended for
transfusion or transplantation is classified as Class IV; and
用于临床输血或移植的消毒或灭菌的血液、组织或器官，归为
IV
类。

(
b
) disinfecting or sterilizing a medical device is classified as Class II.
消毒或灭菌
的医疗器械归为
II
类。

Rule 14
: