2.1. Rule 1 (Class D)

Devices intended to be used for the following purposes are classified as class D:

• • Detection of the presence of, or exposure to, a transmissible agent in blood, blood components, cells, tissues or organs, or in any of their derivatives, in order to assess their suitability for transfusion, transplantation or cell administration;

• • Detection of the presence of, or exposure to, a transmissible agent that causes a life-threatening disease with a high or suspected high risk of propagation;

• Determining the infectious load of a life-threatening disease where monitoring is critical in the process of patient management.

Examples: Hepatitis B/C, HIV, Syphilis, Ebola, SARS-CoV-2 (high risk propagation).

2.1. 规则 1 (D 类)

旨在用于以下目的的器械归类为 D 类：

• • 检测血液、血液成分、细胞、组织或器官或其衍生物中是否存在传染性病原体或接触过传染性病原体，以评估其是否适合输血、移植或细胞给药；

• • 检测导致危及生命的疾病且具有高传播风险或疑似高传播风险的传染性病原体或其接触史；

• 测定危及生命的疾病的感染载量，且其监测在患者管理过程中至关重。

实例：乙肝/丙肝, HIV, 梅毒, 埃博拉, SARS-CoV-2 (高传播风险).

2.2. Rule 2 (Class C / Class D)

Devices intended to be used for blood grouping, or to determine foeto-maternal blood group incompatibility, or for tissue typing are classified as class C, except when intended to determine any of the following markers:

• ABO system [A (ABO1), B (ABO2), AB (ABO3)];
• Rhesus system [RH1 (D), RHW1, RH2 (C), RH3 (E), RH4 (c), RH5 (e)];
• Kell system [Kel1 (K)];
• Kidd system [JK1 (Jka), JK2 (Jkb)];
• Duffy system [FY1 (Fya), FY2 (Fyb)];

in which case they are classified as class D.

2.2. 规则 2 (C 类 / D 类)

旨在用于血型定型、确定胎母血型不相容性或组织分型的器械归类为 C 类，但旨在确定以下标记物的除外（此类情况归为 D 类）：

• ABO 系统 [A (ABO1), B (ABO2), AB (ABO3)];
• Rhesus 系统 [RH1 (D), RHW1, RH2 (C), RH3 (E), RH4 (c), RH5 (e)];
• Kell 系统 [Kel1 (K)];
• Kidd 系统 [JK1 (Jka), JK2 (Jkb)];
• Duffy 系统 [FY1 (Fya), FY2 (Fyb)];

2.3. Rule 3 (Class C)

Devices are classified as class C if they are intended[cite: 333]:

• (a) for detecting the presence of, or exposure to, a sexually transmitted agent;
• (b) for detecting the presence in cerebrospinal fluid or blood of an infectious agent without a high or suspected high risk of propagation;
• (c) for detecting an infectious agent, if there is a significant risk that an erroneous result would cause death or severe disability to the individual, foetus or embryo;
• (d) for pre-natal screening of women in order to determine their immune status towards transmissible agents;
• (e) for determining infective disease status or immune status, where there is a risk that an erroneous result would lead to a patient management decision resulting in a life-threatening situation;
• (f) to be used as companion diagnostics;
• (g) to be used for disease staging (life-threatening situation);
• (h) to be used in screening, diagnosis, or staging of cancer;
• (i) for human genetic testing;
• (j) for monitoring of levels of medicinal products, substances or biological components (life-threatening situation);
• (k) for management of patients suffering from a life-threatening disease or condition;
• (l) for screening for congenital disorders in the embryo or foetus;
• (m) for screening for congenital disorders in new-born babies.

2.3. 规则 3 (C 类)

如果器械旨在用于以下目的，则归类为 C 类 [cite: 333]：

• (a) 用于检测性传播病原体的存在或接触史；
• (b) 用于检测脑脊液或血液中是否存在无高传播风险的传染性病原体；
• (c) 用于检测传染性病原体，如果错误结果存在导致个体、胎儿或胚胎死亡或严重残疾的重大风险；
• (d) 用于对妇女进行产前筛查，以确定其对传染性病原体的免疫状态；
• (e) 用于确定传染病状态或免疫状态，其中错误结果会导致危及生命的患者管理决策；
• (f) 用作伴随诊断 (CDx)；
• (g) 用于疾病分期（危及生命的情况）；
• (h) 用于癌症的筛查、诊断或分期；
• (i) 用于人类基因检测；
• (j) 用于监测药物或生物成分的水平（危及生命的情况）；
• (k) 用于管理患有危及生命的疾病或状况的患者；
• (l) 用于筛查胚胎或胎儿的先天性疾病；
• (m) 用于筛查新生儿的先天性疾病。

2.4. Rule 4 (Self-testing / Near-patient)

(a) Self-testing: Devices intended for self-testing are classified as class C, except for devices for the detection of pregnancy, for fertility testing and for determining cholesterol level, and devices for the detection of glucose, erythrocytes, leucocytes and bacteria in urine, which are classified as class B.

(b) Near-patient testing: Devices intended for near-patient testing are classified in their own right.

2.4. 规则 4 (自我检测 / 近患者检测)

(a) 自我检测： 旨在用于自我检测的器械归类为 C 类，但用于妊娠检测、生育能力测试、胆固醇水平测定以及用于检测尿液中葡萄糖、红细胞、白细胞和细菌的器械除外，这些器械归类为 B 类。

(b) 近患者检测： 旨在用于近患者检测 (POCT) 的器械根据其自身权利进行分类。

2.5. Rule 5 (Class A)

The following devices are classified as class A:

• (a) products for general laboratory use, accessories which possess no critical characteristics, buffer solutions, washing solutions, and general culture media and histological stains, intended by the manufacturer to make them suitable for in vitro diagnostic procedures;
• (b) instruments intended by the manufacturer specifically to be used for in vitro diagnostic procedures;
• (c) specimen receptacles.

2.5. 规则 5 (A 类)

以下器械归类为 A 类：

• (a) 一般实验室用产品、无关键特性的附件、缓冲液、洗涤液、一般培养基和组织学染色剂（制造商预期用于体外诊断程序）；
• (b) 制造商专门预期用于体外诊断程序的仪器；
• (c) 样本容器。

2.6. Rule 6 (Class B)

Devices not covered by the above-mentioned classification rules are classified as class B.

Examples: Thyroid hormones, general metabolic markers, seasonal influenza.

2.6. 规则 6 (B 类)

上述分类规则未涵盖的器械归类为 B 类。

实例：甲状腺激素、一般代谢标志物、季节性流感。

2.7. Rule 7 (Class B)

Devices which are controls without a quantitative or qualitative assigned value are classified as class B.

2.7. 规则 7 (B 类)

无定量或定性赋值的质控品归类为 B 类。