标准编号:	GB/T 22760-2020
中文名称:	消费品安全 风险评估导则
英文名称:	Consumer product safety—General principles for risk assessment
行业分类:	GB    国家标准
ICS分类:	03.120.01 03.120.01    质量综合 03.120.01
发布机构:	国家市场监督管理总局 国家标准化管理委员会
发布日期:	2020-07-21
实施日期:	2020-7-21
标准状态:	valid
替代旧标准:	GB/T 22760-2008 消费品安全风险评估通则
翻译语言:	英文
文件格式:	PDF
中文字符数:	25000 字
翻译价格(元):	1300.0
交付时间:	付款后 1 个工作日

Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative. This standard is developed in accordance with the rules given in GB/T 1.1-2009. This standard replaces GB/T 22760-2008 General principles for risk assessment of consumer product safety, and the following main technical changes have been made with respect to GB/T 22760-2008: ——The standard name is changed from General principles for risk assessment of consumer product safety to Consumer product safety - General principles for risk assessment; ——The terms "hazard characterization", "exposure assessment" and "risk characterization" are added (see Clause 2); ——The requirements of "throughout the consumer product life cycle" are added in the general requirements of risk assessment (see 3.3); ——The informative annex "Risk assessment processes and methods for physical hazards of consumer product safety" is added (see Annex A); ——The informative annex "Risk assessment processes and methods for chemical hazards and biological hazards of consumer product safety" is added (see Annex B); ——The informative annex "Examples of injury types of consumer product safety" is added (see Annex D); ——The informative annex "Example of risk level classification method for consumer product safety hazards" is added (see Annex E). This standard was proposed by and is under the jurisdiction of SAC/TC 508 National Technical Committee on Consumer Product Safety of Standardization Administration of China. The previous edition of this standard is as follows: ——GB/T 22760-2008. Consumer product safety - General principles for risk assessment 1 Scope This standard specifies the procedure, content and requirements of risk assessment of consumer product safety. This standard is applicable to the risk assessment of consumer products during normal use and reasonably foreseeable misuse. 2 Terms and definitions For the purposes of this document, the following terms and definitions apply. 2.1 consumer product product designed and produced primarily for, but not limited to, personal use, including the components, parts, accessories, instructions for use, and packaging of product [GB/T 35248-2017, Definition 2.2] 2.2 injury damage to human health or property Note: It is revised from Definition 3.1 in GB/T 20002.4-2015. 2.3 hazard potential source of injury [GB/T 28803-2012, Definition 3.2] 2.4 hazardous event event that can cause injury Note: It is revised from Definition 3.3 in GB/T 20002.4-2015.   2.5 hazardous situation circumstance in which people and property are exposed to one or more hazards Note: It is revised from Definition 3.4 in GB/T 20002.4-2015. 2.6 risk combination of probability of occurrence and severity of injury Note 1: The probability of occurrence includes the probability of presence of hazardous situations, occurrence of injury events and avoiding or limiting injuries. Note 2: It is revised from Definition 3.9 in GB/T 20002.4-2015. 2.7 safety freedom from unacceptable risk [GB/T 20002.4-2015, Definition 3.14] 2.8 consumer product safety state of consumer product free from unacceptable risk [GB/T 28803-2012, Definition 3.4] 2.9 consumer product life cycle overall process of design, production, packaging, storage and transportation, use (including maintenance) and recycling of consumer product [GB/T 28803-2012, Definition 3.5] 2.10 intended use use of product and/or system as per the information provided by product and/or system or, in case such information is not available, as per the mode generally understood [GB/T 20002.4-2015, Definition 3.6]   2.11 reasonably foreseeable misuse use of product and/or system not in the manner provided by the supplier, which is caused by the human behavior that is easily foreseeable [GB/T 20002.4-2015, Definition 3.7] 2.12 tolerable risk risk which is acceptable in a given context based on the current social value orientation Note: In this standard, the terms "acceptable risk" and "tolerable risk" are considered as synonyms. [GB/T 20002.4-2015, Definition 3.15] 2.13 risk estimation process of assigning values to the probability of occurrence of injury and the severity of its consequences [GB/T 28803-2012, Definition 3.13] 2.14 risk analysis process of systematically using available information to identify hazards and estimate risks [GB/T 20002.4-2015, Definition 3.10] 2.15 risk evaluation process of determining whether tolerable risk has been achieved based on the result of the risk analysis [GB/T 20002.4-2015, Definition 3.12] 2.16 risk assessment overall process comprising risk identification, risk analysis and risk evaluation [GB/T 23694-2013, Definition 4.4.1]   2.17 hazard characterization qualitative or quantitative (if feasible) description of the inherent characteristics of a chemical substance that may cause potential hazard impacts Note: Hazard characterization includes dose-response assessment and accompanying uncertainties. 2.18 exposure assessment evaluation of consumers’ exposure to chemical substances (and their derivatives) 2.19 risk characterization qualitative and quantitative description of the probability of known or potential adverse health effects of chemical substances on consumers under certain exposure conditions and the related uncertainties 3 General requirements of risk assessment 3.1 Information validity Before risk assessment, relevant information shall be widely collected, and during the assessment process, relevant information shall be continuously investigated and supplemented to ensure that the information is true, reliable and timely. 3.2 Combination of qualitative and quantitative methods Scientific and effective risk assessment methods shall be selected according to the types and characteristics of the consumer product safety hazards. When appropriate data are available, priority shall be given to the quantitative risk assessment method. 3.3 Throughout the consumer product life cycle Different risk assessment methods shall be adopted according to the characteristics of each stage of the consumer product life cycle. 3.4 Comprehensive measurement The level of scientific, technological, economic and knowledge development shall be taken into account comprehensively to determine the hazards, tolerable risks and risk levels. Review shall be conducted repeatedly as needed to determine the tolerable risks.   4 Procedure and content of risk assessment 4.1 Procedure The general procedure of risk assessment includes: pre-assessment preparation, hazard identification, risk estimation, risk evaluation and other steps. The procedure of risk assessment of consumer product safety is shown in Figure 1, based on which the risk assessment process for physical hazards, chemical hazards and biological hazards of consumer products may be refined, as given in Annexes A and B. Note: The shaded part is the general procedure of risk assessment. Figure 1 Flowchart for risk assessment of consumer product safety 4.2 Content 4.2.1 Pre-assessment preparation Preparation prior to risk assessment may include: a) Determining the service environment, service life, users, usage quantity, etc. of target consumer products.   b) Determining the tolerable risks in risk assessment of consumer product safety by comprehensively considering the influencing factors of social and economic development level according to relevant laws, regulations, standards, literature, expert experience and other information at home and abroad. 4.2.2 Hazard identification It is a process of identifying the hazards of consumer products during normal use and reasonably foreseeable misuse. Annex C gives the types of hazards. The ways of hazard identification mainly include: a) Published regulations and standards; b) Scientific and technical data (product quality and safety design requirements of various industries); c) Accident report; d) Consumer complaints; e) Media; f) Experiments and tests; g) Expert opinions, etc. 4.2.3 Risk estimation 4.2.3.1 General After hazard identification, the risk shall be estimated according to the hazard, with consideration of the hazardous situation, the severity of injury and the probability of occurrence of injury. See Annex A for specific methods of risk estimation and Annex D for injury types. 4.2.3.2 Content In general, risk estimation may include the following: a) The severity of injury. The degree of injury to human body by consumer products may generally be classified into four levels: very serious, serious, moderate and slight, as shown in Table 1. Injury scope, personal health hazards, property losses, induced secondary hazards, preventability and other aspects are generally taken as classification criteria.

Foreword II 1 Scope 2 Terms and definitions 3 General requirements of risk assessment 4 Procedure and content of risk assessment Annex A (Informative) Risk assessment processes and methods for physical hazards of consumer product safety Annex B (Informative) Risk assessment processes and methods for chemical hazards and biological hazards of consumer product safety Annex C (Informative) Examples of hazard types of consumer product safety Annex D (Informative) Examples of injury types of consumer product safety Annex E (Informative) Example of risk level classification method for consumer product safety hazards Bibliography

消费品安全 风险评估导则 1 范围 本标准规定了消费品安全风险评估的程序、内容和要求。 本标准适用于消费品在正常使用和可合理预见的误用过程中的风险评估。 2 术语和定义 下列术语和定义适用于本文件。 2.1 消费品 consumer product 主要但不限于为个人使用而设计、生产的产品，包括产品的组件、零部件、附件、使用说明和包装。 [GB／T 35248—2017，定义2.2] 2.2 伤害 injury 对人体健康或财产的损害。 注：改写GB／T 20002.4—2015，定义3.1。 2.3 危害（源） hazard 可能导致伤害的潜在根源。 [GB／T 28803—2012，定义3.2] 2.4 危害事件 hazardous event 能导致伤害的事件。 注：改写GB／T 20002.4—2015，定义3.3。 2.5 危害处境 hazardous situation 人员、财产暴露于一种或多种危害中的情形。 注：改写GB／T 20002.4—2015，定义3.4。 2.6 风险 risk 伤害发生概率和伤害严重程度的组合。 注1：发生概率包括出现危害处境、发生伤害事件，以及避免或限制伤害的可能性。 注2：改写GB／T 20002.4—2015，定义3.9。 2.7 安全 safety 免除了不可接受的风险的状态。 [GB／T 20002.4—2015，定义3.14] 2.8 消费品安全 consumer product safety 消费品免除了不可接受风险的状态。 [GB／T 28803—2012，定义3.4] 2.9 消费品生命周期 consumer product life cycle 消费品从设计、生产、包装、储运、使用（包括维修）、回收的全过程。 [GB／T 28803—2012，定义3.5] 2.10 预期使用 intended use 按产品和／或系统提供的信息使用，无此类信息时，按通常理解的模式使用。 [GB／T 20002.4—2015，定义3.6] 2.11 可合理预见的误使用 reasonably foreseeable misuse 由容易预见的人的行为所引起的，未按供方提供的方式对产品和／或系统的使用。 [GB／T 20002.4—2015，定义3.7] 2.12 可容许风险 tolerable risk 按当今社会价值取向在一定范围内可以接受的风险。 注：在本标准中，“可接受风险”和“可容许风险”被视为同义词。 [GB／T 20002.4—2015，定义3.15] 2.13 风险估计 risk estimation 对伤害发生的可能性和其后果严重程度赋值的过程。 [GB／T 28803—2012，定义3.13] 2.14 风险分析 risk analysis 系统地运用现有信息确定危害和估计风险的过程。 [GB／T 20002.4—2015，定义3.10] 2.15 风险评价 risk evaluation 根据风险分析的结果确定是否已实现可容许风险的过程。 [GB／T 20002.4—2015，定义3.12] 2.16 风险评估 risk assessment 包括风险识别、风险分析和风险评价的全过程。 [GB／T 23694—2013，定义4.4.1] 2.17 危害表征 hazard characterization 定性或定量（如果可行）描述一种化学物质可能引起潜在危害影响的固有特性。 注：危害表征包括剂量反应评估以及伴随的不确定性。 2.18 暴露评估 exposure assessment 对消费者暴露于化学物质（以及其衍生物）的评价。 2.19 风险表征 risk characterization 关于化学物质在某种特定暴露条件下对消费者产生已知或潜在不良健康影响的可能性及其相关不确定性的定性及定量描述。 3 风险评估的一般要求 3.1 信息有效 风险评估前应广泛收集相关信息，在评估过程中还应继续调查和补充相关信息，并确保信息的真实、可靠、及时。 3.2 定性定量相结合 应针对消费品安全危害（源）的类型、特点等选择采用科学有效的风险评估方法，当可获得适当的数据时，应优先考虑风险评估的定量方法。 3.3 贯穿消费品生命周期 针对消费品生命周期各阶段的特征，采用不同的风险评估方法。 3.4 综合衡量 应综合考虑科技、经济和知识发展水平，确定危害（源）、可容许风险和风险等级。根据需要，应反复评审以确定可容许风险。 4 风险评估的程序和内容 4.1 程序 风险评估的一般程序包括：评估前准备、危害识别、风险估计、风险评价等步骤。 消费品安全风险评估的程序见图1，消费品的物理危害、化学危害和生物危害的风险评估流程可在此流程的基础上细化，参见附录A和附录B。 开始 评估前准备 危害识别 风险估计 风险分析 风险评价 风险评估 风险控制 降低风险 是否达到可容许风险 是 否 结束 注：阴影部分为风险评估的一般程序。 图1 消费品安全风险评估流程图 4.2 内容 4.2.1 评估前的准备 风险评估前的准备可包括： a） 确定目标消费品的使用环境、使用寿命、使用人群、使用数量等。 b） 根据国内外相关法律法规、标准、文献、专家经验等信息，综合考虑社会及经济发展水平的影响因素，确定消费品安全风险评估的可容许风险。 4.2.2 危害识别 对消费品在正常使用和可合理预见的误使用过程中的危害（源）进行识别。附录C给出了危害（源）的类型。 危害识别的途径主要包括： a） 已发布的法规、标准； b） 科学技术资料（各行业的产品质量安全设计要求）； c） 事故报告； d） 消费者投诉； e） 媒体； f） 实验、检测； g） 专家意见等。 4.2.3 风险估计 4.2.3.1 概述 危害识别后，应针对危害（源），考虑危害处境，伤害的严重程度和伤害发生的可能性，对风险进行估计。风险估计的具体方法参见附录A，伤害类型参见附录D。 4.2.3.2 内容 一般而言，风险估计可包括以下内容： a） 伤害的严重程度 消费品对人体的伤害程度一般可分为四级，即非常严重、严重、一般和微弱，见表1。一般以伤害范围、人身健康危害、财产损失、诱发次生危害、可预防性等方面作为定级标准。 表1 伤害程度分级 等级 特征描述 高 低 非常严重 导致灾难性的伤害。该类伤害可导致死亡、身体残疾，或引发重大财产损失等 严重 会导致不可逆转的人体伤害（如疤痕等）或造成较大财产损失，这种伤害应在急诊室治疗或住院治疗，或引发的财产损失对家庭生活造成一定较大影响 一般 在门诊对伤害进行处理即可，或引发较小财产损失。该类伤害对人体或家庭后续财务开支造成的影响一般 微弱 可在家里自行对伤害进行处理，不需就医治疗，但对人体造成某种程度的不舒适感，并未造成明显财产损失。该类伤害对人体健康和财产的影响较轻 b） 伤害发生的可能性 伤害对应的某一特定危害处境可分成若干个阶段，每个阶段都对应一个潜在的导致伤害发生的阶段可能性，各个阶段可能性构成了伤害发生的可能性。 计算伤害发生的可能性所需信息可通过以下途径获取： 1） 相关的历史数据； 2） 试验模拟； 3） 专家判断等。 伤害发生的可能性一般可分为八种类型，见表2。 表2 伤害发生的可能性类型 可能性 特征描述 大 小 Ⅰ 伤害事件发生的可能性极大，在任何情况下都会重复出现 Ⅱ 经常发生伤害事件 Ⅲ 有一定的伤害事件发生可能性，不属于小概率事件 Ⅳ 有一定的伤害事件发生可能性，属于小概率事件 Ⅴ 会发生少数伤害事件，但可能性较小 Ⅵ 会发生少数伤害事件，但可能性极小 Ⅶ 不会发生，但在极少数特定情况下可能发生 Ⅷ 在任何情况下都不会发生伤害事件 注：可根据实际情况对表中的伤害发生可能性等级确定具体量值。 4.2.3.3 风险估计方法 需考虑消费品和危害（源）的特征，并结合产品生命周期，科学选择合适的风险估计方法，参见附录A。 4.2.4 风险评价 针对某种危害，根据其所导致的伤害发生的可能性、伤害发生的程度，可估算出消费品该种危害的风险等级。消费品危害风险等级划分一般可采用矩阵法，参见附录E。 如果某一消费品有两种或两种以上危害，应对每种危害分别进行风险评价，以各种危害的最高风险等级作为该消费品安全风险等级。 4.2.5 风险评估文件 消费品安全风险评估应以文件形式加以体现，具体内容包括但不限于： a） 风险评估前的信息准备； b） 风险评估的目标； c） 危害类型； d） 伤害程度的判别； e） 伤害发生可能性的判别； f） 风险评估等级的确定； g） 使用数据的不确定性对风险评估的影响。