標準編號:	GB/T 22760-2020
中文名稱:	消費品安全 風險評估導則
英文名稱:	Consumer product safety—General principles for risk assessment
行業分類:	GB    國家標準
ICS分類:	03.120.01 03.120.01    質量綜合 03.120.01
發布機構:	國家市場監督管理總局 國家標準化管理委員會
發布日期:	2020-07-21
實施日期:	2020-7-21
標準狀態:	valid
替代舊標準:	GB/T 22760-2008 消費品安全風險評估通則
翻譯語言:	英文
文件格式:	PDF
中文字符數:	25000 字
翻譯價格(元):	1300.0
交付時間:	付款后 1 個工作日

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

消費品安全 風險評估導則 1 范圍 本標準規定了消費品安全風險評估的程序、內容和要求。 本標準適用于消費品在正常使用和可合理預見的誤用過程中的風險評估。 2 術語和定義 下列術語和定義適用于本文件。 2.1 消費品 consumer product 主要但不限于為個人使用而設計、生產的產品，包括產品的組件、零部件、附件、使用說明和包裝。 [GB／T 35248—2017，定義2.2] 2.2 傷害 injury 對人體健康或財產的損害。 注：改寫GB／T 20002.4—2015，定義3.1。 2.3 危害（源） hazard 可能導致傷害的潛在根源。 [GB／T 28803—2012，定義3.2] 2.4 危害事件 hazardous event 能導致傷害的事件。 注：改寫GB／T 20002.4—2015，定義3.3。 2.5 危害處境 hazardous situation 人員、財產暴露于一種或多種危害中的情形。 注：改寫GB／T 20002.4—2015，定義3.4。 2.6 風險 risk 傷害發生概率和傷害嚴重程度的組合。 注1：發生概率包括出現危害處境、發生傷害事件，以及避免或限制傷害的可能性。 注2：改寫GB／T 20002.4—2015，定義3.9。 2.7 安全 safety 免除了不可接受的風險的狀態。 [GB／T 20002.4—2015，定義3.14] 2.8 消費品安全 consumer product safety 消費品免除了不可接受風險的狀態。 [GB／T 28803—2012，定義3.4] 2.9 消費品生命周期 consumer product life cycle 消費品從設計、生產、包裝、儲運、使用（包括維修）、回收的全過程。 [GB／T 28803—2012，定義3.5] 2.10 預期使用 intended use 按產品和／或系統提供的信息使用，無此類信息時，按通常理解的模式使用。 [GB／T 20002.4—2015，定義3.6] 2.11 可合理預見的誤使用 reasonably foreseeable misuse 由容易預見的人的行為所引起的，未按供方提供的方式對產品和／或系統的使用。 [GB／T 20002.4—2015，定義3.7] 2.12 可容許風險 tolerable risk 按當今社會價值取向在一定范圍內可以接受的風險。 注：在本標準中，“可接受風險”和“可容許風險”被視為同義詞。 [GB／T 20002.4—2015，定義3.15] 2.13 風險估計 risk estimation 對傷害發生的可能性和其后果嚴重程度賦值的過程。 [GB／T 28803—2012，定義3.13] 2.14 風險分析 risk analysis 系統地運用現有信息確定危害和估計風險的過程。 [GB／T 20002.4—2015，定義3.10] 2.15 風險評價 risk evaluation 根據風險分析的結果確定是否已實現可容許風險的過程。 [GB／T 20002.4—2015，定義3.12] 2.16 風險評估 risk assessment 包括風險識別、風險分析和風險評價的全過程。 [GB／T 23694—2013，定義4.4.1] 2.17 危害表征 hazard characterization 定性或定量（如果可行）描述一種化學物質可能引起潛在危害影響的固有特性。 注：危害表征包括劑量反應評估以及伴隨的不確定性。 2.18 暴露評估 exposure assessment 對消費者暴露于化學物質（以及其衍生物）的評價。 2.19 風險表征 risk characterization 關于化學物質在某種特定暴露條件下對消費者產生已知或潛在不良健康影響的可能性及其相關不確定性的定性及定量描述。 3 風險評估的一般要求 3.1 信息有效 風險評估前應廣泛收集相關信息，在評估過程中還應繼續調查和補充相關信息，并確保信息的真實、可靠、及時。 3.2 定性定量相結合 應針對消費品安全危害（源）的類型、特點等選擇采用科學有效的風險評估方法，當可獲得適當的數據時，應優先考慮風險評估的定量方法。 3.3 貫穿消費品生命周期 針對消費品生命周期各階段的特征，采用不同的風險評估方法。 3.4 綜合衡量 應綜合考慮科技、經濟和知識發展水平，確定危害（源）、可容許風險和風險等級。根據需要，應反復評審以確定可容許風險。 4 風險評估的程序和內容 4.1 程序 風險評估的一般程序包括：評估前準備、危害識別、風險估計、風險評價等步驟。 消費品安全風險評估的程序見圖1，消費品的物理危害、化學危害和生物危害的風險評估流程可在此流程的基礎上細化，參見附錄A和附錄B。 開始 評估前準備 危害識別 風險估計 風險分析 風險評價 風險評估 風險控制 降低風險 是否達到可容許風險 是 否 結束 注：陰影部分為風險評估的一般程序。 圖1 消費品安全風險評估流程圖 4.2 內容 4.2.1 評估前的準備 風險評估前的準備可包括： a） 確定目標消費品的使用環境、使用壽命、使用人群、使用數量等。 b） 根據國內外相關法律法規、標準、文獻、專家經驗等信息，綜合考慮社會及經濟發展水平的影響因素，確定消費品安全風險評估的可容許風險。 4.2.2 危害識別 對消費品在正常使用和可合理預見的誤使用過程中的危害（源）進行識別。附錄C給出了危害（源）的類型。 危害識別的途徑主要包括： a） 已發布的法規、標準； b） 科學技術資料（各行業的產品質量安全設計要求）； c） 事故報告； d） 消費者投訴； e） 媒體； f） 實驗、檢測； g） 專家意見等。 4.2.3 風險估計 4.2.3.1 概述 危害識別后，應針對危害（源），考慮危害處境，傷害的嚴重程度和傷害發生的可能性，對風險進行估計。風險估計的具體方法參見附錄A，傷害類型參見附錄D。 4.2.3.2 內容 一般而言，風險估計可包括以下內容： a） 傷害的嚴重程度 消費品對人體的傷害程度一般可分為四級，即非常嚴重、嚴重、一般和微弱，見表1。一般以傷害范圍、人身健康危害、財產損失、誘發次生危害、可預防性等方面作為定級標準。 表1 傷害程度分級 等級 特征描述 高 低 非常嚴重 導致災難性的傷害。該類傷害可導致死亡、身體殘疾，或引發重大財產損失等 嚴重 會導致不可逆轉的人體傷害（如疤痕等）或造成較大財產損失，這種傷害應在急診室治療或住院治療，或引發的財產損失對家庭生活造成一定較大影響 一般 在門診對傷害進行處理即可，或引發較小財產損失。該類傷害對人體或家庭后續財務開支造成的影響一般 微弱 可在家里自行對傷害進行處理，不需就醫治療，但對人體造成某種程度的不舒適感，并未造成明顯財產損失。該類傷害對人體健康和財產的影響較輕 b） 傷害發生的可能性 傷害對應的某一特定危害處境可分成若干個階段，每個階段都對應一個潛在的導致傷害發生的階段可能性，各個階段可能性構成了傷害發生的可能性。 計算傷害發生的可能性所需信息可通過以下途徑獲取： 1） 相關的歷史數據； 2） 試驗模擬； 3） 專家判斷等。 傷害發生的可能性一般可分為八種類型，見表2。 表2 傷害發生的可能性類型 可能性 特征描述 大 小 Ⅰ 傷害事件發生的可能性極大，在任何情況下都會重復出現 Ⅱ 經常發生傷害事件 Ⅲ 有一定的傷害事件發生可能性，不屬于小概率事件 Ⅳ 有一定的傷害事件發生可能性，屬于小概率事件 Ⅴ 會發生少數傷害事件，但可能性較小 Ⅵ 會發生少數傷害事件，但可能性極小 Ⅶ 不會發生，但在極少數特定情況下可能發生 Ⅷ 在任何情況下都不會發生傷害事件 注：可根據實際情況對表中的傷害發生可能性等級確定具體量值。 4.2.3.3 風險估計方法 需考慮消費品和危害（源）的特征，并結合產品生命周期，科學選擇合適的風險估計方法，參見附錄A。 4.2.4 風險評價 針對某種危害，根據其所導致的傷害發生的可能性、傷害發生的程度，可估算出消費品該種危害的風險等級。消費品危害風險等級劃分一般可采用矩陣法，參見附錄E。 如果某一消費品有兩種或兩種以上危害，應對每種危害分別進行風險評價，以各種危害的最高風險等級作為該消費品安全風險等級。 4.2.5 風險評估文件 消費品安全風險評估應以文件形式加以體現，具體內容包括但不限于： a） 風險評估前的信息準備； b） 風險評估的目標； c） 危害類型； d） 傷害程度的判別； e） 傷害發生可能性的判別； f） 風險評估等級的確定； g） 使用數據的不確定性對風險評估的影響。