11.080.01 消毒和灭菌综合 标准查询与下载

DB6101/T 3073.2-2020 学校复课新型冠状病毒肺炎疫情防控消毒 技术指南 第 2 部分：中小学校（试行）

本标准规定了中小学校复课新型冠状病毒肺炎疫情防控的管理要求、消毒要求、消毒人员要求以及常用消毒方法。 本标准适用于各级各类中小学校及校外培训、辅导机构。

Technical Guidelines for Disinfection and Prevention of Novel Coronavirus Pneumonia Epidemic in School Resumption Part 2: Primary and Secondary Schools (Trial)

DB6101/T 3074.3-2020 新型冠状病毒肺炎疫情防控消毒技术指南 第 3 部分：公共交通工具 （试行）

本标准规定了新型冠状病毒肺炎流行期间公共交通工具消毒的术语和定义、管理要求、消毒对象、消毒方法、消毒人员要求。 本标准适用于新型冠状病毒肺炎流行期间公共交通工具的消毒，其他传染病流行适用时也可以参照 执行。

Technical Guidelines for Disinfection for Novel Coronavirus Pneumonia Epidemic Prevention and Control Part 3: Public Transport (Trial)

T/SDNY 003-2020 疫情期间运输车辆及驾乘人员消毒操作规范

本标准规定了运输车辆及驾乘人员消毒方法、消毒程序以及对应的消毒频次和记录。 本标准适用于新型冠状病毒感染肺炎疫情期间运输农药生产用原材料、农药产品的车辆及驾乘人员的消毒作业。

Specifications for Disinfection of Transport Vehicles and Drivers and Passengers During the Epidemic Period

T/ZGXX 0003-2019 医疗器械清洗剂

5 要求 5.1 材料要求 配方中所用的表面活性剂应为已确认能够降解，且在目前科技水平的认知程度上其本身及降解产物对动植物和环境无害的化学品。具体要求如下： a)表面活性剂的初级生物降解度不低于 90%。 b)表面活性剂初级生物降解度低于 90%，但不低于 80%时，其最终生物降解度不低于 60%。 注：烷基酚聚氧乙烯醚、四聚丙烯烷基苯磺酸盐为已知不应使用的表面活性剂品种。 配方用水应为纯化水或电导率≤15us/cm(25℃)的水。 5.2 理化指标 医疗器械清洗剂的理化指标应符合表1的规定。 表1 医疗器械清洗剂的理化指标 项目                                                                                                                               指标                                                                                                    含酶                                                                              非酶                                                                          碱性                   中性              酸性                          碱性                         中性                        酸性 外观                                                                 不分层、无悬浮物或沉淀（加入均匀悬浮颗粒组分的产品除外）、无机械杂质的均匀液体 耐热   （40±2）℃，24h                                  取出恢复至室温后观察不分层，不浑浊，且不改变气味 耐寒   （-10±2）℃，24h                                取出恢复至室温后观察无结晶，无沉淀 pH（25℃，原液）                                         ＞7.5               6.5~7.5             ＜6.5                         ＞7.5                      6.5~7.5                    ＜6.5 腐蚀性    碳钢(规格见 GB/T 700)   基本无腐蚀或轻度腐蚀  基本无腐蚀  基本无腐蚀或轻度腐蚀  基本无腐蚀或轻度腐蚀   基本无腐蚀   基本无腐蚀或轻度腐蚀              不锈钢(规格见 GB/T 1220)                ——                 ——                  ——                        ——                       ——                        —— 总固形物含量/%  ≥                                                                 ——                                                                                 10 蛋白酶相对酶活力或含量/（GBU/mL） ≥                                 16                                                                                  —— 清洗力/ min  ≤                                                                                                               40 泡沫性能（25±2）℃/mm  ≤                                                                                  即时高度： 50 砷/mg/kg  ≤                                                                                                                  5.0 重金属/mg/kg  ≤                                                                                                           100 甲醇含量/％  ≤                                                                                                                0.1 甲醛含量/％  ≤                                                                                                                0.1 注1:不同种类的蛋白酶，水解偶氮酪索的方式和水解产物不同，因此相对于参比酶测定的酶活力的本质含义不一样，数值之间没有可比性，两者活力值与去污效果无关； 注2:同种类蛋白酶，相对于参比酶测定的酶活力越高，说明酶制剂的有效成分越高，去污效果相对越好。 5.3 微生物指标 医疗器械清洗剂的微生物指标应符合表2的规定。 表2 医疗器械清洗剂的微生物指标 项目                                                                指标 菌落总数/（CFU/g 或 CFU/mL） ≤                 200 大肠菌群                                                     不得检出 铜绿假单胞菌                                              不得检出 金黄色葡萄球菌                                           不得检出 5.4 定量包装要求 应符合中华人民共和国国家质量监督检验检疫总局令[2005]第 75 号《定量包装商品计量监督管理办法》的要求。  6 试验方法 6.1 外观 量取不少于 100mL 的试样，置于干燥洁净的无色具塞广口玻璃瓶，在非直射光条件下进行观察。 6.2 耐热耐寒 量取不少于100 mL的试样两份，分别置于250 mL的无色具塞广口玻璃瓶中，一份于（40±2）℃的保温箱中放置24h，取出恢复至室温后观察；另一份于（-10±2）℃的冰箱中放置24h，取出恢复至室温后观察。 6.3 pH 按 GB/T 6368 的规定进行。 6.4 腐蚀性 按消毒技术规范（2002年版）第2.2.4条，以产品的最高使用浓度进行测定并判定。 6.5 总固形物含量 按GB/T 13173规定测试水分及可挥发物，以残留物计算总固形物含量。 6.6 蛋白酶相对酶活力或含量 按 GB/T 13173 相关章节测定。 6.7 清洗力 a)试验浓度：清洗剂按厂家标签说明书标注的最大稀释比例(或最低浓度)使用纯化水进行稀释,并在水温（40±1）℃的条件下进行测试。 b)仪器：清洗测试卡、200mL 烧杯、恒温水浴锅、分析天平（感量 0.0001g）、秒表、温度计 注：可采用统一的清洗测试卡，已有商品化的 STF 清洗测试卡可供选择使用，必要时由本标准技术归口单位统一订制。 c)操作：取清洗剂原液加入 200mL 烧杯中，按照厂家宣称稀释比例的中值，加入纯化水或电导率≤15us/cm(25℃)的水至 200g；将装有稀释液的烧杯放置于水浴锅中，恒温至（40±1）℃。把已固定好的清洗测试卡悬置于烧杯中，启动秒表开始计时。待清洗测试卡上模拟污染物完全去除，按下秒表记录清洗结束时间。 d)结果判定：以清洗时间的长短评价洗净效果，清洗时间不大于 40min，实验组为三组，结果判定取平均值。 6.8 泡沫性能 按GB/T 13173相关章节测定。 6.9 砷 按GB/T 30797规定测定。 6.10 重金属 按GB/T 30799规定测定。 6.11 甲醇 按GB/T 30795规定测定。 6.12 甲醛 按GB/T 30796规定测定。 6.13 微生物 按GB 15979附录B产品微生物检测方法测定。 6.14 净含量 按JJF 1070规定进行。 7 检验规则 7.1 检验分类 产品检验分出厂检验和型式检验。 7.1.1 出厂检验项目为 5.2 中外观、pH、固形物、清洗力及 5.3 中的微生物指标。 7.1.2 型式检验项目包括第 5 章节规定的全部项目，遇有下列情况之一，应进行型式检验： a) 正式生产后原料、工艺有较大改变或配方调整可能影响产品质量时； b) 正常生产时，应定期进行型式检验； c) 长期停产后恢复生产时； d) 出厂检验结果与上次型式检验结果有较大差异时； e) 国家行业管理部门和质量监督机构可对任意一项提出和进行型式检验。 7.2 产品组批与抽样规则 7.2.1 组批 产品按批交付和抽样验收，一次交付的同条件生产的同一类型、规格、批号的产品组成一交付批。生产单位交付的产品 ，应先经其质量检验部门按本标准检验，符合本标准并出具产品质量检验合格证明方可出厂。收货单位根据产品质检验合格证明收货或按本标准抽样验收。 7.2.2 取样 收货单位验收、仲裁检验所需的样品，应根据产品批量大小按表 3 确定样本大小。 表 3 批量和样本大小 批量/箱   ≤50  51~150  151~500  501~3200  3200 以上 样本/箱      3        5              8             13              20 在交货地点随机抽取箱样本。验收包装质量时，检验样箱中全部小包装，合格判定率为 95%以上，检验理化指标时，从每个样本箱中随机取 2 瓶（袋），再从各瓶（袋）取出等量样品，使总量约 3kg[若 取 2 瓶（袋）不够时，可适当增加瓶（袋）数]。混匀后分装在三个洁净、干燥的样品瓶内加盖密封。标签上应注明交货方保管，以备仲裁检验用，保管期不超过 1 个月。 7.3 判定规则 检验结果按照 GB/T 8170 中修约值比较法判定合格与否。如指标有一项不合格，可双方会同重新取两倍箱样本采取样品，对不合格项进行复检，复检结果仍不合格，则判该批产品不合格。交收双方因检验结果不同，如不能取得协议时，可商请仲裁检验，以仲裁结果为最后依据。 8 标志、运输、贮存、保质期 8.1 标志 产品大小包装上的标志（图案及文字）应端正、清晰、牢固、易于识别。 8.1.1 小包装上应有下列标识： a) 产品名称及商品名称和或图案； b) 产品采用标准号，如标识产品条型码应符合我国条形码的有关规定； c) 产品净含量； d) 产品的主要成分、性能、使用说明及必要的注意事项； e) 产品的生产日期和保质期或生产批号和限期使用日期； f) 生产者名称、地址、联系电话及邮政编码。  此项规定也适用于最小销售单元包装。 8.1.2 大包装上应有下列标识： a) 产品名称及商标； b) 产品采用标准号； c) 包装质量规格及箱装总数； d) 货箱毛重、箱体尺寸； e) 产品箱装日期； f) 防水防潮、小心轻放和防止倒置等； g) 生产者名称、地址、联系电话及邮政编码。 8.2 运输 产品在运输时应轻装轻卸，不应倒放，防止重压、避免日晒、雨淋、受潮。 8.3 贮存 产品应贮存在通风干燥且不受阳光直射和雨淋的场所，不宜贮存在高温或冰冻的环境中。堆垛应采 取必要的防护措施，堆垛高度适宜，避免损坏大包装。 8.4 保质期 在符合本标准规定的运输和贮存条件下，在包装完整未经启封的情况下，产品的保质期按销售包装 标注执行。

Medical device cleaning agent

DB11/T 1703-2019 口腔综合治疗台水路消毒技术规范

Technical Specifications for Waterway Disinfection of Comprehensive Dental Treatment Units

ISO 11737-2:2019 医疗器械的灭菌 - 微生物方法 - 第2部分:灭菌过程的定义 验证和维护中进行的无菌检测

Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

KS P ISO 11137-3:2019 保健产品的灭菌 - 辐射 - 第3部分:发展 验证和常规控制剂量学方面的指导

Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control

KS P ISO 11137-3-2019 保健产品的灭菌 - 辐射 - 第3部分:发展 验证和常规控制剂量学方面的指导

Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control

KS P ISO 17665-1:2019 保健产品灭菌 - 湿热 - 第1部分:医疗器械灭菌过程的开发 验证和日常控制的要求

Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

KS P ISO 11137-1:2019 保健产品的灭菌 - 辐射 - 第1部分:医疗器械灭菌过程的开发 验证和日常控制要求

Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

KS P ISO 17665-1-2019 保健产品灭菌 - 湿热 - 第1部分:医疗器械灭菌过程的开发 验证和日常控制的要求

Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

KS P ISO 11137-1-2019 保健产品的灭菌 - 辐射 - 第1部分:医疗器械灭菌过程的开发 验证和日常控制要求

Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

EN ISO 25424:2019 医疗器械的灭菌.低温蒸汽和甲醛.医疗器械灭菌过程的开发,确认和常规控制要求

1.1 Inclusions 1.1.1 This document specifies requirements for the development, validation and routine control of a low temperature steam and formaldehyde (LTSF) sterilization process for medical devices using a mixture of low temperature steam and formaldehyde as sterilizing agent and which operates below ambient pressure. NOTE Although the scope of this document is limited to medical devices, it specifies requirements and provides guidance that can be applicable to other products and equipment. 1.1.2 This document is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized and the organizations with responsibility for sterilizing medical devices (see ISO 14937:2009, Table E.1). 1.2 Exclusions 1.2.1 This document does not specify requirements for the development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents. NOTE See ISO 22442‑1, ISO 22442‑2 and ISO 22442‑3. 1.2.2 This document does not specify requirements for designating a medical device as "STERILE". Such requirements are given in EN 556‑1. 1.2.3 This document does not specify a quality management system for the control of all stages of production of medical devices. NOTE It is not a requirement of this document to have a complete quality management system during manufacture or reprocessing, but those elements of such a system that are required are normatively referenced at appropriate places in the text. Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices including the sterilization process. Further guidance is given in E.4 of ISO 14937:2009. 1.2.4 This document does not specify requirements for occupational safety associated with the design and operation of LTSF sterilization facilities. NOTE 1 Safety requirements for sterilizers are specified in IEC 61010‑2‑040. NOTE 2 Attention is also drawn to the existence in some countries of regulations stipulating safety requirements. 1.2.5 This document does not cover analytical methods for determining levels or residues of formaldehyde and/or its reaction products. NOTE 1 Attention is drawn to EN 14180. NOTE 2 Attention is drawn to the possible existence in some countries of statutory regulations specifying limits for the level of formaldehyde residues on medical devices and products. 1.2.6 This document does not cover preparatory measures that might be necessary before sterilization such as cleaning, disinfection and packing. NOTE For reprocessable medical devices, the manufacturer(s) of these devices can supply information on the preparatory measures (see ISO 17664).

Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)

EN ISO 11135:2014/A1:2019 修订附件E 单批次释放 包含修改件A1,2019

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)

EN ISO 11137-1:2015/A2:2019 医疗保健产品.辐射灭菌.第1部分:发展要求,验证和对医疗器械灭菌过程的常规控制 包含修改件A2,2019

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)

T/WSJD 002-2019 医用清洗剂卫生要求

本标准规定了医用清洗剂原料要求、基本要求、技术要求、检验方法、运输、贮存和包装、标识要求及注意事项。 本标准适用于医用清洗剂的生产与应用。

Hygienic requirements for medical cleaning agents

T/WSJD 001-2019 载体消毒剂卫生要求

本标准规定了载体消毒剂的分类、原材料要求、技术要求、检验方法、应用范围、使用方法、标志和包装、运输和贮存及注意事项。 本标准适用于载体消毒剂的生产、销售和使用。

Hygienic requirements for carrier disinfectants

T/ZSYX 004-2019 医院病理学检查 取材清洁消毒规范

本标准规定了医院病理学检查中取材清洁消毒规范的术语和定义、防护穿戴、清洁消毒要求。 本标准适用于医院病理学检查中取材的清洁消毒规范。

Pathology examination in hospital - Specification for cleaning and disinfection of pathologic sampling

BS EN ISO 11138-7:2019 保健品灭菌 生物指标 结果选择、使用和解释指南

What is ISO 11138-7 – Guidance for biological indicators in sterilization of health care products about? ISO 11138 is an international standard that discusses biological indicators for sterilization of health care products. ISO 11138-7 provides the best industry guidance for the selection, use, and interpretation of results from the application of biological indicators when used in the development, validation, and routine monitoring of sterilization processes to ensure the safety of healthcare products. ISO 11138-7 is the seventh part of a multi-part series that guides on the selection of the correct biological indicator for their sterilization process critical parameters as well as guidance on its appropriate use. Note 1: ISO 11138-7 does not apply to the combination processes using, for example, washer-disinfectors or flushing and steaming of pipelines. Note 2: ISO 11138-7 does not consider those processes that rely solely on physical removal of microorganisms, e.g., filtration. Note 3: ISO 11138-7 does not specify requirements for the selection and use of biological indicators intended to monitor vaporised hydrogen peroxide processes for isolator and room bio-decontamination processes at atmospheric pressure.

Sterilization of health care products. Biological indicators. Guidance for the selection, use and interpretation of results

ISO 11138-7:2019 保健品灭菌.生物指示剂.第7部分:结果的选择、使用和解释指南

This document provides guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring of sterilization processes. It does not consider those processes that rely solely on physical removal of microorganisms, e.g. filtration. It is not applicable to combination processes using, for example, washer-disinfectors or flushing and steaming of pipelines. It does not specify requirements for the selection and use of biological indicators intended to monitor vaporised hydrogen peroxide processes for isolator and room biodecontamination processes at atmospheric pressure. It is not applicable to liquid immersion sterilization processes.

Sterilization of health care products — Biological indicators — Part 7: Guidance for the selection, use and interpretation of results