11.080.01 消毒和灭菌综合 标准查询与下载

T/ZZB 3038-2023 牙科模型消毒液

本标准规定了牙科模型消毒液的术语与定义、基本要求、技术要求、试验方法、检验规则、标志、使用方法、注意事项、包装、运输、贮存以及质量承诺。 本标准适用于以邻苯二甲醛和苯扎氯铵为杀菌成分复配而成的，用于牙科模型人工消毒、配套机器消毒的高水平消毒液。

Dental model disinfectant

T/NTAS 017-2023 社团建设消毒消杀规范

本文件规定了社团建设活动消毒消杀的职责、管理要求消杀范围、消杀方法、消杀防护要求和实施要求。 本文件适用于社团建设活动场馆消杀。

Community Construction Disinfection and disinfecting Specifications

DB6101/T 3152-2023 学校消毒卫生规范

本文件规定了学校消毒卫生一般要求、管理要求、消毒要求、常用消毒方法和预防性消毒方法的要 求。 本文件适用于西安市中小学校、普通高等学校开展消毒工作。

School disinfection and hygiene regulations

ISO 13408-1:2023 保健品无菌加工 第1部分：一般要求

Aseptic processing of health care products — Part 1: General requirements

ISO/FDIS 17665:2023 保健品灭菌 湿热 医疗器械灭菌过程的开发、验证和常规控制要求

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

GSO ISO/TS 22456:2023 保健产品灭菌 微生物学方法 生物制剂和组织产品生物负载测定和无菌测试指南

1.1.1 This document provides guidance for bioburden testing and tests of sterility for biologics and tissue-based products, where this testing is in relation to product sterilization. NOTE This document is intended to be used in conjunction with ISO 11737-1 and ISO 11737-2. 1.1.2 Guidance in this document can be applicable to biologics and tissue-based products that are not sterile but are microbiologically controlled.

Sterilization of healthcare products — Microbiological methods— Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products

GSO ISO 17664-2:2023 医疗保健产品加工 医疗器械制造商应提供的医疗器械加工信息 第2部分：非关键医疗器械

This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of non-critical medical devices not intended to be sterilized (i.e. a medical device that is intended to come into contact with intact skin only or a medical device not intended for direct patient contact). This includes information for processing prior to use or reuse of the medical device. Processing instructions are not defined in this document. Rather, this document specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, where applicable: a) preparation before processing; b) cleaning; c) disinfection; d) drying; e) inspection and maintenance; f) packaging; g) storage; h) transportation. This document excludes processing of: 1) critical and semi-critical medical devices; 2) medical devices intended to be sterilized; 3) textile medical devices used in patient draping systems or surgical clothing; 4) medical devices specified by the manufacturer for single use only and supplied ready for use. NOTE See Annex E for further guidance on the application of the ISO 17664 series to a medical device.

Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices

GSO ISO/TS 22421:2023 保健品灭菌 医疗机构医疗器械终端灭菌灭菌器通用要求

This document specifies the common requirements for sterilizers used for terminal sterilization of medical devices in health care facilities. This document covers sterilizers that operate with a variety of sterilizing agents (alone or in combination) within a sealed vessel at different temperatures, above, at, or below atmospheric pressure. This document provides high-level requirements and respective test methods that are general in nature. This document does not provide quantitative requirements for process parameters or parameters of the sterilization cycle, or requirements for performance testing, validation or routine control of sterilizers because these depend on the respective sterilization method. This document does not supersede or modify requirements or test methods of published standards applying to sterilizers, or future editions thereof. This document does not apply to: — sterilizers using radiation as the sterilizing agent; — sterilizers for laboratory equipment; — sterilizers used to prepare culture media; — sterilizers used for bio-decontamination of laboratory or other waste including decontamination of pathogens in a high risk category; — systems used for bio-decontamination of rooms and isolator systems; — systems used for sterilization in place; or — washer-disinfectors. NOTE Whilst this document provides requirements for sterilizers used in health care applications, there will be elements that are applicable to industrial applications.

Sterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities

GSO ISO 13408-6:2023 保健品的无菌加工 第6部分：隔离系统

This document specifies the requirements for and provides guidance on the specification, selection, qualification, bio-decontamination, validation, operation and control of isolator systems related to aseptic processing of health care products and processing of cell-based health care products. This document does not specify requirements for restricted access barrier systems (RABS). This document does not supersede or replace national regulatory requirements such as Good Manufacturing Practices (GMPs) and/or compendia requirements that pertain in particular to national or regional jurisdictions. This document does not specify requirements for isolators used for sterility testing; however, some of the principles and information in this document could be applicable to this application. This document does not define biosafety containment requirements.

Aseptic processing of health care products — Part 6: Isolator systems

GSO ISO/TS 21387:2023 医疗器械灭菌 使用参数释放的环氧乙烷灭菌过程的验证和常规处理要求指南

This document provides guidance on the requirements of ISO 11135 that apply when parametric release is used to release the product after exposure to the sterilization process. It provides a path for transition of existing cycles, as well as a path for the development and implementation of a parametric release specification for a new cycle. Additionally, it highlights the importance and interrelationship of other process factors, i.e. load configuration and equipment performance, which influence reproducibility of an ethylene oxide (EO) sterilization process. NOTE For ease of reference, the numbering of clauses in this document corresponds to that in the normative parts of ISO 11135. No additional guidance is offered for processes where the declaration of adequacy of the validated sterilization cycle includes a requirement for no growth in biological indicators (BIs) exposed to that process.

Sterilization of medical devices — Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release

CSA ISO 17664-1:2023

1 Scope This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of critical or semi-critical medical devices (i.e. a medical device that enters normally sterile parts of the human body or a medical device that comes into contact with mucous membranes or non-intact skin) or medical devices that are intended to be sterilized. This includes information for processing prior to use or reuse of the medical device. Processing instructions are not defined in this document. Rather, this document specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, where applicable: a) initial treatment at the point of use; b) preparation before cleaning; c) cleaning; d) disinfection; e) drying; f) inspection and maintenance; g) packaging; h) sterilization; i) storage; j) transportation. This document excludes processing of the following: — non-critical medical devices unless they are intended to be sterilized; — textile devices used in patient draping systems or surgical clothing; — medical devices specified by the manufacturer for single use only and supplied ready for use. NOTE See ISO 17664-2:2021, Annex E, for further guidance on the application of the ISO 17664 series to a medical device.

CSA ISO 17664-1:23

CSA ISO 17664-2:2023 医疗保健产品加工 医疗器械制造商应提供的医疗器械加工信息 第2部分：非关键医疗器械

1 Scope This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of non-critical medical devices not intended to be sterilized (i.e. a medical device that is intended to come into contact with intact skin only or a medical device not intended for direct patient contact). This includes information for processing prior to use or reuse of the medical device. Processing instructions are not defined in this document. Rather, this document specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, where applicable: a) preparation before processing; b) cleaning; c) disinfection; d) drying; e) inspection and maintenance; f) packaging; g) storage; h) transportation. This document excludes processing of: 1) critical and semi-critical medical devices; 2) medical devices intended to be sterilized; 3) textile medical devices used in patient draping systems or surgical clothing; 4) medical devices specified by the manufacturer for single use only and supplied ready for use. NOTE See Annex E for further guidance on the application of the ISO 17664 series to a medical device.

Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices

BS EN ISO 11137-2:2015+A1:2023 保健品灭菌 辐射 确定灭菌剂量

What is ISO 11137-2 - Establishing the sterilization dose of healthcare products about? This international standard is the second in a four-part series on the sterilization of heath care products using radiation. BS EN ISO 11137-2:2015+A1:2023  covers how to establish the minimum sterilization dose. Part 1 covers requirements for development, validation and routine control of a sterilization process. Part 3 gives guidance on dosimetric aspects. Part 4 gives guidance on control of irradiation processes.   Who is ISO 11137-2 - Radiation doses for sterilization of healthcare products for? Sterilization equipment manufacturers Sterilization service providers Infection control professionals Other professionals responsible for sterilization Healthcare facilities/hospitals What does ISO 11137-2 - Establishing the sterilization dose of healthcare products cover? This part of ISO 11137 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level (SAL) of 10 −6 . The standard also references methods for substantiating pre-selected doses in addition to 15kGy and 25kGy per ISO 13004. ISO 11137-2 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose and defines product families for sterilization dose establishment and sterilization dose audit. Why should you use ISO 11137-2 - Radiation doses for sterilization of healthcare products ? ISO 11137-2 offers three approaches to establishing the sterilization dose: D...

Sterilization of health care products. Radiation - Establishing the sterilization dose

23/30426672 DC BS EN ISO 11137-1 保健品灭菌 辐射 第 1 部分：医疗器械灭菌过程的开发、验证和常规控制要求

BS EN ISO 11137-1. Sterilization of health care products. Radiation - Part 1. Requirements for development, validation and routine control of a sterilization process for medical devices

EN ISO 11137-2:2015/A1:2023 保健产品的灭菌.辐射.第2部分:确定杀菌剂量 包含修改件A1,2023

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/Amd 1:2022)

T/CIQA 63-2023 会展活动消毒规范 现场消毒

本文件主要内容包括：确定了会展场所的消毒原则，提出了消毒员的要求，规范了会展区、公共区域、室内空气的消毒方法

Disinfection standard for exhibition activities - on-site disinfection

T/CIQA 61-2023 会展活动消毒规范 展品展具消毒

本文件主要内容包括：对展品展具进行了分类，明确了消毒对象和消毒要求，规范了常用消毒方法，提出了展品展具现场消毒方法的选择以及质量控制、现场消毒效果评价。

Disinfection standard for exhibition activities - exhibition equipment disinfection

T/CIQA 62-2023 会展活动消毒规范 消毒剂选择要求

本文件主要内容包括：确定了消毒剂的选择原则，分别为合法适用性、效果可靠性、环保安全性，规定了常规使用消毒剂、特殊使用消毒剂、消毒器械和器具的选择方法。

Disinfection standard for exhibition activities - disinfectant selection requirements

T/CIPR 098-2023 楼梯扶手清理机

本文件规定了楼梯扶手清理机（以下简称“清理机”）技术要求、试验方法、检验规则、标志、包装、运输和贮存。 本文件适用于以淋喷方式工作的清洗机

Stair handrail cleaning machine

23/30424625 DC BS EN ISO 11135 保健产品灭菌 环氧乙烷 医疗器械灭菌过程的开发、验证和常规控制要求

BS EN ISO 11135. Sterilization of health care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices