11.080.01 消毒和灭菌综合 标准查询与下载

EN ISO 11140-6:2022 保健产品的灭菌.化学指示器.第6部分:小型蒸汽灭菌器性能试验用2型指示器和过程挑战装置

This document specifies the performance requirements and test methods for hollow devices and porous devices as well as the chemical indicators and biological indicators that are utilized within these devices for testing a specific steam penetration performance of type B cycles and some type S cycles of small steam sterilizers according to EN 13060. NOTE The hollow and porous devices described in this document are not intended for use as surrogate devices for hollow and porous medical devices used in health care facilities. a) Chemical indicators used with a porous device specified in this document are designed to demonstrate the adequacy of steam penetration into a porous device in small steam sterilizers (see EN 13060). This document specifies the requirements for: — a reference porous device (RPD) as a reference device by which alternative porous indicator systems (APISs) can be shown to be equivalent in performance according to this document, i.e. a textile test pack in which steam penetration is judged by thermometric means; — an alternative porous chemical indicator system equivalent in performance to the RPD, i.e. an APIS, usually commercially manufactured, of any design. b) Chemical indicators used with a hollow load device specified in this document are designed to demonstrate the adequacy of steam penetration into a narrow lumen (previously known as hollow load A) in small steam sterilizers (see EN 13060). This document specifies the requirements for: — a reference hollow device (RHD) used as a reference device in this document, i.e. a lumened device with attached capsule in which steam penetration is judged by inactivation or survival of a specified biological indicator; — an alternative hollow device: — employing the same specific test load as defined for the RHD and a chemical indicator designed specifically for use in the reference hollow test load, i.e. a lumened device with an attached capsule in which steam penetration is judged by visual examination of a chemical indicator; — equivalent in performance to the RHD, i.e. an alternative hollow device, usually commercially manufactured, of any design.

Sterilization of health care products - Chemical indicators - Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers (ISO 11140-6:2022)

DB3305/T 246-2022 传染病防控洗消中心建设与管理规范

Specifications for the construction and management of infectious disease prevention and decontamination centers

ISO 11140-6:2022 保健产品的灭菌.化学指示器.第6部分:小型蒸汽灭菌器性能试验用2型指示器和过程挑战装置

Sterilization of health care products — Chemical indicators — Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers

BS ISO 13004:2022 保健品灭菌 辐射 所选灭菌剂量的证实：方法 VDmaxSD

1   Scope This document describes a method for substantiating a selected sterilization dose of 17,5 kGy, 20 kGy, 22,5 kGy, 27,5 kGy, 30 kGy, 32,5 kGy or 35 kGy that achieves a sterility assurance level ( SAL ) of 10 −6 or less for radiation sterilization of health care products . This document also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose . NOTE 1 Selection and substantiation of the sterilization dose is used to meet the requirements for establishing the sterilization dose within process definition in ISO 11137‑1. This document does not apply to other sterilization doses than the substantiation of a selected sterilization dose of 17,5 kGy, 20 kGy, 22,5 kGy, 27,5 kGy, 30 kGy, 32,5 kGy or 35 kGy. The method is not used for the substantiation of a selected sterilization dose if the average bioburden of the entire product item exceeds the limit specified for the selected sterilization dose (see Table 3).

Sterilization of health care products. Radiation. Substantiation of selected sterilization dose: Method VDmaxSD

BS ISO 22441:2022 保健品灭菌 低温汽化过氧化氢 医疗器械灭菌过程的开发、验证和常规控制要求

1   Scope 1.1   Inclusions 1.1.1    This document provides requirements for the development , validation and routine monitoring and control of a low temperature sterilization process for medical devices using vaporized hydrogen peroxide (VH2O2) as the sterilizing agent . 1.1.2    This document is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized, organizations performing process validation of VH2O2 sterilization , and organizations responsible for sterilizing medical devices . NOTE VH2O2 sterilizers can be used in both health care and industrial facilities, and this document acknowledges the similarities and differences between the two applications.

Sterilization of health care products. Low temperature vaporized hydrogen peroxide. Requirements for the development, validation and routine control of a sterilization process for medical devices

YY/T 1464-2022 医疗保健产品灭菌 低温蒸汽甲醛 医疗器械灭菌过程的开发、确认和常规控制要求

本文件规定了医疗器械低温蒸汽甲醛灭菌过程的开发、确认和常规控制的要求。本文件适用于在负压条件下使用混合低温蒸汽甲醛作为灭菌因子的灭菌过程。本文件不适用于对海绵状脑病(如羊痒症、牛海绵状脑病和克雅症)病原体灭活过程的开发、确认和常规控制的要求。

Development, validation and routine control requirements for low-temperature steam formaldehyde medical device sterilization process for sterilization of healthcare products

ISO 13004:2022 保健产品的灭菌.辐射.选定灭菌剂量的验证:方法VDmaxSD

This document describes a method for substantiating a selected sterilization dose of 17,5 kGy, 20 kGy, 22,5 kGy, 27,5 kGy, 30 kGy, 32,5 kGy or 35 kGy that achieves a sterility assurance level (SAL) of 10−6 or less for radiation sterilization of health care products. This document also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose. NOTE 1 Selection and substantiation of the sterilization dose is used to meet the requirements for establishing the sterilization dose within process definition in ISO 11137-1. This document does not apply to other sterilization doses than the substantiation of a selected sterilization dose of 17,5 kGy, 20 kGy, 22,5 kGy, 27,5 kGy, 30 kGy, 32,5 kGy or 35 kGy. The method is not used for the substantiation of a selected sterilization dose if the average bioburden of the entire product item exceeds the limit specified for the selected sterilization dose (see Table 3). NOTE 2 The methods for substantiation of selected sterilization doses of 25 kGy and 15 kGy are not included in this document. They are described in ISO 11137-2. If the decision is made to use this method of sterilization dose establishment, the method is intended to be followed in accordance with the requirements (shall) and guidance (should) stipulated herein.

Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD

ASTM F3127-22 用于验证在医疗设备制造过程中使用的清洁过程的标准指南

1.1 This guide provides considerations for validating cleaning processes for medical devices during initial fabrication and assembly prior to initial use. Validated cleaning processes are important for achieving consistency in function and consistency in biocompatibility. The considerations include but are not limited to: validation approach, equipment design, procedures and documentation, analytical methods, sampling, development of limits, and other issues. 1.2 Inclusions: 1.2.1 This guide describes the validation of critical cleaning processes for medical devices to reduce contaminants to acceptable levels prior to packaging. 1.3 Exclusions—The following items / medical devices / processes are excluded from the scope of this document: 1.3.1 Reusable medical devices. 1.3.1.1 Validation of cleaning operations for reusable medical devices is not within the scope of this standard guide. Although cleaning of reusable medical devices is beyond the scope of this guide, many of the principles outlined in this guide may be applicable to the validation of cleaning operations for reusable devices. 1.3.2 Cleaning of medical devices in health care facilities. 1.3.2.1 Validation of cleaning processes in patient/health care facilities is not within the scope of this standard guide. 1.4 This standard does not purport to be a replacement for biological safety testing. 1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices

T/WSJD 21-2022 内镜储存干燥柜卫生要求

本文件规定了内镜储存干燥柜的性能要求，结构和功能系统要求，微生物检测方法，标识、包装、铭牌和使用说明书的要求。 本文件适用于非灭菌不耐热软式内镜的储存干燥柜。

Hygienic requirements for storage and drying cabinets for endoscopes

T/WSJD 22-2022 次氯酸消毒剂生成器卫生要求

本文件规定了次氯酸消毒剂生成器的原材料要求、技术要求、应用范围、使用方法、检验方法、运输和贮存及铭牌和使用说明书。 本文件适用于化学法次氯酸消毒剂生成器和电解法次氯酸消毒剂生成器。

Hygienic Requirements for Hypochlorous Acid Disinfectant Generators

T/WSJD 30-2022 儿童抗菌和抑菌洗手液

本文件规定了儿童抗菌和抑菌洗手液的原材料要求、技术要求、检验方法、检验规则、标识与包装、运输和贮存、注意事项。 本文件适用于以抗菌或抑菌成分为主要原材料，适量添加表面活性剂等其它原材料配制而成的，具有清洁、抗菌或抑菌作用，用于3～12周岁儿童使用的产品。 本文件不适用于非水洗型产品。

Antibacterial and antibacterial hand sanitizer for children

22/30409085 DC BS EN ISO 17665 保健产品灭菌 湿热 医疗器械灭菌过程的开发、验证和常规控制要求

BS EN ISO 17665. Sterilization of health care products. Moist heat. Requirements for the development, validation and routine control of a sterilization process for medical devices

T/ZPA 08-2022 保健用品生产企业采标产品评价规范

本标准主要技术内容包括：总体要求、评价原则、评价依据、评价内容、评价方法、评价流程等。

Specification for evaluation of standard products adopted by health care products manufacturers

T/ZPA 07-2022 保健用品生产企业等级评价规范

本标准技术内容包括：基本要求、评价原则、评价依据、评价内容、评价方法、评价流程等。

Specification for grade evaluation of health care products manufacturers

T/ZPA 06-2022 保健用品生产质量管理规范

本标准主要技术内容包括：机构与人员、厂房场地、设施设备、原材料、卫生、生产管理、质量管理、产品销售与回收、成品贮存与运输、自检、文件等内容。

Specification for production quality management of health care products

ISO 22441:2022 保健产品灭菌.低温汽化过氧化氢.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 — Low temperature vaporized hydrogen peroxide — Requirements for the development, validation and routine control of a sterilization process for medical devices

T/ZJJXH 0009-2022 康复室消毒消杀管理规范

本文件规定了康复室消毒消杀的基本要求、人员要求、消毒要求、消杀要求、疫情应急消毒、监督管理的要求。

Disinfection management specification for recovery room

BS EN ISO 25424:2019+A1:2022 保健品灭菌 低温蒸汽和甲醛 医疗器械灭菌过程的开发、验证和常规控制要求

1   Scope 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).

Sterilization of health care products. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices

T/CPQS E00032-2022 具有空气及物表消毒功能的消毒机

本文件规定了具有空气及物表消毒功能的消毒机的分类、命名与型号、技术要求、试验、检验规则、铭牌、使用说明、包装、运输及贮存。

Disinfection machine with air and object surface disinfection function

ISO 18362:2016/Amd 1:2022 基于细胞的保健产品的制造.加工过程中微生物风险的控制.修改件1

Manufacture of cell-based health care products — Control of microbial risks during processing — Amendment 1