C04 基础标准与通用方法 标准查询与下载

ANSI/AAMI ST67-2011 保健品杀菌.选择标有"无菌"产品的灭菌保证水平(SAL)的要求和指导

Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled sterile

ASTM E2548-11e1 药物取样定性和定量分析的标准指南

This guide provides information for the sampling of seized-drug submissions. The principal purpose of sampling in the context of this guide is to answer relevant questions about a population by examination of a portion of the population. For example: What is the net weight of the population? What portion of the units of a population can be said to contain a given drug at a given level of confidence? By developing a sampling strategy and implementing appropriate sampling schemes, as illustrated in Fig. 1, a laboratory will minimize the total number of required analytical determinations, while ensuring that all relevant legal and scientific requirements are met. FIG. 1 Relationship of Various Levels Required in Sampling1.1 This guide covers minimum considerations for sampling of seized drugs for qualitative and quantitative analysis.

Standard Guide for Sampling Seized Drugs for Qualitative and Quantitative Analysis

ANSI/AAMI/ISO 23500:2011 血液透析及相关治疗用液体的制备和质量管理指南

This recommended practice covers the appropriate prescription of dialysate, handling of concentrates, operation of water treatment equipment and handling of its product water, monitoring of systems and the dialysate produced, and risks and hazards of dialysate preparation failure. It presents a systems diagram and explanation for the production, monitoring, and use of dialysate for hemodialysis in the facility.

Guidance for the preparation and quality management of fluids for haemodialysis and related therapies

ASTM F2312-11 组织工程医疗产品的相关标准术语

The need for standards regarding TEMPs has also prompted a need for definitions. This terminology sets forth definitions of the most commonly used terms and specifies the relationship among the sciences and components applied in tissue engineering to develop TEMPs. Use of these terms and an understanding of these relationships will unify the ASTM TEMPs standards with a common language such that the users of these standards can understand and interpret the standards more precisely. Terms specific to a TEMP standard will also be defined within the respective standard as appropriate. Defining Terms8212;Terms are defined with a broad scope to encompass these new products known as TEMPs. For instance, the definition for somatic cell therapy as stated in the “Guidance for Human Somatic Cell Therapy and Gene Therapy” (4) is recognized in this terminology. However, for the purposes of TEMPs that contain cells, we have added the definition of “cell” which is much broader and not limited to the use of living cells. Clinical Effects of TEMPs8212;The users of this terminology should note that terms used regarding the clinical effects of TEMPs, for instance, “modify or modification” of the patient's condition, may also be interpreted to “enhance, augment, transform, alter, improve, or supplement.” Similarly, “repair” may also serve to mean “restore.” The diagram in Fig. 1 shows the relationships of components of TEMPs and of the fields of science (for example, technologies and principles) used in tissue engineering to create TEMPs. Certain TEMPs may be tissue engineered or produced in vitro by using specific components and sciences to create an off-the-shelf TEMP for the users. Other TEMPs may by design require the users to place the components inside the patient, (that is, in vivo) to rely upon the patient's regenerative potential to achieve the product's primary intended purpose. The expectation of a TEMP used for therapeutic clinical applications is to have a therapeutic effect, specifically to repair, modify or regenerate the recipient's cells, tissues, and organs or their structure and function. Such a TEMP may be used for human and non-human applications. In other applications, a TEMP may be used in diagnostic clinical applications, or both, to achieve an investigative outcome of the function of the cells, tissues, and organs. FIG. 1 Relationships of the Fields of Tissue Engineering to Tissue Engineered Medical Products1.1 This terminology defines basic terms and presents the relationships of the scientific fields related to Tissue Engineered Medical Products (TEMPs). Committee F04 has defined these terms for the specific purpose of unifying the language used in standards for TEMPs. 1.2 The terms and relationships defined here are limited to TEMPs. They do not apply to any medical products of human origin regulated by the U.S. Food and Drug Administration under 21 CFR Parts 16 and 1270 and 21 CFR Parts 207, 807, and 1271. 1.3 The terms and nomenclature presented in this standard are for the specific purposes of unifyin......

Standard Terminology Relating to Tissue Engineered Medical Products

KS P 1014-2010 间日疟疾抗原诊断试剂的质量管理标准物质

이 표준은 삼일열원충의 감염에 의해 발생하는 삼일열 말라리아의 발병 여부를 진단하기 위해

Standard reference materials for the quality control of antigen detection tests of Plasmodium vivax malaria

KS P 1013-2010 恶性疟疾抗原诊断试剂的质量管理标准物质

이 표준은 열대열원충의 감염에 의해 발생하는 열대열 말라리아의 발병 여부를 진단하기 위해

Standard reference materials for the quality control of antigen detection tests of Plasmodium falciparum malaria

KS P 1012-2010 恶性疟疾基因诊断试剂的质量控制标准物质

이 표준은 열대열원충의 감염에 의해 발생하는 열대열 말라리아의 발병 여부를 진단하기 위해

Standard materials for the quality control of genetic diagnostic tests of Plasmodium falciparum malaria

KS P 20160-2010 手术用移植物.金属材料.α+β钛合金棒微观结构分类

이 표준은 외과용 이식재 제조용으로 의도된 막대형태 알파+베타 티타늄 합금의 미세구조 호칭

Implants for surgery－Metallic materials－Classification of microstructures for alpha+beta titanium alloy bars

DB31/T 502-2010 医院物业管理服务规范

Hospital Property Management Service Criterion

NF X30-510:2010 医疗保健废弃物术语.

Terminology of health care waste.

SN/T 1088-2010 布氏杆菌检疫技术规范

本标准规定了布氏杆菌显微镜检查、细菌培养、聚合酶链反应、虎红平板凝重试验、缓冲平板凝集试验、试管凝集试验、补体结合试验、酶链免疫吸附试验、荧光偏振试验、全乳环状试验等技术要求。 本标准适用于牛种、猪种布氏杆菌的检疫。

Quarantine Frotocol for Brucellosis

BS PAS 2015:2010 卫生设施弹性框架

Framework for health services resilience

AQ/T 4206-2010 作业场所职业危害基础信息数据

本标准规定了作业场所职业危害基础信息数据及其分类和属性。 本标准适用于作业场所职业危害基础信息数据的一致性表达、采集以及基础信息数据的交换与共享,作业场所职业危害相关信息系统的建设可参照使用。

The basic data of oceupational hazard information at workplace

JIS K 3706-2 ERRATUM 1:2010 勘误表

ERRATUM

JIS K 3706-1 ERRATUM 1:2010 勘误表

ERRATUM

BS EN ISO 14937:2009 保健产品灭菌.医疗器械用消毒剂的特性和消毒方法的研发、验证及常规控制的一般要求

1.1.1 This International Standard specifies general requirements for the characterization of a sterilizing agent and for the development, validation and routine monitoring and control of a sterilization process for medical devices. 1.1.2 This International Standard applies to sterilization processes in which microorganisms are inactivated by physical and/or chemical means. 1.1.3 This International Standard is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized, and organizations responsible for sterilizing medical devices. 1.1.4 This International Standard specifies the elements of a Quality Management System which are necessary to assure the appropriate characterization of the sterilizing agent, development, validation and routine monitoring and control of a sterilization process.

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices

DIN EN ISO 14937:2010 保健产品灭菌.医疗器械用消毒剂的特性和消毒方法的研发,验证及常规控制的一般要求 (ISO 14937-2009); 德文版本 EN ISO 14937-2009

This Standard specifies general requirements for the characterization of a sterilizing agent, and for the development, validation, and routine monitoring and control of a sterilization process for medical devices.Note Although the scope of this International Standard is limited to medical devices, the requirements specified herein can also be applied to sterilization processes for other health care products.This Standard applies to sterilization processes in which microorganisms are inactivated by physical and/or chemical means.

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009); German version EN ISO 14937:2009

DIN EN ISO 14161:2010 医疗保健产品的消毒.生物指示剂.选择、使用和检验结果解释指南(ISO 14161-2009); 德文版本 EN ISO 14161-2009

This International Standard 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. This International Standard applies to biological indicators for which International Standards exist.

Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2009); German version EN ISO 14161:2009

JIS T 0816-1:2010 保健产品的灭菌.湿热.第1部分:医疗机械消毒过程的制定、确认和常规控制的要求

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

JIS T 0806-1:2010 保健产品的灭菌.辐射.第1部分:医疗器件消毒过程的制定、确认、和常规控制的要求

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