C04 基础标准与通用方法 标准查询与下载

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

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 0806-2:2010 保健产品的灭菌.辐射.第2部分:杀菌剂量的确定

Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose

BS EN ISO 10991:2009 微处理技术.词汇表

This International Standard gives terms and definitions for micro process engineering applied in chemistry, pharmacy, biotechnology and food technology.

Micro process engineering - Vocabulary

NF S98-118-2:2010 医疗器材的消毒.微生物法.第2部分:消毒过程的定义、有效性和维护进行的无菌试验

Sterilization of medical devices - Microbiological methods - Part 2 : tests of sterility performed in the definition, validation and maintenance of a sterilization process.

ANSI/NSF 49(i29)-2010 生物安全柜:设计,构造,性能和现场认证

Biosafety Cabinetry: Design, Construction, Performance, and Field Certification

ASTM F2809-10 与内科外科材料和设备有关的标准术语

All approved F04 standards have their terms reproduced in this terminology document, per section 1.3. The terms are listed both alphabetically, and by subcommittee of origin, per section 1.2. This standard maintains a single source for terminology reference for ASTM Committee F04. This standard assists in the authoring of new ASTM standards, and standard revisions, where authors can find and utilize existing terms to avoid generation of extraneous, duplicative, or contradicting terms. Some terms may appear more than once. In some cases, multiple definitions of a term are needed, based on the variety of applications and sectors to which it applies. Because this terminology standard is a repository for all approved terms of Committee F04, it may become evident that multiple definitions for a term have been developed, but need coordination. An objective of this document is to make duplication evident, and to facilitate harmonization of terms by Committee F04 as appropriate. Appendix X2 provides background on the history and objectives of this terminology standard.1.1 This terminology standard is a repository for the terms, and their standardized definitions, as relates to the technical standards generated by ASTM Committee F04 on Medical and Surgical Materials and Devices. The meanings and explanations of the technical terms have been written for both the non-expert and the expert user. 1.2 The terms are listed in alphabetical sequence; in Appendix X1 they are listed by the subcommittee of origin. 1.3 At a minimum, this standard is updated annually (at a time corresponding to the publication of the Annual Book of ASTM Standards containing this terminology standard) to editorially include any terms approved in the Committee''s technical standards. 1.4 The originating standard of each term is included for informational purposes, following each listing of a term and its associated definition.

Standard Terminology Relating to Medical and Surgical Materials and Devices

ASTM E1588-10e1 扫描电子显微术/能量散射X射线光谱法射击残留物分析的标准指南

This document will be of use to forensic laboratory personnel who are involved in the analysis of GSR samples by SEM/EDS (4). SEM/EDS analysis of GSR is a non-destructive method that provides (5, 6) both morphological information and the elemental profiles of individual particles. Particle analysis contrasts with bulk sample methods, such as atomic absorption spectrophotometry (AAS) (7), neutron activation analysis (NAA) (8), inductively coupled plasma atomic emission spectrometry (ICP-AES), and inductively coupled plasma mass spectrometry (ICP-MS), where the sampled material is dissolved or extracted prior to the determination of total element concentrations, thereby sacrificing morphological information and individual particle identification. X-ray fluorescence spectrometry (XRF) is a technique that has been used to map the placement and distribution of GSR particles surrounding bullet holes in order to establish shooting distances (9). Unlike the solution-based bulk methods of analysis, XRF is non-destructive; however, XRF still does not provide morphological information and is incapable of individual GSR particle identification.1.1 This guide covers the analysis of gunshot residue (GSR) by scanning electron microscopy/energy-dispersive X-ray spectrometry (SEM/EDS) by manual and automated methods. The analysis may be performed manually, with the operator manipulating the microscope controls and the EDS system software, or in an automated fashion, where some amount of the analysis is controlled by pre-set software functions. 1.2 Since software and hardware formats vary among commercial systems, guidelines will be offered in the most general terms possible. For proper terminology and operation, consult the SEM/EDS system manuals for each system. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 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 and health practices and determine the applicability of regulatory limitations prior to use.

Standard Guide for Gunshot Residue Analysis by Scanning Electron Microscopy/ Energy Dispersive X-ray Spectrometry

ASTM F1903-10 对体外颗粒物的生物学响应试验的标准实施规程

This practice is to be used to help assess the biocompatibility of materials used in medical devices. It is designed to test the effect of particles from the materials on macrophages. The use of nonhuman, nonprimate cells is recommended in this practice. For laboratories equipped and approved to work with human blood and tissue, the use of these same protocols would be advantageous for development of understanding of the interaction of cells and particles. The appropriateness of the methods should be carefully considered by the user since not all materials or applications need be tested by this practice. Abbreviations: LPS8212;lipopolysaccharide (endotoxin). LAL8212;Limulus Amebocyte Lysate. ATCC8212;American Type Culture Collection. FCS (FBS)8212;Fetal Calf Serum. NCS8212;Newborn Calf Serum. PBS8212;Phosphate Buffered Saline. HANKS8212;A balanced salt solution. MMPS8212;Matrix Metallo Proteases. RPMI 16408212;Specific Growth Medium (Roswell Park Memorial Institute). HEPES8212;A buffering salt.1.1 This practice covers the production of wear debris and degradation products from implanted materials that may lead to a cascade of biological responses resulting in damage to adjacent and remote tissues. In order to ascertain the role of particles in stimulating such responses, the nature of the responses, and the consequences of the responses, established protocols are needed. This is an emerging, rapidly developing area and the information gained from standard protocols is necessary to interpret responses and to determine if there is correlation with the in vivo responses. Since there are many possible and established ways of determining responses, a single standard protocol is not stated. However, well described protocols are needed to compare results from different investigators using the same materials and to compare biological responses for evaluating (ranking) different materials. For laboratories without established protocols, recommendations are given and indicated with an asterisk*. 1.2 Since the purpose of these studies is to predict the response in humans, the use of human cells would provide much information. However, in this practice, the use of non-human and non-primate cells is described. If the user should wish to employ cell lines from humans, cell lines are available from ATCC and most of the information and recommendations will still apply. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 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 and health practices and determine the applicability of regulatory limitations prior to use.

Standard Practice for Testing For Biological Responses to Particles In Vitro

ASTM F2312-10 组织工程医疗产品相关标准术语

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.1.1 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 unifying the language used in TEMP standards and are not intended for labeling of regulated medical products. 1.4 This standard does not purport to address all of the safety con......

Standard Terminology Relating to Tissue Engineered Medical Products

KS P ISO 20776-2:2009 临床实验室测试和体外诊断试验系统.传染者的易感性测试和抗菌剂易感性试验装置的性能评估.第2部分:抗菌剂易感性试验装置的性能评估

이 표준은 의학 검사실에서 항균제에 대한 세균의 감수성, 중간 내성 및 내성(SIR) 균주

Clinical laboratory testing and in vitro diagnostic test systems－Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices－Part 2：Evaluation of performance of antimicrobial susceptibility test d

NF S98-100:2009 医疗保健产品灭菌.生物指示物.选择、使用和检验结果解释指南

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

ISO 10991:2009 微工艺过程.词汇表

Micro process engineering - Vocabulary

ISO 25424:2009 医疗器械的消毒.低温蒸汽和甲醛.医疗器械消毒工序的制订,认证和日常控制要求

Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices

BS DD CEN/ISO TS 11135-2:2009 卫生保健产品的消毒.环氧乙烷.ISO 11135-1标准应用导则

Sterilization of health care products. Ethylene oxide. Guidance on the application of ISO 11135-1

BS DD CEN ISO/TS 11135-2:2008 保健品消毒.环氧乙烷.ISO 11135-1应用指南

Sterilization of health care products. Ethylene oxide. Guidance on the application of ISO 11135-1

BS ISO 29781:2008 修复术和矫形学 包括当说明下肢截肢者或出生时存在肢体缺陷者身体活动性的因素

Prostheses and orthoses - Factors to be included when describing physical activity of a person who has had a lower limb amputation(s) or who has a deficiency of a lower limb segment(s) present at birth

BS ISO 29783-1:2008 修复术和矫正术.词汇.常规步态

Prosthetics and orthotics - Vocabulary - Normal gait

BS ISO 29782:2008 修复术和矫形学.当具体说明下肢截肢者修复术时考虑的因素

Prostheses and orthoses - Factors to be considered when specifying a prosthesis for a person who has had a lower limb amputation

DIN 58948-17:2009 消毒 低温消毒器 第17部分:低温蒸汽甲醛和甲醛消毒器及其电源的安装和操作用要求

Sterilization - Low temperature sterilizers - Part 17: Requirements for the installation and operation of low temperature steam formaldehyde and formaldehyde sterilizers and their supply sources