A40 基础学科综合 标准查询与下载

NF X42-122*NF EN 12298:1998 设备.密封性测试程序指南 (欧洲标准EN 12298)

Equipment. Guidance on testing procedures for leaktightness.

NF X42-124*NF EN 12347:1998 生物技术.蒸气消毒器和高压灭菌器性能规范 (欧洲标准EN 12347)

Biotechnology. Performance criteria for steam sterilizers and autoclaves.

ARMY MIL-HDBK-759 C CHG NOTICE 2-1998 人体工程学设计指导方针

This handbook provides human engineering design guidelines and reference data for design of military systems,equipment, and facilities.(Programmatic and techique-oriented guidelines may be found in DOD-HDBK-763 and MIL

HUMAN ENGINEERING DESIGN GUIDELINES

DIN EN 12305:1998 生物工艺学.环境条件下使用的变性有机体.有目的释放遗传变异植物时取样策略指南

The document illustrates sampling methods for the detection of GMOs.

Biotechnology - Modified organisms for application in the environment - Guidance for the sampling strategies for deliberate releases of genetically modified plants; German version EN 12305:1997

DIN EN 12307:1998 生物工艺学.大规模加工和生产.人员培训和管理优秀方法和程序指南

The document gives guidance for good practice, procedures, training and control for the operation of large scale biotechnological processes.

Biotechnology - Large-scale process and production - Guidance for good practice, procedures, training and control for personnel; German version EN 12307:1997

ASTM E1439-98(2004) 进行蛙胚胎畸形发生鉴定非洲蟾蜍属(FETAX)的标准指南

FETAX is a rapid test for identifying developmental toxicants. Data may be extrapolated to other species including mammals. FETAX might be used to prioritize samples for further tests which use mammals. Validation studies using compounds with known mammalian or human developmental toxicity, or both, suggest that the predictive accuracy will exceed 85 % (2). When evaluating a test material for mammalian developmental toxicity, FETAX must be used with and without a metabolic activation system (MAS). Use of this exogenous MAS should increase the predictive accuracy of the assay to approximately 95 %. The accuracy rate compares favorably with other currently available “ in vitro teratogenesis screening assays” (3). Any assay employing cells, parts of embryos, or whole embryos other than in vivo mammalian embryos is considered to be an in vitro assay. It is important to measure developmental toxicity because embryo mortality, malformation, and growth inhibition can often occur at concentrations far less than those required to affect adult organisms. Because of the sensitivity of embryonic and early life stages, FETAX provides information that might be useful in estimating the chronic toxicity of a test material to aquatic organisms. Results from FETAX might be useful when deriving water quality criteria for aquatic organisms (4). FETAX results might be useful for studying structure-activity relationships between test materials and for studying bioavailability.1.1 This guide covers procedures for obtaining laboratory data concerning the developmental toxicity of a test material. The test utilizes embryos of the South African clawed frog, Xenopus laevis and is called FETAX (Frog Embryo Teratogenesis Assay- Xenopus) (). Some of these procedures will be useful for conducting developmental toxicity tests with other species of frogs although numerous modifications might be necessary. A list of alternative anurans is presented in . 1.2 A renewal exposure regimen and the collection of the required mortality, malformation, and growth-inhibition data are described. Special needs or circumstances might require different types of exposure and data concerning other effects. Some of these modifications are listed in although other modifications might also be necessary. Whenever these procedures are altered or other species used, the results of tests might not be comparable between modified and unmodified procedures. Any test that is conducted using modified procedures should be reported as having deviated from the guide.1.3 These procedures are applicable to all chemicals either individually or in formulations, commercial products or mixtures that can be measured accurately at the necessary concentrations in water. With appropriate modification these procedures can be used to conduct tests on the effects of temperature, dissolved oxygen, pH, physical agents, and on materials such as aqueous effluents (see Guide E 1192), surface and ground waters, leachates, aqueous extracts of water-insoluble materials, and solid phase samples, such as soils and sediments, particulate matter, sediment, and whole bulk soils and sediment.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 Conducting the Frog Embryo Teratogenesis Assay-Xenopus (FETAX)

ASTM F748-98 材料和装置用一般生物试验方法的选择

1.1 This practice recommends generic biological test methods for materials and devices according to end-use applications. While chemical testing for extractable additives and residual monomers or residues from processing aids is necessary for most implant materials, such testing is not included as a part of this practice. The reader is cautioned that the area of materials biocompatibility testing is a rapidly evolving field, and improved methods are evolving rapidly, so this practice is by necessity only a guideline. A thorough knowledge of current techniques and research is critical to a complete evaluation of new materials. 1.2 These test protocols are intended to apply to materials and medical devices for human application. Biological evaluation of materials and devices, and related subjects such as pyrogen testing, batch testing of production lots, and so forth, are also discussed. Tests include those performed on materials, end products, and extracts. Rationale and comments on current state of the art are included for all test procedures described. 1.3 The biocompatibility of materials used in single-component or multicomponent medical devices for human use depends to a large degree on the particular nature of the end-use application. Biological reactions that are detrimental to the success of a material in one device application may have little or no bearing on the successful use of the material for a different application. It is, therefore, not possible to specify a set of biocompatibility test methods which will be necessary and sufficient to establish biocompatibility for all materials and applications. 1.4 The ethical use of research animals places the obligation on the individual investigator to determine the most efficient methods for performing the necessary testing without undue use of animals. Where adequate prior data exists to substantiate certain types of safety information, these guidelines should not be interpreted to mean that testing should be repeated unnecessarily.

Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

ASTM E1439-98 进行蛙胚胎畸形发生鉴定非洲蟾蜍属(FETAX)的标准指南

1.1 This guide describes procedures for obtaining laboratory data concerning the developmental toxicity of a test material. The test utilizes embryos of the South African clawed frog, Xenopus laevis and is called FETAX (Frog Embryo Teratogenesis Assay- Xenopus ) (1). Some of these procedures will be useful for conducting developmental toxicity tests with other species of frogs although numerous modifications might be necessary. A list of alternative anurans is presented in Appendix X1. 1.2 A renewal exposure regimen and the collection of the required mortality, malformation, and growth-inhibition data are described. Special needs or circumstances might require different types of exposure and data concerning other effects. Some of these modifications are listed in Appendix X2 although other modifications might also be necessary. Whenever these procedures are altered or other species used, the results of tests might not be comparable between modified and unmodified procedures. Any test that is conducted using modified procedures should be reported as having deviated from the guide. 1.3 These procedures are applicable to all chemicals either individually or in formulations, commercial products or mixtures that can be measured accurately at the necessary concentrations in water. With appropriate modification these procedures can be used to conduct tests on temperature, dissolved oxygen, pH, physical agents, and on materials such as aqueous effluents (see Guide E1192), leachates, aqueous extracts of water-insoluble materials, particulate matter, sediment, and surface waters. 1.4 This standard does not purport to address all of the safety problems, 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. 1.5 This guide is arranged as follows:

Standard Guide for Conducting the Frog Embryo Teratogenesis Assay-Xenopus (FETAX)

NF X42-081*NF EN 12307:1997 生物技术.大规模加工和生产.人员培训和管理常用方法和程序指南

Biotechnology. Large-scale process and production. Guidance for good practice, procedures, training and control for personnel.

PD 6613-1997 生物技术.微生物学.各种现有动物病原体清单的诊察和报告的制备

Biotechnology. Microorganisms. Examination of the various existing lists of animal pathogens and production of a report

JIS K 3810-2:1997 支原体检测方法.第2部分:非直接DNA斑点试验

Mycoplasma detection method Part 2: Indirect DNA staining assay

JIS K 3810-1:1997 支原体检测方法.第1部分:微生物培养化验

Mycoplasma detection method Part 1: Microbiological cultivation assay

JIS K 3810-3:1997 支原体检测方法.第3部分:PCR试验

Mycoplasma detection method Part 3: Nested PCR assay

ARMY MIL-STD-1474 D CHG NOTICE 1-1997 人体工程学

This commercial item description covers brown kraft paper used for general wrapping applications.

NOISE LIMITS [Superseded: AIR FORCE MIL-STD-1789 A CHG NOT 1 CONT. DIST., AIR FORCE MIL-STD-1789 A CONT.DIST., AIR FORCE MIL-STD-1789 CONT. DIST., ARMY MIL-STD-1294 A CANC NOTICE 1, ARMY MIL-STD-1294 A, ARMY MIL-STD-1294, NAVY MIL-STD-740 -1]

NF X42-108*NF EN 12075:1997 生物技术.大规模加工和生产.发酵和顺流加工方法 (欧洲标准EN 12075)

Biotechnology. Larce-scale process and production. Procedures for fermentation and downstream processes.

BS EN 1620:1997 生物技术.大规模加工和生产.根据危害程度建造的工厂建筑物

This European Standard specifies design requirements for plant buildings used for the safe handling of micro-organisms and the product itself if it presents a biohazard. NOTE 1. When applying this European Standard, attention is drawn to the existing national regulations such as regulations concerning genetic engineering, water and environmental emission concerning the design requirements. Plant buildings include buildings intended, if necessary, to contain all the fermentors and downstream processing apparatus. Plant building design includes design of equipment linked to the building itself and excludes specific production equipment. NOTE 2. Equipment implementation is covered by a standard Equipment implementation according to the degree of hazard which is being prepared (see annex B [3]). This European Standard is not applicable to design requirements which affect good manufacturing practice (see annex B [6]) or product quality, for which attention is drawn to relevant codes of practice and national regulations. It would be advisable to consider both aspects simultaneously.

Biotechnology - Large-scale process and production - Plant building according to the degree of hazard

DIN EN 12075:1997 生物技术.大规模处理和生产.发酵范及下游处理程序

Biotechnology - Large-scale process and production - Procedures for fermentation and downstream processes; German version EN 12075:1997

BS EN 1619:1997 生物技术.大规模加工和生产.应变保存程序管理和组织的一般要求

This European Standard specifies general requirements for management and organization of procedures for conservation of micro-organisms used for large-scale process and production. It is intended to secure safe handling and also to ensure that reproducible results are obtained in biotechnology processes. This European Standard specifies methods of handling and preservation of microbial strains or cell lines obtained from animals, plants and viruses in order to get reproducible and safe cultivation processes for the industrial production of substances. NOTE. Attention is drawn to the existing national regulations concerned with the handling of micro-organisms. This European Standard is applicable to micro-organisms.

Biotechnology - Large-scale process and production - General requirements for management and organization for strain conservation procedures

NF X42-106*NF EN 1620:1997 生物技术.大规模加工和生产.根据危险等级确定的工厂建筑物

Biotechnology. Large-scale process and production. Plant building according to the degree of hazard.

BOCA IPC-1997 APPENDIX B-1997 各城市的降雨量

The BOCA National Mechanical Code was initially prepared and updated on the premise that adequate code requirements are essential to the safe installation and maintenance of all mechanical equipment and systems in order to protect the public health, sa

Rates of Rainfall for Various Cities