11.100 实验室医学 标准查询与下载

KS P ISO 10993-1:2007 医疗器械的生物学评估.第1部分:评估与试验

이 규격은 다음 사항에 대하여 규정하고 있다.a) 의료기기의 생물 안전성 평가를 위

Biological evaluation of medical devices－Part 1：Evaluation and testing

KS P ISO 10993-9:2007 医疗器械的生物学评估.第9部分:潜在降解产品鉴定和量化框架

이 규격은 의료기기에서 잠재되고 관찰되는 생분해에 관한 체계적인 평가와 생분해 연구의 설계

Biological evaluation of medical devices－Part 9：Framework for identification and quantification of potential degradation products

KS P ISO 10993-13:2007 医疗器械的生物学评估.第13部分:聚合物医疗器械降解产物的鉴定与定量

이 규격은 임상용으로 준비된 고분자성 의료기기에서 나온 분해 산물의 확인 및 정량을 위한

Biological evaluation of medical devices－Part 13：Identification and quantification of degradation products from polymeric medical devices

KS P ISO 10993-5:2007 医疗器械的生物学评估.第5部分:致癌力的试验

이 규격은 의료기기의 세포 독성에 대한 체외 시험방법을 규정하고 있다.이러한 시험방법은

Biological evaluation of medical devices－Part 5：Tests for in vitro cytotoxicity

ASTM F2103-01(2007) 作为生物医学和组织工程医疗产品应用的起始材料的壳聚糖盐的特性和试验的标准指南

Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications

ASTM F2148-07(2012) 评定使用鼠科动物局部淋巴结化验 (LLNA) 对延时接触性超敏反应的标准实施规程

1.1 This practice provides a methodology to use an in-situ procedure for the evaluation of delayed contact hypersensitivity reactions. 1.2 This practice is intended to provide an alternative to the use of guinea pigs for evaluation of the ability of a device material to stimulate delayed contact hypersensitivity reactions. This alternative is particularly applicable for materials used in devices that contact only intact skin. However, the guinea pig maximization test is still the recommended method when assessing the delayed hypersensitivity response to metals or when testing substances that do not penetrate the skin but are used in devices that contact deep tissues or breached surfaces. The guinea pig maximization test should be used for these substances. 1.3 This practice consists of a protocol for assessing an increase in lymphocyte proliferation within the nodes draining the site of administration on the ears of mice. 1.4 The LLNA has been validated only for low-molecular-weight chemicals that can penetrate the skin. The absorbed chemical or metabolite must bind to macromolecules, such as proteins, to form immunogenic conjugates. 1.5 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F748 may provide guidance for the selection of appropriate methods for testing materials for a specific application. 1.6 Identification of a supplier of materials or reagents is for the convenience of the user and does not imply a single source. Appropriate materials and reag......

Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)

KS B ISO 12772-2006(2016) 实验室玻璃器皿一次性使用微量红细胞压积毛细管

Laboratory glassware－Disposable microhaematocrit capillary tubes

KS B ISO 12771-2006(2016) 塑料实验室器具一次性血清移液管

Plastics laboratory ware－Disposable serological pipettes

KS B ISO 12771:2006 实验室塑料器皿.一次性血清吸量管

이 규격은 일회용 플라스틱 혈청 피펫, 배출 측정, 일반적 실험 목적의 요구 사항을 규정한

Plastics laboratory ware－Disposable serological pipettes

KS B ISO 12772:2006 实验室玻璃器皿.一次性微量血球容量计毛细管

이 규격은 두 타입의 일회용 유리제 모세관 튜브에 대한 상세를 제공한다. 플라스마와 셀의

Laboratory glassware－Disposable microhaematocrit capillary tubes

KS B ISO 12771-2006(2021) 塑料实验室器具一次性血清移液管

Plastics laboratory ware－Disposable serological pipettes

KS B ISO 12772-2006(2021) 实验室玻璃器皿一次性使用微量红细胞压积毛细管

Laboratory glassware－Disposable microhaematocrit capillary tubes

KS P 6111-2006 孵箱

이 규격은 세균 배양에 사용하는 세균 배양기(의료용 배양기, 이하 배양기라 한다.)에 대하

Incubator

KS P ISO 10993-4:2006 医疗器械的生物学评估.第4部分:与血液相互作用试验选择

이 규격은 혈액과 의료 기기의 상호 작용을 평가하기 위한 일반 요구 사항에 대하여 규정 한

Biological evaluation of medical devices－Part 4：Selection of tests for interactions with blood

CNS 14393-16-2006 医疗器材生物性评估－ 第16部：降解产物与可溶出物毒性动力学之研究设计

本标准适用于进行与医疗器材有关的毒性动力学研究时，所应当具备的设计与执行原理。

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables

CNS 14393-15-2006 医疗器材生物性评估－第15部：金属及合金之降解产物的鉴别及定量

本标准提供设计试验方法一般规定的指引，用以鉴别及定量金属医疗器材成品或预备作为临床使用的材料样品的降解产物。其仅适用于在体外加速降解试验时，金属器材成品经化学改变所产生的降解产物。由于这些试验是加速性，试验结果不会反映出植入物或材料在体内的行为。所述的化

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys

TIS 2276-2006 医学实验室.安全要求

Medical laboratories.requirements for safety

TIS 2277-2006 实验室医学.参考测量实验室的要求

Laboratory medicine.requirements for reference measurement laboratories

ASTM F2147-01(2006) 豚鼠标准实践:接触性过敏原的分裂辅助和封闭补片测试

1.1 This practice is intended to determine the potential for a substance, or material extract, to elicit contact dermal allergenicity. 1.2 This practice is intended as an alternative to the Guinea Pig Maximization Test (GPMT), given the limitations on dosage form and tendency for false positives associated with the latter test. See Rationale and References. 1.3 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 Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens

YY/T 0577-2005 营养琼脂培养基

本标准规定了营养琼脂培养基的质量要求、检验方法、使用说明、标志、标签以及包装、运输、贮存。 本标准适用于一般细菌培养的营养琼脂培养基。

Nutrient agar medium