C04 基础标准与通用方法 标准查询与下载

DIN EN 1041:2008 由医疗装置制造商提供的信息

This standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical devices and Council Directive 93/42/EEC concerning medical devices. It does not specify the language to be used for such informadon, nor does it specify the means by which the information is to be supplied. It is also intended to complement the specific requirements of the cited EU Directives on medical devices by providing guidance on means by which certain requirements can be met. If a manufacturer follows these means, they will provide a presumption of conformity with the relevant Essential Requirements regarding information to be supplied. This standard does not cover requirements for provision of information for in vitro diagnostic medical devices, which are covered by other labelling standards (see Bibliography). NOTE When national transpositions of the Directives specify the means by which information shall be supplied, this standard does not provide derogation from these requirements for that country.

Information supplied by the manufacturer of medical devices; German version EN 1041:2008

ANSI/AAMI/ISO TIR 11135-2:2008 卫生保健产品的消毒.环氧乙烷.第2部分:应用ANSI/AAMI/ISO 11135-1的指南手册

This Technical Specification provides guidance for the requirements in ISO 11135-1:2007. It does not repeat the requirements and is not intended to be used in isolation. The exclusions in ISO 11135-1 apply also to this Technical Specification. For ease of reference, the clause numbering in this Technical Specification corresponds to that in ISO 11135-1:2007. Further guidance for the requirements given in ISO 11135-1 is also included in Annex C of ISO 11135-1:2007 and should be used in conjunction with this Technical Specification. This guidance document is intended for people who have a basic knowledge of the principles of EO sterilization but may need help in determining how to best meet the requirements contained in ISO 11135- 1. This document is not intended for people lacking a basic knowledge of the principles of EO sterilization.

Sterilization of health care products - Ethylene oxide - Part 2: Guideance on the application of ANSI/AAMI/ISO 11135-1

SN/T 2121-2008 流行性造血器官坏死病检疫技术规范

本标准规定了流行性造血器官坏死病病原分离、酶联免疫吸附试验和聚合酶链式反应检测方法。 本标准适用于流行性造血器官坏死病的检疫。

Protocol of quarantine for epizootic haematopoietic necrosis

SN/T 2120-2008 流行性溃疡综合症检疫技术规范

本标准规定了各种淡水与半咸水鱼流行性溃疡综合症的诊断方法。 本标准适用于各种淡水与半咸水鱼流行性溃疡综合症的检疫。

Protocol of quarantine for epizootic ulcerative syndrome

BS EN 1041:2008 医疗装置厂商提供的信息

This standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical devices and Council Directive 93/42/EEC concerning medical devices. It does not specify the language to be used for such information, nor does it specify the means by which the information is to be supplied. It is also intended to complement the specific requirements of the cited EU Directives on medical devices by providing guidance on means by which certain requirements can be met. If a manufacturer follows these means, they will provide a presumption of conformity with the relevant Essential Requirements regarding information to be supplied. This standard does not cover requirements for provision of information for in vitro diagnostic medical devices, which are covered by other labelling standards (see Bibliography). NOTE When national transpositions of the Directives specify the means by which information shall be supplied, this standard does not provide derogation from these requirements for that country.

Information supplied by the manufacturer of medical devices

BS EN 1041:2008+A1:2013 医疗器械厂商提供的信息

Information supplied by the manufacturer of medical devices

AAMI TIR17-2008 材料耐受消毒过程的适应性

The focus of this document is to provide guidance for health care manufacturers in the selection and qualification of polymeric materials, ceramics, and metals in health care products that are sterilized by the following modalities: ~ radiation (gamma, electron beam, or x-ray), ~ ethylene oxide (EO), ~ moist heat (steam), ~ dry heat, ~ hydrogen peroxide, and NOTE--All references to hydrogen peroxide sterilization in this TIn refer to sterilization in the gas phase. Hydrogen peroxide is also used for liquid chemical sterilization, but that application is outside the scope of this TIR. ~ ozone. Guidance in this TIn relates to ~ material selection--choosing sterilization-compatible materials (see clause 3 and Annexes A-F); ~ material processing--optimizing the functional performance of materials selected, to avoid processing errors that can contribute to negative effects from sterilization (see clause 4); ~ material testing-challenging critical aspects of the product for functionality and safety after sterilization and aging (see clause 5); and ~ accelerated aging--applying programs that ensure correlation with real-time aging while reducing the cost and amount of time required for material qualifications (see clause 6). NOTE--Information in this TIn is not intended to provide a rationale for the use of materials without proper qualification of the matedals. The information is general in nature and is intended only as a guide to successfully initiating material qualification programs.

Compatibility of materials subject to sterilization

ANSI/AAMI ST41-2008 卫生保健设施中的环氧乙烷灭菌:安全和效能

This recommended practice provides guidelines for EO sterilization processing in hospitals and other health care facilities. These guidelines are intended to promote sterility assurance and to assist health care personnel in the proper use of processing equipment. These guidelines also are intended to help ensure the safe use of EO by defining equipment and procedures, including ventilation recommendations and (if applicable) emission controls, to minimize personnel exposure to EO or its residuals. NOTE--For purposes of this recommended practice, "health care facilities" means hospitals, nursing homes, extended care facilities, freestanding surgical centers, clinics, and medical and dental offices. For convenience, the term "hospital" is sometimes used in this recommended practice; in all instances, this term should be taken to encompass all other health care facilities. This recommended practice specifically addresses a) design considerations for EO sterilization processing facilities, including traffic control; location of work areas; general and local exhaust ventilation systems; and storage of equipment, supplies, and EO gas sources; b) staff qualifications, supervision, training, health, and other personnel considerations; c) processing recommendations; d) installation, operation, care, and maintenance of EO sterilizers, EO sterilizer-aerators, and aeration cabinets; e) quality control; and f) environmental and employee health monitoring. Definitions of terms, a bibliography, and informative annexes also are provided in this recommended practice. This recommended practice does not cover a) specific construction and performance criteria for EO sterilizers (see ANSI/AAMI ST24), b) detailed design criteria for central service departments (see ANSI/AAMI ST79), c) guidelines for the use of EO sterilizers that release EO or an EO blend inside the package containing the wrapped items to be sterilized, or d) the reprocessing of devices labeled for single use only. NOTE--For more information on the subjects excluded from the scope of this recommended practice and for additional background information on the inclusions, refer to the references listed in Annex K.

Ethylene oxide sterilization in health care facilities: Safety and effectiveness

NS 8434-2008 手动安全设备用合同的一般条款

General conditions of contract for manual security services

YY/T 0606.13-2008 组织工程医疗产品.第13部分:细胞自动计数法

YY/T 0606的本部分所述的原理和方法适用于绝大部分类型细胞的自动计数，包括黏附生长细胞和悬浮生长细胞。

Tissue engineered medical product.Part 13: Standard test method for automated enumeration of cell suspensions

JIS K 3706-2:2008 培养基的试验方法.单核细胞增生李斯特氏菌用培养基.第2部分:单核细胞增生李斯特氏菌的计数

この規格は，培地を用いてリステリア・モノサイトゲネス(Listeria monocytogenes）の生 菌数を測定する方法について規定する。

Test methods for culture media -- Culture medium for Listeria monocytogenes -- Part 2: Enumeration of Listeria monocytogenes

JIS K 3706-1:2008 培养基的试验方法.单核细胞增生李斯特氏菌用培养基.第1部分:单核细胞增生李斯特氏菌的探测

この規格は，培地を用いてリステリア・モノサイトゲネス(Listeria monocytogenes)を検出する方法について規定する。

Test methods for culture media -- Culture medium for Listeria monocytogenes -- Part 1: Detection of Listeria monocytogenes

JIS K 3705:2008 培养基的试验方法.沙门氏菌属用培养基.沙门氏菌属的探测

この規格は，サルモネラ属菌(Salmonellaspp.)用培地を用いて，チフス菌（SalmonellaTyphimurium)及びパラチフス菌(Salmonella Par的+phimurium)を含むサルモネラ属菌を検出する方法について規定する。

Test methods for culture media -- Culture medium for Salmonella spp. -- Detection of Salmonella spp.

JIS K 3704:2008 培养基.大肠杆菌O157的检测

この規格は，大腸菌0157の検出を目的とする培地試験の方法について規定する。

Culture media -- Detection of Escherichia coli O157

JIS K 3702:2008 培养基的试验方法.用于微生物检验试验样品的初始悬浮和十倍稀释的准备

この規格は，微生物の検出を目的とする培地試験に用いる試料懸濁液及び希釈系列の調製方法について規定する。

Test methods for Culture media -- Preparation of initial suspension and decimal dilutions

JIS K 3701:2008 培养基.微生物检验的一般规则

この規格は，微生物の検出を目的とする培地試験の通則について規定する。

Culture media -- General rules for microbiological examinations

ANSI/3-A P3-A 001-2008 药物的3-Ar标准用术语的通用词汇表

Active pharmaceutical ingredient manufacturers have identified the need for standards for the design of equipment that is more efficiently cleanable to enhance acceptance by QA and inspection agencies and advance the state-of-the-art for production equipment. This standard is one in a series of equipment and materials of construction standards.

General Glossary of Terminology Used In Pharmaceutical 3-A? Standards

ANSI/3-A P3-A 002-2008 加工设备和系统用材料的药物3-Ar清洁/卫生标准

Active pharmaceutical ingredient manufacturers have identified the need for standards for the design of equipment that is more efficiently cleanable to enhance acceptance by QA and inspection agencies and advance the state-of-the-art for production equipment. This standard is the second in a series of equipment and materials of construction standards.

Pharmaceutical 3-A? Sanitary/Hygienic Standards for Materials for Use in Process Equipment and Systems

GOST R 53133.2-2008 医学实验室技术.检验科试验的质量控制.第2部分:检验科试验使用控制材料的计量学方法的实验室内质量控制规范

Medical laboratory technologies. Quality control of clinical laboratory tests. Part 2. Rules for intra-laboratory quality control of quantitative methods of clinical laboratory tests using control materials

GOST R 53022.3-2008 临床实验室技术.临床实验室试验的质量要求.第3部分:实验室试验临床意义的评定

Clinical laboratory technologies. Requirements of quality of clinical laboratory tests. Part 3. Assessment of laboratory tests clinical significance