C90 制药、安全机械与设备综合 标准查询与下载

EN 981:1996+A1:2008 机械安全.听觉和视觉的危险和信息信号系统

To reduce risks associated with misinterpretation of visual and auditory danger signals, a system of danger and information signals is specified taking into account the different degrees of urgency. This European Standard is applicable to all danger and information signals which have to be clearly perceived and differentiated as specified in 5.3 of EN 292-2:1991, by other requirements or by the work situation, and to all degrees of urgency - from extreme urgency to an ALL CLEAR situation. Where visual signals are to be complementary to sound signals, the signal character is specified for both. This European Standard does not apply to certain fields covered by specific standards or other conventions in force (international or national); in particular, fire alarms, medical alarms, alarms used in the field of public transport, navigation signals and signals for special fields of activity (for example, military). When new signals are being planned, however, this European Standard should be considered in order to avoid inconsistency. For auditory signals, the system of signal character is a guideline for a signal language based on message categories which are classified according to urgency. Certain characters are specified for purposes which require safe and rapid recognition. Certain categories allow possibilities for variants, e. g. control and warning signals at workplaces where the signalling is intended for personnel with specific training. For visual signals, the established meanings of the safety colours are not affected by this European Standard. For different needs, complementary meanings have been assigned to the signals by timed patterns, and in a very few cases by alternating colours.

Safety of machinery - System of auditory and visual danger and information signals

EN 1526:1997+A1:2008 工业卡车的安全性:卡车上自动功能的附加要求

This European Standard deals with the controls and control systems for automated functions of industrial trucks with an operator (hereinafter referred to as "trucks"). The control system is generally part of the truck but can include components external to the truck, eg for the guidance means for automated steering. This European Standard deals with the technical requirements to minimise the specific hazards listed in clause 4 which can arise during the commissioning, operation and maintenance of automated functions of trucks when carried out in accordance with the specifications given by the manufacturer or his authorised representative. In addition, trucks should comply as appropriate with EN 292 for hazards not covered by this standard or the applicable companion standards. This European Standard is not applicable to safety equipment (e. g. devices for height limitation, speed limitation) used to override driver control. This European Standard deals with the hazards related to the controls and control systems for the following automated functions: Steering (direct mechanical guidance is excluded); Travel; Lifting and lowering operations; Load manipulations, e. g. rotation, reach, slewing, tilting, clamping; Combination and/or sequence of the above movements. This standard must be used in conjunction with one or more of the applicable companion standards listed in the Foreword. This European standard does not establish the additional requirements for the following: a) Operation in severe conditions (e. g. extreme climates, freezer applications, strong magnetic fields); b) Operation in environments subject to special rules (e. g. potentially explosive atmospheres); c) Electromagnetic compatibility; d) Transportation of passengers; e) Handling of loads the nature of which could lead to dangerous situations (e. g. molten metals, acids/bases, radiating materials). Limitations in the scopes of the applicable companion standards also apply to this standard.

Safety of industrial trucks - Additional requirements for automated functions on trucks

EN 13059:2002+A1:2008 工业卡车的安全性.测量振动的试验方法

This European Standard is a type test procedure for establishing the values of vibration emission transmitted to the whole body of operators of industrial trucks under specified conditions. It is not applicable to hand-arm vibration. This standard is applicable to powered industrial trucks listed in ISO 5053:1987. The annex A is applicable for "all-terrain" trucks. It also applies to other powered industrial trucks not covered by ISO 5053:1987, e. g. variable-reach trucks and "low-lift" "order picking" trucks, etc. NOTE The standard may however be useful also for existing trucks. This standard is not applicable to non-stacking "low-lift" straddle carriers (as specified in 3. of ISO 5053:1987) and stacking "high-lift" straddle carriers (as specified in 3. of ISO 5053:1987). The test results, however, are not applicable to the determination of whole-body vibration exposure.

Safety of industrial trucks - Test methods for measuring vibration

JB/T 20091-2007 制药机械(设备)验证导则

本标准规定了制药机械（设备）验证的术语和定义、原则、目的、范围、程序、方案、内容、实施及制造方应提供的技术文件资料。 本标准适用于制药机械（设备）设计确认（DQ）、安装确认（IQ）、运行确认（OQ）和性能确认（PQ）工作的指导。

Guidance on validation of pharmaceutical machinery (equipment)

ASTM E2500-07 制药学和生物制药学制造设备的规范、设计和认证用标准指南

Application of the approach described within this guide is intended to satisfy international regulatory expectations in ensuring that manufacturing systems and equipment are fit for intended use, and to satisfy requirements for design, installation, operation, and performance. The approach described in this guide applies concepts and principles introduced in the FDA initiative, Pharmaceutical cGMPs for the 21st Century—A Risk-Based Approach. This guide supports, and is consistent with, the framework described in ICH Q8 and ICH Q9. This guide may be used independently or in conjunction with other proposed E55 standards to be published by ASTM International.1.1 This guide is applicable to all elements of pharmaceutical and biopharmaceutical manufacturing systems including: facility equipment, process equipment, supporting utilities, associated process monitoring and control systems, and automation systems that have the potential to affect product quality and patient safety.1.2 For brevity, these are referred to throughout the rest of this guide as manufacturing systems.1.3 This guide may also be applied to laboratory, information, and medical device manufacturing systems.1.4 This guide is applicable to both new and existing manufacturing systems. The approach may be used for the implementation of changes to existing systems, and their continuous improvement during operation.1.5 This guide is applicable throughout the life-cycle of the manufacturing system from concept to retirement.This standard does not address employee health and safety, environmental, or other non-GxP regulations. 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 Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

JB/T 20067-2005 制药机械符合药品生产质量管理规范的通则

Pharmaceutical machinery complies with the General Principles of Good Manufacturing Practice for Pharmaceutical Products

YY 0260-1997 制药机械产品分类与代码

本标准规定了制药机械产品分类原则和编码方法。 本标准适用于制药机械行业。

Classification and codes for pharmaceutical machinery products

YY/T 0216-1995 制药机械产品型号编制方法

本标准规定了制药机械产品的型号编制原则、格式和编制方法。 本标准适用于制药机械产品型号的编制。

Editorial nominating method for the model designation of pharmaceutical machinery

prEN 50086-2-2-1992 电气设施的导管系统.第2-2部分:可弯曲导管系统的特殊要求

Conduit systems for electrical installations; part 2-2: particular requirements for pliable conduit systems

prEN 50086-2-3-1992 电气设施的导管系统.第2-3部分:柔性导管系统的特殊要求

Conduit systems for electrical installations; part 2-3: particular requirements for flexible conduit systems

YY 91009-1999 压力蒸汽消毒器技术条件.卧式矩形

Specifications for horizontal and rectangular steam sterilizers

EN 1175:2020 工业卡车的安全性.电气要求.第2部分:内燃机驱动的卡车的一般要求

This standard specifies the electrical and related mechanical safety requirements for the design and construction of the electrical installation in internal combustion engine powered trucks (hereinafter referred to as "trucks") with starter battery nominal voltages up to and including 24 V. NOTE 1 Part 3 of this standard details specific electrical requirements for electrical power transmission systems of internal combustion engine powered trucks. NOTE 2 Reference is made to this standard in other standards which cover the non-electrical requirements of the various industrial truck types. NOTE 3 The special requirements for operation in potentially explosive atmospheres are not covered in this European Standard. The requirements of this standard are applicable, when trucks are operated under the following climatic conditions: Maximum ambient temperature, continuous duty: +40°C; Lowest ambient temperature: -20 °C; Service altitude: up to 2000 m; Relative humidity: in the range 30 % to 95 % (non condensing). This standard covers specific hazards which could occur during the intended use of trucks. For hazards occurring during construction, transportation, commissioning, decommissioning and disposal, reference should be made to EN ISO 12100-2:2003.

Safety of industrial trucks - Electrical requirements - Part 2: General requirements of internal combustion engine powered trucks