Safety and Quality Standards
AdinStruments意识到将电气设备连接到受试者时涉及的关键安全问题。我们投资大量资源，以确保我们的产品获得严格的国际安全标准，并通过独立认证机构进行测试。此外，根据国际认可的ISO9001：2015质量管理系统，AdinStruments产品还设计，制造和维修。
Statement of Intended Use
AdinStruments提供的产品仅用于教学和研究应用程序和环境。AdinStruments提供的产品不打算用作医疗设备或医疗环境。也就是说，无adinstruments提供的产品旨在用于诊断，治疗或监测受试者。此外，没有产品用于预防，治愈或减轻疾病，伤害或障碍。
产品符合IEC 60601-1的地方，其原则是：
- 这是比其他可以采用的标准更严格的标准
- it provides the most appropriate safety level for subjects and operators.
The choice to meet IEC 60601-1 is in no way to be interpreted to mean that a product:
- 是医疗设备；
- 可以解释为医疗设备；
- 可以安全用作医疗设备。
Safety and Quality Standards
When used with ADInstruments isolated front-ends, PowerLab systems are safe for connection to subjects. The Bio Amp and the Isolated Stimulator built into the PowerLab/4ST, PowerLab 4/20T, PowerLab 4/25T, ML818 PowerLab 15T, ML856 PowerLab 26T and the FE132 Bio Amp, FE135 Dual Bio Amp, ML408 Dual Bio Amp/Stimulator, FE116 GSR Amp, FE117 BP Amp and FE180 Stimulus Isolator front-ends, conform to international safety requirements. Specifically these are IEC60601-1 and its addenda (see the table below), and various harmonized standards worldwide (CSA601.1 in Canada and AS/NZS 3200.1 in Australia and New Zealand). In accordance with European standards they also comply with the electromagnetic compatibility requirements under EN60601-1 and EN61326, which satisfy the EMC directive.
These symbols appear next to those applied parts that can be directly connected to human and animal subjects. An applied part is defined as part of the equipment that necessarily comes in contact with the subject in order to perform its function. See below for their definitions.
B型（身体受保护的符号）符号
这意味着如此标记的施加部分适合与人类和动物的联系（前提是没有直接的电气连接），并提供了针对电击的基本保护水平。该施加的部分不是从电源地球上电隔离的。
BF型（身体保护）符号
这意味着应用部分(s)标记suitable for connection to humans and animals provided there is no direct electrical connection to the heart) and gives greater protection from electric shock than B-type applied parts. This applied part is electrically isolated from mains earth.
CF（心脏保护）符号
Appears on some older models of Dual Bio Amp and BP Amps but no current equipment. This means that the applied parts so marked are suitable for connection to human and animal subjects even when there is direct electrical connection to the heart. This applied part is electrically isolated from mains earth.
CE标志
全部PowerLab systems and front-end amplifiers carry the CE mark and meet the appropriate EU directives.
CSA Mark
ADInstruments ML series isolated preamplifiers, 15T, 26 series and 30 series PowerLab data acquisition units meet the standards set by the Canadian Standards Association.Class 8750 01 - Medical Electrical Equipment
8750 81类 - 医疗设备（根据美国标准认证）
UL标记
AdinStruments 35系列隔离前置放大器和35系列PowerLab数据采集单元仅根据CAN/CSA-C22.2 No. 601.1和601.1和601.1和机械危害，符合UL（承销商实验室）设置的数据记录器标准UL 60601-1。显示的UL标记仅指powerLab。对于所有其他设备，请参阅相关文档。| IEC Standard | International Standard - Medical Electrical Equipment |
|---|---|
| IEC60601-1：1998 | 安全的一般要求 |
| IEC60601-1-1:1992 | 医疗电气系统的安全要求 |
| IEC60601-1-2:1993 | 电磁兼容 |
| IEC61326：2002 | Electrical equipment for measurement, control and laboratory use - EMC requirements |
| IEC61010-1ED2.0 | 用于测量，控制和实验室使用的电气设备的安全要求。 |
| CSA标准 | 医疗电气设备 |
|---|---|
| CAN/USA C22.2 No 601.1-M90 | Safety of Medical Electrical Equipment, Part 1: General Requirements for Safety |
| CSA 601.1补充1：1994 | Safety of Medical Electrical Equipment, Part 1: General Requirements for Safety |
| CSA 601.1 Amendment 2:1998 | Safety of Medical Electrical Equipment, Part 1: General Requirements for Safety |
| UL Std No 2601-1 | Safety of Medical Electrical Equipment, Part 1: General Requirements for Safety |
| UL标准 | 医疗电气设备 |
|---|---|
| UL 60601-1 | 医疗电气设备, Part 1: General Requirements for Safety - Edition 1 |
| CSA C22.2 No.601.1 | 医疗电气设备, Part 1: General Requirements for Safety - Edition 1 |
Adinstruments对ROHS指令的承诺
The European Parliament's Restriction of the Use of Certain Hazardous Substances directive (now in its second publishing, RoHS2) aims to restrict the use of hazardous substances in electrical and electronic equipment, and contribute to the protection of human health and the environment. Although ADInstruments products are in a category which only needs to be compliant by July 2017, we place high value on its principles. In conjunction with our product component suppliers, we are actively seeking to fully comply with the directive well before the required date to ensure that our products are beneficial to our employees, customers and the environment.
Quality Management System ISO 9001:2015
ADInstruments manufactures products under a quality system certified as complying with ISO 9001:2015 by an accredited certification body.
ADInstruments ISO 9001:2015 certificate.
GLP和21 CFR第11部分合规性
LabChart features such as date and time stamping, automatic storage of experimental settings, and retention of raw data, will assist your laboratory in meeting its 'Good Laboratory Practice' requirements. In addition, the optional GLP Client and GLP Server software facilitates 21 CFR Part 11 compliance.