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Global Technical Service Co. Ltd
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Tel：0769-8805 6552
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Global Technical Service Co. Ltd
OFFICE Room 2103,21/F Ho King Commercial Centre, No. 2-16 Fa Yuen Street, Mong kok, Kowloon,HK
Global Technical Service Co. Ltd
OFFICE Room 2103,21/F Ho King Commercial Centre, No. 2-16 Fa Yuen Street, Mong kok, Kowloon,HK
Tel: 00852-30697929
FAX：00852-6991 7688
medical instruments
- How do medical device manufacturers choose the notified body?
- the general procedures for obtaining CE certification marks for medical devi
- CE certification mark on medical devices
- Medical device directive
- Countermeasures for FDA certification adoption about electronic non-invasive
- Countermeasures for CE certification adoption about electronic non-invasive
- Do medical device manufacturers who do not use their own trademarks need to
- Main content of MDD
Medical device directive
Medical device products need to do three aspects of work to pass the CE certification.
First, collect EU technical regulations and EU (EN) standards related to certified products, through understand, absorption, and inclusion of corporate product standards.
Second, the company organizes production in strict accordance with the above product standards, that is, the requirements of the above technical regulations and EN standards are implemented in the whole process of design, development and manufacturing of enterprise products.
Third, the company must establish and maintain a quality system in accordance with ISO9000+ISO13485 standards and obtain ISO9000+ISO13485 certification.
EU technical regulations and EN standards for medical device CE certification
For the current 18 types of industrial product orders issued by the European Union, from the structure of these instructions, they can be divided into vertical instructions and horizontal instructions. Vertical instructions are for specific products, such as medical device instructions; horizontal instructions are applicable to various product lines, such as electromagnetic compatibility directives, which are applicable to all electrical and electronic components.
For medical devices, the applicable directives are Articles 14, 1 and 5, namely: 93/42/EEC Medical Device Directive, 73/23/EEC Low Voltage (LVD) Directive 89/336/EEC Electromagnetic Compatibility (EMC) directive.
The EU standards that support these directives are:
（1）EN60601-1 Medical electrical equipment Part 1: General safety requirements；
（2）EN60601-1-1 Medical Electrical Equipment Part 1：General safety requirements and the first amendment；
（3）EN60601-2-11 Medical Electrical Equipment Part 2：γ beam therapy equipment safety specific requirements；
（4）EN60601-1-2 medical electrical equipment part 1：Safety General Requirements Section 1.2 Parallel Standard Electromagnetic Compatibility - Requirements and Testing. The criteria in items (1), (2), and (3) are the basis for the gamma knife low voltage (LVD) test: the standard (4) is the basis for the gamma knife electromagnetic compatibility (EMC) test.