Medical products passed CE certification to the need to do the work in three areas. First, the collection and certification of products related to EU technical regulations and the EU (EN) standard, through digestion, absorption, into the enterprise product standard. Second, enterprises in strict accordance with the above products, standard production, that is, to the technical regulations and EN standards, implement the design of enterprise product development and manufacturing as a whole. Third, companies must ISO9000 + ISO13485 quality system standard of maintenance and construction of, and achieved ISO9000 + ISO13485 certification.
Gamma EU CE certification should follow the technical regulations and standards EN
For the EU published Directive 18 categories of industrial products, from the structure of these commands to see, they can be divided into vertical and horizontal command instructions. Vertical command is targeted specific products, such as the Medical Devices Directive; level of instruction for a variety of product lines, such as electromagnetic compatibility directive, which applies to all electrical and electronic components products.
For the Gamma Knife for a fourteenth instruction, the first and fifth, that is: 93/42/EEC Medical Device Directive, 73/23/EEC Low Voltage (LVD) Directive 89/336/EEC Electromagnetic compatibility (EMC) directives. EU standards to support these instructions are: (1) EN60601-1 Medical electrical equipment Part I: General requirements for safety; (2) EN60601-1-1 Medical electrical equipment Part I: General requirements for safety and the First Amended; (3) EN60601-2-11 Medical electrical equipment Part II: γ beam therapy equipment safety requirements; (4) EN60601-1-2 Medical Electrical Equipment Part I: General requirements for safety standards for electromagnetic compatibility parallel section 1.2 - Requirements and testing . Paragraph (1), (2), (3) low-voltage standard is Gamma Knife (LVD) testing based on: (4) of the electromagnetic compatibility standard is Gamma Knife (EMC) test basis.
Gamma CE certification process, content
EU divided into four categories of medical device products, namely: Ⅰ, Class Ⅱ a, Class Ⅱ b, Class Ⅲ. Section Ⅰ products to affix CE mark can be taken to declare their own way. The preparation of products that manufacturers technical documentation files, while its own products according to relevant EN standards have the ability to test or commission testing laboratory qualified. Ⅱ a first class, first class Ⅱ b, Ⅲ products to affix CE mark, you must verify the agency designated by the European Union validation. The EU also provides that these types of products have CE certification is a prerequisite for manufacturing to be able to live ISO9000 + ISO13485 quality system certification, ISO9000 + ISO13485 quality system certification, and the units should be issued the certificate of accredited certification bodies for the EU. ISO9000 + ISO13485 quality system certification and CE certification could be conducted, but the CE certificate must be ISO9000 + ISO13485 quality system certification passed, only to be issued.
The classification of products according to the European Union is the first gamma knife Ⅱ b class, the CE certification process, and reads as follows:
1) The enterprise application for certification to the certification bodies, and fill out the certification inquiry cross certification body;
2) The certification body applying for certification to the offer enterprises a single, corporate signature confirmation to complete the contract;
3) enterprises to submit ISO9000 + ISO13485 certified quality system documents that the quality manual and program files, system files for the audit certification bodies; quality system approval, the enterprise should have at least three months of the quality system records, and completed 1 - 2 internal quality system audits.
4) The certification body to issue notice to the certified product testing laboratory accredited certification bodies, laboratories will apply for certification of products for low voltage (LVD) testing and electromagnetic compatibility (EMC) testing. If there is failure testing, the company changed again after the next test, until tested so far. End of the test, the laboratory test report issued.
5) The enterprise applications for the preparation of technical documents for certified products file (referred to as TCF file). The test report file as one of TCF. TCF file is the application for CE certification CE certification manufacturers to submit an important document, which is the certification body audits an important basis for certification. TCF file must all be prepared in English. TCF file includes seven aspects: ① Introduction: ② product specifications described; ③ The main contents of the file design; ④ risk analysis and assessment; ⑤ test report and clinical diagnostic data; ⑥ document design control; ⑦ statement of product applications Declaration.
6) The certification body corporate ISO9000 + ISO13485 quality system and TCF files first instance. After the first instance will be pointed out that the quality system certification body and the TCF file problems, enterprises should accordingly improve the quality system and TCF files.
7) The certification body corporate ISO9000 + ISO13485 quality system and TCF file a formal review.
8) After the adoption of a formal audit, certification bodies and the companies signed a framework agreement will be clearly achieved CE certificate should follow the principles of the parties to use the CE mark and product range, and approach with the complaint. Then awarded ISO9000 + ISO13485 quality system certification and CE mark certificate.
In general, companies applying for certification from the certification body to issue a certificate about six months to a year's time.
Effectiveness of CE mark
Products obtained CE certification, CE mark can post on, but only submitted when applying for certification as described in the TCF products, affixed CE mark means the product can enter the EU market and the products obtained CE certification requirements to enter the area countries and regions. Product CE certification is valid for five years. This time we get the CE certificate submitted by the TCF file is the first generation of Gamma Knife head of the information, the CE mark can only be affixed to the head in the first generation of Gamma Knife. Significant changes such as head gamma knife, you must submit changes to the CE certification documentation re-certification, or can not affix CE mark.
Introduction and classification of medical devices
Active implantable medical devices (AIMD 90/385/EEC)
By surgical or medical treatment of any and all or part of the implanted or inserted and set to remain in the body's natural pores of the active medical equipment.
Medical devices (MDD 93/42/EEC)
Designed for use by manufacturers in the body of any individual or combination of instruments, equipment, devices, materials or other items, including necessary software, want to achieve the following situations:
● diagnosis, prevention, tracking, treatment, alleviation of disease
● diagnosis, tracking, treatment, or repair parts of the wound or disability
● anatomical or physiological process of the investigation, replacement or repair
And these devices should not have the pharmacological, immunological or metabolic effect, but can have a supplementary.
In vitro diagnostic medical devices (IVDD 98/79/EC)
Designed by the manufacturer of any individual or combination of reagents, reagent products, calibration, control material, kit, apparatus, equipment, devices, or systems, the main purpose to provide samples or something more, including blood and tissue, the human body derivatives, in vitro test data such as:
- Physiological or pathological state
- Congenital anomalies - and patient safety and compatibility of receptor
- Measures to track treatment
Specimen containers, regardless of whether the vacuum form, especially as bearing mounted specimens from the human body, like the purpose of in vitro diagnostic tests, shall be considered as in vitro diagnostic medical devices.
In the MDD under the instruction of medical products, the designated agency to be involved in conformity assessment procedures. Designated institutions must meet the needs of MDD in Appendix 11.
Classification of medical devices
Medical Device Directive Medical Device Classification Appendix 9 to 18 into the rules. Manufacturers need to do depending on the product-use Category:
Rules 1 to 4 non-invasive medical devices
Rules 5 to 8-invasive medical devices
Rules 9 to 12 active medical device further planning
Rules 13 to 18 special rules
According to the above provisions, the patient or user of medical equipment risk and conformity assessment procedures can thus be determined. The higher the risk, conformity assessment procedures will be more stringent