Tiêu chuẩn quốc tế
Số hiệu
Standard Number
EN ISO 14630:2009
Năm ban hành 2009
Publication date
Tình trạng
A - Còn hiệu lực
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Tên tiếng Anh
Title in English Non-active surgical implants - General requirements (ISO 14630:2008)
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Giá:
Price Liên hệ / Contact us
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Phạm vi áp dụng
Scope of standard This International Standard specifies general requirements for non-active surgical implants, hereafter referred to as implants. This International Standard is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal tissue. With regard to safety, this International Standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements. Additional tests are given or referred to in level 2 and level 3 standards.
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