Tiêu chuẩn quốc tế

• Số hiệu / Standard Number: ISO 15004-1:2020
• Năm ban hành / Publication date: 2020
• Tình trạng / Status: A - Còn hiệu lực
• Tên tiếng Anh / Title in English: Ophthalmic instruments — Fundamental requirements and test methods — Part 1: General requirements applicable to all ophthalmic instruments
• Thay thế cho / Replace: ISO 15004-1:2006
• Chỉ số phân loại Quốc tế (ICS) / By field: 11.040.70 - Thiết bị chữa mắt
• Số trang / Page: 12

Phạm vi áp dụng / Scope of standard

This document specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments and to devices for enhancing low vision. This document is also applicable to tonometers, but not to other ophthalmic instruments which are used in contact with the globe of the eye.

This document is not applicable to operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye.