Tiêu chuẩn quốc tế

• Số hiệu / Standard Number: EN ISO 18778:2009
• Năm ban hành / Publication date: 2009
• Tình trạng / Status: A - Còn hiệu lực
• Tên tiếng Anh / Title in English: Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)
• Phạm vi áp dụng / Scope of standard: This International Standard specifies requirements for the safety and essential performance of monitors used to detect apparent life-threatening events1) in sleeping or resting children under three years of age. This International Standard applies to devices used in home care applications. These monitors are generally used without continual professional supervision. This International Standard also applies to the accessories, e.g. probes and cables necessary to apply the monitor to the patient. This International Standard does not apply to monitors intended for use in health care facilities/institutions. The requirements of this International Standard, which replace or modify the requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995), are intended to take precedence over the corresponding general requirements.