Tiêu chuẩn quốc tế

• Số hiệu / Standard Number: ASTM D7161-05
• Năm ban hành / Publication date: 2005
• Tình trạng / Status: W - Hết hiệu lực
• Tên tiếng Anh / Title in English: Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse Conditions
• Chỉ số phân loại Quốc tế (ICS) / By field: 11.140 - Thiết bị bệnh viện
• Số trang / Page: 2
• Phạm vi áp dụng / Scope of standard: 1.1 This practice covers all surgeon's and examination gloves, made from either synthetic or natural rubber latex, marketed at the time this practice is published, for which there is no previous real time aging data available, and for which there are at least 12 months of storage as finished goods under typical warehouse conditions. This practice describes how to develop real time aging data for gloves that are part of finished goods inventory (including gloves that may no longer be manufactured) in order to verify the estimated expiration date (see Note 1). Manufacturers may use this data as a starting point for real time aging studies as described in Practice D 7160.Note 1 - Accelerated aging for three-year shelf life is described in Practice D 7160.1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.