规定了可验证的程序和流程开发，用于可重复使用的医疗和外科器械和设备的清洁、消毒和灭菌，以及不涉及复杂患者程序和流程的办公室医疗保健设施相关环境的维护。适用于医疗、外科及相关医疗机构和皮肤渗透场所。也可能适用于兽医实践中专门用于动物的仪器和设备。不适用于日间手术或日间程序中心或可能被能引起TSEs的朊病毒污染的物品。 克吕茨费尔特·雅各布先生。

Sets out procedures and process development which can be validated for the cleaning, disinfection and sterilization of reusable medical and surgical instruments and equipment, and maintenance of associated environments in office-based health care facilities not involved in complex patient procedures and processes. Suitable for medical, surgical and allied health facilities and skin penetration establishments. May also be suitable for application to the instruments and equipment used exclusively on animals in veterinary practice. Does not apply to day surgical or day procedures centres or items that may be contaminated with prions capable of causing TSEs, e.g. Creutzfeldt-Jakob.