NBR16064 DE 10/2024

Esta Norma estabelece os requisitos e métodos de ensaio para aventais e campos cirúrgicos de uso único e reutilizáveis, utilizados como dispositivos médicos para pacientes, equipe clínica e equipamentos. NOTA 1 Os requisitos desta Norma asseguram o mesmo nível de segurança aos aventais e campos cirúrgicos de uso único, reutilizáveis ao longo de sua vida útil. Esta Norma também estabelece os requisitos de desempenho e as orientações a serem fornecidas aos usuários e compradores de aventais e campos cirúrgicos. This Standard establishes the requirements and test methods for single-use and reusable surgical gowns and drapes, used as medical devices for patients, clinical staff and equipment.NOTE 1 The requirements of this Standard ensure the same level of safety for gowns and surgical drapes for single use, reusable throughout their useful life.This Standard also establishes the performance requirements and guidelines to be provided to users and buyers of surgical gowns and drapes.This Standard does not apply to the requirements for resistance to laser radiation penetration of products.NOTE 2 For appropriate test methods for resistance to laser radiation penetration and for the appropriate classification system, see ISO 11810.This Standard does not apply to requirements for incisional fields or films, and does not establish flammability requirements.