Produtos afetados
Sistema de classificação Código Nome
HS 90183910 Agulhas
ICS 1104025 Syringes, needles and catheters
ICS 1104099 Other medical equipment
País Egypt
Agência responsável Egyptian Organization for Standardization and Quality16 Tadreeb El-Modarrebeen St., Ameriya, Cairo - EgyptE-mail: + (202) 22845528Fax: + (202) 22845504
Agency or authority designated to handle comments if different from above
Artigos 2.9.2
Covered Products
Cobertura Agulhas hipodérmicas
Title, number of pages and language(s) of the notified document Draft of Egyptian standard for "Sharps injury protection — requirements and test methods — sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling"
Resumo em portugues Propõe Regulamento Técnico para os requisitos e métodos de ensaio para recursos de proteção para agulhas hipodérmicas de uso único, introdutores para cateteres e agulhas usadas para coleta de sangue.
Resumo original This draft standard gives requirements and test methods for evaluating the performance parameters of sharps injury protection features, whether active or passive in design, for medical devices  containing  (sharp) hypodermic needles for single use, introducers for catheters used in blood sampling. The sharps injury protection devices it covers may be provided integral to the device or and lancets, and   other needles used  in containing combined with the device prior to use to achieve the sharps injury protection.  It does not give requirements for the storage and handling of the sharps protection before its intended use, or for the medical device itself.  Worth mentioning is that this draft standards is technically identical with  ISO  23908/2011
Objetivos Saúde Humana
Documentos relevantes ISO  23908/2011
Detalhes do contato Egyptian Organization for Standardization and QualityAddress: 16 Tadreeb El-Modarrebeen St.Ameriya, Cairo - EgyptE-mail: + (202) 22845528Fax: + (202) 22845504