CSA P-09
This Technical Information Letter (TIL) has been prepared to serve as an immediate certification document until the Medical Electrical Robots Equipment and Medical electrical Robots System particular standards (IEC 60601-2-XX) that will be published.
These interim requirements have been developed to provide technical guidance, and address the safety and performance requirements of medical robot equipment/system.
The CSA TIL is limited to the following types of medical robots as per IEC upcoming safety standards:
1. IEC 80601-2-77: Medical Electrical Equipment - Part 2-77: Particular requirements for the basic safety and essential performance of medical robots for surgery, and
2. IEC 80601-2-78: Medical Electrical Equipment - Particular requirements for the basic safety and essential performance of medical robots for rehabilitation, compensation or alleviation of disease, injury or disability.
Statut:
Retiré
Secteur:
Electrical
Applicabilité date:
2016-10-24
Date d'expiration:
Numéro de la norme:
CSA P-09
Date de publication:
Organisme de certification:
CSA Group Testing & Certification Inc.
Autorité canadienne de réglementation:
Canadian Advisory Council Electrical Safety