Legislation/Applicable standard

ReferenceTitle
LVS EN ISO 21535:2009Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2007)
LVS EN ISO 21536:2009Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2007)
LVS EN ISO 21647:2009Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004, including Cor 1:2005)
LVS EN ISO 21649:2006Needle-free injectors for medical use - Requirements and test methods
LVS EN ISO 21969:2006High-pressure flexible connections for use with medical gas systems
LVS EN ISO 22442-1:2008Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
LVS EN ISO 22442-2:2008Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
LVS EN ISO 22442-3:2008Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
LVS EN ISO 22523:2007External limb prostheses and external orthoses - Requirements and test methods
LVS EN ISO 22610:2006Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Test method to determine the resistance to wet bacterial penetration
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