Medical devices. Symbols to be used with information supplied by the manufacturer General requirements
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Standard Guide for Processing Cells, Tissues, and Organs for Use in Tissue Engineered Medical Products
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Standard Classification for Tissue Engineered Medical Products (TEMPs)
Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
€184.00
Privacy of monitoring technology - Guidelines for introducing ambient and wearable monitoring technologies balancing privacy protection against the need for oversight and care
€89.00
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
€50.00
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2015)
Medical device traceability enabled by unique device identification (UDI)
Nomenclature - Collective terms and codes for groups of medical devices
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
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Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2010)
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2006)
Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)
