Medical devices - Application of risk management to medical devices - Amendment 1: Rationale for requirements (ISO 14971:2000/AM1:2003)
€54.00
Medical electrical equipment -- Part 1-8: General requirements for safety - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
€126.00
Medical electrical equipment -- Part 1-6: General requirements for safety - Collateral standard: Usability
Medical supply units. (ISO 11197:2004)
€96.00
Medical electrical equipment -- Part 1-8: General requirements for safety - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems. (IEC 60601-1-8:2003/A1:2006)
€47.00
€0.00
Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
€205.00
Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12)
€184.00
Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020)
€166.00
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)
Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
€89.00
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
€163.00
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
€50.00
Information supplied by the manufacturer of medical devices
