DIN 58921 Test method to demonstrate the suitability of a medical device simulator during steam sterilisation - Medical device simulator testing; Text in German and English
DIN 58953-6 Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized*， 2023-11-01 Update
DIN 58953-7 Sterilization - Sterile supply - Part 7: Use of sterilization paper, nonwoven wrapping material, paper bags and sealable pouches and reels*， 2020-11-01 Update
DIN 58953-8 Sterilization - Sterile supply - Part 8: Logistics of sterile medical devices*， 2019-03-01 Update
EN 13427 Packaging - Requirements for the use of European Standards in the field of packaging and packaging waste
EN 13428 Packaging - Requirements specific to manufacturing and composition - Prevention by source reduction
EN 13430 Packaging - Requirements for packaging recoverable by material recycling
EN 13431 Packaging - Requirements for packaging recoverable in the form of energy recovery, including specification of minimum inferior calorific value
EN 13432 Packaging - Requirements for packaging recoverable through composting and biodegradation - Test scheme and evaluation criteria for the final acceptance of packaging
EN 60601-1 Medical electrical equipment - Part 1: General requirements for safety
EN 868 Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
EN 868-2 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods*， 2017-02-01 Update
EN 868-5 Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods*， 2018-12-01 Update
EN 868-8 Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
IEC 60118-13:2004 Electroacoustics - Hearing aids - Part 13: Electromagnetic compatibility (EMC)
IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*， 2018-08-01 Update
ISO 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals; Technical Corrigendum 1
ISO 11135-1 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11137-1 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 2: Revision to 4.3.4*， 2018-11-08 Update
ISO 11137-2 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Amendment 1*， 2022-06-13 Update
ISO 11137-3 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control*， 2017-06-01 Update
ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
ISO 14708-1 Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer*， 2014-08-01 Update
ISO 14708-2 Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers*， 2019-09-03 Update
ISO 14971 Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirements*， 2019-12-10 Update
ISO 15747 Plastic containers for intravenous injections*， 2018-08-31 Update
ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 1924-2 Paper and board - Determination of tensile properties - Part 2: Constant rate of elongation method (20 mm/min)
ISO 20857 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 2859-1 Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection; Technical Corrigendum 1
ISO 534 Paper and board - Determination of thickness, density and specific volume
ISO/TS 11135-2 Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1; Technical Corrigendum 1
ISO/TS 11139:2006 Sterilization of health care products - Vocabulary
ISO/TS 17665-2 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1
BS PD CEN ISO/TS 16775:2014 history
2014BS PD CEN ISO/TS 16775:2014 Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2