Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
€268.00
Sterilization of health care products—Chemical indicators—Part 1: General requirements
€204.00
Sterilization of health care products—Chemical indicators—Part 3: Class 2 indicator systems for use in the Bowie and Dick steam penetration test
€178.00
Medical devices—Quality management systems—Requirements for regulatory purposes
Sterilization of health care products—Chemical indicators—Part 4: Class 2 indicators as an alternative to Bowie and Dick test for detection of steam penetration
€221.00
Active implantable medical devices—Electromagnetic compatibility—EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
€311.00
Sterilization of health care products—Chemical indicators—Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs
Implants for surgery—Active implantable medical devices—Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
Cardiovascular implants and extracorporeal systems—Blood/tissue contact surface modifications for extracorporeal perfusion systems
€126.00
Implants for surgery—Active implantable medical devices—Part 3: Implantable neurostimulators
€262.00
Implants for surgery—Active implantable medical devices—Part 4: Implantable infusion pumps
€251.00
Medical products containing viable human cells—Application of risk management and requirements for processing practices
Medical devices—Application of risk management to medical devices
Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1: General requirements
Medical devices—Symbols to be used with medical device labels, labeling and information to be supplied—Part 2: Symbol development, selection and validation
€144.00
