Safety and effectiveness of health IT software and systems—Part 1: Fundamental concepts, principles, and requirements

Medical electrical equipment—Part 1-12: General requirements—Collateral standard: Requirements for medical electrical equipment and medical electrical systems intended for use in emergency medical services environment—Amendment 1

Medical Electrical Equipment—Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators

Medical Electrical Equipment—Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators

Medical Electrical Equipment—Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers

Medical electrical equipment—Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

Medical electrical equipment—Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

Medical electrical equipment—Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems

Medical electrical equipment—Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment

Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal and vitrectomy devices for ophthalmic surgery

Medical electrical equipment—Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment

Medical electrical equipment—Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation

Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition

Application of risk management for IT-networks incorporating medical devices—Part 2-1: Step by step risk management of medical IT-networks; Practical applications and examples.

Application of risk management for IT-networks incorporating medical devices—Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls

Biological evaluation of medical devices—Part 14: Identification and quantification of degradation products from ceramics

Sterilization of health care products—Biological indicators—Part 3: Biological indicators for moist heat sterilization processes

Sterilization of health care products—Biological indicators—Part 4: Biological indicators for dry heat sterilization processes

Sterilization of health care products—Biological indicators—Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes

Sterilization of health care products—Biological indicators—Part 8: Method for validation of a reduced incubation item for a biological indicator

Sterilization of health care products—Chemical indicators—Part 1: General requirements

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

Sterilization of health care products—Chemical indicators—Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs

Sterilization of health care products—Chemical indicators—Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers

Cardiovascular implants and extracorporeal systems—Blood/tissue contact surface modifications for extracorporeal perfusion systems