ISO Standards Adopted As Singapore Standards

Medical electrical equipment – Part 11: General requirements for basic safety and essential performance – Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

Medical electrical equipment – Part 10: General requirements for basic safety and essential performance – Collateral standard: Requirements for the development of physiologic closed-loop controllers

Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Medical devices — Symbols to be used with medical device labels, labelling and information

Sterilisation of health care products — Vocabulary of terms used in sterilisation and related equipment and process standards

Sterilisation of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilisation process for medical devices

Sterilisation of health care products — Radiation – Part 3 : Guidance on dosimetric aspects of development, validation and routine control

Sterilisation of health care products — Radiation – Part 1 : Requirements for development, validation and routine control of a sterilisation process for medical devices

Guidelines for auditing management systems