Biological evaluation of medical devices -- Identification and quantification of degradation products from metals and alloys

Biological evaluation of medical devices -- Toxicokinetic study design for degradation products and leachables

Biological evaluation of medical devices -- Establishment of allowable limits for leachable substances

Biological evaluation of medical devices -- Chemical characterization of medical device materials within a risk management process

Biological evaluation of medical devices -- Tests for irritation

Biological evaluation of medical devices -- Selection of tests for interactions with blood

Biological evaluation of medical devices -- Tests for in vitro cytotoxicity

Biological evaluation of medical devices -- Tests for local effects after implantation

Biological evaluation of medical devices -- Ethylene oxide sterilization residuals

Biological evaluation of medical devices -- Selection and qualification of reference materials for biological tests

Biological evaluation of medical devices -- Framework for identification and quantification of potential degradation products

Geometrical product specifications (GPS). Geometrical tolerancing. Tolerances of form, orientation, location and run-out

Sterile, single-use intravascular catheter introducers

Health informatics. Point-of-care medical device communication -- Nomenclature. Annotated ECG

Health informatics. Personal health device communication -- Device specialization. Pulse oximeter

Health informatics. Personal health device communication -- Device specialization. Basic electrocardiograph (ECG) (1- to 3-lead ECG)

Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices

Sterilization of health care products. Ethylene oxide -- Requirements for development, validation and routine control of a sterilization process for medical devices

Sterilization of health care products. Radiation -- Requirements for the development, validation and routine control of a sterilization process for medical devices

Sterilization of health care products. Radiation -- Establishing the sterilization dose

Sterilization of health care products. Radiation -- Guidance on dosimetric aspects of development, validation and routine control

Sterilization of health care products. Biological indicators -- General requirements

Sterilization of health care products. Biological indicators -- Biological indicators for ethylene oxide sterilization processes

Sterilization of health care products. Biological indicators -- Biological indicators for moist heat sterilization processes

Sterilization of health care products. Biological indicators -- Biological indicators for low-temperature steam and formaldehyde sterilization processes