Biological evaluation of medical devices—Part 11: Tests for systemic toxicity

Biological evaluation of medical devices—Part 12: Sample preparation and reference materials

Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric devices

Biological evaluation of medical devices—Part 15: Identification and quantification of degradation products from metals and alloys

Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables

Biological evaluation of medical devices—Part 17: Establishment of allowable limits for leachable substances

Biological evaluation of medical devices—Part 2: Animal welfare requirements

Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity

Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood

Biological evaluation of medical devices—Part 5: Tests for in vitro cytotoxicity

Biological evaluation of medical devices—Part 6: Tests for local effects after implantation

Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals

Biological evaluation of medical devices—Part 9: Framework for identification and quantification of potential degradation products

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

Sterilization of health care products—Radiation—Part 2: Establishing the sterilization dose

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

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

Sterilization of health care products—Biological indicators—Part 2: Biological indicators for ethylene oxide sterilization processes

Sterilization of health care products—Chemical indicators—Part 3: Class 2 indicator systems for use in the Bowie and Dick steam penetration test

Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems Amendment 1: Application of risk management

Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes Amendment 1: Application of risk management

Sterilization of health care products—Microbiological methods—Part 1: Determination of a population of microorganisms on products—AMENDMENT 1

Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose: Method VDmax SD

Aseptic processing of health care products—Part 2: Sterilizing filtration