Aseptic processing of health care products—Part 4: Clean-in-place technologies

Aseptic processing of health care products—Part 5: Sterilization in place

Aseptic processing of health care products—Part 6: Isolator systems (Includes Amendment 1)

Aseptic processing of health care products—Part 7: Alternative processes for medical devices and combination products

Clinical investigation of medical devices for human subjects—Good clinical practice

Implants for surgery—Active implantable medical devices—Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

Implants for surgery—Active implantable medical devices—Part 3: Implantable neurostimulators

Sterilization of health care products—General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices

Medical devices—Symbols to be used with information to be supplied by the manufacturer— 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

Cardiovascular implants and artificial organs—Cardiopulmonary bypass systems—Arterial blood line filters

Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 1: Critical and semi-critical medical devices

Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 2: Non-critical medical devices

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

Medical devices utilizing animal tissues and their derivatives—Part 1: Application of risk management

Medical devices utilizing animal tissues and their derivatives—Part 2: Controls on sourcing, collection and handling

Medical devices utilizing animal tissues and their derivatives—Part 3: Validation of the elimination and/or inactivation of viruses and transimissible spongiform encephalopathy (TSE) agents

Small-bore connectors for liquids and gases in healthcare applications—Part 1: General requirements

Small-bore connectors for liquids and gases in healthcare applications—Part 5: Connectors for limb cuff inflation applications

Small-bore connectors for liquids and gases in healthcare applications—Part 7: Connectors for intravascular or hypodermic applications

Non invasive sphygmomanometers—Part 1: Requirements and test methods for nonautomated measurement type

Non-invasive sphygmomanometers—Clinical investigation of intermittent automated measurement type

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

Evaluation of CPB devices relative to their capabilities of reducing the transmission of gaseous microemboli (GME) to a patient during cardiopulmonary bypass

Transcutaneous electrical nerve stimulators