MEDICAL DEVICE SOFTWARE - PART 2: VALIDATION OF SOFTWARE FOR MEDICAL DEVICE QUALITY SYSTEMS

International Organization for Standardization

High frequency surgical equipment and high frequency surgical accessories - Operation and maintenance

International Electrotechnical Committee

Medical electrical equipment - Part 4-3: Guidance and interpretation - Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirementS.

International Electrotechnical Committee

Medical electrical equipment - Part 4-3: Guidance and interpretation - Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements

International Electrotechnical Committee

MEDICAL ELECTRICAL EQUIPMENT - PART 4-4: GUIDANCE AND INTERPRETATION - GUIDANCE FOR WRITERS OF PARTICULAR STANDARDS WHEN CREATING ALARM SYSTEM-RELATED REQUIREMENTS

International Electrotechnical Committee

APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - APPLICATION GUIDANCE - PART 2-7: GUIDANCE FOR HEALTHCARE DELIVERY ORGANIZATIONS (HDOS) ON HOW TO SELF-ASSESS THEIR CONFORMANCE WITH IEC 80001-1

International Organization for Standardization

MEDICAL ELECTRICAL EQUIPMENT - PART 4-1: GUIDANCE AND INTERPRETATION - MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS EMPLOYING A DEGREE OF AUTONOMY

International Electrotechnical Committee

GUIDANCE ON TRANSITION PERIODS FOR STANDARDS DEVELOPED BY ISO/TC 84 - DEVICES FOR ADMINISTRATION OF MEDICINAL PRODUCTS AND CATHETERS

International Organization for Standardization

APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-6: APPLICATION GUIDANCE - GUIDANCE FOR RESPONSIBILITY AGREEMENTS

International Organization for Standardization

USE AND HANDLING OF MEDICAL DEVICES COVERED BY THE SCOPE OF ISO/TC 84 - RISK ASSESSMENT ON MUCOCUTANEOUS BLOOD EXPOSURE

International Organization for Standardization