Glossary of equivalent standards
Committee representation
Background of AAMI adoption of IEC 60601-2-16:2012
FOREWORD
INTRODUCTION
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing of ME EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
201.7 ME EQUIPMENT identification, marking and documents
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT
and ME SYSTEMS
201.10 Protection against unwanted and excessive
radiation HAZARDS
201.11 Protection against excessive temperatures and
other HAZARDS
201.12 Accuracy of controls and instruments and protection
against hazardous outputs
201.13 HAZARDOUS SITUATIONS and fault conditions
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
201.15 Construction of ME EQUIPMENT
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT
and ME SYSTEMS
202 Electromagnetic compatibility - Requirements
and tests
208 General requirements, tests and guidance for
alarm systems in medical electrical equipment
and medical electrical systems
210 Process requirements for the development of
PHYSIOLOGIC CLOSED-LOOP CONTROLLERS
211 Requirements for MEDICAL ELECTRICAL EQUIPMENT
and MEDICAL ELECTRICAL SYSTEMS used in the
HOME HEALTHCARE ENVIRONMENT
Annexes
Annex G (normative) - Protection against HAZARDS of
ignition of flammable anesthetic mixtures
Annex AA (informative) - Particular guidance and rationale
Annex BB (informative) - Examples of HAZARDS, foreseeable
sequences of events, and HAZARDOUS SITUATIONS
in HEMODIALYSIS EQUIPMENT
Bibliography
Index of defined terms used in this particular standard