EN 60601-2-16:2015

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 anaesthetic mixtures
Annex AA (informative) - Particular guidance and rationale
Annex BB (informative) - Examples of HAZARDS, foreseeable
         sequences of events, and HAZARDOUS SITUATIONS
         in HAEMODIALYSIS EQUIPMENT
Bibliography
Annex ZA (normative) - Normative references to international
         publications with their corresponding
         European publications
Annex ZZ (informative) - Coverage of Essential Requirements
         of EU Directives
Index of defined terms used in this particular standard

IEC 60601-2-16:2012 applies to the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment. IEC 60601-2-16:2012 does not take into consideration the dialysis fluid control system of Haemodialysis equipment using regeneration of dialysis fluid and central delivery systems. It does however take into consideration the specific safety requirements of such haemodialysis equipment concerning electrical safety and patient safety. IEC 60601-2-16:2012 specifies the minimum safety requirements for haemodialysis equipment. These devices are intended for use either by medical staff or for use by the patient or other trained personnel under the supervision of medical expertise. IEC 60601-2-16:2012 includes all electromedical equipment that is intended to deliver a haemodialysis, haemodiafiltration and haemofiltration treatment to a patient suffering from kidney failure. This fourth edition cancels and replaces the third edition of IEC 60601-2-16, published in 2008. This edition constitutes a technical revision. Changes since the previous edition include, among others, better adaptation of IEC 60601-1-8 and improvement of subclause 201.8.3.