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AAMI IEC 60601-2-16 : 2012

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEMODIALYSIS, HEMODIAFILTRATION AND HEMOFILTRATION EQUIPMENT
Available format(s)

Hardcopy , PDF

Superseded date

14-02-2023

Language(s)

English

Published date

01-01-2012

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

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HEMODIALYSIS, HEMODIAFILTRATION and HEMOFILTRATION EQUIPMENT, hereafter referred to as HEMODIALYSIS EQUIPMENT.

Committee
RD
DevelopmentNote
Supersedes AAMI RD5. (01/2011)
DocumentType
Standard
Pages
80
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
IEC 60601-2-16 : 4.0 Identical

ANSI/AAMI ST79:2017 COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES
AAMI TIR72 : 2017 DIALYSIS FLUID CHEMICAL COMPOSITION

ISO 3744:2010 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for an essentially free field over a reflecting plane
IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
ISO 8638:2010 Cardiovascular implants and extracorporeal systems Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
IEC 60601-1-10:2007+AMD1:2013 CSV Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers
ISO 13958:2014 Concentrates for haemodialysis and related therapies
IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
IEC 60601-2-39:2007 MEDICAL ELECTRICAL EQUIPMENT - PART 2-39: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PERITONEAL DIALYSIS EQUIPMENT
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-2-16 : 4.0 MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT
ISO 11197:2016 Medical supply units
IEC 60601-2-39:2007 Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
EN 1275:2005 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic fungicidal or basic yeasticidal activity of chemical disinfectants and antiseptics - Test method and requirements (phase 1)
EN 1040:2005 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic bactericidal activity of chemical disinfectants and antiseptics - Test method and requirements (phase 1)
ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings

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