Name: PREN ISO 80601-2-61 : DRAFT 2009
Brand: CEN

PREN ISO 80601-2-61 : DRAFT 2009

Superseded

MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE

Superseded date

01-04-2011

Published date

12-01-2013

Publisher

Comite Europeen de Normalisation

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
201.101 Pulse oximeter probes and probe cable extenders
201.102 Saturation pulse information signal
202 Medical electrical equipment - Part 1-2: General
        requirements for safety - Collateral standard:
        Electromagnetic compatibility - Requirements and tests
208 Medical electrical equipment - Part 1-8: General
        requirements for safety - Collateral Standard: General
        requirements, tests and guidance for alarm systems in
        medical electrical equipment and medical electrical
        systems
Annex C (informative) - Guide to marking and labelling
        requirements for me equipment and me systems
Annex D (informative) - Symbols on marking
Annex AA (informative) - Particular guidance and rationale
Annex BB (informative) - Skin temperature at the pulse oximeter
         probe
Annex CC (informative) - Determination of accuracy
Annex DD (informative) - Calibration standards
Annex EE (informative) - Guideline for evaluating and documenting
         SpO[2] accuracy in human subjects
Annex FF (informative) - Simulators, calibrators and functional
         testers for pulse oximeter equipment
Annex GG (informative) - Concepts of me equipment response time
Annex HH (informative) - Reference to the Essential Principles
Annex II (informative) - Environmental aspects
Annex ZA (informative) - Relationship between this International
         Standard and the Essential Requirements of EU Directive
         93/42/EEC
Bibliography
Alphabetized index of defined terms used in this standard

Applicable to the basic safety and essential performance of pulse oximeter equipment intended for use on humans, hereafter referred to as me equipment.

Committee	TC 215
DocumentType	Draft
PublisherName	Comite Europeen de Normalisation
Status	Superseded
SupersededBy	EN ISO 80601-2-61:2011

Standards	Relationship
09/30181956 DC : DRAFT MAY 2009	Identical
NF EN ISO 80601-2-61 : 2011	Identical
NEN EN ISO 80601-2-61 : 2011	Identical

IEC TR 60825-9:1999	Safety of laser products - Part 9: Compilation of maximum permissible exposure to incoherent optical radiation
IEC 60825-2:2004+AMD1:2006+AMD2:2010 CSV	Safety of laser products - Part 2: Safety of optical fibre communication systems (OFCS)
IEC 60068-2-27:2008	Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
ISO/IEC Guide 98:1993	Guide to the expression of uncertainty in measurement (GUM)
IEC 60601-1:2005+AMD1:2012 CSV	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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
IEC 60721-3-7:1995+AMD1:1996 CSV	Classification of environmental conditions - Part 3-7: Classification of groups of environmental parameters and their severities - Portable and non-stationary use
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
IEC 60825-1:2014	Safety of laser products - Part 1: Equipment classification and requirements
ISO 14937:2009	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
CFR 21(PTS800-1299) : 0	FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
NFPA 53 : 2016	MATERIALS, EQUIPMENT, AND SYSTEMS USED IN OXYGEN-ENRICHED ATMOSPHERES
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
CLSI C25 A : 1997	FRACTIONAL OXYHEMAGLOBIN, OXYGEN CONTENT AND SATURATION, AND RELATED QUANTITIES IN BLOOD: TERMINOLOGY, MEASUREMENT, AND REPORTING
IEC 60068-2-31:2008	Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-type specimens
IEC 60068-2-64:2008	Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
EN 563:1994/A1:1999/AC:2000	SAFETY OF MACHINERY - TEMPERATURES OF TOUCHABLE SURFACES - ERGONOMICS DATA TO ESTABLISH TEMPERATURE LIMIT VALUES FOR HOT SURFACES
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
ISO/IEC Guide 99:2007	International vocabulary of metrology Basic and general concepts and associated terms (VIM)
IEC TR 60878:2015	Graphical symbols for electrical equipment in medical practice
IEC 60529:1989+AMD1:1999+AMD2:2013 CSV	Degrees of protection provided by enclosures (IP Code)
IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV	Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
CLSI C46 A : 1ED 2001	BLOOD GAS AND PH ANALYSIS AND RELATED MEASUREMENTS
IEC TR 60721-4-7:2001+AMD1:2003 CSV	Classification of environmental conditions - Part 4-7: Guidance for the correlation and transformation of environmental condition classes of IEC 60721-3 to the environmental tests of IEC 60068 - Portable and non-stationary use
ISO 7000:2014	Graphical symbols for use on equipment Registered symbols
ISO 15223-1:2016	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
IEC 60601-1-9:2007+AMD1:2013 CSV	Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
ISO 3534-1:2006	Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability