PREN ISO 80601-2-61 : DRAFT 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE
01-04-2011
12-01-2013
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 |
| 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 |
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