ISO 80601-2-70:2015
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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Medical electrical equipment Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
03-12-2020
French, English
12-01-2015
Important note : Users cannot be edited or removed once added to your Multi user PDF.
ISO 80601-2-70:2015 is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to as me equipment, intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the patient. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment by lay operators as well as in professional healthcare institutions.
It excludes sleep apnoea breathing therapy equipment intended for use with neonates.
ISO 80601-2-70:2015 is applicable to me equipment or an me system intended for those patients who are not dependent on mechanical ventilation.
ISO 80601-2-70:2015 is not applicable to me equipment or an me system intended for those patients who are dependent on mechanical ventilation such as patients with central sleep apnoea.
ISO 80601-2-70:2015 is also applicable to those accessories intended by their manufacturer to be connected to sleep apnoea breathing therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the sleep apnoea breathing therapy equipment.
| DevelopmentNote |
Supersedes ISO/DIS 80601-2-70 and ISO 17510-1. (01/2015)
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| DocumentType |
Standard
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| Pages |
49
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| PublisherName |
International Organization for Standardization
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| Status |
Withdrawn
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| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| PNE-prEN ISO 80601-2-70 | Identical |
| CAN/CSA-C22.2 NO. 80601-2-72:17 | Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (Adopted ISO 80601-2-72:2015, first edition, 2015-09-01, with Canadian deviations) |
| ISO 80601-2-74:2017 | Medical electrical equipment Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment |
| 17/30338753 DC : 0 | BS ISO 80601-2-79 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-79: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF VENTILATORY SUPPORT EQUIPMENT FOR VENTILATORY IMPAIRMENT |
| 16/30346835 DC : 0 | BS ISO 20789 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - PASSIVE HUMIDIFIERS |
| ISO 17510:2015 | Medical devices — Sleep apnoea breathing therapy — Masks and application accessories |
| ISO 4871:1996 | Acoustics — Declaration and verification of noise emission values of machinery and equipment |
| 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 |
| ISO 80601-2-13:2011 | Medical electrical equipment Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation |
| EN 15986:2011 | Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates |
| ISO 10651-2:2004 | Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 2: Home care ventilators for ventilator-dependent patients |
| ISO 10651-6:2004 | Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 6: Home-care ventilatory support devices |
| 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 |
| ISO 5356-1:2015 | Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets |
| ISO 10651-4:2002 | Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators |
| 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 |
| ISO 80601-2-12:2011 | Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators |
| 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 10651-3:1997 | Lung ventilators for medical use Part 3: Particular requirements for emergency and transport ventilators |
| ISO 8185:2007 | Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems |
| ISO/TR 16142:2006 | Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices |
| ISO 14159:2002 | Safety of machinery — Hygiene requirements for the design of machinery |
| ISO 23328-2:2002 | Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects |
| ISO 8601:2004 | Data elements and interchange formats Information interchange Representation of dates and times |
| IEC 60601-1-3:2008+AMD1:2013 CSV | Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
| ISO 80369-1:2010 | Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements |
| ISO 23328-1:2003 | Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 7000:2014 | Graphical symbols for use on equipment Registered symbols |
| ISO 4135:2001 | Anaesthetic and respiratory equipment Vocabulary |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| DIN 45681:2005-03 | ACOUSTICS - DETERMINATION OF TONAL COMPONENTS OF NOISE AND DETERMINATION OF A TONE ADJUSTMENT FOR THE ASSESSMENT OF NOISE IMMISSIONS |
| ISO 17664:2017 | Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices |
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