Hello. Sign In
Standards Store
Look Inside

DS/EN ISO 80601-2-69

2014 Edition, September 22, 2014

Complete Document

Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment

Detail Summary

Active, Most Current

Additional Comments:
SAME AS ISO 80601-2-69
Price (USD)
Single User
In Stock
PDF + Print
In Stock
$187.20 You save 20%
Add to Cart

People Also Bought These:

CSA C22.2 NO 100
ISA 12.12.01
IEC 60601-1-8
CSA C22.2 NO 21

Product Details:

  • Revision: 2014 Edition, September 22, 2014
  • Published Date: September 22, 2014
  • Status: Active, Most Current
  • Document Language: English
  • Published By: Dansk Standardiseringsrad (DS)
  • Page Count: 62
  • ANSI Approved: No
  • DoD Adopted: No

Description / Abstract:

IEC 60601-1:2005+Amendment 1:2012, Clause 1 applies, except as follows: 201.1.1 Scope IEC 60601-1:2005+Amendment 1:2012, 1.1 is replaced by: This particular standard is applicable to the BASIC SAFETY and ESSENTIAL PERFORMANCE of an OXYGEN CONCENTRATOR in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT, intended to increase the oxygen concentration in the gas intended to be delivered to a single PATIENT. Suc OXYGEN CONCENTRATORS are typically intended for use in the HOME HEALTHCARE ENVIRONMENT, including TRANSIT-OPERABLE use by a single PATIENT in various environments including any private and public transportation and commercial aircraft. NOTE 1 An OXYGEN CONCENTRATOR can also be used in professional healthcare facilities. This particular standard is applicable to a TRANSIT-OPERABLE or non-TRANSIT-OPERABLE OXYGEN CONCENTRATOR. This particular standard is applicable to an OXYGEN CONCENTRATOR integrated into or used with other ME EQUIPMENT or ME SYSTEMS. EXAMPLE 1 An OXYGEN CONCENTRATOR with integrated oxygen CONSERVING EQUIPMENT or humidifier. EXAMPLE 2 An OXYGEN CONCENTRATOR used with a flowmeter stand. This particular standard is also applicable to those ACCESSORIES intended by their MANUFACTURER to be connected to an OXYGEN CONCENTRATOR, where the characteristics of those ACCESSORIES can affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the OXYGEN CONCENTRATOR. This particular standard does not specify the requirements for OXYGEN CONCENTRATORS for use with a MEDICAL GAS PIPELINE SYSTEM which are given in ISO 10083. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. NOTE 2 See also 4.2 of the General Standard. This particular standard is a particular standard in the IEC 60601-1 series of standards.