EN ISO 80601-2-69-2014 en Medical electrical equipment - Part 2-69 Particular requirements for basic safety and essential performance of oxygen concentrator equipment《医用电气设备 第2-69部.pdf

1、BSI Standards PublicationBS EN ISO 80601-2-69:2014Medical electrical equipmentPart 2-69: Particular requirements for basicsafety and essential performance of oxygenconcentrator equipmentIncorporating corrigendum November 2014BS EN ISO 80601-2-69:2014ForewordThis British Standard is the UK implementa

2、tion of EN ISO 80601-2-69:2014. It supersedes BS EN ISO 8359:2009+A1:2012 which is withdrawn.The UK participation in its preparation was entrusted by Technical Committee CH/121, Anaesthetic and respiratory equipment, to Subcommittee CH/121/9, Lung Ventilators identification of ESSENTIAL PERFORMANCE

3、for an OXYGEN CONCENTRATOR and its ACCESSORIES; and the following additions: tests for oxygen delivery performance; new symbols; new requirement for a means to prevent the propagation of fire into the OXYGEN CONCENTRATOR and its ACCESSORIES; tests for cleaning and disinfection PROCEDURES; and consid

4、eration of contamination of the breathing gas delivered to the PATIENT from the gas pathways. In this standard, the following print types are used: Requirements and definitions: roman type. Test specifications: italic type. BS EN ISO 80601-2-69:2014 ISO 80601-2-69:2014 (E)viii ISO 2014 All rights re

5、served Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type. TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS TYPE. In referring to the s

6、tructure of this standard, the term “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.); “subclause” means a numbered subdivision of a clause (e.g. 201.7.1, 201.7.2 and 201.7.2.1 are all

7、 subclauses of Clause 201.7). References to clauses within this standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this particular standard are by number only. In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is

8、 true if any combination of the conditions is true. The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb: “shall” means that compliance with a requirement or a test is mandatory for compl

9、iance with this standard; “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard; “may” is used to describe a permissible way to achieve compliance with a requirement or test. An asterisk (*) as the first character of a title

10、 or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex A. The attention of Member Bodies and National Committees is drawn to the fact that equipment manufacturers and testing organizations may need a transitional period followin

11、g publication of a new, amended or revised ISO or IEC publication in which to make products in accordance with the new requirements and to equip themselves for conducting new or revised tests. It is the recommendation of the committee that the content of this publication not be adopted for mandatory

12、 implementation nationally earlier than 3 years from the date of publication for equipment newly designed and not earlier than 5 years from the date of publication for equipment already in production. BS EN ISO 80601-2-69:2014 ISO 80601-2-69:2014 (E)ix ISO 2014 All rights reserved Introduction Oxyge

13、n supplementation can be part of management of PATIENTS with chronic, acuteon-chronic and acute respiratory disorders. The amount of supplemental oxygen depends on the individual PATIENTS needs under various conditions. The managing healthcare team typically prescribes the endpoint of treatment, for

14、 example a target value for oxygen saturation. The amount of supplemental oxygen can be controlled by the flowrate. The goal of long term oxygen therapy is to keep the oxygen saturation above 90 % in PATIENTS that require supplemental oxygen. The flowrate should be adjusted for rest, exertion, and s

15、leep to meet the individual PATIENTS needs under these various conditions. Ideally, the resting flowrate is adjusted to maintain SpO2 90 % as indicated by pulse oximetry. Supplemental oxygen is supplied by various sources: MEDICAL GAS PIPELINE SYSTEMS, OXYGEN CONCENTRATORS, compressed gas cylinders,

16、 and liquid oxygen reservoirs. This standard covers the particular requirements for BASIC SAFETY and ESSENTIAL PERFORMANCE of OXYGEN CONCENTRATORS. OXYGEN CONCENTRATORS produce oxygen enriched air from room air for delivery to a PATIENT requiring oxygen therapy. The most common OXYGEN CONCENTRATOR u

17、ses molecular sieve beds to filter and concentrate oxygen molecules from the ambient air, generating oxygen concentrations of typically 82 % to 96 %. The main component of this type of OXYGEN CONCENTRATOR is the molecular sieve, which adsorbs nitrogen from air to produce a product gas which is a mix

18、ture of typically up to 95 % oxygen and 5 % of other gases. The periodic adsorbing and purging of nitrogen is referred to as the pressure swing adsorption process. BS EN ISO 80601-2-69:2014 ISO 80601-2-69:2014 (E)xBS EN ISO 80601-2-69:2014 ISO 80601-2-69:2014 (E)BS EN ISO 80601-2-69:2014INTERNATIONA

19、L STANDARD ISO 80601-2-69:2014(E) ISO 2014 All rights reserved 1Medical electrical equipment Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment 201.1 Scope, object and related standards IEC 60601-1:2005+Amendment 1:2012, Clause 1 applies, e

20、xcept as follows: 201.1.1 Scope IEC 60601-1:2005+Amendment 1:2012, 1.1 is replaced by: This particular standard specifies requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE of an OXYGEN CONCENTRATOR in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT, intended to incr

21、ease the oxygen concentration of gas intended to be delivered to a single PATIENT. Such OXYGEN CONCENTRATORS are typically intended for use in the HOME HEALTHCARE ENVIRONMENT, including TRANSITOPERABLE use by a single PATIENT in various environments including any private and public well as in commer

22、ctransportation as ial aircraft. ls u cNOTE 1 Such an OXYGEN CONCENTRATOR can a o be sed in professional health are facilities. This particular standard is applicable to a TRANSITOPERABLE and nonTRANSITOPERABLE OXYGEN CONCENTRATOR. This particular standard is applicable to an OXYGEN CONCENTRATOR int

23、egrated into or used edical devices, ME EQUIPMwith other m ENT or ME SYSTEMS. OXYGEN CONCENTRATOR RVING EQUIPMENT 10EXAMPLE 1 An with integrated oxygen CONSEOXYGEN CONCENTRATOR useor humidifier 4. EXAMPLE 2 An d with a flowmeter stand. EXAMPLE 3 An OXYGEN CONCENTRATOR as part of an anaesthetic syste

24、m for use in areas with limited logistical ty and anaesthetic gasupplies of electrici ses. 3 tEXAMPLE 4 An OXYGEN CONCENTRATOR with an in egrated liquid reservoir or gas cylinder filling system. This particular standard is also applicable to those ACCESSORIES intended by their MANUFACTURER to be con

25、nected 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 g

26、iven 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 releva

27、nt. 2 ISO 2014 All rights reservedHAZARDS 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 S

28、tandard. This International Standard is a particular standard in the IEC 606011 series of standards. 201.1.2 Object IEC 60601-1:2005, 1.2 is replaced by: The object of this International Standard is to establish particular BASIC SAFETY and ESSENTIAL RMAN E require ed in PERFO C ments for an OXYGEN C

29、ONCENTRATOR as defin its ACCESSONOTE ACCESSORIES are included because the combination of the OXYGEN CONCENTRATOR and the ACCESSORIES needs to be adequately safe. ACCESSORIES can have a significant impact on the BASIC SAFETY or ESSENTIAL PERFORMANCE of an OXYGEN CONCENTRATOR. 201.3.203 and RIES. 201.

30、1.3 Collateral standards IEC 60601-1:2005+Amendment 1:2012, 1.3 applies with the following addition: This particular standard refers to those applicable collateral standards that are listed in IEC 60601ard and 201.2 of this particular standard. 1:2005+Amendment 1:2012, Clause 2 of the general standI

31、EC 6060113:2008+Amendment 1:2013 does not apply. 201.1.4 Particular standards IEC 60601-1:2005+Amendment 1:2012, 1.4 is replaced by: In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in the general standard, including the collateral standards, as appr

32、opriate for the particular ME EQUIPMENT under consideration, and may add other BASIC SAFETY or ESSENTIAL PERFORMANCE requirements. A requirement of a particular standard takes priority over the general standard or the collateral standards. For brevity, IEC 606011:2005+Amendment 1:2012 is referred to

33、 in this particular standard as the general standard. Collateral standards are referred to by their document number. The numbering of clauses and subclauses of this particular standard corresponds to those of the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the conte

34、nt of Clause 1 of the general standard) or applicable collateral standard with the prefix “2xx” where xx is the final digits of the collateral standard document number (e.g. 202.4 in this particular standard addresses the content of Clause 4 of the IEC 6060112 collateral standard, 208.4 in this part

35、icular standard addresses the content of Clause 4 of the IEC 6060118 collateral standard, etc.). The changes to the text of the general standard are specified by the use of the following words: “Replacement“ means that the clause or subclause of the general standard or applicable collateral standard

36、 is replaced completely by the text of this particular standard. “Addition“ means that the text of this particular standard is additional to the requirements of the general standard or applicable collateral standard. BS EN ISO 80601-2-69:2014 ISO 80601-2-69:2014 (E) ISO 2014 All rights reserved 3“Am

37、endment“ means that the clause or subclause of the general standard or applicable collateral standard is amended as indicated by the text of this particular standard. Subclauses or figures that are additional to those of the general standard are numbered starting from 201.101, additional annexes are

38、 lettered AA, BB, etc., and additional items aa), bb), etc. Subclauses or figures that are additional to those of a collateral standard are numbered starting from 2xx, where “x” is the number of the collateral standard, e.g. 202 for IEC 6060112, 203 for IEC 6060113, etc. The term “this standard“ is

39、used to make reference to the general standard, any applicable collateral standards and this particular standard taken together. Where there is no corresponding clause or subclause in this particular standard, the section, clause or subclause of the general standard or applicable collateral standard

40、, although possibly not relevant, applies without modification; where it is intended that any part of the general standard or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this particular standard. 201.2 Normative references

41、The following referenced documents are indispensable for the application of this document. The way in which these referenced documents are cited in normative requirements determines the extent (in whole or in part) to which they apply. For dated references, only the edition cited applies. For undate

42、d ces ments) applies. referen , the latest edition of the referenced document (including any amendNOTE Informative references are listed in the Bibliography beginning on page 37. IEC 60601-1:2005+Amendment 1:2012, Clause 2 applies, except as follows: Replacement: IEC 6060112:2007, Medical electrical

43、 equipment Part 1-2: General requirements for basic safety and Collateral Standard: Electromagnetic compatibility Requirements and tests essential performanceIEC 6060116:2010, Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance Collateral standard:

44、Usability +Amendment 1:2013 IEC 6060118:2006, Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems +Ame

45、ndment 1:2012 IEC 60601111:2010, Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment Addition: ISO 3744:2010,

46、Acoustics - Determination of sound power levels and sound energy levels of noise sources sure - Engineering methods for an essentially free field over a reflecting plane using sound presISO 7000:2012, Graphical symbols for use on equipment - Registered symbols BS EN ISO 80601-2-69:2014 ISO 80601-2-6

47、9:2014 (E)4 ISO 2014 All rights reservedISO 7010:2011, Graphical symbols - Safety colours and safety signs - Registered safety signs +Amendment 1:2012 012 +Amendment 2:2ISO 14937:2009, Sterilization of health care products - General requirements for characterization of a sterilizing agent and the de

48、velopment, validation and routine control of a sterilization process for medical devices ISO 152231:2012, Medical devices Symbols to be used with medical device labels, labelling and d Part 1: General requirements information to be supplieISO/DIS 146441:2010, Cleanrooms and associated controlled env

49、ironments - Part 1: Classification of air ticle concentration cleanliness by parISO 17664:2004, Sterilization of medical devices - Information to be provided by the manufacturer for the lizable medical devices processing of resteriISO 803691:2010, Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements ISO 80601267:2014, Medical Electrical Equipment Part 2-67: Particular requirements for basic performance of oxygen conserving