BS EN ISO 80601-2-72-2015 Medical electrical equipment Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-.pdf

1、BSI Standards PublicationBS EN ISO 80601-2-72:2015Medical electrical equipmentPart 2-72: Particular requirements forbasic safety and essential performance ofhome healthcare environment ventilatorsfor ventilator-dependent patientsBS EN ISO 80601-2-72:2015 BRITISH STANDARDNational forewordThis British

2、 Standard is the UK implementation of EN ISO80601-2-72:2015. It supersedes BS EN ISO 10651-2:2009, which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/121/9, Lung Ventilators A ; identification of ESSENTIAL PERFORM NCE for a VENTILATOR and its ACCESSORIE

3、S modification o f the obstruction of the expiratory limb (continuing AIRWAY PRESSURE) ALARM CONDITION requirement; and the following additions: tests for ventilation performance; anical strength (via IEC 60601111); tests for mech new symbols; BS EN ISO 80601-2-72:2015ISO 80601-2-72:2015(E) viii ISO

4、 2015 All rights reserved requirements for a VENTILATOR as a component of an ME SYSTEM; tests for ENCLOSURE integrity (water ingress via IEC 60601111); n a tests for cleani g nd disinfection PROCEDURES (via IEC 60601111); consideration of contamination of the breathing gas delivered to the PATIENT f

5、rom the gas pathways. 80601 consists of the following parts, under the general title Medical electrical equipment: ISO Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators Part 2-13: Particular requirements for basic safety and essential performa

6、nce of an anaesthetic workstation Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement Part 2-61: Particula

7、r requirements for basic safety and essential performance of pulse oximeter equipment for medical use Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment Part 2-69: Particular requirements for basic safety and essential performance of oxygen c

8、oncentrator equipment Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients 8

9、0601 consists of the following parts, under the general title Medical electrical equipment: IEC Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers Part 2-35: Particular requirements for the basic safety and essential performa

10、nce of heating devices using blankets, pads and mattresses and intended for heating in medical use Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery Part 2-59: Particular requirements for the basic

11、safety and essential performance of screening thermographs for human febrile temperature screening Part 2-60: Particular requirements for basic safety and essential performance of dental equipThe ISO and IEC 80601 family of standards are also parts of the IEC 60601 family of standards. ment BS EN IS

12、O 80601-2-72:2015ISO 80601-2-72:2015(E) ISO 2015 All rights reserved ixIntroduction This part of ISO 80601 specifies requirements for lung ventilators that are intended for use in the HOME HEALTHCARE ENVIRONMENT for PATIENTS who are dependent for ventilation for their life support. These VENTILATORS

13、 are frequently used in locations where the power driving the VENTILATOR is not reliable. These VENTILATORS are often supervised by nonhealthcare personnel (LAY OPERATORS) with varying levels of training. Lung ventilators complying with this standard can be used elsewhere (i.e. in healthcare facilit

14、ies). In referring to the structure of this part of ISO 80601, “clause” means one of the 17 numbered divisions within the ta ble of contents, inclusive of all subdivisions (e.g. Clause 7 includes 7.1, 7.2, etc.), and “subclause” means a numbered subdivision of a clause (e.g. 20 1.7.1, 201.7.2 and 20

15、1.7.2.1 are all subclauses of Clause 201.7). References to clauses within this part of ISO 80601 are preceded by the term “Clause” followed by the clause number. References to subclauses within this particular part of ISO 80601 are by number only. In this part of ISO 80601, the conjunctive “or” is u

16、sed as an “inclusive or” so a statement is true if any combination of the conditions is true. The verbal forms used in this part of ISO 80601 conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this part of ISO 80601, the auxiliary verb “shall” means that com

17、pliance with a requirement or a test is mandatory for compliance with this part of ISO 80601, “should” means that compliance with a requirement or a test i s recommended but is not mandatory for compliance with this part of ISO 80601, and “may” is used to describe a permissible way to achieve compli

18、 ance with a requirement or test. An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex AA.The attention of Member Bodies and National Committees is drawn to the fact that equipm

19、ent manufacturers and testing organizations might need a transitional period following 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 them for conducting new or revised tests. It is the recommendation of

20、 the committee that the content of this part of ISO 80601 not be adopted for mandatory implementation nationally earlier than three years from the date of publication for equipment newly designed and not earlier than five years from the date of publication for equipment already in production. BS EN

21、ISO 80601-2-72:2015BS EN ISO 80601-2-72:2015 ISO 2015 All rights reserved 1Medical electrical equipment Part 2-72: Particularrequirements for basic safety and essential performance ofhome healthcare environment ventilators for ventilator-dependent patients 201.1 Scope, object, and related standards

22、IEC 606011:20 5+AMD1:2012, Clause 1 applies, except as follows: 201.1.1 *Scope0IEC 606011:2005+AMD1:2012, 1.1 is replaced by: This part of ISO 80601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a VENTILATOR in EQUIPMENT: combination with its ACCESSORIES, hereafter referred to as MECARE E

23、NVIRONMENT; intended for use in the HOME HEALTH intended for use by a LAY OPERATOR; nd r use with epende pport. inte ed fo PATIENTS who are d nt on mechanical ventilation for their life suENTILATORS can also be used fo ependent o rt. NOTE 1 Such V r PATIENTS who are not d n ventilatory suppoHOME HEA

24、LTNOTE 2 In the HCARE ENVIRONMENT, the power driving the VENTILATOR is often not reliable. NOTE 3 Such VENTILATORS can also be used in noncritical care applications of professional health care facilities. This part of ISO 80601 is also applicable to those ACCESSORIES intended by their MANUFACTURER t

25、o beconnected to a VENTILATOR BREATHING SYSTEM or to a VENTILATOR where the characteristics of those S caACCESSORIE n affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the VENTILATOR. EXAMPLES Breathing tubes, connectors, water traps, expiratory valve, HUMIDIFIER, BREATHING SYSTEM FILTER,external

26、electrical power source, and DISTRIBUTED ALARM SYSTEM. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only or to ME SYSTEMSonly, the title and content of that clause or subclause will say so. If that is not the case, the clause orsubclause applies both to ME EQUIP

27、MENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scopeof this part of ISO 80601 are not covered by specific requirements in this part of ISO 80601 except in 01IEC 606 1:2005+AMD1:2012, 7.2.13 and 8.4.1. NOTE 4 Addit

28、ional information can be found in IEC 606011:2005+AMD1:2012, 4.2. This part of ISO 80601 is not applicable to continuous positive airway pressure (CPAP) ME EQUIPMENT,highfrequency jet ventilators (HFJVs), and highfrequency oscillatory ventilators (HFOVs)35. This part of ISO 80601 does not specify th

29、e requirements for cuirass and “ironlung” VENTILATORS. This part of ISO 80601 does not specify the requirements for VENTILATORS or ACCESSORIES intended forcritical care applications, which are given in ISO 80601212. INTERNATIONAL STANDARDISO 80601-2-72:2015(E)BS EN ISO 80601-2-72:2015ISO 80601-2-72:

30、2015(E) This part of ISO 80601 does not specify the requirements for VENTILATORS or ACCESSORIES intended for 2 ISO 2015 All rights reservedanaesthetic applications, which are given in ISO 80601213. This part of ISO 80601 does not specify the requirements for VENTILATORS or ACCESSORIES intended for n

31、cemerge y and transport which are given in ISO 106513. NOTE 5 In the future, ISO 106513 is expected to be harmonized with IEC 606011:2005, at which time it will be replaced by ISO 806012xx. This part of ISO 80601 does not specify the requirements for VENTILATORS or ACCESSORIES intended for homecare

32、ventilatory support equipment (intended only to augment the ventilation of spontaneously g breathin PATIENTS), which are given in ISO 106516. NOTE 6 In the future, ISO 106516 is expected to be harmonized with IEC 606011:2005 and IEC 60601111:2015, at which time it will be replaced by ISO 806012xx. T

33、his part of ISO 80601 does not specify the requirements for obstructive sleep apnoea therapy ME EQUIPMENT, which are given in ISO 80601270.16This part of ISO 80601 is a particular International Standard in the IEC 606011 and ISO/IEC 80601 series of standards. 201.1.2 Object IEC 606011:2005+AMD1:2012

34、, 1.2 is replaced by: The object of this part of ISO 80601 is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for a VENTILATOR, as defined in 201.3.217, and its ACCESSORIES. NOTE ACCESSORIES are included because the combination of the VENTILATOR and the ACCESSORIES needs

35、to be adequately safe. ACCESSORIES can have a significant impact on the BASIC SAFETY or ESSENTIAL PERFORMANCE of a VENTILATOR. 201.1.3 Collateral standards IEC 606011:2005+AMD1:2012, 1.3 applies with the following addition: This part of ISO 80601 refers to those applicable colateral standards that a

36、re listed in se 2, as well as 201.2 of this part of ISO 80601. IEC 606011:2005+AMD1:2012, ClauIEC 6060113:2008 does not apply. 201.1.4 Particular standards IEC 606011:2005+AMD1:2012, 1.4 is replaced by: In the IEC 60601 series, particular standards can modify, replace, or delete requirements contain

37、ed in the general standard, including the collateral standards, as appropriate for the particular ENT EMEEQUIPMunder consideration, and may add other BASIC SAF TY or ESSENTIAL PERFORMANCE requirements. A requirement of a particular standard takes priority over IEC 606011:2005+AMD1:2012 or the collat

38、eral standards. For brevity, IEC 606011:2005+AMD1:2012 is referred to in this part of ISO 80601 as the general standard. Collateral standards are referred to by their document number. The numbering of clauses and subclauses of this part of ISO 80601 corresponds to those of the general standard with

39、the prefix “201” (e.g. 201.1 in this part of ISO 80601 addresses the content 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 addresses the content of IEC 6060112, Clause 4

40、 collateral standard, 208.4 addresses the content of IEC 6060118, Clause 4 collateral standard, etc.). The changes to the text of the general standard are specified by the use of the following words: BS EN ISO 80601-2-72:2015ISO 80601-2-72:2015(E) “Replacement” means that the clause or subclause of

41、IEC 606011:2005+AMD1:2012 or the xt o ISO 2015 All rights reserved 3and essential performance Cmedical electrical systems used applicable collateral standard is replaced completely by the te f this part of ISO 80601. “Addition” means that the text of this particular standard i s additional to the re

42、quirements of 0IEC 606011:20 5+AMD1:2012 or the applicable collateral standard. “Amendment” means that the clause or subclause of IEC 60601 1:2005+AMD1:2012 or the applicable collateral standard is amended as indicated by the text of this part of ISO 80601. Subclauses or figures that are additional

43、to those of the general standard are numbered starting from 201.101, additional annexes are 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 20x, where “x” is the number of the collateral

44、 standard, e.g. 202 for IEC 6060112, 203 for IEC 6060113, etc. The term “this standard” is used to make reference to IEC 606011:2005+AMD1:2012, any applicable collateral standards, and this part of ISO 80601 taken together. Where there is no corresponding clause or subclause in this part of ISO 8060

45、1, the clause or subclause of IEC 606011:2005+AMD1:2012 or the applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of IEC 606011:2005+AMD1:2012 or the applicable collateral standard, although possibly relevant, is not to be

46、 applied, a statement to that effect is given in this part of ISO 80601. 201.2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated c

47、esreferen , the latest edition of the referenced document (including any amendments) applies. NOTE 1 The way in which these referenced documents are cited in normative requirements determines the n wextent (i hole or in part) to which they apply. on page 81. NOTE 2 Informative references are listed

48、in the bibliography beginning IEC 606011: 005+AMD1:2012, Clause 2 applies, except as follows: 2Replacement: IEC 6060112:2014, Medical electrical equipment Part 1-2: General requirements for basic safety and Collateral standard: Electromagnetic disturbances Requirements and tests essential performanc

49、e IEC 6060116:20101, Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance Collateral standard: Usability +Amendment 1:2013 IEC 6060118:20062, 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 syste