ANSI ID54-1996 Enteral feeding set adapters and connectors.pdf

1、ANSI/AAMI ID54:1996/(R)2012Enteral feeding set adapters and connectorsAmerican National StandardAssociation for the Advancementof Medical Instrumentation1110 N. Glebe Rd., Suite 220Arlington, VA 22201-4795 2000 by the Association for the Advancement of Medical InstrumentationAll Rights ReservedCopyr

2、ight and PermissionsPublication, reproduction, photocopying, storage, or transmission, electronically or otherwise, of all or any part ofthese documents without the prior written permission of the Association for the Advancement of MedicalInstrumentation or the copyright holder (if not AAMI) is proh

3、ibited by law. It is illegal under federal law (17 U.S.C. 101, et seq.) to make copies of all or any part of these documents (whether internally or externally) without theprior written permission of the copyright holder. Violators risk legal action, including civil and criminal penalties,and damages

4、 of $100,000 per offense. For permission regarding the use of all or any part of these documents,contact AAMI, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax: (703)525-1067.Violators of this copyright policy should be reported to AAMIs legal counsel:McKenna “shou

5、ld” indicates that among several possibilities one is recommended as particularlysuitable, without mentioning or excluding others, or that a certain course of action is preferred but notnecessarily required, or that (in the negative form) a certain possibility or course of action should be avoided b

6、utis not prohibited; “may” is used to indicate a course of action is permissible within the limits of the standard;and “can” is used as a statement of possibility and capability. “Must” is used only to describe “unavoidable”situations, including those mandated by government regulation.Recommendation

7、s for improving this standard are invited. Comments and suggested revisions should be sent to:AAMI, 3330 Washington Boulevard, Suite 400, Arlington, VA 22201-4598.NOTEThis foreword is not a part of the American National Standard, Enteral feeding set connectors andadapters (ANSI/AAMI ID541996), but i

8、t does provide important information about the development andintended use of the document.Enteral feeding set connectors and adapters1 ScopeThis standard specifies safety requirements for enteral feeding set connectors and adapters.2 Normative referencesThe following documents contain provisions wh

9、ich, through reference in this text, constitute provisions of thisstandard. At the time of publication, the editions indicated were valid. All standards are subject to revision, andparties to agreements based on this standard are encouraged to use the most recent editions of the documentsindicated b

10、elow.2.1 AMERICAN NATIONAL STANDARDS INSTITUTE. Luer taper fittings and performance, ANSI/HIMAMD 70.11983. New York (NY): ANSI, 1983. (Withdrawn.)2.2 INTERNATIONAL ORGANIZATION FOR STANDARDIZATION. Conical fittings with a 6 percent(luer) taper for syringes, needles and certain other medical equipmen

11、tPart One: General requirements, ISO594/1, Geneva, Switzerland: ISO, 1986.2.3 INTERNATIONAL ORGANIZATION FOR STANDARDIZATION. Conical fittings with a 6 percent(luer) taper for syringes, needles and certain other medical equipmentPart Two: Lock fittings, ISO 594/2,Geneva, Switzerland: ISO, 1991.3 Def

12、initionsFor the purposes of this standard, the following definitions apply:3.1 adapter: Separate device, components, integrated fixtures, or other means or mechanisms, which permit afunctional connection between two incompatible devices.NOTEPresently, adapters that allow a functional connection betw

13、een enteral feeding sets and rigid female luer 2000 Association for the Advancement of Medical Instrumentationconnectors are sold, given away, or provided to users by original manufacturers or other (third) parties.3.2 compatible: Allowing a functional connection.3.3 connector: An integral component

14、 of the enteral feeding set that joins the set to the enteral access device.3.4 enteral feeding: Nutrition support for patients using liquids as a substitute for solid food that involvesdelivery of nutrient liquids into the alimentary tract (stomach, duodenum, or jejunum) using specializedtubesinclu

15、ding but not limited to nasoenteral, gastrostomy, jejunostomy, or oesophagostomy tubes. Feeding isadministered by an enteral pump or gravity.NOTEThe word “enteral“ specifically excludes delivery of liquids into an artery or vein.3.5 parenteral administration: Delivery of a specialized fluid or medic

16、ine specifically and only into a vein orartery; sometimes referred to as “IV” or “intravenous” delivery.3.6 set: A system that consists of tubing and other components through which fluids are delivered to either anenteral or parenteral access device.4 Requirements4.1 Elimination of adaptersAdapters

17、that are provided with, or for use with, enteral feeding sets shall not allow the direct or functionalconnection of an enteral feeding set to a rigid female luer connector. Examples of connections that shall not bepossible by use of an adapter include but are not limited to the following:a) enteral

18、feeding set to a parenteral administration set;b) enteral feeding set to an indwelling intravenous catheter or port;c) enteral feeding set to an epidural catheter;d) enteral feeding set to balloon inflation ports.4.2 Enteral feeding set connectorsEnteral feeding set connectors shall not be compatibl

19、e with rigid female luer connectors that meet ANSI/HIMAMD 70.11983, ISO 594/1, and/or ISO 594/2.5 TestsCompliance with 4.1 and 4.2 can be verified by inspection.Annex A(Informative)Rationale for the development and provisions of this standardThe purpose of enteral adapters is to provide a means to c

20、onnect enteral feeding sets to enteral access devices(e.g., jejunostomy tubes), which are constructed with rigid luer taper connectors that meet the AmericanNational Standard (now withdrawn), Luer taper fittings and performance (ANSI/HIMA MD 70.1-1983);International Standard Conical fittings with a

21、6 percent (luer) taper for syringes, needles and certain othermedical equipmentPart One: General requirements (ISO 594/1) and/or International Standard Conical fittingswith a 6 percent (luer) taper for syringes, needles and certain other medical equipmentPart Two: Lockfittings (ISO 594/2).Some enter

22、al access devices are constructed with rigid luer taper connectors, and one unintended consequenceof these adapters is that they provide a link between two unrelated systems, i.e., enteral to intravenous (IV). 2000 Association for the Advancement of Medical InstrumentationThese systems are intended

23、to have unique methods of delivery, with distinctly different purposes, which theseadapters can circumventpossibly resulting in harm or serious injury to the patient.In 1993, the AAMI Enteral Feeding Set Working Group began developing this standard in an effort to minimizethe possibility of potentia

24、lly harmful connections occurring between enteral feeding sets and indwelling IVports, catheters, peritoneal catheters, and tracheostomy tubes.It is intended that this standard will result in changes to the design of enteral feeding sets so that, within 6months, all new enteral feeding sets will be

25、incompatible with rigid IV female luers.In addition to encouraging manufacturers to eliminate the use of rigid female luer connectors on enteral feedingaccess devices, the working group hopes that this standard will help educate users about the potential risk topatients of using enteral adapters alr

26、eady in their facility.The ultimate goal is the prevention of any reasonable likelihood of connections between enteral feeding sets anddevices other than enteral access devices.In light of the serious risk involved, it was decided not to delay this functional standard for want of exactphysical and d

27、imensional specifications. However, the committee may eventually add dimensional requirementsand requests that manufacturers provide the working group, via the AAMI Standards Department, withinformation about physical dimensional requirements that they have developed and permission to use same in afuture edition of this standard. 2000 Association for the Advancement of Medical Instrumentation